WO2013013175A1 - Systèmes et procédés de traitement de réfraction manifeste - Google Patents

Systèmes et procédés de traitement de réfraction manifeste Download PDF

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Publication number
WO2013013175A1
WO2013013175A1 PCT/US2012/047655 US2012047655W WO2013013175A1 WO 2013013175 A1 WO2013013175 A1 WO 2013013175A1 US 2012047655 W US2012047655 W US 2012047655W WO 2013013175 A1 WO2013013175 A1 WO 2013013175A1
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WIPO (PCT)
Prior art keywords
manifest refraction
eye
subjective
manifest
measurement
Prior art date
Application number
PCT/US2012/047655
Other languages
English (en)
Inventor
Michael Brownell
Original Assignee
Amo Development, Llc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Amo Development, Llc. filed Critical Amo Development, Llc.
Publication of WO2013013175A1 publication Critical patent/WO2013013175A1/fr
Priority to US14/701,037 priority Critical patent/US20150290032A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/0016—Operational features thereof
    • A61B3/0025—Operational features thereof characterised by electronic signal processing, e.g. eye models
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00878—Planning
    • A61F2009/0088—Planning based on wavefront
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00878—Planning
    • A61F2009/00882—Planning based on topography

Definitions

  • Embodiments of the present inventi on relate to systems and methods for vision correction, and in particular to techniques for planning a prescription treatment for a patient's eye.
  • fCM fCM>03
  • As light rays enter the eye they are bent by the anterior portion of the eye before reaching the retina. This refraction of the light is a consequence of the optical power of the cornea and lens, if there are refractive errors in the eye, incoming light does not properly converge at the retina.
  • the eye may present spherical or cylindrical irregularities that prevent the proper focusing of light.
  • Manifest refraction such as that measured by a phoropter device., is an indication of how much spherical and cylindrical error shows up as a person perceives vision.
  • a treatment provider can manually evaluate the subjective manifest refraction of the patient coixespoiiding to a spectacle correction, convert that manifest refraction to the cornea.? plane using a vertex distance adjustment, and use the resulting manifest refraction for determining the prescription.
  • Embodiments of the present invention encompass systems and methods for determining a vision prescription or planning a refractive treatment for a patient, based on a prc-trcatment refractive measisremeiit, without altering the prescription in response to any measured subjective manifest refraction, in some instances, subjective manifest refraction may be measured but not factored into the prescription generation process. That can be the case even where the subjective manifest refraction measurement differs significantly from the objective manifest refraction measurement. In some instances, subjection manifest refraction may be measured and used as a safety check.
  • a prescription can be generated for a patient based on an objective optical manifest refraction measurement, without taking a measurement of the subjective manifest refraction at all
  • Such techniques are well suited for use in any of a variety of vision treatment modalities based on manifest refraction measurements, including without limitation laser ablation treatments, contact lens treatments, spectacle treatments, surgical vision treatments or modifications, intraocular lens and custom intraocular lens treatments, and the like.
  • embodiments of the present invention encompass methods and systems for treating an eye of a patient.
  • An exemplary method includes measuring, with a manifest refraction instrunient an objective optical manifest refraction of the eye of the patient, transmitting the objective optical manifest refraction measurement from the manifest refraction instrument to a treatment planner, determining, with the treatment planner, a prescription based on the objective optical manifest refraction measurement, without altering the prescription in response to amy subjective manifest refraction measurement of the eye, and transmitting the prescription from the treatment planner so as to facilitate surgically altering the eye per the prescription.
  • the objective optical manifest refraction measurement includes a wavefront eval uation of the eye.
  • the objective optical manifest relf action measurement includes a combined wavefront and topographic evaluation of the eye.
  • methods may include interactively, in response to subjective input from the patient, measuring the subjective manifest refraction of the eye, the subjective mani fest refraction measurement differing significantly from the optical manifest refraction measurement, in some cases, the objective optical manifest refraction measurement transmitted from the manifest refraction instrument may differ from the subjective manifest refraction measurement by more than about 0.10 Diopters. In some cases, the objective optica! manifest: refraction measurement transmitted from the manifest refraction instrument may differ from the subjective manifest refraction measurement by more than about 0.25 Diopters. In some cases, the objective optica!
  • manifest refraciion measurement transmitted from the manifest refraction insirament may differ from the subjective manifest refraction measurement by more than about 0,37 Diopters.
  • the objective optical manifest refraction measurement transmitted from the manifest refraction instrument may differ from the subjective manifest refraction measurement by more than about 0.50 Diopters.
  • the subjective manifest refraction measurement includes a phoropter evaluation of the eye.
  • tire subjective manifest refraciion measurement includes a trial frame evaluation of the eye.
  • subjective manifest refraction measurement includes a trial lens evaluation of the eye.
  • manifest refraction includes an objective optical sphere value
  • subjective manifest refraction includes a subjective sphere value that differs from the optical sphere value by greater than about 0.3 Diopters.
  • the difference may be between about 0.5 Diopters and about 1.0 Diopters.
  • the difference may be greater than about 0,5 Diopters.
  • Methods may further include repeating at least one of the subjective manifest refraction measurement and the objective manifest refraction measurement in response to the difference in objective optical and subjective sphere values.
  • Methods may also include determining and imposing the prescription on the eye without altering the objective optical manifest refraction or the transmitted prescription in response to the subjective manifest refraction measurements).
  • the eye is surgically altered under direction of a treating physician
  • the eye can be surgically altered without the treating physician measuring subjective manifest refraction of the eye or otherwise obtaining the subjective manifest refraction of the eye in preparation for the surgical alteration.
  • embodiments of the present invention encompass methods for treating an eye of a patient, which include measuring, with a manifest refraction instrument, an objective optical manifest refraction of the eye of the patient, transmitting the objective optical manifest refraction measurement from the manifest refraction instrument to a treatment planner, reviewing a subjective manifest refraction measurement of the eye, where the subjective manifest refraction differing significantly from the objective manifest refraction, determining, with the treatment planner, a prescription based on the objective optical manifest refraction measurement, without altering the prescription in response to the subjective manifest refraction measurement of the eye, and transmitting the prescription from the treatment planner so as to facilitate surgically altering the eye per the prescription.
  • the subjective manifest refraction measurement can be determined using a phoropter having a tens, where the patient is able to effectively evaluate vision provided by the lens, where the patient is in good health and able to provide sufficient input to effectively determine the subjective manifest refraction measurement, and where the patient is mature enough to be able to provide sufficient input to effectively determine the subjective manifest refraction mea.3 ⁇ 4 wement.
  • embodiments of the present invention encompass methods for treating an eye of a patient which include receiving an objective optical manifest refraction of the eye of the patient, transmitting the objective optical manifest refraction measurement from the manifest refraction instrument to a treatment planner, determining, with the treatment planner, a prescription based on the objective optical manifest refraction measurement, without altering the prescription in response to any subjective manifest refraction measurement of the eye, and transmitting the prescription from the treatment planner so as to facilitate surgically altering the eye per the prescription, in some cases, methods may further include measuring the objective optical manifest refraction of the eye of the patient.
  • embodiments of the present, invention encompass systems for deriving a prescription for an eye of a patient.
  • exemplary systems may include a manifest refraction instrument that measures an objective optical manifest, refraction of the eye of the patient, and a treatment planner that determines a prescription based on the objective optica,! manifest refraction measurement, without altering the prescription in response to any subjective manifes refraction measurement of the eye.
  • the treatment planner can be coupled with the manifest refraction instrument so as to receive the objective optical manifest refraction therefrom.
  • Systems may also include a surgical devic that alters the eye per the prescription.
  • the surgical device can be coupleable with the treatment planner so as to receive the prescription from the treatment planner.
  • the objective optical manifest refraction measurement includes a wavefront evaluation of the eye. In some instances, the objective optical manifest retraction measurement includes a combined wavefront and topographic evaluation, of the eye. in some instances, the treatment planner can be configured to determine the prescription based on the objective optical manifest refraction measurement when the subjective manifest refraction measurement differs significantly from ihe optical manifest retraction measurement. In some instances, the txeatment planner can be contlgured to determine the prescription baseci on the objective optical manifest refraction measurement when the objective optical manifest refraction measurement differs from the subjective manifest .refraction measurement by more than about 0.1 Diopters.
  • the treatment planner can be configured to determine the prescription based on the objective optical manifest refraction measurement when the objective optical manifest refraction measurement differs from the subjective manifest retraction measurement by more than about 0.25 Diopters. In some instances, the treatment planner can be configured to determine the prescription based on the objective optical manifest refractioti measurement when the objective optical manifest refraction measurement differs from the subjective manifest refraction measurement by more than about 0.37 Diopters. In some instances, the treatment planner can be configured to determine the prescription based on the objective optical manifest refraction measurement when the objective optical manifest refraction measurement differs from the subjective manifest refraction measurement by more than about. 0.50 Diopters.
  • the treatment planner can be configured to determine the prescription based oti the objective optical manifest refraction measurement when the objective optical manifest refraction measurement differs from the subjective manifest refraction measurement by more than about one standard deviation associated with the subjective manifest refraction measurement.
  • embodiments of the present invention encompass sy stems for deriving a prescription for an eye of a patient that include a wavefront-based instrument that measures a wavefront-derived objective optical manifest refraction measurement of the eye of the patient.
  • the wavefront-derived manifest refraction can include a sphere component, a cylinder component, and an axis component.
  • Systems may also include a treatment planner that determines a prescription based on the objective optical manifest refraction measurement, without, altering the prescription in response to any subjective manifest refraction measurement of the eye.
  • Systems may also include a surgical device that alters the eye per the prescription.
  • systems can include a memory that receives the subjective manifest refraction measurement of the eye
  • the wavefront-based instrument can include the memory.
  • the treatment planner can include the memory.
  • the surgical device can include the memory.
  • systems may include a processor that calculates a difference between the wavefront-derived objective optical manifest retraction measurement and the subjective manifest refraction measurement.
  • Systems may also include a prompting mechanism that presents a signal if the difference exceeds a threshold.
  • systems may in.ci.ude an input that receives a physician acknowledgement of the difference.
  • systems may include an input that receives a re-measurement instruction from the physician.
  • Fig. 1 illustrates a laser ablation system according to an embodiment of the present invention.
  • Fig. 2 illustrates a simplified computer system according to an embodiment of the present invention, j ' 0t)1
  • [OOiSj Fig. 3 A illustrates another wavefront measurement system according to an embodiment of the present invention.
  • Fig. 4 illustrates aspects of prescription methods according to embodiments of the present invention.
  • Figs. 5 ⁇ and SB depict aspects of refraction study results according to embodiments of the present invention.
  • fOOlSJ Fig. 6 depicts aspects of refraction study results according to embodiments of the present invention.
  • Fig. 7 depicts aspects of refraction study results according to embodiments of the present i vention.
  • Fig. 8 depicts aspects of refraction study results according to embodiments of the present invention.
  • Fig. 9 depicts aspects of refraction study results according to embodiments of the present invention.
  • Fig. 1 0 depicts aspects of refraction study results according to embodiments of the present invention.
  • Fig. 1 1 depicts aspects of refraction study results according to embodiments of the present invention.
  • FIG. 100241 Figs. 1.2 A. and 12B depict aspects of refraction study results according to embodiments of the present invention.
  • Exemplary systems and methods as described herein involve the use of an objective optical manifest refraction, such as that measured with a wavefront device, for developing a vision prescription for a patient without altering the prescription in response to any subjective manifest refraction, such as that measured with a phoropter device.
  • an objective optical manifest refraction such as that measured with a wavefront device
  • Embodiments of the present invention can be readily adapted for use with existing laser systems and other optical treatment devices.
  • system, software, and method embodiments of the present invention are described primarily in the context of a laser eye surgery system, it should be understood that embodiments of the present invention may be adapted for use in alternative eye treatment procedures, systems, or modalities, such as spectacle lenses, intraocular lenses, accommodating lOLs, contact lenses, corneal ring implants, collagenous corneal tissue thermal remodeling, corneal inlays, corneal onlays, other corneal implants or grafts, and the like.
  • Relatediy, systems, software, and methods according to embodiments of the present invention are well suited for customizing any of these treatmenL modalities to a specific patient.
  • FIG. 1 illustrates a laser eye surgery system 10 of the present invention, including a laser 12 that produces a laser beam 14.
  • Laser 12 is optically coupled to laser delivery optics 16, which directs laser beam 14 to an eye E of patient P,
  • a delivery optics support structure (not shown here for clarity) extends from a frame 18 supporting laser 12.
  • A, microscope 20 is mounted on the delivery optics support structure, the microscope often being used to image a cornea of eye E.
  • Laser 12 generally comprises an excimer laser, ideally comprising an argon-fluorine laser producing pulses of laser light having a wavelength of approximately 193 mn.
  • Laser 12 will preferably be designed to provide a feedback stabilized fluenee at the patient's eye, delivered via delivery optics 16.
  • the present invention may also be useful with alternative sources of ultraviolet or infrared radiation, particularly those adapted to controllably ablate the corneal, tissue without causing significant damage to adjacent and/or underlying tissues of the eye.
  • sources include, but are not limited to, solid state lasers and other devices which can generate energy in the ultraviolet wavelength between about 185 and 205 tun and/or those which utilize. frequency-multiplying techniques.
  • an exeimcr laser is the illustrative source of an ablating beam, other .lasers may be used in the present invention.
  • Laser system 10 will generally include a computer or programmable processor 22, Processor 22 may comprise (or interface with) a conventional PC system including the standard user interface devices such as a keyboard, a display monitor, and the like.
  • Processor 22 will typically include art input device such as a magnetic or optical disk drive, an internet connection, or the like. Such input devices will often be used to download a computer executable code from a tangible storage media 29 embodying any of the methods of the present invention.
  • Tangible storage media 29 may take the form of a floppy disk, an optical disk, a data tape, a volatile or non-volatile memory, RAM, or the like, and the processor 22 will include the memory boards and other standard components of modern computer systems for storing and executing this code.
  • Tangible storage media 29 may optionally embody wavefront sensor data, wavefront gradients, a waveiront elevation map, a treatment map, a corneal elevation map, and/or an ablation table. While tangible storage media 29 will often be used directly in cooperation with an input device of processor 22, the storage media may also be remotely operatively coupled with processor by means of network connections such as the internet, and by wireless methods such as infrared, Bluetooth, or the l ike. 100301 Laser i 2 and delivery optics 16 will generall y direct laser beam 14 to the eye of patient
  • Computer 22 will often selectively adjust laser beam 14 to expose portions of the cornea to the pulses of laser energy so as to effect a predetermined sculpting of the cornea and alter the refractive characteristics of the eye.
  • both laser beam 14 and the laser delivery optical system 16 will be under computer control of processor 22 to effect the desired laser sculpting process, with the processor effecting (and optionally modifying) the pattern of laser pulses.
  • the pattern of pulses may by summarized in machine readable data of tangible storage media 29 in the form of a treatment table, and the treatment table may be adjusted according to feedback input into processor 22 from an automated image analysis system in response to feedback data provided from an ablation monitoring system feedback system.
  • the feedback may be manually entered into the processor by a system operator.
  • Such feedback might be provided by integrating the wavefront measurement system described below with the laser treatment system 10, and processor 22 may continue and/or terminate a sculpting treatment in response to the feedback, and may optionally also modify the planned sculpting based at least in part on the feedback.
  • Measurement systems are further described in U.S. Patent No. 6,315,413. the full disclosure of which is incorporated herein by reference.
  • f 00 11 Laser beam 14 may be adjusted to produce the desired sculpting using a variety of alternative mechanisms.
  • the laser beam 1 may be selectively limited using one or more variable aperture;;.
  • An exemplary variable aperture system having a variable iris arid a variable width slit is described in U.S. Patent No. 5,713,892, the full disclosure of which is incorporated herein by reference.
  • the laser beam may also be tailored by varying the size and offset of the laser spot from an axis of the eye, as described in U.S. Patent Nos. 5,683,379, 6,203539, and 6,331 , 177, the full disclosures of which arc incorporated herein by reference.
  • Still further alternatives are possible, including scanning of the laser beam over the surface of the eye and controlling the number of pulses and/or dwell time at each location, as described, for example, by U.S. Patent No. 4.665, 13, the full disclosure of which is
  • Additional components and subsystems may be included with laser system 10, as should be understood by those of skill in tire art.
  • spatial and/or temporal integrators may be included to control the distribution of energy within the !aser beam, as described in U.S. Patent No. 5,646,791 , the full disclosure of which is incorporated herein by reference.
  • Ablation effluent evacuators/ filters, aspirators, and other ancillary components of the laser surgery system are known in the art. Further details of suitable systems for perfoniiing a - laser ablation procedure can be found in commonly assigned U.S. Pat. Nos. 4,665,913,
  • Su itable systems also include commercially available refractive laser systems such as those manufactured and/or sold by Alcon, Bausch & Lomb, Nidek, WaveLight, LaserSight, Schwind, Zeiss-Meditec, and the like. Basis data can be further characterized for particular lasers or operating conditions, by taking into account localized environmental variables such as temperature, humidity, airflow, and aspiration. f0034] Fig.
  • Computer system 22 typically ly includes at least one processor 52 which may communicate with a number of peripheral devices via a bus subsystem 54. These peripheral devices may include a storage subsystem 56, comprising a memoiy subsystem 58 and a file storage subsystem 60, user interface input devices 62. user interface output devices 64, and a network interlace subsystem 66. Network interface subsystem 66 provides an interface to outside networks 68 and/or other devices, such as the wavefront measurement system 30.
  • User interface input devices 62 may include a keyboard, pointing devices such as a mouse, trackball, touch pad, or graphics tablet, a scanner, foot pedals, a joystick, a touchscreen incorporated into the display, audio input devices such as voice recognition systems, microphones, and other types of input devices.
  • User input devices 62 will often, be used to download a computer executable code from a tangible storage media 29 embodying any of the methods of the present invention.
  • use of the term "input device” is intended to include a variety of conventional and proprietary devices and ways to input information into computer system 22.
  • User interface output devices 64 may include a display subsystem, a printer, a tax machine, or non- visual displays such as audio output devices.
  • the display subsystem may be a cathode ray tube (CRT), a flat-panel device such as a liquid crystal display (LCD), a projection device, or the like.
  • the display subsystem may also provide a non-visual display such as via audio output, devices, in general, use of the term "output device" is intended to include a variety of conventional and proprietary devices and ways to output information from computer system 22 to a user.
  • Storage subsystem 56 can store the basic programming and data constructs that provide the functionality of the various embodiments of the present invention.
  • Storage subsystem 56 typically comprises memory subsystem 58 and file storage subsystem 60.
  • Memory subsystem 58 typically includes a number of memories including a main random access memory (RAM) 70 for storage of instructions and data during program execution and a read only memory (ROM) 72 in which fixed instructions are stored.
  • File storage subsystem 60 provides persistent (non-volatile) storage for program and data files, and may include tangible storage media 29 (FIG. 1 ) which may optionally embody wavefront sensor data, wavefront gradients, a wavefron elevation map, a treatment map, and/or an ablation tabic.
  • File storage subsystem 60 may include a hard disk drive, a floppy disk drive along with associated removable media, a Compact Digital Read Only Memory (CD-ROM) drive, an optical drive, DVD, CD-R, CD-RW, so!id-state removable memory, and/or other removable media cartridges or disks.
  • CD-ROM Compact Digital Read Only Memory
  • One or more of the drives may be located at remote locations on other connected computers at other sites coupled to computer system 22.
  • the modules implementing the functionality of the present invention may be stored by file storage subsystem 60.
  • Bus subsystem 54 provides a mechanism for letting the various components and subsystems of computer system 22 communicate with each other as intended.
  • the various subsystems and components of computer system 22 need not be at the same phy sical location but may be distributed at various locations within a distributed network.
  • bus subsystem 54 is shown schematically as a single bus, alternate embodiments of the bus subsystem may utilize multiple busses,
  • Comouter system 22 itself can be of varying types including a persona! computer, a portable computer., a workstation, a computer terminal, a network computer, a control system in a wavefront measurement system or laser surgical system, a mainframe, or any other data processing system. Due to the ever-changing nature of computers and networks, the description of computer system 22 depicted in FIG, 2 is intended only as a specific example for purposes of illustrating one embodiment of the present invention. Many other configurations of computer system 22 are possible having more or less components than the computer system depicted in
  • wavefront measurement system 30 is schematically i llustrated in simplified form.
  • wavefront measurement system 30 is configured to sense local slopes of a gradient map exiting the patient's eye
  • Devices based on !he Hartmann-Shack principle generally include a lenslet array to sample the gradient map uniformly over an aperture, which is typically the exit pupil of the eye. Thereafter, the local slopes of the gradient map are analyzed so as to reconstruct tire wavefront surface or map.
  • one wavefront measurement system 30 includes an image source 32, such as a laser, which projects a source image through optical tissues 34 of eye E so as to form an image 44 upon a surface of retina R.
  • the image from retina R is transmitted by the optical system of the eye (e.g., optical tissues 34) and imaged onto a wavefront sensor 36 by system optics 37.
  • the wavefront sensor 36 communicates signals to a computer system 22' for measurement of the optical errors in the optical tissues 34 and/or determination of an optical tissue ablation treatment program.
  • Computer 22/ may include the same or simitar hardware as the computer s stem 22 illustrated in FIGS. 1 and 2.
  • Computer system 22' may be in
  • Wavefront sensor 36 generally comprises a lenslet array 38 and an image sensor 40. As rite image from retina R. is transmitted through optical tissues 34 and imaged onto a surface of image sensor 40 and an image of the eye pupil 1* is similarly imaged onto a surface of lenslet array 38, the lenslet array separates the transmitted image into an array of beamlets 42, and (in combination with other optica!
  • Sensor 40 typically comprises a charged couple dev ice or "CCD,” and senses the characteristics of these individual beamlets, which can be used to determine the characteristics of an associated region of optical tissues 34,
  • image 44 comprises a point or small spot of ligh
  • a location of the transmitted spot as imaged by a beamlet can directly indicate a local gradient of the associated region of optical tissue.
  • ⁇ 00441 Rye E generally defines an anterior orientation ANT and a posterior orientation POS.
  • image source 32 generally projects an image in a posterior orientation through optica! tissues 34 onto retina R as indicated in FIG. 3.
  • Optical tissues 34 again transmit image 44 from the retina anteriorly toward wavefront sensor 36.
  • Image 44 actually formed on retina R may be distorted by any imperfections in the eye's optical system when tire image source is originally transmitted by optical tissues 34.
  • image source projection optics 46 may be configured or adapted to decrease any distortion of image 44,
  • image source optics 46 may decrease lower order optical errors by compensating for spherical and/or cylindrical errors of optical tissues 34. Higher order optical errors of the optical tissues may aiso be compensated through the use of an adaptive optic element, such, as a deformable mirror (described beiovv).
  • an image source 32 selected to define a point or small spot at image 44 upon retina R may facilitate the analysis of the data provided by wavefront sensor 36. Distortion of image 44 may be limited by transmitting a source image through a central region 48 of optical tissues 34 which is smaller than a pupil 50 ; as the central portion of the pupil may be less prone to optical errors than the peripheral portion. Regardless of the particular image source structure, it will be generally be bene!iciai to have a well-defined and accurately formed image 44 on retina R.
  • the wavefront data may be stored in a computer readable medium 29 or a memory of the wavefront sensor system 30 in two separate arrays containing the x and y wavefront gradient values obtained from image spot analysis of the Hartm.ann-Sha.ck sensor images, plus the x and y pupil center offsets from the nominal center of the Hartmarm-Shack lcnslet array, as measured by the pupil camera 51 (FIG. 3) image.
  • Such information contains all the available information on the wavefront error of the eye and is sufficient to reconstruct the wavefront or any portion of it. In such embodiments, there is no need to reprocess the
  • an array of a 20 x 20 size i.e., 400 elements is often sufficient.
  • the wavefront data may be stored, in a memory of the wavefront sensor system in a single array or multiple arrays.
  • a time series of wavefront data readings may help to provide a more accurate overall determination of the ocular ti ssue aberrations.
  • a plurality of temporally separated wavefront sensor measurements can avoid relying on a single snapshot of the optical characteristics as the basis for a refractive correcting procedure.
  • Still further alternatives are also available, including taking wavefront sensor data of the eye with the eye in differing configurations, positions, and/or orientations.
  • a patient will often help maintain alignment of the eye with wavefront measurement system 30 by focusing on a fixation target, as described in U.S. Patent No. 6.004,313, the full disclosure of which is incorporated herein by reference.
  • optical characteristics of the eye may be determined while the eye accommodates or adapts to image a field of view at a varying distance and/or angles.
  • the location of the optical axis of the eye may be verified by reference to the data provided from a pupil camera 52.
  • a pupil camera 52 images pupil 50 so as to determine a position of the pupil for registration of the wavefront sensor data relative to the optical tissues,
  • FIG. 3A An alternative embodiment of a wavefront measurement system is illustrated in FIG. 3A.
  • the major components of the system of FIG. 3A are similar to those of JBIG. 3.
  • FIG. 3A includes an adaptive optical element 53 in the form of a .deformable mirror.
  • the source image is reflected from deformable mirror 98 during transmission to retina K, and the deformable mirror is also along the optical path used, to form the transmitted image between retina R and imaging sensor 40.
  • Deformable mirror 98 can be controllably deformed by
  • the components of an embodiment of a wavefront measurement system for measuring the eye and ablations may comprise elements of a WavcScan* system, available from VISX, INCORPORATED of Santa Clara, California.
  • VISX VISX
  • INCORPORATED of Santa Clara
  • One embodiment includes a WavcScan system with a defonnable mirror as described above.
  • An alternate embodiment of a wavefront measuring system is described in U.S. Patent No.
  • optical properties of the eye can be used when determining a treatment for the patient's eye.
  • Various measurement modalities can be used to assess tire eye, including wavefront aberrometry, keratomelry, topography, pupilometry, refractometry (e.g. measurement of manifest refraction), pac ymetry, biometry, and the like. Such measurements are made prior to treating or retreating the eye.
  • a subjective eye examination is performed so as to provide an initial measurement of a patient's low order aberrations.
  • wavefront examination may optionally include a wavefront examination, with the wavefront measurements specifically being performed to provide an additional assessment of the patient's eye.
  • the wavefront measurement may utilize the results of the standard subjective manifest measurements.
  • many wavefront aberrometers include optical elements which adjust or precompensate for standard optical errors of the eye being measured so as to more accurately and reliably measure the high-order aberrations, for example, by avoiding cross-over between local gradient-indicating spots from one element of the Hartmann-Shack lcnslet array being misinterpreted as being associated with another element of the array.
  • subjective manifest refraction examination may again be separately performed.
  • embodiments of the present invention encompass techniques wherein the treatment: is based only upon the results of an objective optica! manifest refraction, which can be determined for example based on a wavefront examination.
  • the results of the objective optical manifest refraction examination override the results of any measured subjective manifest refraction.
  • a prescription can be determined without measuring the subjective manifest refraction.
  • manifest refraction can be used to determine the treatment, and subjective manifest refraction can be disregarded.
  • subjective manifest refraction results can also be used to develop a filter for a wavefront examination procedure. Wavefront analysis typically captures both low order and high order aberrations, whereas subjective manifest refraction captures low order aberrations. In some instances, the presence of low order aberrations can limit the ability of a wavefront mechanism to accurately evaluate the high order aberrations. Using the results of a subjective manifest refraction examination, however, it is possible to develop a low order filter.
  • the filter may include, for example, a set of one or more lenses that are placed between the wavefront mechanism and the patient's eye.
  • the filter operates to cancel out or counteract the low order aberrations (e.g. cylinder), and thus only information corresponding to the high order aberrations reaches the wavefront mechanism.
  • a filter can be implemented by software or hardware modules of a treatment system. For example, a subjective manifest refraction measurement can be inputted into a treatment system, which in turn compensates for low order aberrations present in the subjective manifest when performing a wavefront examination or evaluating wavefront exam i nation results.
  • subjective manifest refraction measurements can be performed in order to establish a filter or cancelation factor or mechanism for a wavefron examination, to establish a baseline or starting point for a wavefront examination, or to establish an adjustment factor or mechanism for a wavefront examination.
  • Embodiments of the present invention encompass methods in which a subjective manifest refraction is not performed at ail. or in which a subjective manifest refraction is performed but not used in combination with a wavefront examination when adjusting or generating a prescription, for a patient's eye.
  • a measured subjective manifest refraction may, however, be used as a basis for, or to facilitate, a wavefront evaluation.
  • FIG. 4 shows aspects of an exemplary method 400 for treating an eye of a patient.
  • Method 400 includes measuring an objective optical manifest refraction of the patient's eye, as indicated by step 410. Measurement of the manifest refraction can be performed with. a. manifest refraction instrument 420.
  • the manifest refraction instrument can be an apparatus such as a wavefront measurement assembly, a combined wavefront and topography measurement assembly, an aberrometer assembly, and the like.
  • the method also includes transmitting objective optical manifest refraction measurement data, as indicated by step 430.
  • the treatment method further includes determining a prescription tor the patient's eye based on the objective optical manifest refraction, without altering the prescription in response to any measured subjective manifest refraction, as indicated by step 450. Determination of the prescription can be performed with treatment planner 440. Method 400 additionally includes transmitting the prescription from the treatment planner, as indicated by step 460, so as to facilitate surgically altering the eye per the
  • the manifest refraction instrument and the treatment planner can be configured as components of a single system that can perform measurement, planning, and treatment procedures, for example.
  • 7.461 ,938, and 7,490,940 describe techniques for determining sphere and cylinder components of subjective retraction using an objective wavefront measurement. Additionally, techniques for predicting refraction from wavefront aberrations are discussed in Thibos, ''Accuracy And Precision Of Objective Refraction Prom Wavefront Aberrations" J. Vision 4:329-351 (2004).
  • wavefront examination involves passing a wave of light into the patient's eye. and analysing the quality of light which is reflected back out of the patient's eye. In this way, it is possible to analyze the optical properties of the patient's visual based on how the eye iransfbrnis or alters the light wave, Wavefront examination is particularly useful in diagnosing vision conditions or characterizing vision performance in an eye of a patient.
  • the objective optical .manifest refraction measurement can be based on or determined by a wavefront evaluation of the eye.
  • the objective optical manifest refraction measurement can be based on or determined by a combined wavefront and topographic evaluation of the eye.
  • Wavefront techniques can provide an objective optical basis for evaluating the optical properties of the patient's eye.
  • wavefront evaluation data may be used to determine a vision treatment for a patient.
  • wavefront evaluation data in combination with topographic evaluation data can be used to determine a vision treatment for a patient.
  • wavefront techniques, optionally in combination with corneal topography can provide an objective optical basis for determining a vision treatment for an eye of a patient. It has been discovered that an objective optical manifest refraction measurement can be used solely or primarily to derive a prescription for a patient,
  • Exemplary vision treatment techniques may include measuring the subjective manifest refraciion of the eye, interactively in response to subjecti ve input from the patient.
  • tire subjective manifest refraction measurement can be based on or determined by a phoropter evaluation of the eye.
  • Phoropter mechanisms typically include a series of fenses which focus or refract light into the patient ' s eye, thus allowing tire operator to calculate how much sphere, cylinder, and axis is needed to treat the patient's refractive error.
  • the subjective manifest retraction measurement can be based on or determined by a trial frame evaluation of the eye.
  • the subjective manifest refraction measurement can be based on or determined by a trial lens evaluation of the eye.
  • subjective manifest can be measured manually.
  • subjective manifest can be measured using a, computer.
  • measurement of subjective manifest takes into account the effect of patient neural signals or processing, and may reflect particular aspects of the patient's perception of vision, what the patient is accustomed to seeing, or specific vision preferences of the patient.
  • the subjective measurement of manifest refraction therefore may present some level of uncertainty or unpredictability, for example with regard to how light is received at the patient's retina, how nerve signals corresponding to that light are transmitted to the brain via the optic nerve, and how the signals are perceived or processed by neural tissue such as the brain.
  • subjective manifest can be measured with an autorefractor.
  • subjective manifest can be determined based on a combined manual and autorefractor evaluation of the eye. For example, an operator may use an autorefractor to determine a baseline retraction of the eye, and a manual phoropter to determine the actual prescription, taking into account the results of the autorefractor examination.
  • the subjective manifest refraction measurement may differ significantly from the optical manitest refraction measurement.
  • the objective optical manifest refraction measurement may differ from the subjective manifest refraction measurement by more than about 0.10 Diopters.
  • the objective optical manifest refraction measurement may differ from the subjective manifest refraction measurement by more than about 0.25 Diopters.
  • the objective optical manifest refraction measurement may differ from the subjective manifest retraction measurement by more than about 0.37 Diopters.
  • the objective optical manifest refraction measurement may differ from the subjective manifest reftaction measurement by more than about 0.50 Diopters.
  • a prescription for the patient's eye can be determined effectivel based on the objective optical manifest reftaction, without altering the prescription in response to the measured subjective manifest refraction.
  • techniques may involve remeasuring the objective manifest the subjective manifest, or both, when, there is a significant difference between the measured objective and subjective manliest refractions.
  • the eye can be surgically altered under direcrion of a treating physician, such that the eye is surgically altered without the treating physician measuring subjective manifest refraction of the eye or otherwise obtaining the subjective manifest refraction of the eye in preparation for the surgical alteration.
  • subjective manifest measurements can be used as a safety check, to establish a filter, or to establish a baseline for objective optical measurements, it is possible to ignore or disregard the subjective manifest when developing a prescription for treatment purposes,
  • objective optical manifest refraction measurements may include techniques having a subjective or neural adaptation component that are not related lo phoropters or other traditional subjective manifest refraction devices.
  • objective optical manifest refraction measurements can be based on results obtained from a device having dei rmable mirror optics, such as an adaptive optics system. Results from such wave front o:r objective measurements may reflect a subjective or patient-input based element.
  • an adaptive optics system or similar vision simulator may be used to provide the patient with a preview of the effect a particular vision treatment (e.g. negating or diminishing aberrations) may have on their vision.
  • Manifest refraction can include a sphere component.
  • an objective optical manifest refraction can include an objective optical sphere value
  • a subjective manifest refraction can include a subjective sphere value.
  • Exemplary techniques can include determining a prescription for the patient's eye based on an objective optical manifest sphere value, without altering the prescription in response to any measured subjective manifest refraction sphere value.
  • the objective sphere value may differ from the subjective sphere value by more than about 0.3 Diopters. In some eases, the difference may be between about 0.5 Diopters and. about 1.0 Diopters.
  • the difference may be greater than about 0.5 Diopters.
  • embodiments encompass techniques for determining a prescription where the results from an. objective optical manifest examination override any results from a subjective manifest examination, Reiatedly, embodiments encompass approaches for determining a prescription based upon the results from an objective optical manifest examination, in the absence of performing a subjective manifest examination.
  • the techniques may include a manifest refraction instrument in cooperative association with a treatment planner.
  • the manifest refraction instrument can operate to measure an objective optical manifest refraction of the eye of the patient, and the treatment planner can operate to determine a prescription for the patient, based on the objective optical manifest refraction measurement.
  • the prescription can be used to facilitate a surgical alteration of the eye.
  • the system may include an input for receiving a subjective manifest refraction of the eye, which can be used as a safety check or low order filter as described elsewhere herein.
  • the system may be configured to receive the subject manifest refraction, but not to use the subjective manifest when detemiining a prescription, in some instances, the system may have no input that receives a subjective manifest refraction.
  • Embodiments of the present invention encompass any of a variety of pre-treatment refractive measurements that can be used to for planning a desired refractive treatment for the patient.
  • embodiments may include aspects of measurement and planning techniques such, as those described in U.S. Patent Application Nos, 12/418J41 filed April 6, 2009, and 61/428,644 filed December 30, 2010. the contents of which are incorporated herein by reference.
  • Exemplar ⁇ ' treatment planners can use objective optical manifest refraction
  • Embodiments of the present invention provide for objective manifest refraction measurements having a standard, deviation of about 0.15 Diopters.
  • the instant techniques provide for the measurement of objective optical manifest refraction, to standard deviations significantly less than the 0,37 Diopter standard deviation associated with a subjective manifest refraction measurement of the eye.
  • the standard deviation may be within a range from about 0.25 Diopters to about 0.50 Diopters.
  • These objective measurements are much more repeatable and accurate than the currently used subjective manifest refraction measurements obtained with phoropters or the like. Contrary to current practices in prescription development. which often are based in large part upon, incorporating the results of phoropter evaluations and other subjective manifest refraction measurements, the techniques disclosed herein are well suited for use in generating prescriptions without relying upon any subjective manifest refraction measurements.
  • sueh treatments may- include contract lens prescriptions, scleral lens prescriptions, laser sculpting or treatment prescriptions, TOL prescriptions including custom IOL prescriptions, and spectacle prescriptions including prescriptions that involve different pairs of glasses for different uses (e.g. low ambient fighting conditions, high, ambient lighting conditions).
  • exemplary techniques involve developing a prescription for the patient based on the objective optical manifest refraction, without altering the prescription in response to the measured subjective manifest refraction.
  • Such approaches can be implemented even where there is a significant difference, for example 0.37 Diopters or more, between the subjective and objective optical manifests.
  • such approaches can be implemented even where the objective measurement differs from the subjective measurement by more than a standard deviation associated with subjective measurement.
  • a prescription is based on optical factors alone.
  • the difference between the subjective and objective optical manifests can be more than about 0.40 or 0.50 Diopters.
  • the ability to generate effective prescriptions in such circumstatices by disregarding the subjective manifest, or by determining the prescription independently of the subjective manifest, is surprising and unexpected.
  • techniques ma involve repeating an objective measurement, a subjective measurement, or both, when there is a significant difference between original objective and. subjective measurements.
  • significant differences between objective and subjecti ve measurements e.g. 0.50 Diopters
  • objective and subjective results can be compared, for example, by providing a patient with an objective-based treatment in one eye, and a subjective-based treatment in the other eye.
  • objective-based treatments and subjective -based treatments can be compared using adaptive optics or similar vision simulation techniques.
  • the difference between prescriptions based on objective and subjective manifest refraction measurements without administering the prescription to the patient in a surgical procedure.
  • the visual acuity can be determined based on objective and subjective manifest refraction measurements, without surgically treating the patient.
  • a wavefront based refraction that provides a better visual acuity can be considered as more accurate than a phoropter based refraction that provides a worse visual acuity.
  • the accuracy or precision of the objective manifest refraction measurement can be evaluated based on visual acuity or contrast sensitivity techniques.
  • the accuracy or precision of an objective measurement approach can be compared with the accuracy or precision of a subjective measurement approach.
  • Adaptive optic techniques can be used to evaluate the difference between an objective- based treatment e.g prescription determined by wavefront measurement) and a subjective-based treatment (e.g.. prescription determined by phoropter).
  • adaptive technique evaluations can be performed, after the patient treatment is allowed to stabilize.
  • Embodiments of the present invention therefore encompass techniques that involve the use of adaptive optics for diagnostic applications as well as development applications.
  • Cylinder can be used as a prescription measure for astigmatism, and is a low order aberration. In some cases, currently used techniques may involve undereorrecting or undermeasuring cylinder. It has been reported that the use of conventional manifest refraction in exciraer laser vision treatment can result in an midercorrection of cylinder, For example, Choi et a!., ''Exciraer Laser Photorefractive Keratectomy for Astigmatism" Korean J. Ophthalmol.. Vol. 7:20-24 ( 1.993) reports a mean refractive cylinder change from i .62 Diopters to 0.48 Diopters following a manifest-guided ablation procedure.
  • exemplary techniques may include fully measuring cylinder (e.g. with little or no wider-measurement) and fully correcting cylinder (e.g. with little or no under-correction). Such, techniques can be applied even where a patient, may already be accustomed to, or otherwise express an initial preference for, an under-correction for cylinder. It has been observed that autorefractors may be paiticiilarly effective in obtaining cylinder measurements (see e.g. Cheng et al. "Predicting subjective judgment of best focus with objective image quality metrics" Journal of Vision, 4, 310-321 (2004), the content f which is incorporated herein by reference.
  • Embodiments of the present invention encompass techniques for registering or combining objective optical manifest refraction measurements with other measurements provided by pupillometry, aberrometry, topography, and other evaluation modalities for the development of treatment prescriptions.
  • evaluation modalities can reside on a single instrument or system, and can be registered to each, other, for example as described in U.S. Patent Application No. 12/41.8,841 filed April 6, 2009 (Atty. Docket No. 18 I 58C-03741 OUS), [0096] .
  • RMS root mean square
  • Slope 1.9; Intercept— 0.061; R 7 -0.89
  • MR manifest refraction
  • FIG. 6 shows the results of a first study involving thirty five eyes, where fourteen measurements per eye were performed. All eyes with fourteen or more measurements were included. The sphere repeatability was observed to be about 0.12 Diopters.
  • FIG. 7 shows the result s of a second study involving thirty eight eyes, where three measurements per eye were performed. All eyes with three or more measurements were included. The sphere repeatability was observed to be about 0.14 Diopters.
  • FIG. 8 provides the results of a first study showing that sphere variability is greater for younger patients. As depicted in the lower panel, the repeatability is 0.12 Diopters and there is a slight trend with age.
  • FIG. 9 provides the results of a second study also showing that sphere variability is greater for younger patients. As depicted in the lower panel, the repeatability is 0.14 Diopters and there is a slight trend with age. (01 3] 4. 4 mm Cylinder Repeatability
  • FIG, 1 shows the results of a first study, where cylinder repeatability was observed to be about 0.088 Diopters.
  • FIG. 1 1 shows the results of a second study, where cylinder repeatability was observed to be about 0.085 Diopters. The cylinder repeatabiiities of the first, and second studies are similar. [0105] 5. 4 mm Sphere and Cylinder Correlation t Manifest Refraction
  • FIGS. J.2A and 12B depict correlation between subjective (e.g. Manifest Refraction) and objective (e.g. wavefront-derived) measurement methods for a group of 108 pre-operative eyes enrolled in a clinical study.
  • FIG. 12A shows pre-operative manifest refraction versus preoperative objective refraction for sphere. The comparison characterizes an ability to accurately measure the optics of the eye. when using either wavefront-derived values of sphere or those obtained by a manifest refraction method. Refractions were calculated over a 4 nun pupil at 12.5 tmii vertex.
  • FIG, 12B shows pre-operative manifest refraction versus pre-operative objective refraction for cylinder.
  • the comparison characterizes an ability to accurately measure the optics of the eye, when using either wavefront-derived values of cylinder or those obtained by a manifest refraction method. Refractions were calculated over a 4 mm pupil at 12.5 ram vertex. The data shows a strong correlation (R-square of 0.9794 and 0.9754, respectively) between the manifest measurement and the wavefront-derived measurement of sphere and cylinder for the same eye.
  • pfui it is h pfui to ensure that an appropriate or maximum amount of information from one or more measurements is used to set the uutorefraction level. For example, it may be useful to not autorcftact to a significantiy more myopic setting than was previously measured. Further, it may be desirable to dynamically track a sphere reading and provide feedback to operator, a patient, or both. Moreover, it may be helpful to allow a patient So participate more actively in the measurement, for example, by gating the measurement when ready, triggering measurement, providing a placebo button, and the like. Also, it may be useful to evaluate dynamically changing fixation targets.
  • kits for such use may comprise a system for profiling an optical surface, such as an optical surface of an eye, and instructions for use. Opiionally, such kits may further include any of the other system components described in relation to the present invention and any other materials or items relevant to the present invention.
  • the instructions for use can set forth any of the methods as described herein.
  • Each of the calculations or operations described herein may be performed using a computer or oilier processor having hardware, software, and/or firmware.
  • the various method steps may be performed by modules, and the modules may comprise any of a wide variety of digital and/or analog data processing hardware and/or software arranged to perform the method steps described herein.
  • the modules optionally comprising data processing hardware adapted to perform one or more of these steps by having appropriate machine programming code associated therewith, the modules for two or more steps (or portions of two or more steps) being integrated into a single processor board or separated into different processor boards in any of a wide variety of integrated and/or distributed processing architectures.
  • These methods and systems will often employ a tangible media embodying machine-readable code with instructions for performing the method steps described above.
  • Suitable tangible media may comprise a memory (including a volatile memory and/or a non-volatile memory), a storage media (such as a magnetic recording on a floppy disk, a hard disk, a tape, or the like; on. an optical memory such as a CD, a CD- /W, a CD-ROM, a DVD, or the like: or any other digital or analog storage media), or the like.
  • a memory including a volatile memory and/or a non-volatile memory
  • a storage media such as a magnetic recording on a floppy disk, a hard disk, a tape, or the like; on. an optical memory such as a CD, a CD- /W, a CD-ROM, a DVD, or the like: or any other digital or analog storage media, or the like.

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Abstract

Des modes de réalisation de la présente invention concernent des systèmes et techniques permettant d'établir une prescription visuelle pour un patient sur la base d'une réfraction manifeste optique objective, telle que celle mesurée avec un dispositif de front d'onde, sans modifier la prescription en réponse à une quelconque réfraction manifeste subjective, telle que celle mesurée avec un dispositif réfracteur.
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