NL2010980C2 - Customized optical calibration surface for accommodating intraocular lens. - Google Patents

Customized optical calibration surface for accommodating intraocular lens. Download PDF

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Publication number
NL2010980C2
NL2010980C2 NL2010980A NL2010980A NL2010980C2 NL 2010980 C2 NL2010980 C2 NL 2010980C2 NL 2010980 A NL2010980 A NL 2010980A NL 2010980 A NL2010980 A NL 2010980A NL 2010980 C2 NL2010980 C2 NL 2010980C2
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Netherlands
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optical
lens
eye
free
individual
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NL2010980A
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Dutch (nl)
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NL2010980A (en
Inventor
Aleksey Nikolaevich Simonov
Michiel Christiaan Rombach
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Akkolens Int Bv
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1613Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1624Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside
    • A61F2/1632Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside for changing radial position, i.e. perpendicularly to the visual axis when implanted
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1613Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1648Multipart lenses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1613Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1637Correcting aberrations caused by inhomogeneities; correcting intrinsic aberrations, e.g. of the cornea, of the surface of the natural lens, aspheric, cylindrical, toric lenses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2240/00Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001Designing or manufacturing processes
    • A61F2240/002Designing or making customized prostheses

Description

Customized optical calibration surface for accommodating intraocular lens
Intraocular lenses, henceforth: ‘IOLs’, are implanted in the aphakic, lens-less, eye to 5 replace the natural lens of the eye to treat, for example, cataracts, a disorder caused by cloudiness of the natural lens. Such IOLs can be monofocal IOLs which include only a single lens component with a single fixed focal power which IOL corrects refraction of the eye by focusing of the eye at a single distance, for example, at infinity, so spectacles are required for sharp vision at closer distances. Alternatively, such IOLs can be 10 multifocal lenses which include a combination of two, three etc. , lens components of different fixed focal powers. Such a combination corrects refraction of the eye and, at a cost in resolution, increases depth of field (DOF) by focusing the eye at multiple distances simultaneously, so the need for spectacle support is less compared to the need with monofocal IOLs. Alternatively, such IOLs can be accommodating IOLs, AIOLs, 15 which generally include at least one lens of fixed optical power to correct refraction and at least one lens of variable optical power, a variable lens, which lens is generally driven by the natural accommodation means to adjust the optical power, for example, driven by the ciliary muscle in the eye. So, such AIOLs restore accommodation of the eye, restore the ability of the eye to focus itself, glidingly, from, for example, infinity to reading 20 distance.
The present document discloses adaptations to the optical arrangement of ‘shifting AIOLs’, also ‘SAIOLs’, meaning SAIOLs which include a variable lens with two optical elements, each with at least one free-form, rotationally asymmetrical optical 25 surface (or aspherical surfaces) of which at least one element shifts in a direction largely perpendicular to the optical axis. The focal power of the variable lens depends on the mutual position, i. e. the degree of mutual shift of the optical elements. Such SAIOLs are known from prior art documents, for example from W02005084587 and US2008046076, on basics of optics and mechanics, from W02008071760 and 30 US2010094413, on corrections of variable aberrations, from US2009062912, on mechanical adaptations, and from WO2011053143, US2010280609, US2009062912, and US2008215146, on additional mechanical and optical aspects.
2
The above prior art documents describe lenses having:
First, an anterior optical element comprising an anterior optical surface, generally fitted with a relatively weak spherical lens to brake an otherwise flat optical surface and a posterior optical surface, fitted with the first free-form optical surface for 5 accommodation and variable correction of undesired variable aberrations (of the eye), and,
Second, a posterior optical element comprising an anterior optical surface, fitted with the second free-form optical surface to complement the first such surface and a posterior optical surface, fitted with, for example, a spherical lens of relatively high focal power 10 to correct basic refraction of the eye.
Note that prior art documents on SAIOLs not restricted to only documents listed herein and that said documents are considered to be incorporated in the present document by the fact of said listing.
15
The free-form optical surfaces of such SAIOLs are presently made per order, are customized, for the individual eye into which the SAIOL will be implanted. Such customization is demanding for manufacturing, for example, by lathing and milling, and such customization is difficult to achieve with mass-production manufacturing 20 procedures such as molding of the free-form surfaces.
The present document discloses adaptations of the optical arrangement of such SAIOLs which adaptations concern optical calibration surfaces, or eye pre-correction surfaces, which ease requirements for manufacturing and allow mass-production manufacturing procedures such as molding. For example, adaptations to the anterior optical surface of 25 the anterior optical element can correct the light beam for individual optical properties of components of the eye, for example, individual optical properties of the cornea, such that each the SAIOL for each individual eye can be fitted with a standard, not customized, free-form optical surfaces, with the shape and dimensions of said free-form surfaces being independent from the individual optical properties of the eye in which 30 the lens is implanted. So, the same free-form optical surfaces can be fitted to each SAIOL for each individual eye.
In the preferable embodiment the optical calibrations surfaces are spherical in shape, although may include cylindrical terms, for example, to correct astigmatism of the 3 individual cornea etc. The optical calibrations surfaces may also include terms of any order to correct overall aberrations of the individual eye. Such surface may be fabricated at the customization stage of AIOL manufacturing process when the patient biometry data are obtained.
5
Three important properties of the light beam at the plane of the first free-form optical surface have to be standardized: first, the degree of convergence of the light beam, henceforth ‘beam-convergence’, and, second, the diameter of the light beam, and, third, the ‘disc-size’, and, the shape of said disc, ‘disc-shape’, with additional properties of the 10 light beam not excluded.
Beam-convergence depends largely, but not exclusively, on the optical power of the cornea, ‘cornea-power’, the disc-size depends, largely, but not exclusively, on cornea power as well as on the individual depth, the distance from the cornea to the SAIOL, the 15 depth of the anterior chamber of the eye, ‘chamber-depth’, while the disc-shape depends largely, but not exclusively, on aberrations of the cornea, ‘cornea-aberrations’. The cornea aberrations, in practice, are generally limited to astigmatic aberrations and spherical aberrations. So, in practice, to allow for standardized free-form optical surfaces, a calibration is required to standardize properties of the light beam at the plane 20 of the first free-form optical surface to correct for optical at least one deviation of individual cornea-power and chamber-depth, with optical deviation meaning deviations from standard values of comea-power and chamber-depth on which standard values the standard free-form optical surfaces of the SAIOL design are based.
25 For example, the free-form optical surfaces of a lens can be designed and optimized for one of the eye models, or average eyes, described, for example, in [S. Norrby et al., Appl. Opt. 46(26), pp. 6595-6605, (2007)] and [M. Katz and P.B. Kruger, The Human Eye as an Optical System, (in W. Tasman, E.A. Jaeger, eds., Duane’s Ophthalmology, Philadelphia, Pa: Lippincott Williams & Wilkins, 2012, Vol 1, Chap 33)]. Consider a 30 model eye comprising a 40 D perfectly symmetrical cornea (having no aberrations except for focal power) and a variable-focus lens positioned at 4 mm from the anterior cornea (aka anterior chamber depth), with the variable lens providing 0-3 D of additional optical power, i. e. accommodation of the eye, by mutual shifting of freeform optical elements of 5 mm in diameter. The free-form surfaces of the variable lens 4 can be optimized such that they provides perfect, i. e. close to diffraction-limited, performance of the variable-focus lens in the whole range of accommodation.
However, in practice, the cornea-power and properties of the cornea and of the anterior 5 chamber of an individual eye are unlikely to be precisely similar to said properties of the model eye. So, an optical calibration surface is required such that the light beam, propagating from the posterior cornea and the anterior optical surface of the variable-focus lens, has the same degree of convergence (local and global) as in the model eye considered above. In this case, the focusing effect produced by the free-form surfaces 10 will not deteriorate the overall performance of the eye. The additional optical power of the variable-focus lens providing emmetropia of the eye can be obtained by adjusting the posterior calibration surface of the posterior element. So, a curtail advantage of the calibration surfaces is that the same set of free-form surfaces can be used for any patient eye. The adjustment, or customization, of the lens per patient is accomplished by 15 calibration surfaces.
Figure 1 provides a schematic drawing of the SAIOL, in this example a more or less oval design, with optical calibration surface in the eye and arrangement of optics. In this example a convergent light beam, 1, is focused by the cornea, 2, onto the anterior 20 optical surface of then SAIOL, 3, comprising an optical calibration surface, 4, on the anterior optical element, 5, which beam is focused onto the first free-form optical surface, 6, fitted to the anterior optical element, 5, which surface focuses the light beam onto the second free-form optical surface, 7, with the variable lens comprised of both free-form surfaces focuses the light beam onto the refractive spherical lens, 8, on the 25 posterior optical surface of the posterior optical element, 9, which, in turn, provides a final focus, 10, of the light beam onto the retina, 11, the sensor, of the eye. Note that the shape, in this schematic for example the diameter, 12, of the first free-form surface is different from the shape, diameter, 13, of the second free-form surface, due to the distinct distance of about 0.5mm between the free-form surfaces which distance allows 30 further convergence of the light beam between said free-form surfaces.
Figure 2. Free-form surfaces formed by insert in lens manufacturing button. A lens manufacturing button, 14, can be the starting component for lathing of an intraocular 5 lens, which button, in this example, includes an insert, 15, to define, mold, the first freeform optical surface, 6, and to define the second free-form optical surface, 7.
Figure 3. Example of a lens without optical calibration surface in an eye with a cornea 5 with relatively weak optical power. The cornea, 2, in this example, provides less convergence of the light beam compared to the standard convergence for which the lens is designed (dotted line, 16) resulting in a light beam which not only covers the freeform optical surfaces, 6, 7, but also covers a significant, peripheral or transition areas of the free-form surfaces, 17, yielding degradation of the final image on the retina by 10 scattering of light, 18.
[1], The present document discloses SAIOLs for restoration of accommodation of the eye and correction of refraction of the eye. The SAIOLs comprise a combination of at least two optical elements, with the combination including an anterior optical element 15 facing the cornea of the eye and a posterior optical element facing the retina of the eye. Said combination of optical elements comprise a combination of at least two free-form optical surfaces with at least one such free-form optical surface positioned on each optical element. The optical surfaces have such a shape that only a combination of freeform surfaces is adapted to provide a lens for variable focus of which the focal distance 20 depends on the relative mutual position of optical elements in a plane largely perpendicular to the optical axis. The SAIOLs comprise at least one lens of fixed optical power fitted to at least one of said optical elements for correction of refraction of the eye. The novelty of the present disclosure, as disclosed in the present document, concerns the adaptation to the optical arrangement that, for correction of individual 25 properties of the eye, the anterior optical element of the lens comprises a customized optical calibration surface adapted to provide correction of individual properties of at least one component of the eye such that a light beam with a predetermined degree of convergence and predetermined shape of the disc is projected onto the first free-form optical surface with the ‘disc’, having a ‘dose size’, generally diameter, and ‘disc’shape, 30 which can be any shape, with the dose being the section of the light beam at the anterior optical surface of the anterior optical element at a plane perpendicular to the optical axis. So, the anterior optical element of the lens comprises a customized optical calibration surface adapted to provide a standardized light beam with a predetermined degree of convergence and predetermined shaope and size of the disc. Note that the 6 term ‘individual properties of the eye’ means, in the context of the present document, ‘deviations of properties of components of the individual eye from properties of standard, average, components of the eye’. Clearly, the individual properties must be measured, by, for example, OCT, IOLMaster or corneal topography and the results 5 included in customized lens designs before proceeding with manufacturing of the lens to allow manufacturing of the proper optical calibration surface. As a result, the SAIOL comprises a combination of at least two free-form optical surfaces with standard optical properties which properties are independent from the individual properties of the eye, which allows for moulding and for mass production of such free-form surfaces.
10
So, the SAIOL is for implantation in an aphakic and, consequently, presbyope human eye. The SAIOL comprises a combination of optical surfaces which combination corrects for said the fixed refractive error due to said aphakia and which combination corrects for said presbyopia. The combination comprises a combination of at least two 15 optical elements, which combination includes an anterior optical element and a posterior optical element with said combination of optical elements comprising a combination of at least two free-form optical surfaces for a variable lens with at least one such freeform optical surface fitted to each optical element with the combination of free-form optical surfaces adapted to provide a lens for variable optical power of which the focal 20 power depends on the relative shift of optical elements in a plane perpendicular to the optical axis. The lens of variable optical power is adapted to provide restoration of accommodation of the eye, is adapted to provide correction of said presbyopia. The combination also comprises at least one lens of fixed optical power adapted to provide correction of the error in fixed refraction of the aphakic eye. The novelty of the present 25 invention is that the combination of optical surfaces comprises at least one customized optical calibration surface adapted to provide the first free-form optical surfaces for a variable lens with a standardized light beam which beam is optically corrected for, at least one, individual at least one deviation of at least one individual optical property from the corresponding standard property of the model eye on which the properties of 30 the free-form optical surfaces of the variable lens are based. The at least one individual optical property depends on, at least one, deviation of, at least one, individual component of the eye from the corresponding component of the model eye on which the properties of the free-form optical surfaces of the variable lens are based. Also, said two free-form surface for a variable lens with at least one such free-form optical surface 7 fitted to each optical element with the combination of free-form optical surfaces adapted to provide a lens for variable optical power are standardized free-form surfaces with optical properties which are independent from the individual optical properties of the individual eye in which the intraocular lens is implanted.
5 [2-7] Such SAIOL can comprise at least one customized optical calibration surface adapted to provide a standardized light beam which beam is optically corrected for at least one deviation of individual optical properties of the individual cornea of the individual eye, the cornea being said individual component of the eye, in which the 10 intraocular lens is implanted. So, such customized optical calibration surface can be adapted to provide optical correction of at least one deviation in individual focal power of the individual cornea, or, alternatively, provide optical correction of at least one deviation in, at least one, individual astigmatism of the cornea, or, alternatively, provide optical correction of at least one deviation in individual asphericity of the cornea. Also, 15 such SAIOL can comprise a customized optical calibration surface adapted to provide optical correction of at least one deviation in individual anterior chamber-depth, the individual anterior chamber-depth being said individual component of the eye. Finally, Such SAIOL can comprise at least one customized optical calibration surface adapted to provide optical correction of at least two optical deviations provided by any 20 combination of components of the individual eye mentioned above or, alternatively, any combination of components of the eye mentioned above and additional components of the eye.
[8-11] Such SAIOL can comprise at least one customized optical calibration surface 25 adapted to provide a standardized light beam optically corrected for the at least one deviation in individual degree of convergence of the light beam, or, alternatively, such SAIOL can comprise at least one optical calibration surface adapted to provide a standardized light beam optically corrected for at least one deviation in the individual disc-size of the light beam, or, alternatively, such SAIOL can comprise at least one 30 customized optical calibration surface adapted to provide a standardized light beam optical corrected for at least one deviation in the individual disc-shape of the light beam, or, alternatively, such SAIOL can comprise at least one optical calibration surface adapted to provide a standardized light beam optical corrected for any at least two 8 deviations in any combination of said convergence, disc-size and disc-shape of the light beam.
So, the optical calibration surface can, for example, correct for individual defocus 5 optical properties of the cornea to provide said standardized light beam with said predetermined degree of convergence. Corneas differ in optical power from about 35-45 diopters with a mean optical power of 40D and the optical calibration surface can be designed to provide a standardized light beam. Also, the optical calibration surface can correct for astigmatic optical properties of the cornea, cornea astigmatism, to provide 10 said standardized light beam with said predetermined degree of convergence. Such correction will introduce rotational asymmetry in the optical calibration surface to match such asymmetry of the cornea. Also, the optical calibration surface corrects for aspheric optical properties of the cornea to provide said standardized light beam with said predetermined degree of convergence. Also, the optical calibration surface can 15 correct for any combination of optical properties of the cornea said standardized light beam with said predetermined degree of convergence. Note that the defocus optical properties are most important for said calibration of the light beam and that correction of other order aberrations can also be achieved by adding optical correction surfaces to other optical surfaces on both optical elements of the SAIOL.
20 [12-13] The method for manufacturing of such an SAIOL, an SAIOL according to the foregoing, comprising said standardized free-form surface for the variable lens, can include at least one clinical investigation of the individual eye, prior to manufacturing of said accommodating lens, which investigation is adapted to provide specification of 25 individual deviation of at least one individual optical property from the corresponding standard property of the model eye on which the properties of the free-form optical surfaces of the variable lens are based which at least one individual optical property depends on, at least one, deviation of, at least one, individual component of the eye from the corresponding component of the model eye on which the properties of the free-30 form optical surfaces of the variable lens are based. Also, such method can include at least one calculation procedure, alternatively, a computer simulation procedure, adapted to provide the shape of the customized optical calibration surface with the calculation procedure providing a design of the calibration surface such that the calibration surface provides the required at least one optical correction for, at least one, deviation of the at 9 least one individual optical property from the corresponding standard property of the model eye.
[14-15] The method can include a molding procedure adapted to provide at least one 5 such standardized free-form surface of the variable lens fitted to at least one optical element, for example, the method can include a one-element molding procedure for standardized free-form surfaces adapted to provide one such standardized free-form surface of the variable lens fitted to one optical element with the method, for example, also including at least one assembly procedure adapted to connect at least two optical 10 elements to form an accommodating intraocular lens.
[17-20] Alternatively, the method can include includes at least one two-element molding procedure, molding the two optical elements in combination, directly, adapted to provide the starting manufacturing component, the lens fabrication button, with said 15 standardized free-form surfaces connected to each other directly by said molding procedure. Also, the method can be adapted to provide inclusion, inside the lens-fabrication button, of at least one molding-insert for the standardized free-form surfaces around which insert the additional optical surface are lathed and around which insert the lens shape can be milled.
20 In combination with said examples of molding, the molding procedure can include additional molding procedures for optical surfaces adapted to provide manufacturing of the additional optical surfaces, with additional optical surfaces meaning the anterior optical side on the anterior optical element and the posterior optical side on the posterior optical element. With regard to shape of the SAIOL, the method can include additional 25 molding procedures for lens-shape adapted to provide the outer-dimensions, the shape of the optical elements, the shape of the haptics and the shape of any additional supporting components.
So, with such standardized free- form optical surfaces the manufacturing steps of the 30 lens can include a molding step of the lens which molding step includes a molding insert adapted to provide said combination of at least two free-form optical surfaces with fixed optical properties which properties are independent from individual optical properties of the cornea. For example, a ‘lens button’ can be provided which button includes said insert and around said button the rest of the lens can be lathed, including 10 the customized optical calibration surface, for example on the anterior optical surface of the anterior optical element, and the customized spherical lens for correction of refraction, for example on the posterior optical surface of the posterior optical element.
5 [21-24] However, intraocular lenses can also be manufactured by machining of small blocks, buttons, of the lens material. So, the method can include at least one lensmachining procedure adapted to provide manufacturing of the additional optical surfaces or the shape of the SAIOL, for example, the lens-machining procedure can include at least one lens-lathing procedure adapted to provide manufacturing of at least 10 one optical surface. Also, the lens-machining procedure can include at least one milling procedure adapted to provide manufacturing of at least one shape of the SAIOL. Clearly, that the method can include any combination of at least one molding procedure, at least one lathing procedure and at least one milling procedure which combination is adapted to provide manufacturing of any combination of any optical surfaces and shape 15 of any component of the SAIOL.
[25-26] So, in summary, the SAIOL comprises any combination of at least two standardized free-form optical surfaces for the variable lens, and additional optical surfaces including at least one customized optical calibration surface and at least one 20 lens of fixed focal power with the SAIOL adapted to provide restoration of accommodation of the presbyope eye and correction of refraction of the aphakic eye.
Note that the SAIOL disclosed thus far can be provide a lens for variable focus comprising a combination of at least two free-form optical surfaces with the free-form 25 surfaces adapted such that the degree of focal power depends on a corresponding relative distance between optical elements in the direction parallel to the optical axis. Also, the SAIOL disclosed thus far can include a combination of free-form optical surfaces which provide simultaneous variable correction of at least two variable aberrations of at least two different orders of which the degrees of corrections depend 30 on the relative position of the optical elements.

Claims (26)

1. Accommoderende intraoculaire lens, ook aangeduid als SAIOL, voor implantatie in een afakisch, en als gevolg van afakie ook presbyoop, menselijk oog, 5 waarbij de accommoderende lens een combinatie omvat van optische oppervlakken, welke combinatie de vaste brekingsfout ten gevolge van de afakie corrigeert en welke combinatie de presbyopie corrigeert, waarbij de combinatie omvat: - een combinatie van ten minste twee optische elementen, welke combinatie een voorste optisch element en een achterste optisch element 10 omvat, - waarbij de combinatie van optische elementen een combinatie omvat van ten minste twee optische oppervlakken met vrije vorm voor het verschaffen van een variabele lens, - waarbij ten minste één dergelijk optisch oppervlak met vrije vorm geschikt is 15 voor elk optisch element, - waarbij de combinatie van optische oppervlakken met vrije vorm is ingericht voor het verschaffen van een lens met variabele optische sterkte waarvan het focale sterkte afhangt van de relatieve verschuiving van de optische elementen in een vlak loodrecht op de optische as, 20. waarbij de lens met variabele optische sterkte is ingericht om herstel van de accommodatie van het oog te verschaffen, waarbij de variabele lens is ingericht om correctie van de presbyopie te verschaffen, - waarbij ten minste één lens met een vaste optische sterkte is ingericht voor correctie van de fout in de vaste breking van het afakische oog, 25 met het kenmerk dat: - de combinatie van optische oppervlakken ten minste één aangepast optisch ijkoppervlak omvat, dat is ingericht voor het verschaffen van de eerste optische oppervlakken met vrije vorm voor een variabele lens met een gestandaardiseerde lichtbundel, welke bundel optisch is gecorrigeerd voor ten minste één afzonderlijke 30 afwijking in ten minste één afzonderlijke optische eigenschap van de betreffende standaardeigenschap van het modeloog, waarop de eigenschappen van de optische oppervlakken met vrije vorm van de variabele lens zijn gebaseerd, waarbij ten minste één afzonderlijke optische eigenschap afhangt van ten minste één afwijking in ten minste één afzonderlijke component van het oog van de betreffende component van het modeloog waarop de eigenschappen van de optische oppervlakken met vrije vorm van de variabele lens zijn gebaseerd, - de twee oppervlakken met vrije vorm voor een variabele lens met ten minste één dergelijk optisch oppervlak met vrije vorm omvatten, dat geschikt is voor elk 5 optisch element, waarbij de combinatie van optische oppervlakken met vrije vorm die is ingericht voor het verschaffen van een lens voor een variabel optisch vermogen, wordt gevormd door gestandaardiseerde oppervlakken met vrije vorm met optische eigenschappen die onafhankelijk zijn van de afzonderlijke optische eigenschappen van het afzonderlijke oog waarin de intraoculaire lens wordt geïmplanteerd. 101. Accommodating intraocular lens, also referred to as SAIOL, for implantation in an aphakic, and as a result of aphakia also presbyopic, human eye, wherein the accommodating lens comprises a combination of optical surfaces, which combination is the fixed refractive error due to the aphakia and which combination corrects the presbyopia, the combination comprising: - a combination of at least two optical elements, which combination comprises a front optical element and a rear optical element 10, - wherein the combination of optical elements comprises a combination of at least two free-form optical surfaces for providing a variable lens, - wherein at least one such free-form optical surface is suitable for each optical element, - wherein the combination of free-form optical surfaces is adapted to provide a variable optical strength lens whose focal strength depends on the relat effective shift of the optical elements in a plane perpendicular to the optical axis, wherein the lens with variable optical strength is arranged to provide restoration of the accommodation of the eye, wherein the variable lens is arranged to provide correction of the presbyopia - wherein at least one lens with a fixed optical strength is adapted to correct the error in the fixed refraction of the aphakic eye, characterized in that: - the combination of optical surfaces comprises at least one adapted optical calibration surface, that is arranged to provide the first free-form optical surfaces for a variable lens with a standardized light beam, which beam is optically corrected for at least one separate deviation in at least one separate optical property from the relevant standard property of the model eye, on which the properties of the optical surfaces with the free form of the variable lens are based, wherein at least one separate optical property depends on at least one deviation in at least one individual component of the eye of the relevant component of the model eye on which the properties of the free-form variable surface optical surfaces of the variable lens are based, the two free-form surfaces for a variable lens comprising at least one such free-form optical surface suitable for any optical element, the combination of free-form optical surfaces adapted to provide a lens for variable optical power, is formed by standardized surfaces with free form with optical properties that are independent of the individual optical properties of the individual eye into which the intraocular lens is implanted. 10 2. Lens volgens conclusie 1, met het kenmerk dat het ten minste ene aangepaste optische ijkoppervlak is ingericht voor het verschaffen van een gestandaardiseerde lichtbundel, welke bundel optisch is gecorrigeerd voor ten minste één afwijking in afzonderlijke optische eigenschappen van het afzonderlijke hoornvlies van het 15 afzonderlijke oog, waarbij het hoornvlies de afzonderlijke component van het oog vormt, waarin de intraoculaire lens wordt geïmplanteerd.2. A lens according to claim 1, characterized in that the at least one adapted optical calibration surface is adapted to provide a standardized light beam, which beam is optically corrected for at least one deviation in individual optical properties of the individual cornea of the individual cornea. eye, wherein the cornea forms the separate component of the eye into which the intraocular lens is implanted. 3. Lens volgens conclusie 2, met het kenmerk dat het ten minste ene aangepaste optische ijkoppervlak is ingericht voor het verschaffen van optische correctie voor ten 20 minste één afwijking in afzonderlijke focale sterkte van het afzonderlijke hoornvlies.3. A lens according to claim 2, characterized in that the at least one adjusted optical calibration surface is adapted to provide optical correction for at least one deviation in individual focal strength of the individual cornea. 4. Lens volgens conclusie 2, met het kenmerk dat het ten minste ene aangepaste optische ijkoppervlak is ingericht voor het verschaffen van optische correctie voor ten minste één afwijking in ten minste één afzonderlijk astigmatisme van het hoornvlies. 25A lens according to claim 2, characterized in that the at least one adapted optical calibration surface is adapted to provide optical correction for at least one deviation in at least one separate astigmatism of the cornea. 25 5. Lens volgens conclusie 2, met het kenmerk dat het ten minste ene aangepaste optische ijkoppervlak is ingericht voor het verschaffen van optische correctie voor ten minste één afwijking in afzonderlijke asfericiteit van het hoornvlies.A lens according to claim 2, characterized in that the at least one adjusted optical calibration surface is adapted to provide optical correction for at least one deviation in individual aspheric corneal integrity. 6. Lens volgens conclusie 1, met het kenmerk dat het ten minste ene aangepaste optische ijkoppervlak is ingericht voor het verschaffen van optische correctie voor een afwijking in de afzonderlijke voorste kamerdiepte, waarbij de afzonderlijke voorste kamerdiepte de afzonderlijke component van het oog is.The lens of claim 1, characterized in that the at least one adjusted optical calibration surface is adapted to provide optical correction for a deviation in the individual anterior chamber depth, wherein the individual anterior chamber depth is the individual component of the eye. 7. Lens volgens conclusie 1, met het kenmerk dat het aangepaste optische ijkoppervlak is ingericht voor het verschaffen van optische correctie voor ten minste twee optische afwijkingen die worden veroorzaakt door elke combinatie van componenten van het afzonderlijke oog volgens conclusie 2 tot en met 6. 5A lens according to claim 1, characterized in that the adjusted optical calibration surface is adapted to provide optical correction for at least two optical aberrations caused by any combination of components of the separate eye according to claims 2 to 6. 5 8. Lens volgens conclusie 7, met het kenmerk dat het aangepaste optische ijkoppervlak is ingericht voor het verschaffen van een gestandaardiseerde lichtbundel die optisch is gecorrigeerd voor de afwijking in de afzonderlijke convergentiegraad van de lichtbundel. 108. A lens according to claim 7, characterized in that the adjusted optical calibration surface is adapted to provide a standardized light beam that is optically corrected for the deviation in the individual degree of convergence of the light beam. 10 9. Lens volgens conclusie 7, met het kenmerk dat het optische ijkoppervlak is ingericht voor het verschaffen van een gestandaardiseerde lichtbundel die optisch is gecorrigeerd voor de afwijking in de afzonderlijke doorsneegrootte van de lichtbundel.A lens according to claim 7, characterized in that the optical calibration surface is adapted to provide a standardized light beam which is optically corrected for the deviation in the individual cross-sectional size of the light beam. 10. Lens volgens conclusie 7, met het kenmerk dat het aangepaste optische ijkoppervlak is ingericht voor het verschaffen van een gestandaardiseerde lichtbundel die optisch is gecorrigeerd voor de afwijking in de afzonderlijk doorsneevorm van de lichtbundel.10. A lens according to claim 7, characterized in that the adjusted optical calibration surface is adapted to provide a standardized light beam which is optically corrected for the deviation in the separate cross-sectional shape of the light beam. 11. Lens volgens conclusie 7, met het kenmerk dat het optische ijkoppervlak is ingericht voor het verschaffen van een gestandaardiseerde lichtbundel die optisch is gecorrigeerd voor elke afwijking in elke combinatie van convergentie, doorsneegrootte en doorsneevorm van de lichtbundel volgens conclusie 8 tot en met 10.A lens according to claim 7, characterized in that the optical calibration surface is adapted to provide a standardized light beam that is optically corrected for any deviation in any combination of convergence, cross-sectional size and cross-sectional shape of the light beam according to claims 8 to 10. 12. Werkwijze voor het vervaardigen van een accommoderende intraoculaire lens volgens één van de conclusies 1-11, welke lens het gestandaardiseerde oppervlak met vrije vorm voor de variabele lens omvat, met het kenmerk dat de werkwijze ten minste één klinisch onderzoek van het afzonderlijke oog omvat, voorafgaand aan het vervaardigen van de accommoderende lens, welk onderzoek is ingericht om een 30 specificatie te verschaffen van de afzonderlijke afwijking in ten minste één afzonderlijke optische eigenschap van de overeenkomstige standaard eigenschap van het modeloog waarop de eigenschappen van de optische oppervlakken met vrije vorm van de variabele lens zijn gebaseerd, waarbij ten minste één afzonderlijke optische eigenschap afhangt van ten minste één afwijking in ten minste één afzonderlijke component van het oog van de overeenkomstige component van het modeloog waarop de eigenschappen van de optische oppervlakken met vrije vorm van de variabele lens zijn gebaseerd.A method of manufacturing an accommodating intraocular lens according to any one of claims 1 to 11, which lens comprises the standardized free-form surface for the variable lens, characterized in that the method comprises at least one clinical examination of the individual eye prior to manufacturing the accommodating lens, which examination is arranged to provide a specification of the individual deviation in at least one separate optical property from the corresponding standard property of the model eye on which the properties of the free-form optical surfaces of the variable lens are based, wherein at least one separate optical property depends on at least one deviation in at least one individual component of the eye from the corresponding component of the model eye on which the properties of the free-form variable surface optical surfaces are based. 13. Werkwijze volgens conclusie 12, met het kenmerk dat de werkwijze ten minste één berekeningswijze omvat die is ingericht voor het verschaffen van de vorm van het aangepaste optische ijkoppervlak, waarbij de berekeningswijze een zodanig ontwerp van het ijkoppervlak verschaft dat het ijkoppervlak de vereiste ten minste ene optische correctie verschaft voor ten minste één afwijking in de ten minste ene afzonderlijke 10 optische eigenschap van de overeenkomstige standaard eigenschap van het modeloog.A method according to claim 12, characterized in that the method comprises at least one calculation method adapted to provide the shape of the adjusted optical calibration surface, the calculation method providing a design of the calibration surface such that the calibration surface has the required at least one optical correction provided for at least one deviation in the at least one separate optical property from the corresponding standard property of the model eye. 14. Werkwijze voor het vervaardigen van een lens volgens conclusie 13, met het kenmerk dat de werkwijze een wijze van vormgeven omvat die is ingericht voor het verschaffen van ten minste één dergelijk gestandaardiseerd oppervlak met vrije vorm 15 van de variabele lens, dat geschikt is voor ten minste één optisch element.14. A method of manufacturing a lens according to claim 13, characterized in that the method comprises a shaping method adapted to provide at least one such free-form standardized surface of the variable lens suitable for at least one optical element. 15. Werkwijze voor het vervaardigen van een lens volgens conclusie 14, met het kenmerk dat de werkwijze een wijze van vormgeven met één element omvat voor gestandaardiseerde oppervlakken met vrije vorm, die is ingericht voor het verschaffen 20 van één dergelijk gestandaardiseerd oppervlak met vrije vorm, dat geschikt is voor één optisch element.15. A method of manufacturing a lens according to claim 14, characterized in that the method comprises a one-element shaping method for standardized free-form surfaces, which is adapted to provide one such free-form standardized surface, that is suitable for one optical element. 16. Werkwijze voor het vervaardigen van een lens volgens conclusie 15, met het kenmerk dat de werkwijze ten minste één wijze van samenstellen omvat, die is 25 ingericht voor het verbinden van ten minste twee optische elementen te verbinden voor het vormen van een accommoderende intraoculaire lens.16. A method of manufacturing a lens according to claim 15, characterized in that the method comprises at least one method of assembling, which is arranged for connecting at least two optical elements to be connected to form an accommodating intraocular lens . 17. Werkwijze voor het vervaardigen van een lens volgens conclusie 15, met het kenmerk dat de werkwijze ten minste één wijze van vormgeven met twee elementen 30 omvat, die is ingericht voor het verschaffen van de aanvankelijke fabricagecomponent, de lens-fabricageknop, waarbij de gestandaardiseerde oppervlakken met vrije vorm direct met elkaar worden verbonden door de wijze van vormgeven.A method of manufacturing a lens according to claim 15, characterized in that the method comprises at least one form of shaping with two elements 30, which is adapted to provide the initial manufacturing component, the lens manufacturing button, the standardized Free-form surfaces are directly connected to each other by the manner of shaping. 18. Werkwijze volgens conclusie 17, met het kenmerk dat de wijze van vormgeven is ingericht voor het vestigen van insluiting, in de lens-fabricageknop, van ten minste één vorminzetstuk voor de gestandaardiseerde oppervlakken met vrije vorm.A method according to claim 17, characterized in that the shaping method is adapted to establish containment, in the lens manufacturing button, of at least one shaping insert for the standardized surfaces with free form. 19. Werkwijze volgens conclusie 18, met het kenmerk dat de werkwijze extra wijzen van vormgeven omvat voor optische oppervlakken, die geschikt zijn voor de vervaardiging van de extra optische oppervlakken, waarbij met extra optische oppervlakken wordt bedoeld de voorste optische zijde aan het voorste optische element en de achterste optische zijde aan het achterste optische element. 10A method according to claim 18, characterized in that the method comprises additional shaping methods for optical surfaces which are suitable for the manufacture of the additional optical surfaces, wherein additional optical surfaces are understood to mean the front optical side on the front optical element and the rear optical side on the rear optical element. 10 20. Werkwijze volgens conclusie 18, met het kenmerk dat de werkwijze extra wijzen van vormgeven omvat voor een lensvorm, die zijn ingericht voor het verschaffen van de buitendimensies, de vorm van de optische elementen, de vorm van de haptiek en de vorm van alle extra ondersteunende componenten.A method according to claim 18, characterized in that the method comprises additional shaping methods for a lens shape, which are adapted to provide the outer dimensions, the shape of the optical elements, the shape of the haptics and the shape of all the additional supporting components. 21. Werkwijze volgens één van de conclusies 12 tot en met 20, met het kenmerk dat de werkwijze ten minste één werkwijze voor het machinaal bewerken van de lens omvat, die is ingericht voor het vervaardigen van de extra optische oppervlakken of de vorm van de accommoderende intraoculaire lens. 20A method according to any one of claims 12 to 20, characterized in that the method comprises at least one method of machining the lens, which is arranged for manufacturing the additional optical surfaces or the shape of the accommodating intraocular lens. 20 22. Werkwijze volgens conclusie 21, met het kenmerk dat de werkwijze voor het machinaal bewerken van de lens ten minste één werkwijze voor het bewerken van de lens op een draaibank omvat, die is ingericht voor de vervaardiging van ten minste één optisch oppervlak. 25A method according to claim 21, characterized in that the method of machining the lens comprises at least one method of machining the lens on a lathe, which is adapted to manufacture at least one optical surface. 25 23. Werkwijze volgens conclusie 22, met het kenmerk dat de werkwijze voor het machinaal bewerken van de lens ten minste één maalwerkwijze omvat, die is ingericht voor de vervaardiging van ten minste één vorm.A method according to claim 22, characterized in that the method for machining the lens comprises at least one grinding method, which is adapted to manufacture at least one form. 24. Werkwijze volgens één van de conclusies 14 tot en met 23, met het kenmerk dat de werkwijze elke combinatie van ten minste één wijze van vormgeven, ten minste één werkwijze op de draaibank en ten minste één gietwerkwijze omvat, welke combinatie is ingericht voor de vervaardiging van elke combinatie van alle optische oppervlakken en elke vorm van elke component van de accommoderende intraoculaire lens.Method according to one of claims 14 to 23, characterized in that the method comprises any combination of at least one shaping method, at least one method on the lathe and at least one casting method, which combination is adapted for the manufacture of any combination of all optical surfaces and any shape of any component of the accommodating intraocular lens. 25. Lens volgens één van de conclusies 1-11, die is vervaardigd volgens de 5 werkwijze voor het vervaardigen van een accommoderende intraoculaire lens volgens één van de conclusies 12-24, met het kenmerk dat de lens elke combinatie van ten minste twee gestandaardiseerde optische oppervlakken met vrije vorm voor de variabele lens omvat, en extra optische oppervlakken met inbegrip van ten minste één aangepast optisch ijkoppervlak en ten minste één lens met een vaste focale sterkte. 1025. A lens according to any one of claims 1-11, which is manufactured according to the method for manufacturing an accommodating intraocular lens according to any one of claims 12-24, characterized in that the lens comprises any combination of at least two standardized optical variable-shape surfaces for the variable lens, and additional optical surfaces including at least one adjusted optical calibration surface and at least one fixed focal-strength lens. 10 26. Lens volgens conclusie 25, met het kenmerk dat de lens is ingericht voor het verschaffen van herstel van de accommodatie van het presbyope oog en voor correctie van de breking van het afakische oog.A lens according to claim 25, characterized in that the lens is adapted to provide restoration of the accommodation of the presbyopic eye and to correct the refraction of the aphakic eye.
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