WO2021007377A1 - Conceptions de lentille intraoculaire pour résultat clinique optimal - Google Patents

Conceptions de lentille intraoculaire pour résultat clinique optimal Download PDF

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Publication number
WO2021007377A1
WO2021007377A1 PCT/US2020/041288 US2020041288W WO2021007377A1 WO 2021007377 A1 WO2021007377 A1 WO 2021007377A1 US 2020041288 W US2020041288 W US 2020041288W WO 2021007377 A1 WO2021007377 A1 WO 2021007377A1
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WO
WIPO (PCT)
Prior art keywords
iol
lens
shape factor
spherical aberration
eye
Prior art date
Application number
PCT/US2020/041288
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English (en)
Inventor
Yueai Liu
Original Assignee
Aaren Scientific Inc.
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 Aaren Scientific Inc. filed Critical Aaren Scientific Inc.
Priority to CN202080015006.XA priority Critical patent/CN113423362A/zh
Publication of WO2021007377A1 publication Critical patent/WO2021007377A1/fr

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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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular 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
    • A61F2/1637—Correcting aberrations caused by inhomogeneities; correcting intrinsic aberrations, e.g. of the cornea, of the surface of the natural lens, aspheric, cylindrical, toric lenses
    • A61F2/164—Aspheric lenses
    • G—PHYSICS
    • G02—OPTICS
    • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C2202/00—Generic optical aspects applicable to one or more of the subgroups of G02C7/00
    • G02C2202/22—Correction of higher order and chromatic aberrations, wave front measurement and calculation
    • G—PHYSICS
    • G02—OPTICS
    • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00—Optical parts
    • G02C7/02—Lenses; Lens systems ; Methods of designing lenses

Definitions

  • This disclosure generally relates to a design of intraocular lenses that reduce the adverse impact on the clinical performance of the lens related to surgical induced misalignment of lens resulting in decentration and/or tilt and the variation of spherical aberration on the corneas in the patient population, and more particularly to an intraocular lens having an aspherical profile and exhibiting a certain amount of spherical aberration and a certain range of shape factors.
  • IOL implant surgery has resulted in the rise of more sophisticated surgical procedures and increasingly more complex IOL designs that have improved the quality of the lives of many.
  • Symptoms of misaligned IOLs may range from light ghosting of objects and double vision to astigmatism.
  • VA visual acuity
  • CS contrast sensitivity
  • Decentration occurs when the optical axis of the IOL is shifted from the visual axis of the eye so that the visual axis of the eye and the optical axis of the IOL are parallel to each other but at some offset. Decentration of an IOL may be the result of surgical placement of the lens, or it may develop in the postoperative period because of external (e.g. trauma, eye rubbing) or internal forces such as scarring or capsular contraction.
  • FIG. 1 A shows schematically IOL 10 properly positioned posteriorly to cornea 12 in the eye so that visual axis 14 of the eye and optical axis 16 of IOL 10 are congruent with one another.
  • FIG. 1B shows the decentration of
  • IOL 10 in that optical axis 16 is offset from visual axis 14 by some distance 18.
  • Lens tilt is defined as the angle between the IOL’s optical axis and the visual axis of the eye. Tilt of an IOL may be the result of inaccurate IOL surgical positioning, lack of capsular support, scleral tunnel positioning, and more. Tilt is shown in FIG. 1C where optical axis 16 of
  • IOL 10 is at some angular offset 20 from the eye’s visual axis 14.
  • IOL decentration of greater than 1 mm or a tilt of greater than 5 degrees noticeably decreases VA and CS. Additionally, multifocal or toric IOLs exacerbate the effects of decentration or tilt so that decentration of less than 1 mm or a tilt of less than 5 degrees may adversely impact VA and CS. Although proper placement of the IOL within the capsular bag has become more commonplace as surgery techniques have improved, decentration and/or tilt may still occur even after an uneventful surgery. Therefore, it is important to decrease the amount of decentration and/or tilt of an implanted IOL by not only the utilization of improved surgical techniques but also by incorporating certain design features into the IOL so that the clinical performance of the IOL is insensitive to decentration and/or tilt as disclosed herein.
  • a negative spherical aberration can be created on the IOL to counter this corneal aberration so that patients using an IOL may have vision with little to no spherical aberration.
  • U.S. Pat. No. 5,336,262 to Chu disclosed an intraocular lens suitable for scleral fixation having a disk-shaped lens optic with two flexible haptics projecting outwardly from opposite points on the lens optic's periphery.
  • Each haptic includes one or more suture holes for use in suturing the haptic to the ciliary sulcus of an eye during implantation surgery.
  • the suture holes are positioned such that they are located substantially at the haptic apexes when the lens is implanted, and the haptics have been flexed inwardly a predetermined amount.
  • U.S. Pat. No. 7,381,221 to Lang and et al discloses a multi-zonal monofocal IOL that comprises an inner zone, an intermediate zone, and an outer zone.
  • the inner zone has a first optical power.
  • the intermediate zone surrounds the inner zone and has a second optical power that is different from the first power by a magnitude that is less than at least about 0.75 Diopter.
  • the outer zone surrounds the intermediate zone and has a third optical power different from the second optical power.
  • Lang states that the intermediate zone may also provide correction in cases of decentralization or tilting of the lens when the intermediate zone has a correction power that is less than the correction power of the inner zone.
  • the Lang lens may have inherent tolerances against decentration or tilt, however, conceptually it is not a monofocal lens.
  • a series of monofocal or the spherical equivalent base curve of multifocal, toric, or extended depth of focus IOL having an optical power for implantation in an eye having a cornea comprising: an anterior surface having an anterior radius; and a posterior surface having a posterior radius where one of the surfaces is aspherical; wherein the anterior radius and the posterior radius, along with the refractive index of the lens material, determine the optical power; and wherein the anterior radius and the posterior radius determine a shape factor of the lens that is negative and selected to minimize the adverse effects of decentration and/or tilt of the lens.
  • An embodiment of the prior lens having a surface wherein any number of combinations of shape factor, conic constant, and/or aspheric coefficients may be modified to produce a certain spherical aberration that when combined with the spherical aberration of the cornea minimizes the overall ocular spherical aberration of the cornea and the IOL system.
  • Another embodiment is series of IOLs from low to high powers with a shape factor in the range from -0.45 to -0.8.
  • the variable shape factor in the power series allow for sharing of the radius of curvature for one of the two surfaces of the lens.
  • the embodiment shows the sharing of the radius of anterior surface curvature amongst a few adjacent diopters. This sharing strategy can be used for reducing the engineering complexity in manufacturing of the lenses
  • FIG. 1 A shows a schematic of a properly positioned IOL within the eye showing the cornea of the eye wherein the optical axis of the IOL is congruent with the visual axis of the eye.
  • FIG. 1B shows a schematic of a decentralized IOL within the eye showing the cornea of the eye wherein the optical axis of the IOL is parallel with the visual axis of the eye.
  • FIG. 1C shows a schematic of a tilted IOL within the eye showing the cornea of the eye wherein the optical axis of the IOL is at some angular offset with the visual axis of the eye.
  • FIG. 2 shows a chart depicting the relationship between the Zernike Standard
  • FIG. 3 A shows a chart depicting the relationship between the Zernike Standard
  • FIG. 3B shows a chart depicting the relationship between the Zernike Standard
  • FIG. 3C shows a chart depicting the relationship between the Zernike Standard
  • FIG. 4 shows graphs depicting the performance of aspheric designs of a mid-power IOL in terms of MTF with a spherical aberration of 0.0 mm at 3 mm aperture for ISO model eye 2.
  • FIG. 5 shows graphs depicting the performance of aspheric designs of a mid-power IOL in terms of MTF with a spherical aberration of -0.14 mm at 3 mm aperture for ISO model eye 2.
  • FIG. 6 shows graphs depicting the performance of aspheric designs of a mid-power IOL in terms of MTF with a spherical aberration of -0.28 mm at 3 mm aperture for ISO model eye 2.
  • FIG. 7 shows graphs depicting the performance of aspheric designs of a mid-power IOL in terms of MTF with a spherical aberration of 0.0 mm at 5 mm aperture for ISO model eye 2.
  • FIG. 8 shows graphs depicting the performance of aspheric designs of a mid-power IOL in terms of MTF with a spherical aberration of -0.14 mm at 5 mm aperture for ISO model eye 2.
  • FIG. 9 shows graphs depicting the performance of aspheric designs of a mid-power IOL in terms of MTF with a spherical aberration of -0.28 mm at 5 mm aperture for ISO model eye 2.
  • FIG. 10 shows a table containing the relevant lens parameters for the first embodiment of an IOL power series having an aspherical anterior lens and a spherical posterior lens where R a and R p yields a shape factor of -1.5 and a spherical aberration value of -0.19 mm.
  • FIG. 11 shows a table containing the relevant lens parameters for the second
  • an IOL power series having a spherical anterior lens and an aspherical posterior lens where R a and R p yields a shape factor between -0.45 to -0.75 and a spherical aberration value of -0.12 mm.
  • the present invention encompasses a series of IOL designs that reduces sensitivity to variations of spherical aberration existent on the cornea of the patient and clinical decentration and tilt of the IOL; as described in FIGs 1A, IB, and 1C; as measured by the Modulus Transfer
  • MTF Modulus of the OTF
  • MTF is a measure of visual performance that can be plotted vertically on a non- dimensional scale ranging from a minimum of 0.0 to a maximum of 1.0 against a horizontal range of a dimensional attribute. As MTF approaches 1.0 so will the VA or CS of the optical system improve. Conversely, as MTF approaches 0.0, so will the VA or CS of the optical system decrease. Theoretically, the MTF of any optical system including the human eye, can never reach to 1.0 at any spatial frequency other than 0. In this disclosure MTF will be plotted vertically against an attribute referred to as“focus shift” in millimeters. Focus shift represents the distance between the desired focus point in the eye, which is the retina, and the actual focal point.
  • a negative focus shift indicates a focal point that is in front of the retina while a positive focus shift indicates a focal point that is behind the retina.
  • the focus shift will be zero, that is the image being formed on the retina, resulting in excellent VA and CS.
  • the MTF decreases indicating that VA or CS has been degraded.
  • the lens system in the eye for this disclosure comprises the cornea and the IOL and is also known as the pseudophakic eye.
  • the principles disclosed herein may also be applied to a lens system for the eye that comprises the cornea, IOL, and the crystalline lens which is known as the phakic eye.
  • the IOL design that reduces sensitivity to decentration and tilt of the IOL is based on the shape factor of the IOL base lens.
  • An IOL consists of a circular disk portion, being a lens, usually having two or more side struts, called haptics, extending therefrom. The haptics hold the disk portion within the capsular bag of the eye.
  • the IOL deflects light by both the structure of the disk and the structure of any surface effect on the anterior or posterior surface of the circular disk.
  • the base lens is the lens defined by the structure of the disk and expressed as shape factor. Shape factor is dimensionless and is determined by the radii of the anterior and posterior curvature of the lens by the following formula according to ISO-
  • R a and R p are the anterior and posterior radius of curvature of the lens, respectively.
  • the shape factor of a lens may also be defined with
  • C a and C p are the anterior and posterior curvature of the lens, respectively.
  • shape factor will be defined as shown in Eq. 1.
  • FIG. 2 shows the relationship between Zernike Standard Coefficient Z 11 of the spherical aberration type in waves and the shape factor of an IOL.
  • the results shown in FIG. 2 indicates that an IOL with an increasingly negative shape factor produce an increasingly positive Zernike spherical aberration.
  • an IOL with an increasingly positive shape factor produces an increasingly negative Zernike spherical aberration.
  • the sign of the shape factor is in line with the definition in Eq. (1).
  • Zemax® markets a family of optical system design software that may be used to model and simulate lens systems in the human eye. Their software is used in the analysis that follows.
  • the cornea is the first lens element of the human eye and generally has a positive spherical aberration from the fact that the human cornea has a prolate shape that produces a negative comeal Q value.
  • FIG. 2 it was shown that lenses with a positive shape factor inherently has a negative spherical aberration. Therefore, it becomes natural that IOLs with a certain positive shape factor will be able to compensate for the positive spherical aberration existing on the human cornea. IOLs with this positive shape factor will possess the“best form” for overall spherical aberration reduction in the aphakic eye.
  • Prior art such as U.S. Patent
  • FIG. 2 shows the effect of a lens’ shape factor on spherical aberration lens as discussed earlier.
  • a lens’ dioptric power also has an effect on spherical aberration along with the variation of lens shape factor.
  • FIGs 3 A, B, and C shows that
  • IOLs with a lower dioptric power will exhibit a lower Z 11 absolute spherical aberration than
  • FIG. 3A shows that the absolute value for Z 11 at an aperture of 6 mm in waves for an IOL of 10 diopters that ranges from zero to roughly 0.025 while FIG. 3C shows a range of zero to roughly 0.5 for an IOL of 30 diopters.
  • FIG. 3B shows an absolute value for Z 11 at an aperture of 6 mm in waves for an IOL of 20 diopters that ranges from zero to roughly 0.17.
  • FIGs 4 through 9 shows varying simulations in the form of charts to demonstrate the performance of IOL with various shape factors under three conditions: On- Axis where the IOL is properly positioned witting the capsular bag, 1.0 mm Decentered where decentration 20 in FIG.
  • IB is one millimeter, and 5° Tilted where tilt angle 22 shown in FIG. 1C is five degrees.
  • nine simulations were run for the following shape factors: -2.0, -1.5,
  • each of figures 4 through 9 contains 27 charts representing 27 simulations.
  • the y-axis for each chart ranges from 0.0 to 1.0 and represents the
  • MTF determined by the simulation. As discussed earlier, as MTF approaches 1.0 VA and CS is improved and as MTF approaches zero VA and CS is degraded.
  • the x-axis for each chart ranges from -0.3 mm to 0.3 mm and represents the focal shift from zero, or the retina.
  • the four lines in each of the charts are defined as follows:
  • the solid line shows the results of the simulation in the sagittal plane at a resolution of 50 lp/mm.
  • the dash dotted line shows the results of the simulation in the sagittal plane at a resolution of 100 lp/mm.
  • Axis column of simulations only shows the solid line for MTF performance at 50 lp/mm and the dash dotted line for MTF performance at 100 lp/mm.
  • FIG. 4 shows simulations of the three conditions as to various shape factors for an aspheric mid-power IOL at 3 mm aperture and a spherical aberration of 0.0 mm.
  • FIG. 5 is similar to FIG. 4 but for a spherical aberration of -0.14 mm.
  • FIG. 6 is similar to FIG. 4 but for a spherical aberration of -0.28 mm.
  • FIG. 7 shows simulations of the three conditions as to various shape factors for an aspheric mid-power IOL at 5 mm aperture and a spherical aberration of 0.0 mm.
  • FIG. 8 is similar to FIG. 7 but for a spherical aberration of -0.14 mm.
  • FIG. 9 is similar to
  • FIG. 7 but for a spherical aberration of -0.28 mm. All simulations were performed using an ISO model eye 2 with spherical aberration matching that of the IOL.
  • r is the radius of the lens aperture
  • c is the coverture of the lens surface
  • k is the conic constant
  • a i is the aspheric coefficient.
  • IOL or aspheric coefficients. Both shape factor and aspheric parameters can be optimized for optimal clinical outcome.
  • FIG. 10 shows a first embodiment being a family of lenses where the anterior surface is aspherical and the posterior surface is spherical for a 5 mm model eye where the spherical aberration of the IOL offsets the spherical aberration of the cornea.
  • a 6 , and A 8 are determined so that each lens in this family of lenses will have a shape factor of -
  • MTF25 shows the MTF value at focus with zero decentration and zero tilt at 25 lp/mm.
  • MTF50 shows the MTF value at focus with zero decentration and zero tilt at 50 lp/mm.
  • MTF 100 shows the MTF value at focus with zero decentration and zero tilt at 100 lp/mm.
  • FIG. 11 shows a second embodiment being a family of lenses where the anterior surface is spherical and the posterior surface is aspherical for a 5 mm model eye where the spherical aberration of the IOL offsets the spherical aberration of the cornea.
  • the aspheric coefficients A 4 and A 6 are determined so that each lens in this family of lenses will have a shape factor in the range of -0.75 to -0.45 with a spherical aberration of -0.12 mm.
  • MTF25 shows the MTF value at focus with zero decentration and zero tilt at 25 lp/mm.
  • MTF50 shows the MTF value at focus with zero decentration and zero tilt at 50 lp/mm.
  • MTF 100 shows the MTF value at focus with zero decentration and zero tilt at 100 lp/mm.

Abstract

La présente invention concerne une lentille intraoculaire (LIO) qui est, par exemple mais non exclusivement : monofocale, torique, multifocale ou à profondeur de champ étendue, à implanter dans la chambre postérieure du sac capsulaire d'un œil humain. La LIO a une partie optique sensiblement en forme de disque comprenant deux haptiques flexibles faisant saillie vers l'extérieur depuis des points opposés de la partie optique pour fixer la LIO à l'intérieur du sac capsulaire. La partie optique a un rayon de courbure de surface antérieure R a et un rayon de courbure de surface postérieure R p qui définissent un facteur de forme (X) où X = (R a + R p ) / (R a - R p ) de telle sorte que le facteur de forme de la LIO est inférieur à zéro et au moins l'une des surfaces antérieure ou postérieure a une hauteur sagittale pour donner à la LIO une aberration sphérique particulière pour compenser l'aberration sphérique normalement positive de la cornée humaine.
PCT/US2020/041288 2019-07-09 2020-07-08 Conceptions de lentille intraoculaire pour résultat clinique optimal WO2021007377A1 (fr)

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CN202080015006.XA CN113423362A (zh) 2019-07-09 2020-07-08 用于最佳临床结果的人工晶状体设计

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US201962872008P 2019-07-09 2019-07-09
US62/872,008 2019-07-09

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114748242B (zh) * 2022-04-13 2023-01-10 南开大学 一种波前引导屈光手术的角膜切削量设计方法和装置

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US20060116763A1 (en) * 2004-12-01 2006-06-01 Simpson Michael J Contrast-enhancing aspheric intraocular lens
US20060244904A1 (en) * 2005-04-05 2006-11-02 Xin Hong Intraocular lens
US20070093891A1 (en) * 2005-10-26 2007-04-26 Juan Tabernero Intraocular lens for correcting corneal coma
US20160193037A1 (en) * 2014-09-09 2016-07-07 Staar Surgical Company Ophthalmic implants with extended depth of field and enhanced distance visual acuity
US20170245985A1 (en) * 2016-02-09 2017-08-31 Amo Groningen B.V. Progressive power intraocular lens, and methods of use and manufacture

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US6767363B1 (en) * 1999-11-05 2004-07-27 Bausch & Lomb Surgical, Inc. Accommodating positive and negative intraocular lens system
US7998198B2 (en) * 2008-02-07 2011-08-16 Novartis Ag Accommodative IOL with dynamic spherical aberration

Patent Citations (5)

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Publication number Priority date Publication date Assignee Title
US20060116763A1 (en) * 2004-12-01 2006-06-01 Simpson Michael J Contrast-enhancing aspheric intraocular lens
US20060244904A1 (en) * 2005-04-05 2006-11-02 Xin Hong Intraocular lens
US20070093891A1 (en) * 2005-10-26 2007-04-26 Juan Tabernero Intraocular lens for correcting corneal coma
US20160193037A1 (en) * 2014-09-09 2016-07-07 Staar Surgical Company Ophthalmic implants with extended depth of field and enhanced distance visual acuity
US20170245985A1 (en) * 2016-02-09 2017-08-31 Amo Groningen B.V. Progressive power intraocular lens, and methods of use and manufacture

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