DE102021212091A1 - Systems and methods for computer-aided verification, as well as positioning and position analysis of intraocular lenses - Google Patents

Abstract

An ophthalmic implant (10) is provided with at least one marker element (14), the at least one marker element (14) being designed to store information for machine identification and/or characterization of the ophthalmic implant (10) and information for machine determination of a to provide alignment of the ophthalmic implant (10). The marker element (14) is arranged in and/or on the ophthalmic implant (10) in such a way that the information for identifying and/or characterizing the ophthalmic implant (10) and/or the information for mechanically determining the alignment of the ophthalmic implant (10 ) can be read out by machine intraoperatively and/or postoperatively.

Description

An ophthalmic implant, a data storage unit for an ophthalmic implant, a use of a marker element of an ophthalmic implant, a method for machine identification of an ophthalmic implant and/or determination of an orientation and/or positioning of an ophthalmic implant, a planning device, a reading device are provided System for the mechanical support of an implantation of an ophthalmic implant, a method for the production of an intraocular lens, a computer program product, a computer-readable storage medium and a method for determining an eye position and/or eye movement. The embodiments are thus in particular in the field of ophthalmic implants, in particular intraocular lenses.

In conventional cataract surgery, the pathologically altered, usually cloudy, natural lens is extracted from the capsular bag through an incision in the cornea and replaced by an intraocular lens (IOL), which is inserted into the eye through the same incision and inserted into the capsular bag. Over the past few decades, cataract surgery has evolved from an implantation procedure solely to replace a clouded lens to a refractive procedure in which the implant both replaces the clouded natural lens and corrects any refractive error. This created a need for innovation with the aim of achieving the most perfect postoperative visual results possible. For the best visual result, the IOL should be aligned in the optimal position in the eye, i.e. perfectly centered, not tilted and toric exactly aligned, and have the correct depth position in the capsular bag.

The positioning and alignment of an IOL in the capsular bag is carried out by the surgeon and can be supported by computer-aided surgical systems such as Zeiss CALLISTO eye, Alcon ORA or Alcon VERION, or intraoperative imaging such as OCT for intraoperative guidance of the surgeon. These systems offer different functionalities specifically for the alignment of toric IOLs. A toric IOL is a lens that has two different refractive powers in two mutually perpendicular directions. Intraoperative OCT can provide visual control of IOL position and intraoperative wavefront aberrometry can verify refractive outcome.

However, the success of the precise positioning and/or alignment of the IOL is mainly based on the skills and dexterity of the surgeon, since conventional surgical systems offer no or only very rudimentary support in this regard. As a rule, the surgical systems are a "black box" for the surgeon, which is associated with a limited repeatability of the precision achieved. The reasons for the limited repeatability are in particular only implicit information about the IOL position from refractive wavefront measurements, limited precision due to varying surgical parameters and variations due to the presence of the patient's eye in an abnormal / unnatural state, and/or inefficiency due to multiple measurements.

Conventional computer-assisted surgery systems are not designed to reliably detect the IOL position. Corresponding markers on IOLs have so far only been available for toric IOLs. These conventional markings allow the surgeon to identify the toric axis of the IOL, which must then be manually aligned by the surgeon to the intended toric target axis. In many cases, the visibility of the markers is affected by the surgical conditions or the position of the IOL in the eye during the implantation process. Current markers are only optimized for visibility and recognizability by the surgeon and offer the possibility of adjusting the axis position of the toric axis.

It is therefore the task to facilitate the reliable implantation of an ophthalmic implant. In particular, the task may include enabling precise, reproducible and efficient IOL positioning across all skill levels of the surgeon (minimal learning curve).

The object is achieved by an ophthalmic implant, a data storage unit for an ophthalmic implant, use of a marker element of an ophthalmic implant, a method for mechanically determining an alignment and/or positioning of an ophthalmic implant, a planning device, a readout device, a system for mechanical support an implantation of an ophthalmic implant, a method for producing an intraocular lens, a computer program product, a computer-readable storage medium and a method for determining an eye position and/or eye movement with the features of the respective independent claim. Optional refinements are specified in the dependent claims and in the description.

A first embodiment relates to an ophthalmic implant with at least one marker element, wherein the at least one marker element is designed to provide information for machine identification and/or characterization of the ophthalmic implant and information for machine determination of an orientation of the ophthalmic implant. Furthermore, the marker element is arranged in and/or on the ophthalmic implant in such a way that the information for identifying and/or characterizing the ophthalmic implant and the information for mechanically determining the orientation of the ophthalmic implant can be read out by machine intraoperatively and/or postoperatively, i.e. in particular in one machine-readable state of the ophthalmic implant implanted in a patient's eye.

A further embodiment relates to a data storage unit for an ophthalmic implant, the data storage unit being designed to store information for machine identification and/or characterization of the ophthalmic implant in the form of electronically readable data. The data storage unit has such a spatial configuration and can be attached in and/or on the ophthalmic implant in such a way that the orientation of the ophthalmic implant can be determined based on a position and/or orientation of the data storage unit in and/or on the ophthalmic implant.

A further embodiment relates to the use of a marker element of an ophthalmic implant or for an ophthalmic implant to provide information for machine identification and/or characterization of the ophthalmic implant and for providing information for machine determination of an alignment of the ophthalmic implant.

A further embodiment relates to the use of a data storage unit for an ophthalmic implant to provide information for machine identification and/or characterization of the ophthalmic implant and for providing information for machine determination of an alignment of the ophthalmic implant.

A further embodiment relates to a method for mechanically determining an alignment of an ophthalmic implant with at least one marker element relative to a patient's eye to support an implantation operation. The method includes mechanical, optionally optical and/or electronic, detection of the marker element. In addition, the method includes mechanically determining a position and/or alignment of the marker element and mechanically determining a position and/or an alignment of at least part of the patient's eye. In addition, the method includes determining a position and/or orientation of the ophthalmic implant relative to the patient's eye based on the determined position and/or orientation of the marker element and the determined position and/or orientation of the at least part of the patient's eye, and outputting information about the Position and/or orientation of the ophthalmic implant relative to the patient's eye to a surgeon during implantation surgery.

Another embodiment relates to a system for exchanging information with an ophthalmic implant. The system includes a writing and/or reading device which is designed to read information for machine identification and/or characterization of the ophthalmic implant from a marker element arranged in and/or on the ophthalmic implant or to write the marker element with it. the writing and/or reading device is set up to optically detect the marker element for reading out the information and/or to set up a contactless electrical communication connection with the ophthalmic implant. In addition, the system has a computing unit which is designed to take a measure relating to the ophthalmic implant based on the information read out and/or to output a message to a user and/or based on measures taken and/or to be taken and/or based on a User input provided information to provide the information for machine identification and / or characterization of the ophthalmic implant to describe the marker element, therefore, for example, to plan a surgical intervention.

Another embodiment relates to a readout device for reading out information for machine identification and/or characterization of the ophthalmic implant from a marker element arranged in and/or on the ophthalmic implant, the readout device being set up to optically detect and read out the information from the marker element /or establish a contactless electrical communication connection with the ophthalmic implant.

A further embodiment relates to a system for mechanically assisting a user when implanting an ophthalmic implant in a patient's eye. The system includes an image capturing device for capturing images of at least part of the patient's eye and at least one marker element of the ophthalmic implant, as well as a computing unit unit which is set up to determine a relative position and/or alignment of the ophthalmic implant relative to the patient's eye based on the recorded images of the patient's eye and the marker element. In addition, the system includes an output unit which is set up to output information about the determined orientation of the ophthalmic implant relative to the patient's eye to a user.

Another embodiment relates to a method for producing an intraocular lens. The method includes providing an intraocular lens with at least one optical part and at least one haptic connected to the optical part. The method also includes arranging a marker element with information for machine identification and/or characterization of the ophthalmic implant at least partially in and/or on the optical part and/or in and/or on the at least one haptic such that in a patient's eye implanted state of the ophthalmic implant, the information for identifying and/or characterizing the ophthalmic implant can be read out by machine and information for mechanically determining the orientation of the ophthalmic implant using the marker element can be optically detected.

A further embodiment relates to a computer program product, comprising instructions which, when the program is executed by a computing unit, cause the computing unit to carry out a method according to an embodiment.

A further embodiment relates to a computer-readable storage medium, comprising instructions which, when the program is executed by a computing unit, cause the computing unit to carry out a method according to an embodiment.

A further embodiment relates to a method for determining an eye position and/or eye movement of an eye with an implanted ophthalmic implant, which has an optically and/or electronically detectable marker element. The method includes detecting the marker element of the ophthalmic implant of the eye, determining a position and/or movement of the marker element and determining the position and/or movement of the ophthalmic implant and/or the eye based on the determined position and/or movement of the marker element .

An ophthalmic implant is an implant which is suitable for implantation in an eye of a patient, in particular a human or animal eye. An ophthalmic implant can optionally be configured as an intraocular lens (IOL). The ophthalmic implant can have an optical part and a non-optical part, wherein the optical part can have a lens with a refractive and/or diffractive effect or can be designed as such. It can be essential that the optical part is optically transparent and that the light passing through is not deflected and/or reflected and/or absorbed by undesired influences. Alternatively or additionally, the ophthalmic implant may include a sensor to determine one or more parameters inside the eye, such as the internal pressure of the eye and/or a concentration of a substance such as sugar. The non-optical part can in particular have a haptic or be designed as such. The fact that the non-optical part is connected to the optical part means that there is mechanical contact between the optical and non-optical parts. Optionally, the optic and non-optic parts may be integrally formed together to form the ophthalmic implant. The fact that the non-optical part can alternatively be connected to the optical part means that the optical part can be assembled with the non-optical part, so that they are connected to one another after assembly. Some embodiments can be designed in such a way that assembling the ophthalmic implant includes connecting the optical and non-optical parts during the implantation process. For example, an ophthalmic implant can be in the form of a modular and/or multi-part IOL that is only assembled in the capsular bag, which involves connecting the optic and non-optic parts.

In this case, a marker element is an element which provides a marking of the ophthalmic implant. Accordingly, a marker element represents an information carrier firmly connected to the ophthalmic implant. The marker element can provide optically detectable information, such as a machine-readable character and/or a character recognizable to the human eye and/or a geometric shape, from which a information can be extracted. Within the scope of the present disclosure, a marker element represents a computer-readable marker element. In particular, the marker element can have a coded marker, for example in the form of a bar code, and/or an electronically readable data storage unit. The marker element can, for example, be applied to the ophthalmic implant and/or represent one or more characters incorporated therein and can be applied, for example, by printing and/or engraving on and/or in the ophthalmic implant be brought. Alternatively or additionally, the marker element can represent an independent element which can be introduced into the ophthalmic implant, for example by casting, and/or can be fastened to it, for example by gluing. In particular, a marker element can be present as an encoded marker or be referred to as such. A "coded marker" is a marking on or in the intraocular lens in which information can be stored/coded that can be made visible with imaging methods and can therefore also be "read" by interpreting the information obtained with the imaging methods become. This is possible, for example, by—in the preferred variant—a corresponding physical structure of the marking or a printed marking, ie a marking that can be recognized by differences in color (including fluorescence). Due to the fact that this information in the "coded marker" can be assigned to a precise position on or in the intraocular lens, the "coded markers" can also be used in a very simple manner for alignment processes or for checking an alignment and, in general, the correct one Position in the eye usable.

Information for machine identification and/or characterization of the ophthalmic implant is information that can be recorded by a machine, for example by an image recording device, and evaluated, for example by an image evaluation. The fact that this is possible by machine means that the information can be recorded and evaluated using purely machine means, without this necessarily requiring human intervention. In other words, the marker element is machine-readable, so that the information provided can be read out automatically. Likewise, the information for mechanically determining an alignment of the ophthalmic implant can be acquired using purely mechanical means, so that the alignment of the ophthalmic implant can be automatically acquired on the basis of the information.

The fact that the marker element is arranged in and/or on the ophthalmic implant means that the marker element can be partly or completely arranged and in particular attached to an outer surface of the ophthalmic implant and/or can be partly or completely integrated into the ophthalmic implant. For example, the marker element can be glued onto the ophthalmic implant. Alternatively, the marker element can be cast into the ophthalmic implant. A combination of both is also possible, with part of the marker element being cast into the ophthalmic implant, for example, and another part of the marker element being attached to an outer surface of the ophthalmic implant.

The fact that the information can be read out by machine means that the information provided by the marker element can be recorded by a machine system without the user or surgeon having to do anything. For example, a suitable machine system can have an image acquisition device, which can have a camera, for example, and a computing unit, by means of which the information can be optically acquired and evaluated by image evaluation.

A data storage unit is an electrical or electronic component or an arrangement of such, which can provide information in electronically readable form. In particular, electronic reading can enable the information to be read out without contact, without a reading device having to be in physical contact with the data storage unit. Rather, the data storage unit can be designed to provide the information using wireless connection technology, such as using WiFi, Bluetooth and/or using inductive transmission technology. Information can also optionally be stored contactlessly in the data storage unit. Optionally, the data storage unit can have an RFID element or be designed as such, which can be read and/or written to without contact using a suitable RFID reading and writing device.

A data storage unit can optionally also be referred to as an "electronic tag" and can represent an identifier on or in the ophthalmic implant, which contains information that is contactlessly written in electronic form in this unit, read again and - for information for which this has been approved - can be changed. Such a data storage unit can optionally contain RFID structures. The writing, reading and changing steps for information when using a data storage unit can be implemented very easily. To determine the position and/or orientation of the marker element, the data storage unit can have correspondingly shaped and/or precisely arranged antenna structures and/or several sub-units of the data storage units that are precisely positioned relative to one another and that provide access to position information through appropriate localization. In addition to these variants of position determination, however, a data storage unit in the form of an electronic chip can also be made visible and thus its precise position can also be used as a visual reference for positioning the ophthalmic implant.

Information in a coded marker can be created and/or written, for example, at the beginning of the manufacturing process of the ophthalmic implant and can then optionally be visualized and/or read out and/or interpreted over the entire lifetime of the ophthalmic implant. Information in a data storage unit can be created in the manufacturing process of the ophthalmic implant and can then optionally be read out contactlessly over the entire lifetime of the IOL, but can also be changed according to an optional embodiment if this should be necessary or desired, for example for the benefit of the patient. When using a marker element in the form of a coded marker as well as in the form of a data storage unit, adding and changing information in the manufacturing process, pre-operatively, intraoperatively and/or postoperatively is optional in a database (preferably in an electronic health record (EMR system) ) possible, to which optionally an ID stored in the coded marker or the data storage unit specific to the respective intraocular lens grants access.

A mechanical determination of an alignment of the ophthalmic implant is a determination of the position and/or orientation of the ophthalmic implant relative to the patient's eye or a part of the patient's eye during and/or after implantation in the patient's eye using mechanical means. In particular, this can be done by an image acquisition device and a computer-aided image analysis. The determined orientation of the ophthalmic implant can then be provided to the surgeon, for example by a suitable output device such as a computer display, to support the implantation operation. “Mechanically” means that the steps or the method can be carried out partially and/or fully automatically by a system and optionally the intervention of the surgeon is not required. In particular, the steps can be performed by a computerized system. In particular, the mechanical determination of an alignment of the ophthalmic implant can include an imaging method. An imaging method is used, for example, to detect the presence of a marker element and the data provided by the marker element under production, intra-operative and/or post-operative data can be reliably read. Alternatively or additionally, a data storage writing and/or reading method is used during the manufacture of the IOL, intra-operatively and/or post-operatively, in which the data storage unit can be used.

The object of the invention is also achieved by a marking unit and/or a planning and/or control unit and/or an evaluation unit which, together with corresponding imaging systems and/or data storage writing and/or reading systems, stores data on or in the intraocular lens marked or encoded, reads data, processes data and thus controls pending further steps in the life of an intraocular lens, as well as through appropriate methods for marking, planning, control and evaluation.

A reading device is a reading and/or writing device, by means of which information or data can be read from and/or written to a data storage unit of an ophthalmic implant. For example, this can be an RFID transceiver.

A computer program product can be in the form of a program code, for example, which is stored on a physical data carrier and/or can be downloaded via a network. A computer-readable storage medium can therefore be in the form of a physical data carrier or a storage unit on which a corresponding program code is stored.

A determination of an eye position and/or eye movement can be used in particular for eye tracking in order to trace any movements of the patient's eye. This can be advantageous in particular during follow-up care and/or in connection with another type of refractive surgical operation, in particular on the cornea, since movements of the patient's eye can necessitate any readjustment of an ophthalmic laser system. In special cases, of course, the cataract operation itself can also be supported with an ophthalmic laser system, in particular a femtosecond laser system.

The embodiments offer the advantage that a marker element and optionally a coded marker for ophthalmic implants is provided, by means of which an optical mechanical determination of an alignment of the ophthalmic implant and a machine identification and/or characterization of the ophthalmic implant is made possible intraoperatively and/or postoperatively. As a result, a computer-aided system, which can optionally use an image evaluation algorithm, the implantation process by providing information under be supported. In particular, this makes it possible to determine a positioning and/or orientation of the ophthalmic implant relative to the eye by machine and in particular with computer support and to support the surgeon during the implantation process by outputting corresponding information. This is made possible in particular by the fact that the marker element can be detected and read out by machine when the ophthalmic implant is implanted in a patient's eye.

Consequently, the embodiments offer the advantage that better clinical outcomes, such as better visual acuity, can be achieved through implantation. In particular, a more precise positioning of the ophthalmic implant in the eye with regard to several geometric degrees of freedom, such as rotation (toric IOL), inclination, and depth or the effective lens position (ELP), can thereby optionally be achieved. This can reduce variability in cataract surgery and allow surgeons to better standardize and optimize their surgical parameters. The risk of refractive "surprises" can also be reduced, since any user errors can be avoided through better instructions. For example, software encoded in a planning or control unit can be designed to provide the surgeon with information as to whether and, if so, how he can finely adjust the position and/or orientation of the ophthalmic implant in the eye in order to optimize the result.

The embodiments also offer the advantage of greater efficiency during alignment: the surgeon optionally receives immediate feedback when the ophthalmic implant is perfectly in the target position. This can help reassure the surgeon and optionally eliminate the need for multiple, time-consuming checks.

The embodiments also offer the advantage that a more efficient workflow can be achieved during the production of an intraocular lens or an ophthalmic implant, and before, during and/or after the implantation of the ophthalmic implant. The marker element can not only contain relevant information or data for the automatic identification, but can optionally also enable precise tracking of the position of the ophthalmic implant during the operation and during the healing process. Optionally, if required, an ophthalmic implant according to an embodiment can also facilitate realignment of the ophthalmic implant in the event of post-operative movements of the ophthalmic implant. The high level of identification reliability also supports processes associated with cataract surgery, such as re-ordering the ophthalmic implant.

In addition, the embodiments offer the advantage that the mechanical optical detection of the marker element and the determination of the information provided by the marker element is possible according to some embodiments using conventional image detection devices. For example, the image capturing device can have a conventional video camera system for optically capturing the marker element. This therefore offers the advantage that no cost-intensive additional hardware is required for determining the information provided by the marker.

Traditionally, OCT is not required in cataract surgery. An OCT system is also not required for the presently disclosed embodiments in order to determine a position and/or orientation of the ophthalmic implant relative to the patient's eye, although a combination with an OCT is possible according to optional embodiments.

The embodiments thus offer the advantage of significantly improving the quality that can be achieved in cataract surgery and aftercare through the use of marker elements in ophthalmic implants according to the embodiments and corresponding systems.

Optionally, the marker element is designed in such a way that the information provided by the marker element is visible or detectable both to the human eye and to a machine. This offers the advantage that they can be used by a system for machine support of an implantation and can also be used directly for orientation by a surgeon. Alternatively or additionally, the marker element is designed in such a way that the information can also be reliably recorded automatically under conditions when only part of the ophthalmic implant is visible, for example when the pupil of the patient's eye is small and the iris covers part of the ophthalmic implant . Alternatively or additionally, the marker element of an IOL can be optimized for illumination coaxial with the optical axis of the IOL in order to have a particularly high reflectivity and/or to be particularly easy to detect mechanically when the coaxial illumination is incident.

The marker element can be designed in one piece or in multiple pieces. One and the same part can contain both the information(s) for machine identification and/or characterization of the Provide ophthalmic implant, as well as the information (s) for mechanically determining an orientation of the ophthalmic implant. According to another optional embodiment, different parts of the marker element can provide the information for machine identification and/or characterization of the ophthalmic implant or the information for machine determination of an orientation of the ophthalmic implant.

Optionally, cataract surgery, at the end of which an IOL is implanted, may include capsulorhexis using a laser ophthalmic system to open the capsular bag of the lens of the eye. Optionally, further steps of a cataract operation can also be carried out using the ophthalmic laser system, preferably using a femsosecond laser system. In this case, two or more markings can be made in the eye using the laser, on which a toric IOL can then be aligned. Such markings can optionally also be used to determine a relative orientation of the ophthalmic implant and the patient's eye by means of the marker element.

The marker element is optionally arranged in and/or on the ophthalmic implant in such a way that it can only be detected optically when the pupil of the patient's eye is dilated. Typically, the diameter of the adult pupil is between 2mm and 4mm in bright light conditions and between 4mm and 8mm in low light conditions. However, the average pupil diameter can be influenced by the patient's age and refractive status in addition to the lighting conditions. A range in which the pupil diameter therefore typically lies extends from about 2.5 mm to about 6 mm. In particular, it can be advantageous to arrange the marker element outside of a central diameter of 4.4 mm, since this area is also prescribed for conventional toric markings by relevant ISO standards. Typically, IOLS have an overall diameter of the optical part of 5 mm to 6.5 mm. The marker element can optionally be placed in the peripheral area of the IOL, such as outside a 4.4 mm diameter of the central optic part, or the marker element can be extended to cover the entire optic part or the entire IOL.

This offers the advantage that the marker element does not impair the optical properties of the ophthalmic implant when the pupil is not artificially dilated and thus does not impair the patient's perception of vision. Nevertheless, the marker element is accessible or optically detectable if required when the pupil of the eye is dilated.

The marker element is optionally arranged in and/or on the ophthalmic implant in such a way that the information for identifying and/or characterizing the ophthalmic implant can also be read out by machine preoperatively and/or intraoperatively and/or during production of the ophthalmic implant and the information for machine determination the orientation of the ophthalmic implant is optically detectable. This offers the advantage that the information is provided over the entire service life of the ophthalmic implant and/or the patient and can be read out if necessary. Furthermore, this offers the advantage that the information carrier is permanently linked to the ophthalmic implant and accordingly can neither be lost nor assigned incorrectly. Optionally, this offers the advantage that an identification and/or characterization of the ophthalmic implant is made possible over the entire lifetime of the ophthalmic implant. The information provided by the marker element can optionally be used during manufacture, verification, packaging, delivery, preparation for implantation (preoperative), during implantation (intraoperative) and after the operation, for example during follow-up examinations (postoperative). This allows identification and/or characterization and optionally determination of the orientation of the ophthalmic implant relative to the patient's eye at any time. The embodiments also offer the advantage that post-operatively it is possible to check mechanically and without contact which ophthalmic implant has been implanted. This can be advantageous, for example, if corresponding proof of the identification and/or characterization of the ophthalmic implant is to be provided in a legal procedure, in the event of complaints and/or for quality management. Accordingly, the ophthalmic implant can optionally be designed in such a way that the information for identifying and/or characterizing the ophthalmic implant and the information for mechanically determining the orientation of the ophthalmic implant can be provided not only intraoperatively and/or postoperatively, but also preoperatively and/or or during a manufacturing and/or packaging process. The information can be read out electronically and/or optically.

The marker element optionally has a marking in the form of a machine-readable code, with the information for machine identification and/or characterization of the ophthalmic implant in the machine-readable code is saved. This offers the advantage that the information can be read from the marker element by means of a simple image evaluation. For example, the machine-readable code can have a serial number and/or other unique identification numbers, based on which the ophthalmic implant can be uniquely identified and/or characterized. Alternatively or additionally, the machine-readable code can provide one or more network addresses under which or which information about the ophthalmic implant can be provided. This offers the advantage that the information or amount of data to be provided in the marker element can be selected to be very small, while a significantly larger amount of data and a large amount of information can be provided under the network address. This also offers the advantage that the data stored on a data memory to be found at the network address can be expanded and/or updated in order to add any additional information about the implantation process and/or postoperative examinations. Alternatively or additionally, a size and/or position and/or orientation of the marking can provide the information for mechanically determining the orientation of the ophthalmic implant. This offers the advantage that a number of functions can be fulfilled by means of one marker element and the effort and costs for providing the marker element or marker elements can accordingly be kept low.

Optionally, the machine-readable code has or consists of a one-dimensional bar code and/or a two-dimensional matrix code and/or a three-dimensional matrix code. This offers the advantage that the machine-readable code can be provided in a particularly simple manner. For example, such a machine-readable code can be engraved or printed on the ophthalmic implant.

Optionally, the machine-readable code can have a grid of points. In this case, the dot pattern can have marking points, which can have a pseudo-random, irregular character. The point grid can optionally be arranged in the optical part or in the optically effective zone of the ophthalmic implant. The coded point grid can be constructed from the marking points in such a way that a virtual polar or Cartesian base grid is arranged on the optical part, so that this base grid can be used to describe sectors or cells of the same type, each with a defined base grid point of the sector or cell . A real marker point of the grid of points is arranged in each sector or in each cell in a position that is offset from the associated base grid point, with the offset in each sector or in each cell in one of four possible directions, of which preferably run two opposite each other, takes place and has a defined distance to the base grid point. This provides four states. A fifth state can be defined, for example, by the absence of a marker point at one of the four possibilities around a base grid point. Other states can also be provided by other distances and/or offset directions.

The marker element optionally comprises or consists of a data storage unit which is designed to provide the information for machine identification and/or characterization of the ophthalmic implant in the form of electronically readable data. This offers the advantage that a large amount of data can be provided by a marker element with very small spatial dimensions. In particular, this offers the advantage that the spatial dimensions of the marker element can be decoupled from the amount of data to be stored on it. For example, the marker element can have or consist of an RFID element. This offers the advantage that conventional RFID writing and reading devices can be used to write to and/or read from the marker element. In addition, this offers the advantage that no internal energy supply has to be provided in the marker element or in the patient's eye.

The data storage unit is optionally configured and arranged in and/or on the ophthalmic implant in such a way that the orientation of the ophthalmic implant can be determined based on a position and/or orientation of the data storage unit. This offers the advantage that the optically detectable properties of the data storage unit provide permanently stored information regarding the orientation of the ophthalmic implant and this information can then be used to determine the orientation and/or positioning of the ophthalmic implant relative to the patient's eye or a part thereof. This therefore offers the advantage that another part of the marker element, such as a marking, does not necessarily have to be provided in order to provide the information regarding the position or alignment of the ophthalmic implant.

Optionally, the method for mechanically determining an orientation of an ophthalmic implant is designed in such a way that determining the orientation of the ophthalmic implant is rela tive to the patient's eye is repeated several times and optionally carried out continuously. This offers the advantage that a continuous computer-assisted monitoring of the alignment and/or position of the ophthalmic implant relative to the patient's eye is made possible and the surgeon thereby receives real-time assistance during the implantation of the ophthalmic implant.

Optionally, the method also includes reading out information for machine identification and/or characterization of the ophthalmic implant from the marker element. This offers the advantage that the identification and/or characterization can also be automated and accordingly the risk of an incorrect and/or unsuitable implant being implanted in the patient's eye can be reduced. For example, the method can include issuing a warning to the surgeon if the identification and/or characterization comes to the conclusion that the implant intended for the implantation is not suitable and/or does not correspond to any stored specifications. Optionally, the marker element has or consists of a marking in the form of a machine-readable code. In this case, reading out the information for machine identification and/or characterization of the ophthalmic implant from the marker element can include reading out the information from the machine-readable code. The machine-readable code can have or consist of a one-dimensional bar code and/or a two-dimensional matrix code and/or a three-dimensional matrix code.

Optionally, the marker element includes or consists of a data storage unit. The reading out of information for machine identification and/or characterization of the ophthalmic implant can include an electronic readout of data from the data storage unit which have the information for machine identification and/or characterization of the ophthalmic implant. The mechanical determination of the position and/or alignment of the marker element relative to the ophthalmic implant can include determining a position and/or alignment of the data storage unit.

A system for the mechanical support of an implantation of an ophthalmic implant in a patient's eye can optionally be designed in such a way that the image acquisition device comprises a camera and optionally a microscope. This offers the possibility of reliably optically detecting even small structures of the marker element and/or small marker elements. Optionally, the microscope can be designed as a surgical microscope. This offers the advantage that a surgical microscope is often used anyway for the implantation of the implant and accordingly no further microscope has to be provided for the mechanical support of the implantation. Accordingly, the requirements for additional hardware to be provided for the system can be kept low.

The output unit of the system optionally has a display device, in particular a display. This offers the advantage that the information about the determined alignment of the ophthalmic implant relative to the patient's eye can be displayed to the surgeon in a simple and clearly visible manner.

The method for producing an IOL can be designed in such a way that the arrangement of the marker element includes the attachment of a machine-readable code, the machine-readable code optionally having or consisting of a one-dimensional bar code and/or a two-dimensional matrix code and/or a three-dimensional matrix code. This offers the advantage that the marker element can be provided particularly cost-effectively in and/or on the intraocular lens. This can also offer the advantage that the marker element can only be attached after the other production steps have been completed. In this way, for example, the marker element does not need to be attached if one or more previous manufacturing steps have led to a faulty IOL. It is also possible to take into account such information in the marker element that may not have been available in the previous production steps, for example information relating to the patient.

Alternatively or additionally, the arrangement of the marker element includes or consists of attaching a data storage unit which has the information for machine identification and/or characterization of the ophthalmic implant in the form of electronically readable data. This offers the advantage that a larger amount of data can optionally be stored on the data storage unit than on a machine-readable code. This also offers the option of expanding and/or changing the data stored on the data storage unit, if this is desired. For this purpose, for example, the data can be accessed using a read/write device. Optionally, the data storage unit can have an RFID element and the read/write device can be in the form of an RFID read/write device.

• 1) Ein Verwenden der bereitgestellten Information zur maschinellen Identifikation und/oder Charakterisierung zur Identifikation und/oder Charakterisierung während einer Herstellung und/oder Verpackung des ophthalmischen Implantats. Dies kann beispielsweise dazu dienen, um ab Anbringen des Markerelements in/oder an dem ophthalmischen Implantat eine lückenlose Nachverfolgbarkeit und/oder eine ständige Identifizierbarkeit des ophthalmischen Implantats zu ermöglichen. Insbesondere kann dies dahingehend vorteilhaft sein, dass die Richtigkeit einer Zuordnung von ophthalmischem Implantat und zugehöriger Verpackung und/oder von zugehörigen Dokumenten überprüft werden kann.
• 2) Ein Verwenden der bereitgestellten Information zur maschinellen Identifikation und/oder Charakterisierung präoperativ für eine Zuordnung und/oder Überprüfung einer Zuordnung des ophthalmischen Implantats zu einem Patientenauge. Dies kann etwa dazu dienen, unmittelbar vor der Implantation die korrekte Zuordnung des ophthalmischen Implantats zum Patientenauge sicherzustellen und das Risiko einer Implantation eines falschen ophthalmischen Implantats zu reduzieren.
• 3) Ein Verwenden der bereitgestellten Information zum maschinellen Ermitteln einer Position und/oder einer Ausrichtung des ophthalmischen Implantats intraoperativ für ein maschinelles Ermitteln der Ausrichtung des ophthalmischen Implantats relativ zum Patientenauge zur Unterstützung des Implantationsvorgangs. Dies kann die Ausrichtung des ophthalmischen Implantats relativ zum Patientenauge erleichtern und ein Risiko einer fehlerhaften Implantation reduzieren.
• 4) Ein Verwenden der bereitgestellten Information zum maschinellen Ermitteln einer Ausrichtung des ophthalmischen Implantats postoperativ für ein maschinelles Ermitteln und/oder Überprüfen der Ausrichtung des ophthalmischen Implantats relativ zum Patientenauge. Dies bietet den Vorteil, dass auch im Rahmen der Nachsorge und/oder bei auftretender subjektiver Unzufriedenheit des Patienten mit dem Implantationsergebnis ein Überprüfen der Ausrichtung des ophthalmischen Implantats relativ zum Patientenauge erfolgen kann und entsprechend ein Abgleich der Soll-Ausrichtung mit einer Ist-Ausrichtung maschinell vorgenommen werden kann.
• 5) Ein Verwenden der bereitgestellten Information zur postoperativen maschinellen Identifikation und/oder Charakterisierung zur Identifikation und/oder Charakterisierung des ophthalmischen Implantats und/oder zur Überprüfung einer Zuordnung des ophthalmischen Implantats zum Patientenauge, in welches das ophthalmische Implantat implantiert ist. Dies bietet die Möglichkeit, auch nach der Implantation das implantierte ophthalmische Implantat zweifelsfrei zu identifizieren und/oder zu charakterisieren und entsprechend eine Übereinstimmung oder Diskrepanz zwischen geplanter und tatsächlicher Implantation zu bestimmen. Dies kann insbesondere zum Überprüfen einer korrekten Implantation vorteilhaft sein, wenn die korrekte Implantation in Frage gestellt werden sollte.

A use of a marker element, ie a marking in the form of a machine-readable bare code and/or a data storage unit, can optionally include one or more of the following applications:

• 1) Using the machine identification and/or characterization information provided for identification and/or characterization during manufacture and/or packaging of the ophthalmic implant. This can be used, for example, to enable seamless traceability and/or constant identifiability of the ophthalmic implant from the time the marker element is attached in/or on the ophthalmic implant. In particular, this can be advantageous in that the correctness of an assignment of ophthalmic implant and associated packaging and/or associated documents can be checked.
• 2) Using the information provided for machine identification and/or characterization preoperatively for an assignment and/or verification of an assignment of the ophthalmic implant to a patient's eye. This can be used, for example, to ensure the correct assignment of the ophthalmic implant to the patient's eye immediately before implantation and to reduce the risk of implanting an incorrect ophthalmic implant.
• 3) Using the information provided to mechanically determine a position and/or an orientation of the ophthalmic implant intraoperatively for mechanically determining the orientation of the ophthalmic implant relative to the patient's eye to support the implantation process. This can facilitate alignment of the ophthalmic implant relative to the patient's eye and reduce a risk of incorrect implantation.
• 4) Using the information provided to mechanically determine an orientation of the ophthalmic implant post-operatively for mechanically determining and/or checking the orientation of the ophthalmic implant relative to the patient's eye. This offers the advantage that the alignment of the ophthalmic implant relative to the patient's eye can also be checked during aftercare and/or if the patient is subjectively dissatisfied with the implantation result, and the target alignment can be compared with an actual alignment by machine can be.
• 5) Using the information provided for postoperative machine identification and/or characterization to identify and/or characterize the ophthalmic implant and/or to check an assignment of the ophthalmic implant to the patient's eye in which the ophthalmic implant is implanted. This offers the possibility of unequivocally identifying and/or characterizing the implanted ophthalmic implant even after the implantation and of correspondingly determining a match or discrepancy between the planned and actual implantation. This can be advantageous in particular for checking correct implantation if correct implantation should be questioned.

The features and embodiments mentioned above and explained below are not only to be regarded as disclosed in the combinations explicitly mentioned in each case, but are also covered by the disclosure content in other technically sensible combinations and embodiments. In particular, features that are described with reference to one embodiment can also be implemented in other embodiments.

Further details and advantages will now be explained in more detail using the following examples and optional embodiments with reference to the figures, but without the embodiments being restricted to these.

• 1 eine schematische Darstellung einer Intraokularlinse mit einem Markerelement gemäß einer optionalen Ausführungsform;
• 2 eine schematische Darstellung einer Intraokularlinse mit einem Markerelement gemäß einer weiteren optionalen Ausführungsform;
• 3 eine beispielhafte Visualisierung einer IOL zur Unterstützung eines Implantationsvorgangs.
• 4 ein System zur maschinellen Unterstützung eines Benutzers bei einer Implantation eines ophthalmischen Implantats gemäß einer optionalen Ausführungsform.
• 5 zeigt ein System zum Informationsaustausch mit einem ophthalmischen Implantat gemäß einer optionalen Ausführungsform.
• 6 in einer schematischen Darstellung ein Zusammenwirken eines Markerelements eines ophthalmischen Implantats mit einer Schreib- und/oder Auslesevorrichtung und einer separaten Informationsquelle.
• 7 zeigt schematisch und beispielhaft in einem Flussdiagramm verschiedene optinoale Anwendungsfälle eines Markerelements eines ophthalmischen Implantats über die Lebensdauer des ophthalmischen Implantats

It shows:

• 1 a schematic representation of an intraocular lens with a marker element according to an optional embodiment;
• 2 a schematic representation of an intraocular lens with a marker element according to a further optional embodiment;
• 3 an exemplary visualization of an IOL to support an implantation process.
• 4 a system for mechanically assisting a user in an implantation of an ophthalmic implant according to an optional embodiment.
• 5 12 shows a system for exchanging information with an ophthalmic implant according to an optional embodiment.
• 6 in a schematic representation, an interaction of a marker element of an ophthalmic implant with a writing and/or reading device and a separate information source.
• 7 shows schematically and by way of example in a flow chart different optional applications of a marker element of an ophthalmic implant over the life of the ophthalmic implant

According to an optional embodiment, an ophthalmic implant 10 in the form of an intraocular lens 12 (IOL) is provided.

1 12 shows an optional embodiment of an ophthalmic implant 10 formed from an IOL 12. FIG. The IOL 12 has an optical part 12a, which is formed by a lens, and a non-optical part 12b, which has two haptics 12c. The IOL 12 also has a marker element 14 which provides machine-detectable information for identifying and/or characterizing the IOL 12 and also provides machine-detectable information about the positioning and/or orientation of the IOL 12 . In other words, the marker element 14 is machine-readable, so that the information provided by the marker element 14 can be extracted and evaluated by machine.

The marker element 14 comprises according to in 1 illustrated embodiment a coded marker 14a, which comprises a plurality of markings. The marker element 14a comprises a line and dot pattern running parallel to the diameter of the IOL 12, which on the one hand provides information regarding the position and/or orientation of the IOL due to its arrangement. For this purpose, for example, the line and dot pattern can be arranged in such a way that an axis position of a possible toric axis of the IOL 12 can be derived from it. On the other hand, information can be encoded by means of the arrangement of the lines and dots and/or their length, size and/or color, which information can be evaluated by a machine and correspondingly represents a machine-readable code 20 . For example, the information may be stored in the bar and dot pattern in the manner of a bar code, providing machine-readable information for identifying and/or characterizing the IOL 12 . In addition, the marker element of the IOL 12 can have other, additional markings, which are 1 are arranged, for example, as cross-shaped markings along the outer edge of the optical part 12a. These markings can be used, for example, to determine a center point and/or other geometric points and/or properties of the IOL 12 by machine. For example, the markings of the marker element 14 can be applied to the IOL 12 . This can be done, for example, by printing and/or engraving.

The marker element 14 and all associated markings are arranged on and/or in the IOL 12 in such a way that they do not interfere with the optical properties of the IOL 12 when it is typically used. In particular, the marker element can be arranged at the edge of the optical part in such a way that it is covered by the iris in a normal state of the patient's eye in the implanted state and accordingly does not impair the light entering the eye through the pupil. In order to make the marker element 14 accessible for optical detection even in the implanted state, the marker element 14 can be arranged in such a way that it can be at least partially optically detected when the pupil of the patient's eye is dilated by medication and allows the information provided to be extracted.

In 2 an ophthalmic implant 10 designed as an IOL 12 is shown according to an optional embodiment, in which the marker element 14 has a data storage unit 14b. The data storage unit 14b includes a chip 16 on which information in particular in the form of electronic data can be stored electronically. In addition, the data storage unit 14b has an antenna structure 18 which is connected to the chip 16 . The data storage unit 14b can be read and/or written to mechanically and optionally contactlessly using a suitable writing and reading device. For example, the data storage unit can be embodied as an RFID element and can accordingly be read out and written to in a contactless manner. The data stored in the chip 16 can in particular include information for identifying and/or characterizing the IOL 12 . Furthermore, the antenna structure 18 can be arranged in and/or on the IOL in such a way that it can be optically detected by a machine when the pupil is dilated and can be used for positioning and/or orienting the IOL 12 relative to the patient's eye. For example, the antenna structure can be designed and arranged in such a way that the center point of the optical part 12a of the IOL 12 can be derived from it.

Also, according to an optional embodiment, a system is provided for mechanically assisting implantation of an ophthalmic implant, such as the IOL 12, that assists the surgeon in IOL positioning. In particular, the procedure provides the surgeon with immediate intraoperative feedback to optimize IOL positioning. The IOL has a marker element 14 which, according to the optional embodiment shown, is designed as a coded marker on the intraocular lens 12 . The marker element 14 not only enables the IOL to be reliably identified by information provided by the marker element mation, but also determining the position and/or orientation of the marker element, based on which the position and/or orientation of the IOL relative to the patient's eye can be derived during the operation. The information provided by the marker element opens up new possibilities for computer-aided optimization of IOL positioning. Additionally or alternatively, the marker element can have one or more data storage units 14b, each with at least one corresponding antenna structure 18, which are capable of providing information about the position and/or orientation of the IOL. In addition to these variants of position determination, however, a data storage unit in the form of an electronic chip can also be made visually visible and its precise position can therefore also be used as a visual reference for positioning and/or aligning the IOL.

The systems and methods of the explained optional embodiments are described here for a corresponding intraocular lens 12 that is provided with a marker element that has a coded marker and/or a data storage unit. According to further optional embodiments, however, other ophthalmic implants that can be positioned in the eye are also included in the disclosure, such as a capsular tension ring, stents and ICLs (implantable contact lenses), which are provided with a marker element according to the same or a similar principle and can be positioned accordingly .

According to an optional embodiment, the coded marker on an intraocular lens 12 is formed by a machine-readable pattern or a machine-readable code 20 . Such a pattern is optionally recognizable under different types of lighting, e.g. B., but not limited to standard white light illumination, fluorescent illumination, laser illumination, etc. The encoded marker is positioned on an IOL 12 so that it is detectable during surgical implantation and optionally also after the operation. Optionally, the coded marker is positioned at the periphery of an optical part 12a of the IOL, which is usually accessible by means of a dilated pupil (see an exemplary embodiment in Fig 1 ).

The marker element 14 contains information such as specification data of the individual ophthalmic implant 10 (in the case of an IOL e.g. diopter, type, manufacturer, model, material, toric axis). However, the specification data can also be represented by a unique identifier that enables the data to be retrieved from a database.

In addition, the marker element 14 represents information about geometric data of the individual implant, which enables a computer-assisted detection of its position and/or orientation. Due to the encoded nature of the marker element, even a subset of recognized features of an encoded marker can provide useful information to enable reliable positioning and/or alignment of an IOL 12 in the patient's eye. The marker element 14 optionally contains means for error detection, error tolerance and, ideally, for error correction.

In general, a marker element on an IOL 12 can have any type of visually recognizable encoded information that provides the functionality described above. Examples of encoding types include (i) standard codes such as linear barcodes or matrix (2D) barcodes including dot code, QR code, or (ii) advanced codes such as 3D matrix codes. Machine-readable codes can vary in the number, size or width of the (individual) elements (e.g. pixels or bars of a barcode), the overall code size, the spacing between the elements and/or the orientation of the elements within the code. With regard to specific configurations of marker elements or data storage units on an intraocular lens, reference is made to other documents by the applicant, the content of which is to be included here by reference: DE 10 2020 214 126 , DE 10 2021 206 092 , DE 10 2021 206 093 and DE 10 2021 121 166 .

• (i) Assistenzfunktionen für eine intraoperative Positionierung von IOLs während einer Kataraktoperation basierend auf Markerelementen, deren Positionen detektierbar sind. Sofern das Markerelement eine Datenspeichereinheit umfasst kann beispielsweise das optische Erfassen der Information zur Positionierung und/oder Ausrichtung eine visuelle Detektion eines elektronischen Chips und/oder einer Antennenstruktur oder eines Teils davon umfassen.
• (ii) Analyse- und Visualisierungsfunktionen einer IOL-Position nach einer Kataraktoperation basierend auf einem kodierten IOL-Marker bzw. ggf Datenspeichereinheiten mit Antennenstrukturen bzw. mehreren Datenspeicherteileinheiten eines Markerelements, deren Positionen detektierbar sind, bzw. durch visuelle Detektion eines elektronischen Chips, den die Datenspeichereinheit umfasst.

Such marker elements can offer the following advantages, for example:

• (i) Assistance functions for intraoperative positioning of IOLs during cataract surgery based on marker elements whose positions can be detected. If the marker element comprises a data storage unit, for example, the optical detection of the information for positioning and/or alignment can comprise a visual detection of an electronic chip and/or an antenna structure or a part thereof.
• (ii) Analysis and visualization functions of an IOL position after cataract surgery based on a coded IOL marker or possibly data storage units with antenna structures or several data storage sub-units of a marker element whose positions can be detected, or by visual detection of an electronic chip that the Includes data storage unit.

• - Auslesen, Visualisieren und/oder Dokumentieren von IOL-Daten;
• - Überprüfung, Identifizierung und/oder Bestätigung einer Übereinstimmung der tatsächlichen IOL mit der für die Implantation vorgesehenen IOL;
• - Assistenz zur torischen Ausrichtung einer IOL, d.h. zur Ausrichtung der Zylinderachse einer torischen IOL;
• - optional: Assistenz zur:
  • • Zentrierpositionierung einer IOL;
  • • Kipp- bzw. Neigungs-Positionierung einer IOL;
  • • Tiefenpositionierung einer IOL (entlang der optischen Achse des Patientenauges)
  • • Assistenz für das Einstellen eines Bildgebungsfokus und/oder einer Zoomsteuerung eines Bilderfassungssystems.

The use of a marker element enables the provision of IOL design specification data (incl. IOL geometry) and actual IOL position data. Based on the data provided by the marker element, the following functionalities can be enabled:

• - Reading, visualizing and/or documenting IOL data;
• - Verification, identification and/or confirmation of a match of the actual IOL with the IOL intended for implantation;
• - Assistance for toric alignment of an IOL, ie alignment of the cylinder axis of a toric IOL;
• - optional: Assistance to:
  • • center positioning of an IOL;
  • • tilt or tilt positioning of an IOL;
  • • Depth positioning of an IOL (along the optical axis of the patient's eye)
  • • Assistance for setting an imaging focus and/or a zoom control of an image acquisition system.

By using a marker element on the IOL optics, i.e. on an optical part of the IOL, the functionalities mentioned above are available during the intra- and post-operative workflows. Conventional systems for computer-aided surgery do not offer any assistance and in particular no comprehensive instructions for the exact alignment of the IOL to the planned target position in the patient's eye (usually only the rotation and centering target for the IOL are displayed) or are even a "black box" whose exact function is different beyond the knowledge of the surgeon and therefore offer only a very limited repeatability for the surgeon. In particular, only implicit information about the IOL position relative to the patient's eye is conventionally provided by refractive wavefront measurements, on the basis of which only limited precision can be achieved because of varying surgical parameters and the unnatural state in which the patient's eye is due to fixation during the Operation is located, the setting of exactly the same parameters in different implantation processes is typically not possible. Conventional solutions therefore support the pre-implantation stage and an early phase of implantation. However, the conventional methods cannot reliably be carried out in a computer-aided manner, especially when the IOL is implanted in a patient's eye: This shortcoming of the conventional methods is overcome by using a machine-detectable marker element with an encoded marker and/or a data storage unit according to the present disclosure.

Ophthalmic implants and systems for mechanically supporting an implantation of such an ophthalmic implant can have different features and offer different functions in different optional embodiments.

• - ein ophthalmisches Implantat mit zumindest einem Markerelement, das eine Information zur maschinellen Identifikation und/oder Charakterisierung des ophthalmischen Implantats und eine Information zum maschinellen Ermitteln einer Ausrichtung des ophthalmischen Implantats bereitstellt. Das Markerelement kann dazu einen kodierten Marker und/oder eine Datenspeichereinheit aufweisen, welche intra- und postoperativ sichtbar und detektierbar sind, d.h. optisch erfassbar sind, und zumindest eine Fehlererkennung ermöglichen;
• - ein bildgebendes Verfahren, um das Vorhandensein des Markerelements zu erkennen und die vom Markerelement bereitgestellten Daten unter Herstellungs-, pre-operativen, intra-operativen und/oder post-operativen Bildgebungsbedingungen zuverlässig zu erfassen, und optional entsprechende Verfahren zum Beschreiben, Auslesen, Bewerten und/oder Ändern der Daten, welche durch das Markerelement bereitgestellt werden (bspw. von einer Datenspeichereinheit);

• - eine Anwendungssoftware, welche beispielsweise dazu ausgelegt ist, die mit dem bildgebenden Verfahren erfassten Bilddaten vom Markerelement auszuwerten und die vom Markerelement bereitgestellten Informationen auszuwerten;
• - ein Computersystem zum Importieren von Daten, Exportieren von Daten, Berechnen und/oder Verarbeiten von Daten, welche mit den ausgewerteten Daten verglichen werden können;
• - Mittel, um Ergebnisse zu kommunizieren und dem Anwender, bspw. dem Chirurgen, ein Feedback zu geben, z.B. in visueller, auditiver und/oder haptischer Form. Beispielsweise können diese Mittel eine Ausgabeeinheit umfassen, welche bspw. ein Display umfassen kann.

Some optional embodiments have at least the following features:

• - An ophthalmic implant with at least one marker element that provides information for machine identification and/or characterization of the ophthalmic implant and information for machine determination of an orientation of the ophthalmic implant. For this purpose, the marker element can have a coded marker and/or a data storage unit, which are visible and detectable intraoperatively and postoperatively, ie can be detected optically, and enable at least error detection;
• - an imaging method to detect the presence of the marker element and to reliably record the data provided by the marker element under manufacturing, pre-operative, intra-operative and/or post-operative imaging conditions, and optionally corresponding methods for describing, reading out, evaluating and/or changing the data provided by the marker element (e.g. from a data storage unit);

• - an application software which is designed, for example, to evaluate the image data captured by the imaging method from the marker element and to evaluate the information provided by the marker element;
• - a computer system for importing data, exporting data, calculating and/or processing data, which can be compared with the evaluated data;
• Means for communicating results and for giving the user, for example the surgeon, feedback, for example in visual, auditory and/or haptic form. For example, these means can include an output unit, which can include a display, for example.

• - eine derartige Ausgestaltung und/oder Positionierung des Markerelements, anhand welcher die tatsächliche Positionierung und/oder Ausrichtung der IOL ermittelbar sind (z. B. Zentrum, physischer Rand, torische Achse, eindeutiges visuelles Identifikationsmuster);
• - durch das Markerelement bereitgestellte Informationen, die eine Spezifikation des IOL-Designs darstellen und/oder den Zugriff darauf ermöglichen (d. h. bspw. geometrische Abmessungen, Zentrum, Rand);
• - Referenzdaten, die eine Biometrie, Geometrie und/oder Eigenschaften des Patientenauges spezifizieren;
• - optional: Operationsplanungsdaten für die IOL-Positionierung und/oder Ausrichtung (bspw. Zielrefraktion, torische Achse, etc.).

According to an optional embodiment, the system can also check a allow intra-operative IOL positioning and/or alignment and post-operative IOL position analysis. To this end, the system may also include the following elements:

• - Such a configuration and/or positioning of the marker element, based on which the actual positioning and/or alignment of the IOL can be determined (e.g. center, physical edge, toric axis, clear visual identification pattern);
• - information provided by the marker element representing and/or providing access to a specification of the IOL design (eg, geometric dimensions, center, edge);
• - reference data specifying biometrics, geometry and/or properties of the patient's eye;
• - optional: operation planning data for IOL positioning and/or alignment (e.g. target refraction, toric axis, etc.).

• - ein Bereitstellen von Informationen durch bzw, über das Markerelement, beispielsweise in Form von kodierter Daten, die eine IOL-Identifikation der implantierten Intraokularlinse darstellen und/oder den Zugriff auf zugehörige Daten, die anderswo gespeichert sind, ermöglichen;
• - ein Bereitstellen von Informationen durch bzw. über das Markerelement, welche Operationsplanungsdaten aufweisen, die die IOL-Identifikation der geplanten Intraokularlinse enthalten (z. B. Kataraktplaner oder Anbindung an ein EMR-System, also einer Elektronischen Gesundheitsakte).

In order to enable intraoperative characterization and/or identification of the IOL, i.e. to check the correct presence of the intended IOL before and/or during implantation, it can also be advantageous if the system has the following features:

• - a provision of information by or via the marker element, for example in the form of encoded data representing an IOL identification of the implanted intraocular lens and/or enabling access to associated data stored elsewhere;
• - A provision of information through or via the marker element, which have operation planning data that contain the IOL identification of the planned intraocular lens (z. B. cataract planner or connection to an EMR system, ie an electronic health record).

• - Informationen zur Spezifikation des IOL-Designs in den kodierten Daten; insbesondere einen Schlüssel bzw. Informationen zur eindeutigen IOL-Identifikation;
• - Erkennbarkeit des Markerelements mittels OCT-Bildgebung, sodass mittels der OCT-Bildgebung eine visuelle Überprüfung und/oder eine Plausibilitätsprüfung der IOL-Positionierung und/oder Ausrichtung erfolgen kann. Alternativ oder zusätzlich kann zur Überprüfung und/oder Plausibilitätsprüfung der Positionierung und/oder Ausrichtung der IOL eine Wellenfrontmessung durchgeführt werden. Dies kann auch zur Optimierung des refraktiven Ergebnisses dienen.

Furthermore, the data provided by the marker element can optionally have the following information and the properties of the marker element can be designed as follows:

• - IOL design specification information in the encoded data; in particular a key or information for unique IOL identification;
• - Recognizability of the marker element by means of OCT imaging, so that a visual check and/or a plausibility check of the IOL positioning and/or orientation can be carried out by means of OCT imaging. Alternatively or additionally, a wavefront measurement can be carried out to check and/or plausibility check of the positioning and/or alignment of the IOL. This can also serve to optimize the refractive result.

The data content of the marker element, ie for example the encoded marker and/or the data storage unit, can vary depending on the application or depending on the optional embodiment. Different coding techniques and/or designs of the coded marker and/or different configurations of the data storage unit and in particular of antenna structures of the data storage unit can also be possible. Readout techniques for determining the information provided by the marker element can also vary between different embodiments. These can include, for example, an imaging method for detecting the presence of a coded marker and for reliably reading out the data from the coded marker and/or a method for contactless electronic detection and for reading out the data storage unit.

The embodiments thus offer the advantage that more machine-readable information about the IOL can be provided and/or used in the intraocular lens manufacturing process, the preoperative, intraoperative and/or postoperative workflow. Thereby, new, additional lens positioning functionalities can be provided in addition to the existing toric lens implantation and existing steps of a conventional implantation procedure (e.g. toric alignment, lens confirmation) can be simplified and/or made more reliable and robust.

Some of the features enabled by this invention for positioning and/or alignment (centering, tilting, depth) and/or verification of an ophthalmic implant may be beneficial in the implantation of both toric and non-toric IOLs.

• Das System und das Verfahren können insbesondere zur computergestützten IOL-Datenverarbeitung und IOL-Positionierung während einer Kataraktchirurgie basierend auf zumindest einem Markerelement ausgelegt sein.

A system and a method for mechanically supporting an implantation of an ophthalmic implant in a patient's eye according to an optional embodiment are explained below:

• The system and the method can be designed in particular for computer-aided IOL data processing and IOL positioning during cataract surgery based on at least one marker element.

For this purpose, a system for recognizing and identifying marker elements, in particular coded IOL markers, is provided. It will further provided methods for data processing, visualization, documentation, IOL identification and IOL positioning based on the encoded IOL marker.

• - ein ophthalmisches Visualisierungssystem (z. B. ein Operationsmikroskop)
• - eine Bilderfassungseinrichtung, wie etwa ein Kamerasystem;
• - eine Anwendungssoftware für die Auswertung von Informationen zur
  • (i) IOL-Datenverarbeitung, Visualisierung, Dokumentation,
  • (ii) IOL-Positionierung,
  • (iii) IOL-Bestätigung bzw. Identifizierung, und
  • (iv) Verwaltung von Operationsdaten einschließlich Planungsdaten;
• - ein Computersystem zum Importieren von Daten, Exportieren von Daten, Berechnen und Verarbeiten von Daten;
• - Mittel zur Kommunikation von Ergebnissen und zur Präsentation von Rückmeldungen an den Anwender bzw. Chirurgen, z. B. in visueller, auditiver und/oder haptischer Form
• - optional: eine IOL-Datenbank, die Implantatspezifikationen enthält;
• - optional: eine Bildgebungs-/Meßmodalität, wie etwa OCT oder Wellenfront-Aberrometrie;
• - optional: eine angeschlossene elektronische Patientenakte (EMR) mit Informationen über den Patienten, seinen Augenzustand und den Operationsplan.

The system is used to support an implantation of an ophthalmic implant (eg IOL) with a machine-detectable marker element which has a coded marking (a coded marker). The system includes

• - an ophthalmic visualization system (e.g. a surgical microscope)
• - an image capture device, such as a camera system;
• - an application software for the evaluation of information on
  • (i) IOL data processing, visualization, documentation,
  • (ii) IOL positioning,
  • (iii) IOL confirmation or identification, and
  • (iv) management of operational data including planning data;
• - a computer system for importing data, exporting data, calculating and processing data;
• - Means for communicating results and for presenting feedback to the user or surgeon, e.g. B. in visual, auditory and / or haptic form
• - optional: an IOL database containing implant specifications;
• - optional: an imaging/measurement modality such as OCT or wavefront aberrometry;
• - optional: a connected electronic patient record (EMR) with information about the patient, his eye condition and the operation plan.

• - Auslesen, Visualisieren und Dokumentieren von IOL-Daten aus dem Markerelement;
• - optional: Rückmeldung des Vergleichs der tatsächlichen IOL mit der vorgesehenen IOL;
• - optional: Assistent zur:
  • • torischen Ausrichtung einer IOL
  • • Zentrierpositionierung einer IOL
  • • Kipp-Positionierung einer IOL
  • • Tiefenpositionierung einer IOL
  • • Einstellung des bildgebenden Fokus- und/oder Steuerung des Zooms
• - Optional: Automatisierte Geschäftsprozesse, die durch das zuverlässige Auslesen der IOL ermöglicht werden, wie z. B. eine automatische IOL-Nachbestellung.

The system is designed to enable the following functionalities:

• - Reading, visualization and documentation of IOL data from the marker element;
• - optional: feedback of the comparison of the actual IOL with the intended IOL;
• - optional: assistant for:
  • • Toric alignment of an IOL
  • • Center positioning of an IOL
  • • Tilting positioning of an IOL
  • • Depth positioning of an IOL
  • • Adjustment of imaging focus and/or zoom control
• - Optional: Automated business processes that are made possible by the reliable reading of the IOL, such as B. an automatic IOL reorder.

The assistants for supporting the positioning and/or alignment of the IOL, i.e. for toric, centering, tilting and/or depth positioning of an IOL, are designed in such a way that the surgeon can efficiently assess/evaluate the result of the IOL implantation. Visual and/or audible feedback is available during alignment to indicate if the result is within the planned or best practice parameter range.

If the marker element or marker elements includes a data storage unit as an alternative or in addition to coded markers, then the system requires a writing and/or reading device for reading out the information from the data storage unit. If the data storage unit is used instead of the coded markers and if positioning functions are to be used, then specially designed antenna structures and/or a specially designed data storage unit and/or a number of sub-units of the data storage unit that are precisely positioned relative to one another must be used to determine the positioning and/or alignment of the ophthalmic implant .

According to other optional embodiments, a data storage unit in the form of an electronic chip can be made visually visible and its precise location can thus also be used as a visual reference for positioning and/or aligning the IOL.

1. a) Auslesen, Visualisierung und Dokumentation der IOL-Daten:
   • Anhand des kodierten Markers bzw. der Datenspeichereinheit des Markerelements kann das System das Vorhandensein des Markers bzw. der Datenspeichereinheit erkennen und
     • - die vom Markerelement bereitgestellten Daten (ggf. einschließlich der Positionsinformationen) der IOL auslesen oder ggf. die Implantatspezifikation aus der IOL-Datenbank importieren;
     • - eine Fehlererkennung / -korrektur für die kodierten Daten anwenden;
     • - dem Anwender die IOL-Daten in textueller oder grafischer Form visualisieren,
     • - die IOL-Daten in elektronischer Form dokumentieren.
2. b) Bestätigung der tatsächlichen IOL und Vergleich mit der geplanten IOL:
   • Das System verwendet ein bildgebendes Verfahren oder ein elektronisches Ausleseverfahren, um die aus dem kodierten Marker bzw. der Datenspeichereinheit abgeleiteten IOL-Konstruktionsspezifikation zu importieren oder zu extrahieren. Basierend auf der IOL-Design-Spezifikation aus dem kodierten Marker bzw. der Datenspeichereinheit und/oder der IOL-Datenbank, und der gemäß Operationsplan vorgesehenen Intraokularlinse aus dem Operationsplan generiert das System eine elektronische Ausgabe einer Information für den Chirurgen bzw. Anwender, die angibt, dass entweder die richtige IOL zur Implantation ausgewählt wurde (IOL-Bestätigung) oder, dass eine falsche IOL zur Implantation ausgewählt wurde (IOL-Fehlanpassung). Im Falle einer IOL-Bestätigung gibt das System dem Anwender eine Meldung aus, dass die IOL bestätigt wurde. Im Falle einer IOL-Fehlanpassung gibt das System dem Benutzer eine Warnung aus und fordert eine Überprüfung der ausgewählten und geplanten IOL.
3. c) Assistent zur torischen Ausrichtung einer IOL:
   • Das System nutzt ein bildgebendes Verfahren, um die torische Achse der IOL aus einer durch das Markerelement, insbesondere aus einer durch den kodierten Marker, bereitgestellten Information zu extrahieren. Alternativ oder zusätzlich nutzt das System ein Lesegerät, um die entsprechenden Daten kontaktlos aus der Datenspeichereinheit des Markerelements, die in diesem Fall so ausgestaltet ist, dass eine Positionsdetektion ermöglicht wird, auszulesen. Ein in der Datenspeichereinheit enthaltender elektronischer Chip kann bzgl. seiner präzisen Lage alternativ auch visuell erfasst werden. Basierend auf
     • - den Referenzdaten, die die Biometrie, Geometrie und Eigenschaften des Auges spezifizieren (optional einschließlich Femtosekundenlaser-Kapselmarkierungen), und
     • - der torischen Achse der IOL

erzeugt das System eine i.d.R. elektronische Ausgabe einer Information an den Anwender, um die korrekte Ausrichtung einer torischen IOL zu steuern. Das System gibt dem Anwender eine direkte Rückmeldung, z. B. visuell (wie als Beispiel in der 3 dargestellt) und/oder akustisch.The functionalities of such an optional embodiment are described in detail below.

1. a) Reading, visualization and documentation of the IOL data:
   • Using the encoded marker or the data storage unit of the marker element, the system can recognize the presence of the marker or the data storage unit and
     • - read out the data provided by the marker element (possibly including the position information) of the IOL or, if necessary, import the implant specification from the IOL database;
     • - apply an error detection/correction to the encoded data;
     • - visualize the IOL data for the user in textual or graphic form,
     • - document the IOL data in electronic form.
2. b) Confirmation of the actual IOL and comparison with the planned IOL:
   • The system uses an imaging method or an electronic readout method to import or extract the IOL design specification derived from the encoded marker or data storage device. Based on the IOL design specification from the coded marker or the data storage unit and/or the IOL database, and the intraocular lens provided according to the operation plan from the operation plan, the system generates an electronic output of information for the surgeon or user that indicates that either the correct IOL was selected for implantation (IOL confirmation) or that an incorrect IOL was selected for implantation (IOL mismatch). In the case of an IOL confirmation, the system provides the user with a message that the IOL has been confirmed. In the event of an IOL misfit, the system will warn the user and request a review of the selected and planned IOL.
3. c) IOL Toric Alignment Wizard:
   • The system uses an imaging method to extract the toric axis of the IOL from information provided by the marker element, in particular from information provided by the encoded marker. Alternatively or additionally, the system uses a reading device in order to read out the corresponding data without contact from the data storage unit of the marker element, which in this case is designed in such a way that position detection is made possible. Alternatively, an electronic chip contained in the data storage unit can also be detected visually with regard to its precise position. Based on
     • - the reference data specifying the biometrics, geometry and properties of the eye (optionally including femtosecond laser capsule markings), and
     • - the toric axis of the IOL

the system generates information that is usually electronically output to the user in order to control the correct alignment of a toric IOL. The system gives the user direct feedback, e.g. B. visually (as an example in the 3 shown) and/or acoustically.

3 FIG. 12 illustrates an example visualization of an IOL 12 such as may be displayed to a surgeon to aid in the implantation process. The orientation and position of the toric axis of the IOL 12 is determined automatically using the information provided by the marker element 14 and is displayed as the axis 1000 together with a visualization of the IOL 12 . Also indicated with visualized arrows 1002 is a direction of rotation along which the IOL 12 is to be rotated to bring the toric axis 1000 of the IOL 12 into alignment with the axis position of the astigmatism axis 1004 of the patient's eye. The astigmatism axis 1004 is also visualized for visual assistance.

A special feature is that the data of the coded marker or the data storage unit provide the physical position of the toric axis of the IOL within the surgical scene and at least provide error detection that ensures that the system provides the information that the marker element regarding the toric axis provides , correctly recognized.

4 12 shows a system 30 for mechanically assisting a user with an implantation of an ophthalmic implant according to an optional embodiment. The system 30 has a surgical microscope 32 which is used when an ophthalmic implant 10 is implanted in a patient's eye 34 . The patient's eye 34 is symbolically shown lying on a patient bed 36, although in actual use the patient's eye 34 naturally forms part of the patient (not shown). The surgical microscope 32 serves as an image acquisition device for acquiring images of at least part of the patient's eye 34 and at least one marker element 14 of the ophthalmic implant 10 during the implantation process in which the ophthalmic implant 10 is implanted in the patient's eye 34 .

In addition, the system 30 has a computing unit 38, which is connected to the image acquisition device, i.e. to the surgical microscope 32, and is set up to use the acquired images of the patient's eye 34 and the marker element 14 to determine a relative alignment of the ophthalmic implant 10 relative to the patient's eye 34 to determine. For example, the arithmetic unit 38 can be embodied as a control unit and/or as a computer or can include one(s).

Furthermore, the system 30 has an output unit 40 which is set up to output information about the determined alignment of the ophthalmic implant 10 relative to the patient's eye 34 to a user. For this purpose, the output unit 40 can have corresponding output elements in order to output a visual and/or acoustic and/or haptic signal to the user. For example, the output unit 40 can have one or more screens or displays for image output and/or have one or more loudspeakers for audio output. For example, the system 30 can be set up in such a way that, to support the user during the implantation process, the output unit 40 provides a relative alignment of the ophthalmic implant 10 relative to the patient's eye 34 and/or instructions for reducing any deviation of the target alignment from the actual alignment be issued.

In addition, the system 30 can be set up to read out information for identifying and/or characterizing the ophthalmic implant 10 from the marker element 14 . For this purpose, for example, an identification number can be read out from the marker element, by means of which the ophthalmic implant 10 can be uniquely identified preoperatively and/or intraoperatively. The system 30 can optionally be set up to compare the information for identification and/or characterization provided by the marker element 14 with corresponding information from an electronic patient file and in this way to check the correctness of the assignment. In this case, the user can optionally be informed that the correct ophthalmic implant 10 is being used or a warning that the information read out for identification and/or characterization does not match the information provided in the patient file or otherwise. Optionally, the information for identification and/or characterization can be provided directly by the marker element 14 . Alternatively or additionally, the information provided by the marker element 14 can specify a storage location at which the desired information can be called up, for example a server or network address. The system 30 can also be set up, for example, to place and/or suggest a repeat order for the ophthalmic implant 10 used in order to maintain any inventory.

5 12 shows a system 42 for exchanging information with an ophthalmic implant 10 according to an optional embodiment. The system 42 is embodied as a diagnostic system and allows a patient's eye 34 to be diagnosed or measured. For example, the system 42 can have a wavefront aberrometer and/or an autorefractometer and/or a keratometer or be embodied as such. The system 42 is also set up to enable information to be exchanged with an ophthalmic implant of a patient's eye 34 to be diagnosed. For this purpose, the system 42 has a writing and reading device 44, which is designed to read information for the machine identification and/or characterization of the ophthalmic implant 10 from a marker element 14 arranged in and/or on the ophthalmic implant 10 or the To describe marker element 14 with such information. The writing and/or reading device is set up in particular to optically detect the marker element 14 for reading out the information and/or writing and/or to set up a contactless electrical communication connection with the ophthalmic implant 10 . A computing unit 38 connected to the writing and reading device 44 is designed to evaluate the information read out and/or to provide the information for writing to the marker element 10 . For example, evaluating the information that has been read out can include retrieving associated information from a separate information source, for example from a server that provides information for the ophthalmic implant identified by the data that has been read out. The marker element and/or a separate information source 46 (see 6 ) Information about the implantation process is provided, for example the time of the implantation and any peculiarities and/or complications and/or information about previous diagnoses. The system 42 also includes an output unit 40 in order to be able to output information to the user. For example, the output unit 40 can have one or more displays in order to visually present information to the user. Alternatively or additionally, the output unit 40 can have one or more loudspeakers in order to output an acoustic signal. Optionally, the output unit 40 can also be designed to output a haptic signal.

6 shows a schematic representation of the interaction of a marker element 14 of an ophthalmic implant 10 with a writing and/or reading device 44 and a separate information source 46. The writing and/or reading device 44 represents an interface which enables the separate Information source 46 to retrieve information characterizing the ophthalmic implant 10 . For this purpose, the marker element 14 can provide information for identifying the ophthalmic implant 10, such as a unique manufacturer number and/or identification number, which can be read from the marker element 14 without contact by the writing and/or reading device 44. Alternatively or In addition, the marker element can provide one or more additional information, which can be used to retrieve the associated information from the separate data source 46, such as a network address and/or access data to the stored information. The writing and/or reading device 46 can be integrated into another system, such as a diagnostic system and/or a surgical microscope. The system and in particular the writing and/or reading device 44 are connected directly or indirectly to the separate information source 46, for example via a computing unit. For example, the connection can be via a computer network, such as a local area network and/or the Internet. Optionally, the separate information source can be in the form of a data cloud, which is provided, for example, by the manufacturer of the system and/or the manufacturer of the ophthalmic implant and/or third parties. The separate information source 46 can also optionally be an electronic patient file, which is provided locally in a clinic and/or a doctor's practice and/or is maintained by a health authority. Such embodiments offer the advantage that information in the form of data can be provided both on the marker element 14 and on a separate information source 46 . In particular, the separate information source 46 can be designed in such a way that much larger amounts of data and information can be provided there than is possible on a marker element 14 . A separate information source 46 can also offer the possibility that the information stored there can be adjusted and/or supplemented and/or expanded and/or updated. In some optional embodiments, information that is stored on the marker element 14, in particular on a data storage unit 14b, can also be adjusted and/or supplemented and/or expanded and/or updated.

• Anwendungsfall 102: Während der Herstellung des ophthalmsichen Implantats 10 kann die Information zur Identifizierung und/oder Charakterisierung genutzt werden, um das ophthalmische Implantat 10 eindeutig zu identifizieren und eine Verwechslung auszuschließen. Außerdem kann die Information zum maschinellen Ermitteln einer Ausrichtung des ophthalmischen Implantats 10 dazu genutzt werden, das ophthalmsiche Implantat 10 bei der Bearbeitung korrekt zu positionieren und/oder orientieren.
• Anwendungsfall 104: Während der Logistik kann die Information zur Identifikation und/oder Charakterisierung dazu verwendet werden, das ophthalmische Implantat 10 mit der korrekten zugehörigen Verpackung und/oder Dokumentation zu versehen und/oder das ophthalmische Implantat 10 dem korrekten Vertriebsweg zuzuführen. Die Gefahr einer falschen Zuordnung von ophthalmischem Implantat 10 und Verpackung und/oder ein falsches Ausliefern an einen nicht bestimmungsgemäßen Empfänger kann dadurch reduziert werden.
• Die Anwendungsfälle 106 bis 110 können insbesondere in einer Klinik 200 und/oder in einer Praxis, in welchen Implantationen derartiger ophthalmischer Implantate vorgenommen werden, auftreten.
• Anwendungsfall 106: Präoperativ kann etwa die Information zur Identifikation und/oder Charakterisierung des ophthalmischen Implantats 10 dazu genutzt werden, um eine korrekte Zuordnung des ophthalmischen Implantats 10 zum vorgesehenen Patientenauge 34 zu erreichen und/oder diese zu überprüfen. Dadurch kann die Gefahr einer Verwechslung bzw. einer falschen Zuordnung reduziert werden und der Benutzer erhält eine Hilfestellung bei der Überprüfung der korrekten Zuordnung.
• Anwendungsfall 108: Intraoperativ kann insbesondere die Information zum maschinellen Ermitteln der Ausrichtung des ophthalmischen Implantats 10 dazu genutzt werden, um maschinell eine relative Ausrichtung des ophthalmischen Implantats zum Patientenauge zu ermitteln und dadurch dem Benutzer bzw. Chirurgen eine Hilfestellung bei der Positionierung und/oder Orientierung des ophthalmischen Implantats 10 zu bieten. Auch kann optional die Information zur Identifkation und/oder Charakterisierung genutzt werden, um korrekte Zuordnung des ophthalmischen Implantats 10 und dessen Eigenschaften zum Patientenauge 34 gegebenenfalls nochmals überprüfen zu können. Auch kann optional eine Information zur Identifikation und/der Charakterisierung auf dem Markerelement 14 abgespeichert und/oder geändert werden. Beispielsweise kann ein Zeitpunkt, wie etwa ein Datum der Implantation, auf dem Markerelement abgespeichert werden.
• Anwendungsfall 110: Postoperativ können die Informationen genutzt werden, um nach Abschluss der Implantation das Implantationsergebnis zu überprüfen. Beispielsweise kann anhand der Information zur maschinellen Identifikation und/oder Charakterisierung überprüft werden, ob das vorgesehene ophthalmische Implantat 10 implantiert wurde. Alternativ oder zusätzlich kann anhand der Information zur Identifikation und/oder Charakterisierung des ophthalmischen Implantats 10 die Position und/oder Orientierung des ophthalmsichen Implantats im Patientenauge überprüft werden und mögliche Abweichungen erkannt werden.
• Anwendungsfall 112: Auch bei der Nachsorge, etwa in regelmäßigen Untersuchungen lange nach der Implantation, können die Informationen genutzt werden, um das ophthalmische Implantat 10 zu identifizieren und/oder zu charakterisieren und/oder desen Ausrichtung zu überprüfen. Beispielsweise kann anhand der Information zur maschinellen Identifikation und/oer Charakterisierung überprüft werden, welches ophthalmische Implantat 10 implantiert wurde und welche Eigenschaften dieses aufweist. Alternativ oder zusätzlich kann anhand der Information zur Identifikation und/oder Charakterisierung des ophthalmischen Implantats 10 die Position und/oder Orientierung des ophthalmsichen Implantats 10 im Patientenauge 34 überprüft werden und mögliche Abweichungen und/oder Änderungen über die Zeit erkannt werden. Optional können die Informationen auch für mögliche Reklamationen und/oder eine Qualitätskontrolle herangezogen werden.

7 shows schematically and by way of example in a flowchart 100 various optional applications of a marker element 14 of an ophthalmic implant 10 over the life of the ophthalmic implant, which information for machine identification and / or characterization of the ophthalmic implant 10 and information for machine determination of an alignment of the ophthalmic implant 10 provides. The following use cases may apply:

• Application 102: During the manufacture of the ophthalmic implant 10, the information for identification and/or characterization can be used in order to uniquely identify the ophthalmic implant 10 and to rule out confusion. In addition, the information for mechanically determining an orientation of the ophthalmic implant 10 can be used to correctly position and/or orient the ophthalmic implant 10 during processing.
• Use Case 104: During logistics, the identification and/or characterization information may be used to provide the ophthalmic implant 10 with the correct associated packaging and/or documentation and/or to route the ophthalmic implant 10 to the correct distribution channel. The risk of an incorrect assignment of ophthalmic implant 10 and packaging and/or incorrect delivery to an incorrect recipient can be reduced as a result.
• The applications 106 to 110 can occur in particular in a clinic 200 and/or in a practice in which implantations of such ophthalmic implants are carried out.
• Application 106: Preoperatively, the information for identifying and/or characterizing the ophthalmic implant 10 can be used to achieve a correct assignment of the ophthalmic implant 10 to the intended patient's eye 34 and/or to check this. As a result, the risk of confusion or incorrect assignment can be reduced and the user receives assistance in checking the correct assignment.
• Use case 108: In particular, the information for mechanically determining the alignment of the ophthalmic implant 10 can be used intraoperatively to mechanically determine a relative alignment of the ophthalmic implant to the patient's eye and thereby provide the user or surgeon with assistance in positioning and/or orienting the ophthalmic implant 10 to offer. The information can also optionally be used for identification and/or characterization in order to be able to check the correct assignment of the ophthalmic implant 10 and its properties to the patient's eye 34 again, if necessary. Information for identification and/or characterization can also optionally be stored and/or changed on the marker element 14 . For example, a point in time, such as the date of the implantation, can be stored on the marker element.
• Use case 110: Postoperatively, the information can be used to check the implantation result after the implantation has been completed. For example, can based on the information for machine identification and/or characterization, it can be checked whether the intended ophthalmic implant 10 has been implanted. Alternatively or additionally, the position and/or orientation of the ophthalmic implant in the patient's eye can be checked and possible deviations can be detected using the information for identifying and/or characterizing the ophthalmic implant 10 .
• Use case 112: The information can also be used during follow-up care, for example in regular examinations long after implantation, in order to identify and/or characterize the ophthalmic implant 10 and/or to check its alignment. For example, the information for machine identification and/or characterization can be used to check which ophthalmic implant 10 was implanted and what properties it has. Alternatively or additionally, the position and/or orientation of the ophthalmic implant 10 in the patient's eye 34 can be checked using the information for identifying and/or characterizing the ophthalmic implant 10 and possible deviations and/or changes over time can be detected. Optionally, the information can also be used for possible complaints and/or quality control.

Further optional embodiments are described below.

According to an optional embodiment, the method and the system provide an assistance for center positioning of an IOL. The system uses an imaging technique to recognize the actual position data (i.e. center, toric axis, physical edge) of the IOL based on the coded marker. Alternatively or additionally, the system uses a reading device in order to read out the corresponding data without contact from the data storage unit, which in this case is designed in such a way that a position detection is made possible. Alternatively, an electronic chip of the marker element contained in the data storage unit can also be detected visually with regard to its precise position, provided it is positioned in a corresponding area of the optical part of the IOL. In addition, the reader imports the IOL design specification (i.e. geometric dimensions, center, edge) from a separate information source, such as a server, or extracts it from the encoded marker or data storage unit.

• - den Referenzdaten, die die Biometrie, Geometrie und Eigenschaften des Auges spezifizieren und
• - der IOL-Design-Spezifikation und der tatsächlichen IOL-Positionsdaten

erzeugt das System eine elektronische Ausgabe von Informationen für den Anwender, um die korrekte Zentrierung einer IOL zu indizieren. Das System gibt dem Anwender eine direkte Rückmeldung, z. B. visuell und/oder auditiv. Eine Besonderheit darin, dass die Daten des kodierten Markers und/oder der Datenspeichereinheit die physische Position des IOL-Randes und des IOL-Zentrums innerhalb der Operationsszene liefern und zumindest eine Fehlererkennung bieten, die sicherstellt, dass das System das IOL-Zentrum korrekt erkennt.Based on

• - the reference data specifying the biometrics, geometry and characteristics of the eye and
• - the IOL design specification and the actual IOL position data

the system generates an electronic output of information for the user to indicate the correct centering of an IOL. The system gives the user direct feedback, e.g. B. visual and / or auditory. A special feature in that the data of the encoded marker and/or the data storage unit provide the physical position of the IOL edge and the IOL center within the surgical scene and at least provide an error detection that ensures that the system recognizes the IOL center correctly.

• - der IOL-Designspezifikation und den tatsächlichen IOL-Positionsdaten,
• - den optischen Parametern aus der Beobachtung mittels des Mikroskops und/oder der Kamera,
• - optional: aus präoperativen Referenzdaten oder intraoperativen Messdaten, die die Biometrie und Geometrie des Patientenauges spezifizieren (z. B. Referenzkoordinatensystem),

erzeugt das System eine elektronische Ausgabe, um die korrekte Einstellung einer Verkippung bzw. Neigung der Intraokularlinse zu steuern. Das System gibt dem Anwender eine direkte Rückmeldung, z.B. visuell und/oder auditiv. Eine Besonderheit besteht darin, dass die Daten des kodierten Markers die physikalische Position der IOL innerhalb der Operationsszene liefern und zumindest eine Fehlererkennung bieten, die sicherstellt, dass das System die IOL korrekt erkennt.According to a further optional embodiment, the method and the system offer assistance for tilting the positioning or alignment of an IOL. The system preferably uses an imaging method to identify the actual position data (ie center, physical edge) of the IOL using the coded marker. In addition, it imports the IOL design specification (ie geometric dimensions, center, edge) from a separate information source such as a server or extracts it from the encoded marker. Based on

• - the IOL design specification and the actual IOL position data,
• - the optical parameters from the observation using the microscope and/or the camera,
• - optional: from preoperative reference data or intraoperative measurement data that specify the biometrics and geometry of the patient's eye (e.g. reference coordinate system),

the system generates an electronic output to control the correct adjustment of a tilt of the intraocular lens. The system gives the user direct feedback, eg visual and/or auditory. A special feature is that the coded marker data provides the physical position of the IOL within the surgical scene and at least provides an error detection that ensures that the system correctly recognizes the IOL.

Alternatively or additionally, the system uses a reading device to read out the corresponding data from the data storage unit, which in this case is designed in such a way that position detection is made possible. Alternatively, an electronic chip contained in the data storage unit can also be detected visually with regard to its precise position, as long as it is positioned in a corresponding area of the optical part of the IOL.

According to a further optional embodiment, the system and the method offer an assistance for depth positioning of an IOL.

The system uses an imaging technique to detect the actual position data (i.e. center, physical edge, unique visual identification pattern) of the IOL from the encoded marker. In addition, it imports the IOL design specification (i.e. geometric dimensions, center, edge) from a separate information source, such as a server, and/or extracts it from the encoded marker.

• - den Referenzdaten, die die Biometrie, Geometrie und Eigenschaften des Patientenauges spezifizieren;
• - der IOL-Design-Spezifikation und der tatsächlichen IOL-Positionsdaten;
• - den optischen Parametern aus der Beobachtung des Patientenauges und des ophthalmischen Implantats mittels eines Mikroskops und/oder einer Kamera

erzeugt das System eine elektronische Ausgabe einer Information für den Anwender, die Tiefeninformationen über die IOL liefert.Based on

• - the reference data specifying the biometrics, geometry and properties of the patient's eye;
• - the IOL design specification and the actual IOL position data;
• - the optical parameters from the observation of the patient's eye and the ophthalmic implant by means of a microscope and/or a camera

the system generates an electronic output of information to the user providing depth information about the IOL.

Alternatively or additionally, the system uses a reading device in order to read out the corresponding data without contact from the data storage unit, which in this case is designed in such a way that a position detection is made possible. Alternatively, an electronic chip contained in the data storage unit can also be detected visually with regard to its precise position.

According to an optional embodiment, the system and method provide imaging focus and/or zoom control adjustment.

The system uses an imaging technique to detect the actual position data (i.e. center, physical rim, toric axis, unique visual identification pattern) of the IOL from the encoded marker. In addition, it imports the IOL design specification (i.e., geometric dimensions, center, edge) from another information source, such as a server, and/or extracts it from the encoded marker.

• - der Kenntnis von Struktur und Inhalt des kodierten Markers,
• - den Ergebnissen der Bilderkennung bzw. Detektion des kodierten Markers,
• - den optischen Parametern aus der Beobachtung mittels des Mikroskops und/oder der Kamera,

kann das System den Bildfokus und/oder den Zoom steuern bzw. einstellen, um die implantierte IOL bestmöglich darzustellen.Based on

• - knowledge of the structure and content of the encoded marker,
• - the results of the image recognition or detection of the coded marker,
• - the optical parameters from the observation using the microscope and/or the camera,

the system can control or adjust the image focus and/or the zoom in order to display the implanted IOL in the best possible way.

A system and method for analyzing IOL position after cataract surgery based on encoded IOL markers according to an optional embodiment is described below.

A system for recognizing and identifying coded IOL markers or a data storage unit in medical diagnostic devices is provided. Methods for data processing, visualization and identification of the IOL orientation based on encoded IOL markers or a data storage unit are also described.

• - ein ophthalmologisches Implantat (z.B. eine IOL) mit einem Markerelement, insbesondere einem kodierten Marker und/oder einer Datenspeichereinheit;
• - ein optisches Auslesegerät, um die Information vom Markerelement auszulesen. Das Auslesegerät kann etwa als ein medizinisches Diagnosegerät ausgebildet sein (z. B. Spaltlampe, biometrisches Gerät, Autorefraktor, Retroillumination). Alternativ oder zusätzlich kann das System ein separates Lesegerät nutzen, um die entsprechenden Daten kontaktlos aus der Datenspeichereinheit auszulesen.
• - optional eine Bilderfassungseinrichtung, insbesondere ein Kamerasystem;
• - eine Anwendungssoftware für (i) Datenverarbeitung und Visualisierung der vom Markerelement bereitgestellten Informationen und (ii) zur Positionserkennung des ophthalmischen Implantats auf Basis der vom Markerlemenet bereigestellten Informationen;
• - optional: eine IOL-Datenbank mit Implantatspezifikation, welche einen Teil des Systems bilden kann oder separat vom System bereitgestellt werden kann, etwa auf einem Server, der über ein Netzwerk erreichbar ist;
• - optional: eine angeschlossene elektronische Patientenakte (EMR) mit Informationen über den Patienten und/oder die Operationsergebnisse, wobei es die elektronische Patientenakte optional ermöglicht, Ergebnisse der vom System durchgeführten Positionsanalyse zu speichern.

The system includes:

• - an ophthalmological implant (eg an IOL) with a marker element, in particular a coded marker and/or a data storage unit;
• - an optical reader to read the information from the marker element. The read-out device can be embodied as a medical diagnostic device (e.g. slit lamp, biometric device, autorefractor, retro-illumination). Alternatively or additionally, the system can use a separate reading device to read out the corresponding data from the data storage unit without contact.
• - optionally an image acquisition device, in particular a camera system;
• - an application software for (i) data processing and visualization of the information provided by the marker element and (ii) for position detection of the ophthalmic implant based on the information provided by the marker element;
• - optional: an IOL database with implant specification, which may form part of the system or may be provided separately from the system, such as on a server accessible over a network;
• - optional: a connected Electronic Medical Record (EMR) with information about the patient and/or the results of the operation, with the electronic patient record optionally making it possible to store the results of the position analysis carried out by the system.

• - Auslesen und Visualisieren zumindest eines Teils der vom Markerelement bereitgestellten Informationen;
• - optional: Unterstützung des Chirurgen bei einer Analyse der torischen IOL-Ausrichtung einschließlich Änderungen im Zeitverlauf;
• - optional: Unterstützung des Chirurgen bei der Analyse der
  • • Zentrierpositionierung einer IOL;
  • • Kipp- bzw. Neigungspositionierung bzw. Ausrichtung einer IOL;
  • • Tiefenpositionierung einer IOL;
• - optional: Analyse von Veränderungen der IOL-Positionierung bzw. Ausrichtung über die Zeit (z. B. über den Heilungsprozess).

The system is designed to enable the following functionalities:

• - Reading out and visualizing at least part of the information provided by the marker element;
• - optional: assisting the surgeon in an analysis of the toric IOL alignment including changes over time;
• - optional: assisting the surgeon in analyzing the
  • • center positioning of an IOL;
  • • tilting or tilting positioning or orientation of an IOL;
  • • depth positioning of an IOL;
• - optional: analysis of changes in IOL positioning or alignment over time (e.g. over the healing process).

The post-operative option to read and visualize the data provided by the marker element, also referred to as IOL data throughout the disclosure, allows the surgeon to verify and/or confirm that the correct intraocular lens (IOL) has been implanted. It can also be used as a legal argument in the event of a liability claim, for example to provide evidence that the intended ophthalmic implant was implanted correctly or that the wrong implant was implanted and/or that an implantation was incorrect in some other way. The IOL toric, centering, tilting and depth positioning wizards are designed to allow the surgeon to efficiently assess and/or evaluate the postoperative outcome of IOL implantation. The surgeon can also use these wizards to view the results, e.g. B. to track the rotational stability of toric IOLs in individual patients over time. Additionally, the wizards can be used while the surgeon adjusts the IOL alignment postoperatively if further IOL alignment is required.

The functionalities are described in detail below.

a) Reading and visualization of the IOL data

• - die IOL-Designspezifikation (d.h. geometrische Abmessungen, Zentrum, Rand) aus dem Markerelement zu extrahieren und/oder aus einer Datenbank zu importieren;
• - die Fehlererkennung / -korrektur für die kodierten Daten anzuwenden;
• - dem Anwender bzw. Chirurgen die IOL-Daten in textueller und/oder grafischer Form zu visualisieren.

The system uses an imaging technique to detect the presence of the marker element and

• - extract the IOL design specification (ie geometric dimensions, center, edge) from the marker element and/or import it from a database;
• - apply error detection/correction to the encoded data;
• - to visualize the IOL data in textual and/or graphical form for the user or surgeon.

The system provides the user with information identifying and/or characterizing the implanted intraocular lens that can be used to verify and/or confirm that the correct IOL has been implanted or to specify the implant. Alternatively, the system uses a reading device to read out the corresponding data from a data storage unit of the marker element.

b) Toric IOL alignment analysis wizard including changes over time

• - Referenzdaten, die die Biometrie, Geometrie und Eigenschaften des Auges spezifizieren;
• - der torische Achse der IOL; und/oder
• - einem Operationsplan / bzw. -bericht

generiert das System eine elektronische Ausgabe, um dem Anwender einen Grad der torischen IOL-Achsenfehlstellung (Delta der tatsächlichen IOL-Ausrichtung gegenüber einer Referenz-IOL-Ausrichtung) zu liefern. Optional können die Analyseergebnisse in der EMR dokumentiert werden.The system uses an imaging technique to extract the toric axis of the IOL, which is derivable from the marker element. Based on the

• - reference data specifying the biometrics, geometry and properties of the eye;
• - the toric axis of the IOL; and or
• - an operation plan / or report

the system generates an electronic output to provide the user with a degree of toric IOL off-axis (delta of actual IOL alignment versus a reference IOL alignment). Optionally, the analysis results can be documented in the EMR.

Alternatively, the system uses a reading device in order to read out the corresponding data without contact from a data storage unit of the marker element, which in this case is designed in such a way that position detection is made possible. Alternatively, an electronic chip contained in the data storage unit can also be detected visually with regard to its precise position and can be used to determine the position and/or orientation of the ophthalmic implant.

c) IOL center alignment analysis wizard

The system uses an imaging technique to acquire the actual position data (ie, center, physical rim, toric axis, unique visual identification pattern) of the IOL recognizable by the marker element. In addition, it imports or extracts the IOL design specification (i.e. geometric dimensions, center, edge) from the marker element.

• - Referenzdaten, die die Biometrie, Geometrie und Eigenschaften des Auges spezifizieren;
• - der IOL-Designspezifikation;
• - der tatsächlichen IOL-Positionsdaten, die von dem kodierten Marker abgeleitet werden;

erzeugt das System eine i.d.R. elektronische Ausgabe, um dem Anwender einen Grad der IOL-Dezentrierung, d.h. einen Grad einer Abweichung der tatsächlichen Position und/oder Ausrichtung von einer vorgesehenen Position und/oder Ausrichtung der IOL relativ zum Patientenauge, zu liefern. Optional können die Analyseergebnisse in der EMR dokumentiert werden.Based on the

• - reference data specifying the biometrics, geometry and characteristics of the eye;
• - the IOL design specification;
• - the actual IOL position data derived from the encoded marker;

the system generates an output, usually electronic, to provide the user with a degree of IOL decentering, ie a degree of deviation of the actual position and/or orientation from an intended position and/or orientation of the IOL relative to the patient's eye. Optionally, the analysis results can be documented in the EMR.

Alternatively, the system uses a reading device to read out the relevant data without contact from the data storage unit of the marker element, which in this case is designed in such a way that position detection is made possible. Alternatively, an electronic chip contained in the data storage unit can also be detected visually with regard to its precise position.

d) Wizard to analyze tilting orientation of an IOL

The system uses an imaging technique to detect the actual position data and/or orientation (i.e. center, physical rim, toric axis, unique visual identification pattern) of the IOL from the marker element, specifically a coded marker. In addition, it imports the IOL design specification (i.e. geometric dimensions, center, edge) or extracts it from the encoded marker.

• - IOL-Designspezifikation;
• - den tatsächlichen IOL-Positionsdaten, die aus dem kodierten Marker abgeleitet werden;
• - optischen Parametern aus der Beobachtung mittels des Diagnosegeräts und/oder der Kamera; und
• - optional: präoperativen Referenzdaten, intraoperativen Messdaten und/oder post-operativen Messdaten, die die Biometrie und Geometrie des Auges spezifizieren (z. B. Referenzkoordinatensystem),

erzeugt das System eine optional elektronische Ausgabe, um dem Anwender einen Grad der IOL-Neigung bzw. -Verkippung zu liefern. Optional können die Analyseergebnisse in der EMR dokumentiert werden.Based on the

• - IOL design specification;
• - the actual IOL position data derived from the encoded marker;
• - optical parameters from the observation using the diagnostic device and/or the camera; and
• - optional: preoperative reference data, intraoperative measurement data and/or postoperative measurement data specifying the biometrics and geometry of the eye (e.g. reference coordinate system),

the system generates an optional electronic output to provide the user with a degree of IOL tilt. Optionally, the analysis results can be documented in the EMR.

Alternatively, the system uses a reading device in order to read out the corresponding data without contact from the data storage unit, which in this case is designed in such a way that position detection is made possible. Alternatively, an electronic chip contained in the data storage unit of the marker element can also be detected visually with regard to its precise position.

e) Assistant to analyze the depth positioning of an IOL

The system uses an imaging technique to detect the actual position data (i.e. center, physical rim, toric axis, unique visual identification pattern) of the IOL from the encoded marker. In addition, it imports the IOL design specification (i.e. geometric dimensions, center, edge) from a separate information source, such as a server, or extracts it from the encoded marker.

• - Referenzdaten, die die Biometrie, Geometrie und Eigenschaften des Auges spezifizieren;
• - den IOL-Design-Spezifikationen;
• - tatsächlichen IOL-Positionsdaten, die von dem kodierten Marker abgeleitet werden,
• - optischen Parametern aus der Beobachtung mittels des Diagnosegeräts und/oder der Kamera, d.h. einer Bilderfassungseinrichtung,

erzeugt das System eine elektronische Ausgabe, um dem Benutzer Tiefeninformationen über die IOL zur Verfügung zu stellen. Optional können die Analyseergebnisse in der EMR dokumentiert werden.Based on the

• - reference data specifying the biometrics, geometry and properties of the eye;
• - the IOL design specifications;
• - actual IOL position data derived from the encoded marker,
• - optical parameters from the observation using the diagnostic device and/or the camera, ie an image acquisition device,

the system generates an electronic output to provide the user with depth information about the IOL. Optionally, the analysis results can be documented in the EMR.

Alternatively, the system uses a reading device in order to read out the corresponding data without contact from the data storage unit, which in this case is designed in such a way that position detection is made possible. Alternatively, an electronic chip contained in the data storage unit can also be detected visually with regard to its precise position.

Further optional and possibly additional workflow use cases are described below.

The marker element can have an encoded marker and/or a data storage unit. The encoded marker and/or data store A security unit (electronic tag) on the IOL optionally enables full traceability of the implant throughout the life of the implant. If required, the encoded marker or the data storage unit can be read by a system as described in the disclosure in order to identify the implant and/or to obtain individual implant specifications. It should be noted that the system is optionally adapted to the standard devices and modules used for the respective application. In principle, the systems described are based on the marker element of the ophthalmic implant, in particular an encoded IOL marker and/or a data storage unit, a device with imaging capabilities and/or an electronic reader, in order to read the data/information stored in the encoded marker or in the data storage unit to the intraocular lens in question and a computer to extract and process the information.

a) during the manufacture of the intraocular lens or the ophthalmological implant

When the coded marker or data storage unit is placed inside the IOL material, the creation of the intraocular lens can be followed throughout the manufacturing process including turning, milling and sterilizing as well as packaging. Alternatively or additionally, however, a marker element 14 can also be applied at the end of the manufacturing process of the ophthalmic implant 10 . In an optional embodiment, the markers can be used to align the samples in manufacturing to ensure toricity and haptics are on the correct axis. Alternatively or additionally, a data storage unit can be used for alignment. In addition to the variants described above with the formation of special antennas that can be detected in their spatial position or by using several sub-units of the data storage units to determine the position, a data storage unit in the form of an electronic chip can also be made visible and can be used as a reference structure. The traceability of the individual intraocular lens or ophthalmic implant during production enables the production of individual IOLs or implants instead of producing larger quantities of a specification. In addition, automation of production is possible. Since the implant specification is stored on the coded marker or in the data storage unit, more precise specifications are also possible, e.g. B. indicate the exact dioptric power.

b) for quality control of the intraocular lens or the ophthalmological implant

A comparison between the coded marker or data storage unit on the IOL and the existing Unique Device Identifier (UDI) on the lens packaging enables a further safety check at the end of the production process. Here the system is able to extract the lens information provided by the coded marker or data storage unit on the IOL and the UDI, compare them and generate an electronic output indicating that the information either matches or does not match. When using a coded marker, it is necessary to provide access to the packaging (e.g. a transparent window) to have visual contact with the coded marker on the implant. Such a window is not necessary when using a data storage unit.

c) Post-operative IOL adjustments

The system for analyzing the IOL position postoperatively or after cataract surgery is combined with postoperative IOL adjustment methods (e.g. thermal, electroactive, magnetic, light-induced, acoustic). This enables assistance functions that support the surgeon or enable automatic IOL adjustment. Both lead to greater precision in postoperative IOL adjustment.

d) Spectacle lenses optimized for the IOL

A coded marker or data storage unit on the IOL can be read with a device at the optician's. The optician receives information about the IOL implanted in the patient and can include the IOL design specification in the lens calculation.

e) Digital IOL passport

The coded marker or data storage unit on the IOL can provide the information given on the implant passport in digital form. The patient always has a digital copy with him.

f) Legal argument

The coded marker or data storage unit on the IOL provides the implant specification and can be used as a legal argument in the event of liability claims.

g) Automated patient identification on devices

By linking the coded marker or the data storage unit on the IOL with patient information (e.g. from the EMR system), the system enables automated identification of patients on devices in the clinical environment. Instead of first having to register each patient on the respective devices, the staff can start working with the devices immediately.

h) Manufacturer complaints/quality management

Coded markers or data storage units on and/or in intraocular lenses can be read with the system described in the implanted or explanted state in order to identify and track the implant. This helps to understand customer complaints and to identify the source of the complaint.

i) Diagnostic measurements

Various diagnostic measuring devices can read the implant, the implant specification, e.g. material properties and optical design, and incorporate the implant specifications into their measurement process. This makes it possible to carry out more reliable measurements and to deliver more precise measurement results.

j) Analysis of the operation result and optimization of the IOL constant

Devices for measuring the surgical result, such as e.g. Devices such as autorefractors or biometric devices can identify the implant, extract the implant specification, combine the results of the measurement with the implant specification and upload them to a software application for results analysis and IOL constant optimization.

k) tracking of eye movements

• (i) Messverfahren von Diagnosegeräten zur Reduzierung von Messfehlern
• (ii) für Assistenzfunktionen während der Operation zur Unterstützung der Leistung des Chirurgen, z. B. automatische Anpassungen des Operationsmikroskops oder der Bildgebungseinstellungen.

In the event of upcoming eye measurements or eye surgery, the devices can recognize the actual position (ie center, physical edge, toric axis, unique visual identification pattern) of the IOL using the marker element, in particular a coded marker. This detection allows tracking of eye movements that can be included in

• (i) Measurement methods of diagnostic devices to reduce measurement errors
• (ii) for assistance functions during surgery to support the surgeon's performance, e.g. B. automatic adjustments of the operating microscope or the imaging settings.

Alternatively, the corresponding data is read contactlessly from the data storage unit, which in this case is designed in such a way that position detection is made possible. Alternatively, an electronic chip contained in the data storage unit can also be visually detected with regard to its precise position.

Reference List

10

ophthalmic implant

12

intraocular lens

12a

optical part

12b

non-optical part

12c

feel

14

marker element

14a

coded marker

14b

data storage unit

16

chip

18

antenna structure

20

machine-readable code

30

System for mechanically supporting a user during an implantation of an ophthalmic implant

32

surgical microscope

34

patient eye

36

patient couch

38

unit of account

40

output unit

42

System for exchanging information with an ophthalmic implant

44

Writing and/or reading device

46

separate source of information

100

Ophthalmic implant life cycle flowchart

102 - 112

Use cases of the marker element

200

clinical use cases

1000

Visualization of the toric axis of an IOL

1002

rotation angle indicators

1004

Visualization of the astigmatic axis of the patient's eye

QUOTES INCLUDED IN DESCRIPTION

This list of documents cited by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent Literature Cited

• DE 102020214126 [0072]
• DE 102021206092 [0072]
• DE 102021206093 [0072]
• EN 102021121166 [0072]

Claims (32)

Ophthalmic implant (10) with at least one marker element (14), - wherein the at least one marker element (14) is designed to provide information for machine identification and/or characterization of the ophthalmic implant (10) and information for machine determination of an alignment of the ophthalmic implant (10), and - The marker element (14) being arranged in and/or on the ophthalmic implant (10) in such a way that the information for identifying and/or characterizing the ophthalmic implant (10) and/or the information for mechanically determining the alignment of the ophthalmic implant ( 10) can be read out by machine intraoperatively and/or postoperatively. Ophthalmic implant (10) according to claim 1 , wherein the information for identifying and/or characterizing the ophthalmic implant (10) and the information for mechanically determining the orientation of the ophthalmic implant (10) can be read electronically and/or optically by machine intraoperatively and/or postoperatively. Ophthalmic implant (10) according to claim 1 or 2 , wherein the marker element (14) is arranged in and/or on the ophthalmic implant (10) in such a way that the information for identifying and/or characterizing the ophthalmic implant (10) and/or the information for mechanically determining the alignment of the ophthalmic implant ( 10) can also be read out by machine preoperatively and/or during production of the ophthalmic implant (10). Ophthalmic implant (10) according to one of the preceding claims, wherein the marker element (14) is arranged in and/or on the ophthalmic implant (10) in such a way that it can only be detected optically when the pupil of the patient's eye is dilated. Ophthalmic implant (10) according to any one of the preceding claims, - wherein the marker element (14) has or consists of a marking in the form of a machine-readable code (20), - wherein the information for machine identification and/or characterization of the ophthalmic implant (10) is stored in the machine-readable code (20), and - a size, a position and/or an orientation of the marking is designed to provide the information for mechanically determining the orientation of the ophthalmic implant (10). Ophthalmic implant (10) according to claim 5 , wherein the machine-readable code (20) has or consists of a one-dimensional bar code and/or a two-dimensional matrix code and/or a grid of dots, in particular with marking points which have a pseudo-random, irregular character, and/or a three-dimensional matrix code. Ophthalmic implant (10) according to one of the preceding claims, wherein the marker element (14) comprises or consists of a data storage unit (14b) which is designed to store the information for machine identification and/or characterization of the ophthalmic implant (10) in the form of provide electronically readable data. Ophthalmic implant (10) according to claim 7 , wherein the data storage unit (14b) is designed and arranged in and/or on the ophthalmic implant (10) such that the orientation of the ophthalmic implant (10) can be determined based on a position and/or orientation of the data storage unit (14b). An ophthalmic implant (10) according to any one of the preceding claims, wherein the ophthalmic implant includes or is formed as an intraocular lens (12). Data storage unit (14b) for an ophthalmic implant (10), - wherein the data storage unit (14b) is designed to store information for machine identification and/or characterization of the ophthalmic implant (10) in the form of electronically readable data, and - wherein the data storage unit (14b) has such a spatial configuration and can be attached in and/or on the ophthalmic implant (10) in such a way that based on a position and/or alignment of the data storage unit (14b) in and/or on the ophthalmic implant (10) the orientation of the ophthalmic implant (10) can be determined. Use of a marker element (14) for an ophthalmic implant (10) to provide information for machine identification and/or characterization of the ophthalmic implant (10) and for providing information for machine determination of an orientation of the ophthalmic implant (10). use according to claim 11 , - wherein the marker element (14) has or consists of a machine-readable code (20), and - wherein the machine-readable code (20) is optional has or consists of a one-dimensional bar code and/or a two-dimensional matrix code and/or a grid of dots, in particular with marking points which have a pseudo-random, irregular character, and/or a three-dimensional matrix code. Use of a data storage unit (14b) for an ophthalmic implant (10) to provide information for machine identification and/or characterization of the ophthalmic implant (10) and for providing information for machine determination of an alignment of the ophthalmic implant (10). Use according to any of Claims 11 until 13 , wherein the use of the marker element (14) and/or the data storage unit (14b) comprises one or more of the following applications: - using the information provided for machine identification and/or alignment and/or characterization for identification and/or characterization during manufacture and/or packaging of the ophthalmic implant (10); - Using the information provided for machine identification and/or characterization preoperatively for an assignment and/or verification of an assignment of the ophthalmic implant to a patient's eye; - Using the information provided to mechanically determine a position and/or an alignment of the ophthalmic implant intraoperatively for a mechanical determination of the alignment of the ophthalmic implant relative to the patient's eye to support the implantation process; - using the information provided for mechanically determining an alignment of the ophthalmic implant postoperatively for mechanically determining and/or checking the alignment of the ophthalmic implant relative to the patient's eye; and - using the information provided for machine identification and/or characterization postoperatively for identifying and/or characterizing the ophthalmic implant (10) and/or for checking an assignment of the ophthalmic implant to the patient's eye in which the ophthalmic implant (10) is implanted. Method for mechanically determining an alignment of an ophthalmic implant (10) with at least one marker element (14) relative to a patient's eye to support an implantation operation, the method comprising: - Mechanical, optionally optical and/or electronic, detection of the marker element (14); - Mechanically determining a position and/or alignment of the marker element (14); - Mechanically determining a position and/or an orientation of at least a part of the patient's eye; and - Determining the orientation of the ophthalmic implant (10) relative to the patient's eye using the determined position and/or orientation of the marker element (14) and the determined position and/or orientation of the at least part of the patient's eye. procedure after claim 15 , wherein the method comprises an optionally visual and/or auditory output of information about the position and/or the alignment of the ophthalmic implant (10) relative to the patient's eye during and/or after an implantation operation of the ophthalmic implant (10). procedure according to Claim 14 or 15 , wherein the determination of the orientation of the ophthalmic implant (10) relative to the patient's eye is repeated several times and optionally takes place continuously. Method according to one of Claims 15 until 17 , further comprising reading out information for machine identification and/or characterization of the ophthalmic implant (10) from the marker element (14). procedure according to Claim 18 , - wherein the marker element (14) has or consists of a marking in the form of a machine-readable code (20), and - wherein the reading out of the information for machine identification and/or characterization of the ophthalmic implant (10) from the marker element (14). Reading out the information for machine identification and/or characterization of the ophthalmic implant (10) from the machine-readable code (20). procedure according to claim 19 , wherein the machine-readable code (20) has or consists of a one-dimensional bar code and/or a two-dimensional matrix code and/or a grid of dots, in particular with marking points which have a pseudo-random, irregular character, and/or a three-dimensional matrix code. Method according to one of claims 18 until 20 , - wherein the marker element (14) comprises or consists of a data storage unit (14b), and - wherein the reading out of information for machine identification and/or characterization of the ophthalmic implant (10) comprises electronically reading out data from the data storage unit (104b) which have the information for machine identification and/or characterization of the ophthalmic implant (10). procedure according to Claim 21 , wherein the mechanical determination of the position and / or orientation of the marker element (14) comprises determining a position and / or orientation of the data storage unit (14b). Read-out device for reading out information for machine identification and/or characterization of the ophthalmic implant (10) from a marker element (14) arranged in and/or on the ophthalmic implant (10), the read-out device being set up to read the marker element (14) for Reading out the information to detect optically and / or establish a contactless electrical communication link with the ophthalmic implant. System for exchanging information with an ophthalmic implant, the system comprising: - a writing and reading device which is designed to read information for machine identification and/or characterization of the ophthalmic implant (10) from a marker element (14) arranged in and/or on the ophthalmic implant (10) or the marker element therewith to describe, wherein the writing and / or reading device is set up to optically detect the marker element (14) for reading out the information and / or establish a contactless electrical communication connection with the ophthalmic implant; - A processing unit which is designed to take a measure relating to the ophthalmic implant based on the information read out and/or to output a message to a user and/or based on measures taken and/or to be taken and/or based on a user input provided information provide information for machine identification and/or characterization of the ophthalmic implant (10) for describing the marker element. System for mechanically assisting a user in implanting an ophthalmic implant (10) in a patient's eye, the system comprising: - An image acquisition device for acquiring images of at least a part of the patient's eye and at least one marker element (14) of the ophthalmic implant (10); - A computing unit which is set up to determine a relative orientation of the ophthalmic implant (10) relative to the patient's eye based on the captured images of the patient's eye and the marker element (14); - an output unit which is set up to output information about the determined orientation of the ophthalmic implant (10) relative to the patient's eye to a user. system according to Claim 25 , wherein the image acquisition device comprises a camera and optionally a microscope. system according to Claim 25 or 26 , wherein the output unit has a display device, in particular a display. A method of making an intraocular lens (12), IOL, comprising: - providing an IOL (12) with at least one optical part (12a) and at least one haptic (12c) connected to the optical part; - Arranging a marker element (14) with information for machine identification and/or characterization of the IOL (12) at least partially in and/or on the optical part and/or in and/or on the at least one haptic (12c) in such a way that in a state of the IOL (12) implanted in a patient's eye, the information for identifying and/or characterizing the IOL (12) can be read out by machine and information for mechanically determining the alignment of the IOL (12) using the marker element (14) can be optically detected. procedure according to claim 28 , wherein the arrangement of the marker element (14) includes the attachment of a machine-readable code (20), the machine-readable code optionally being a one-dimensional bar code and/or a two-dimensional matrix code and/or a point grid, in particular with marking points which have a pseudo-random, irregular character, and/or has or consists of a three-dimensional matrix code. procedure according to claim 28 or 29 , wherein the arrangement of the marker element (14) comprises or consists of the attachment of a data storage unit (14b) which contains the information for machine identification and/or characterization of the IOL (12) and/or the information for machine determination of the orientation of the IOL (12 ) in the form of electronically readable data. Computer program product or computer-readable storage medium, comprising instructions which, when the program is executed by a computing unit, cause the latter to carry out a method according to one of Claims 15 until 22 to execute. Method for determining an eye position and/or eye movement of an eye with an implanted ophthalmic implant (10) which has an optically detectable marker element (14), the method comprising the following steps: - detecting the marker element (14) of the ophthalmic implant (10) of the eye; - Determining a position and / or movement of the marker element (14); - Determining the position and/or movement of the ophthalmic implant (10) and/or the eye based on the determined position and/or movement of the marker element (14).

Images