New monofocal intraocular lens for extended macular vision in patients with macular degeneration

Abstract

An intraocular lens system includes a single lens including two optical surfaces selected to maintain image quality at the center of the fovea while reducing image aberrations at preferred retinal sites outside the foveal region.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This PCT patent application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 770,999, filed on November 23, 2018. Where appropriate to teach additional or alternative details, features, and / or technical background, the disclosure of this provisional application is incorporated herein by reference in its entirety, and priority is claimed from each detail, feature, and / or technical background. Background Art

[0003] In the decades since the first introduction of intraocular lenses (IOLs), a major focus has been on optimizing the visual prognosis of normal-sighted individuals undergoing clear lens extraction and cataract surgery. This has led to the development of injectable soft acrylic IOLs designed to minimize surgically induced astigmatism, as well as aspheric lens optics to offset age-related positive spherical aberration of the cornea. Standard soft acrylic intraocular lenses are now able to provide tightly focused images at the fovea and consistent high-quality visual prognosis for otherwise healthy patients. However, the image quality provided by such lenses significantly decreases at only a few degrees outside the foveal center, and this may have a significant impact on the visual prognosis of patients with maculopathy, who typically use eccentric fixation to utilize a healthier retina outside the foveal center. Eyes suffering from age-related macular degeneration have poor contrast sensitivity and dark spots (usually central), which make them particularly sensitive to retinal image quality degradation. Patients with central macular disease can expect to have reduced visual quality with standard intraocular lenses, which exacerbates the poor contrast sensitivity and localized photoreceptor loss associated with diseases such as age-related macular degeneration (AMD). In addition, as diseases such as AMD progress, patients can expect the image quality provided to the preferred retinal site to deteriorate as more of the macula is affected.

[0004] Surgical options for patients with macular degeneration who undergo cataract extraction and intraocular lens implantation are extremely limited. To date, surgeons have largely used standard monofocal IOLs to target emmetropia and tightly focus the image at the center of the fovea in such patients; however, cone density is still relatively high at approximately 20,000 / mm at a retinal eccentricity of only 4 degrees (approximately 1.15 mm). 2 , but the image quality provided by standard IOLs rapidly deteriorates in this area 13 .

[0005] Alternatives include implanting an intraocular telescope to provide an amplified image or using a prism device to aim at a single PRL. Some devices adopt a combined approach. AMD patients often rely on utilizing multiple preferred retinal sites to complete daily living activities, so the disadvantage of aiming at a specific PRL is that the image quality at other retinal sites used for daily living activities will be compromised. If the patient begins to rely on another PRL as the disease progresses, any image optimization at a specific PRL may also become completely redundant.

[0006] Intraocular telescopes attempt to exploit the advantages of handheld magnifiers by conferring the optical advantages of intraocular magnification and eliminating the need for hand-eye coordination. Such devices are often relatively large and complex and more difficult to safely implant than standard IOLs. Depending on the magnification, the main disadvantage of intraocular telescopes is the resulting reduction in peripheral visual field. With some devices, the peripheral visual field may be limited, making implantation in only one eye possible. Intraocular telescopes also disperse a limited amount of light over a wider area of ​​the retina, thus inevitably reducing the contrast of the resulting image. Therefore, both intraocular telescopes and prismatic devices may impair the patient's natural mechanisms for coping with central visual field defects and therefore affect visual function, as both contrast sensitivity and fixation stability are related to reading ability. Similarly, if the device is implanted in only one eye, reading function is likely to be disrupted because it will impair binocular summation and affect the scanning of the image on the macula that occurs during reading.

[0007] The evolution of a single injectable soft polymer (e.g., acrylic) intraocular lens for implantation in the capsular bag herein, wherein the optics are uniquely configured to provide a focused image to all areas of the macula extending from the center of the fovea to 10 degrees, is an advancement in the art. The optics are designed to maintain image quality at the center of the fovea for patients with early-stage disease. By correcting the optical aberrations generated when the patient gazes eccentrically up to 10 degrees of retinal eccentricity, the IOL of the embodiments optimizes visual potential in macular disease and prevents progressive vision loss. It is estimated that a +2D to +3.5D target utilizing this new intraocular lens can also provide 10% to 20% magnification utilizing glasses, but this is not necessary for the mechanism of action. Summary of the invention

[0008] In an embodiment of the invention, a one-piece, injectable, soft, hydrophobic polymer (e.g., acrylic) intraocular lens is provided that is designed to be placed in the capsular bag. The lens optics are uniquely optimized to provide enhanced image quality anywhere in the macula for eccentric gaze from 0 to 10 degrees in any direction from the center of the fovea. The embodiment lens achieves its effect by being shaped to minimize the optical aberrations generated by a standard lens if the patient is to gaze eccentrically. The embodiment lens is designed to have a radius and cone constant that provides a focused image at the center of the fovea and reduces higher-order aberrations over an entire area extending to (but not necessarily limited to) 10 degrees from the center of focus along all gaze directions.

[0009] Compared to standard monofocal IOLs, the new lenses provide better image quality at increased retinal eccentricities, with potential benefits for patients with maculopathy. Embodiment IOLs can be used to target hyperopic postoperative refraction: a target of +2D to +3.5D can provide 10% to 20% magnification with glasses. Emmetropia or myopia results can be targeted in individuals with better visual potential, or to avoid postoperative anisometropia (as in the case of standard monofocal IOLs).

[0010] Embodiment IOLs may be available in the following powers: 11, 13, 15, 17, 19, 21, 23, and 25 D, but embodiment IOLs are not limited to this range of powers. The appropriate IOL power for an individual eye may be estimated in a manner similar to a standard IOL implanted during cataract surgery, using the SRK / T (or similar) biometric formula and an A constant of 119.2.

[0011] The IOL of the embodiments provides significant advantages over existing intraocular telescopes in the treatment of macular diseases. In contrast, intraocular telescopes such as the Implantable Micro Telescope (IMT) and the Intraocular Lens for the Visually Impaired (IOL-VipTM) are expensive and complex devices that are relatively inconvenient to use due to the large incisions required in the eye, reduced visual field, risk of corneal decompensation, and the need for postoperative visual rehabilitation. 11,12 , its risk-return characteristics become less attractive.

[0012] In an embodiment, the present invention is a one-piece, injectable, soft, hydrophobic polymer (e.g., acrylic) IOL designed to sit in the capsular bag. The lens optics are uniquely optimized to provide enhanced image quality in all macular regions extending 10° from the center of the fovea, and the device thus constitutes a new class of IOLs.

[0013] As described in Example 1, the lens provides better image quality at increased retinal eccentricities compared to a standard monofocal IOL, with potential benefits for patients with maculopathy. IOL embodiments of the present invention can also be used to target hyperopic postoperative refraction. For example, a +2.00 to +3.50 diopter target can provide 10% to 20% magnification using glasses, but the degree of hyperopia may be increased or decreased depending on the severity of the maculopathy and the patient's preference or adaptability to this approach. Emmetropia or myopia outcomes can be targeted in individuals with better visual potential, or to avoid postoperative anisometropia (as in the case of a standard monofocal IOL).

[0014] In an embodiment, an intraocular lens system for improving a patient's vision to enhance the image quality of the entire macular area extending 10% from the center of the fovea is provided, the intraocular lens system comprising: a lens having a first surface and a second surface and providing a refractive power of P diopters; the lens being characterized by an optical zone diameter (D) and a central thickness (T); the first surface being a spherical surface having a first radius of curvature (R1); the second surface being a rotationally symmetric conical surface having a second radius of curvature (R2) and having a surface sag (z coordinate), the surface sag being given by the following formula as a function of a radial coordinate (r):

[0015]

[0016] Where: c = 1 / R2

[0017] k = constant.

[0018] In a specific embodiment, the preferred variables are P = 11 diopters, D = 6.00 mm, T = 0.7 mm, R1 = 19.99 mm, R2 = -143.7 mm, and k = -12.7. In another specific embodiment, the preferred variables are P = 17 diopters, D = 6.00 mm, T = 0.7 mm, R1 = 110.53 mm, R2 = -12.96 mm, and k = -12.7. In yet another specific embodiment, the preferred variables are P = 25 diopters, D = 6.00 mm, T = 0.7 mm, R1 = -45.52 mm, R2 is in the range from -6 mm to -19 mm, and k = -12.7. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Embodiments of the invention are illustrated in the accompanying drawings, in which:

[0020] Figure 1 It is a schematic diagram of the design process.

[0021] Figure 2is a side view of an embodiment of an IOL providing 17 diopters of optical power.

[0022] Figure 3 is a side view of an embodiment of an IOL providing 19 diopters of optical power.

[0023] Figure 4 is a side view of an embodiment of an IOL providing 21 diopters of optical power.

[0024] Figure 5 is a side view of an embodiment of an IOL providing 23 diopters of optical power.

[0025] Figure 6 is a side view of an embodiment of an IOL providing 25 diopters of optical power. DETAILED DESCRIPTION

[0026] Standard monofocal IOLs provide a focused image to the fovea. In patients with dry AMD, central GA often results in functional vision loss at the fovea. However, if the patient is able to fixate eccentrically, there is still sufficient receptor density / visual function in the peripheral macula to enable the patient to maintain functional vision.

[0027] The present invention, as disclosed herein in an embodiment of the IOL, is designed to maintain image quality at the center of the fovea, but corrects the optical aberrations that would be generated by a standard monofocal IOL when the eye is tilted to adopt eccentric gaze. This optimizes image quality in any area within 10 degrees of the foveal center, thereby facilitating the use of these areas as a PRL and improving functional outcomes after implantation. The goal is to provide a good retinal image at up to 10 degrees of eccentricity while having the option of appropriate magnification when combined with external glasses to correct for a maximum +3D refractive target.

[0028] The IOL design of the embodiments can be performed using commercially available ray tracing software (Zemax OpticStudio, Zemax LLC, USA) in an eye model describing an average eye known from the literature (Liou-Brenan: Liou HL, Brennan NA. Anatomically accurate, finite model eye for optical modelling. J Opt Soc Am A. 1997; 14(8): 1684-1695.). Figure 1 is a schematic diagram of how the design process is implemented.

[0029] Ray tracing techniques can be used to optimize the optical performance of different IOLs in the previously described eye model. Optical design software (Zemax OpticStudio, Zemax LLC, USA) can be used. Once the material is selected, a merit function can be developed to design the IOL of the embodiment. Generally, parameters can be selected from those parameters related to the expected performance of the lens. During the optimization process, different values ​​can be systematically assigned to the independent variables. Subsequently, those values ​​can be used to calculate the selected merit function components. The goal is to find a set of values ​​of the variables that minimize the merit function. Ideally, the process ends with finding a global or absolute minimum rather than a local minimum. The generated merit function contains constraints on the geometric parameters of the IOL to keep it within a physiologically compatible range. In this example, the variable parameters used for optimization are the thickness of the lens, the position of the lens in the capsule, the radius of curvature, and the asphericity of different surfaces. Three configurations are included in the merit function at the same time, corresponding to the incident beam on the axis in the horizontal direction, with an eccentricity of 5 degrees and an eccentricity of 10 degrees.

[0030] The IOLs of various embodiments have the following common features:

[0031] The front surface is a standard spherical surface with a curvature range or a curvature radius, and the rear surface is a rotationally symmetric conical surface.

[0032] The surface depression (z coordinate) as a function of the radial coordinate r is given by:

[0033]

[0034] Where c is the reciprocal of the radius of curvature R: c = 1 / R

[0035] For a specific non-restrictive 17D version of the lens, the relevant parameters are:

[0036] Optical zone diameter: 6.00mm

[0037] Central thickness: 0.7mm

[0038] First (front) surface:

[0039] Standard sphere

[0040] The radius of curvature is 110.53mm

[0041] Second (rear) surface:

[0042] Rotationally symmetric conical surface. The surface depression (z coordinate) as a function of the radial coordinate r is given by:

[0043]

[0044] Where c is the reciprocal of the radius of curvature R: c = 1 / R

[0045] The specific parameters are:

[0046] R=-12.96mm

[0047] k = -12.7

[0048] Using these values ​​and units, z in mm is obtained.

[0049] For the standard IOL reference in the design, the same eye model can be used (Liou-Brennan cornea, axial length 23.5 mm), but instead of the IOL of the embodiment, the optimal refractive power required for the IOL to focus light on the retina is modeled. For this eye model and this IOL position (the axial distance from the second corneal surface to the front IOL is also 4.16 mm), a 21.5D IOL (immersed in a refractive index of 1.336) with a spherical surface (the radii of curvature of the front and back surfaces are 27.51 mm and -14.59 mm, respectively) with a refractive index of 1.54 and a thickness of 0.70 mm is used.

[0050] To evaluate the image quality of the IOL of the embodiment, a NIMO instrument (LAMBDA-X, Nivelles, Belgium) was used, which included an optical bench and whose software version was 4.5.15. The working principle of the instrument is based on the phase shift schlieren technique. 71,72 . By combining the Schlieren imaging principle with the phase shift method, the NIMO instrument allows the measurement of beam deviations that can be used to calculate the wavefront analysis taking into account the 36 Zernikes coefficients. This technique has been shown to be effective in measuring the in vitro optical quality of intraocular lenses. The device complies with the International Organization for Standardization (ISO) 11979-216. All IOLs are measured while immersed in a saline solution with a composition of 0.154 milliequivalents of NaCl per milliliter (Laboratoires Sterop SA, Anderlecht, Belgium). The cuvette or wet cell used to keep the IOL and the saline solution in place during the measurement has been validated with the aid of an interferometer; and has been shown to have a refractive power of <0.005D. This additional cross-check of the wet cell is performed to exclude potential interferences with the measurement. Furthermore, accurate refractive power measurements can only be made if the setup has been thoroughly calibrated, which is why the instrument is calibrated for each measurement.

[0051] In Example 1, described in detail below, the axial length of the eye model was set to 23.5 mm. The corneal parameters (curvature, asphericity, thickness and refractive index) were taken from the Liou-Brennan eye model (reference). The retina was simulated as a -12 mm sphere, and the anterior IOL surface was axially set at 4.16 mm from the second surface of the cornea.

[0052] The external eyeglass lens was modeled using a refractive index of 1.585 (polycarbonate) and a central thickness of 5 mm, set at 12 mm (vertex distance) from the apex of the cornea. The radii of curvature of the front and back surfaces were 32 mm and 36 mm, respectively (+3 diopters). In addition, a +6D eyeglass lens was simulated (the object was set at 33 cm from the cornea), which had the same front curvature but a back radius of curvature of 44.7 mm. All calculations were performed at a wavelength of 550 nm and a pupil diameter of 3 mm.

[0053] The IOL lens of an embodiment is optimized to have a refractive index of 1.54 (for 550 nm), an Abbe number of 40, and a thickness of 0.70 mm.

[0054] The optimization process is repeated for different models with specified axial length values. This provides optimized lenses of different refractive powers. Figures 2 to 6 The actual shapes of the IOLs of the optimized embodiments of different refractive powers are shown. The corresponding emmetropia targets are located at the base of each lens. For these non-limiting examples, these methods were used for setup and alignment: As the refractive power of the IOL increases, the back surface of the lens becomes more curved, while the front surface changes the sign of curvature from positive curvature to flatter curvature and then to negative curvature. This is the result of the shape factor optimization process for each model.

[0055] Example 1

[0056] Research

[0057] A study was designed and conducted to evaluate the safety and preliminary outcomes following implantation of this novel intraocular lens in patients with advanced, bilateral age-related macular degeneration. Eight eyes of seven subjects with ≤1+ cataract (no LOCSIII grading parameter >2), bilateral advanced geographic atrophy / dry age-related macular degeneration (AMD), and preoperative corrected distance visual acuity ≥0.60 (CDVA; LogMAR) underwent lenticule extraction and IOL implantation with a hyperopic postoperative refractive target. The amount of target postoperative hyperopia was determined after careful discussion with the patient of the potential benefits of using this approach to provide magnification with spectacles while balancing the disadvantages of increased spectacles dependence for activities of daily living. All patients had moderate to severe visual loss in the operated eye, so a hyperopic outcome of 1.5 D to 4.5 D was chosen depending on individual circumstances (including consent for surgery on the second eye if necessary). Initial follow-up and assessments were performed at baseline, 1 week, 1 month, and 2 months.

[0058] The following examinations were performed at baseline and 1 week, 1 month, and 2 months after surgery: total subjective refraction, corrected near visual acuity (N point at 30 cm with LogMAR conversion), corrected distance visual acuity (LogMAR), intraocular pressure (Goldmann applanation tonometer), specular microscopy (Nidek CEM-530, Nidek Co. Ltd.; 3 acceptable images obtained from the central cornea), clinical examination, anterior segment OCT (Visante, Carl Zeiss Meditec AG), and macular OCT (Stratus OCT). TMCarlZeiss Meditec, Germany). Lens opacity was graded according to the LOCSIII system. Visual field was assessed by a full threshold 80-point test. After correction of refractive error in the operated eye 1 month after surgery, the MNREAD chart was used to assess reading acuity, critical print size, and reading speed. Microperimetry was performed at baseline and 1 to 2 months after surgery using a macular integrity assessor (MAIA, Ellex Medical Lasers Ltd.); additional microperimetry was performed at intervals of 1 to 3 months to confirm any changes observed. Microperimetry was performed using an "expert" algorithm under mesopic conditions without mydriasis to assess macular threshold sensitivity and fixation stability (37 points were tested in a 10-degree area centered on a preferred retinal site; 4-2 strategy; stimulus size was Goldmann III, duration 200ms). Exclusion criteria included: active choroidal neovascularization (CNV) treated within 6 months of recruitment; axial length >24.5 mm or <20.5 mm; uncontrolled glaucoma and intraocular surgery within 6 months of recruitment.

[0059] The mean age of the patients was 77 ± 16 years (range, 43 to 91), with a male to female ratio of 5:3. Surgery was performed by a single surgeon (MAQ) using standard techniques. Topical mydriatics were used for pupil dilation and anesthesia was induced by sub-Tenon delivery. A femtosecond laser surgical platform ( Fort Worth, Texas, USA) with a 5 mm capsulotomy and lens pulverization, and WHITESTAR The phacoemulsification system (Abbot Medical Optics, Abbot Laboratories Inc., Illinois, USA) was used to complete the lens extraction with a standard 2.6 mm corneal incision located at 100°. The capsular bag was filled with a viscous ophthalmic viscoelastic device (OVD), and the lens was then loaded into a syringe barrel, followed by injection into the capsular bag via the primary wound, lens centering, and OVD / balanced salt solution exchange. All subjects achieved a postoperative spherical equivalent within 1 D of the target refraction (mean +2.9 ± 1.3 D).

[0060] result

[0061] Specular microscopy showed a mean postoperative reduction in endothelial cell counts of 13% ± 14% (range 0%-37%). 2 eyes had a reduction of 37% and 31% - the subject was lost to follow-up after 2 weeks and lack of drop compliance may have accounted for these changes. Otherwise results were consistent with the expected reduction after standard phacoemulsification cataract surgery (4%-13%) 8 Results of 80-point visual field testing were similar before and after surgery (mean number of points seen was 50±31 before surgery and 53±27 after surgery), and anterior segment and macular OCT imaging showed a well-centered IOL and a stable macula after surgery. Intraocular pressure remained stable in all subjects after surgery—mean preoperative and postoperative intraocular pressures were 16±2.8 mmHg and 14±2 mmHg, respectively, at 2 months.

[0062] Postoperative MN reading data were unavailable for one subject. In the remaining subject, a modest improvement in mean reading visual acuity from 1.07±0.31 to 0.9±0.37LogMAR and a modest improvement in critical font size from 1.04±0.25 to 0.95±0.27 was observed. Mean reading speed was observed to increase from 28±19 words per minute to 44±31 words per minute, a 57% improvement.

[0063] In all but one subject's eyes, microperimetry data were obtained approximately 1 month and / or 2 months after surgery. An average improvement in microperimetry threshold sensitivity from 8.2 ± 4.6 dB to 12.0 ± 5.6 dB was observed. The average percentage of fixation points within a 4-degree circle increased from 77% ± 17% to 91% ± 11%. Although postoperative microperimetry data were not available for one subject, that individual's vision improved significantly in the postimplantation period. Minimal changes in microperimetry testing were observed in three eyes postoperatively, with signs of gradual improvement at 1 and 2 months in the remaining eyes.

[0064] Further microperimetry testing was performed on three of the operated eyes, and these data indicated a gradual improvement in visual function after the two-month time point. A progressive shift of the preferred retinal sites away from the area of ​​geographic atrophy was observed in these eyes. In subject 1, mean threshold sensitivity increased from 0 dB to 16.6 dB at 5 months, and the mean percentage of fixation points within a 4-degree circle increased from 64% to 94% in association. For this subject’s second eye, testing performed 4 months postoperatively indicated a slight decrease in mean threshold sensitivity from 4.2 dB to 3 dB, but an increase in the mean percentage of fixation points within a 4-degree circle from 57% to 93%, with these points concentrated in the narrow channel between the optic disc and the large area of ​​geographic atrophy. Testing of the third subject at 4 months showed an increase in threshold sensitivity from 12.9 dB to 27 dB, and a slight decrease in the mean percentage of fixation points within a 4-degree circle from 99% to 83%.

[0065] No symptoms of aniseikonia were reported, but all subjects subsequently went on to have the device implanted in their other eye.

[0066] The visual outcomes for the study subjects with moderate to severe age-related macular degeneration were consistent with the laboratory simulations, corresponding to an average improvement of 18 ETDRS letters in both distance and near visual acuity, and a mean increase in reading speed of 57% was observed. These results compare very favorably with published outcomes of cataract surgery in patients with AMD, including those undergoing CNV treatment—a recent meta-analysis showed that AMD subjects who underwent cataract surgery and were implanted with a standard monofocal IOL can expect to achieve a visual acuity improvement of 6.5 to 7.5 ETDRS letters after 6 to 12 months of follow-up. 9,10 .

[0067] Statement on the Preferred Embodiments

[0068] Although the present invention has been described with respect to the foregoing, it will be readily appreciated by those skilled in the art that various changes and / or modifications may be made to the present invention without departing from the spirit or scope of the invention as defined by the appended claims.

[0069] Abbreviations and acronyms

[0070] Age-related macular degeneration (AMD)

[0071] Bivariate Contour Ellipse Area Analysis (BCEA)

[0072] Confidence Interval (CI)

[0073] Corrected distance visual acuity (CDVA)

[0074] Corrected Near Vision (CNVA)

[0075] Choroidal neovascularization (CNV)

[0076] Early Treatment Diabetic Retinopathy Study (ETDRS)

[0077] Implantable Microtelescope (IMT)

[0078] Intraocular Lens (IOL)

[0079] Intraocular pressure (IOP)

[0080] Logarithm of the minimum angle of resolution (LogMAR)

[0081] Macular Integrity Assessment Instrument (MAIA)

[0082] Ophthalmic Viscoelastic Device (OVD)

[0083] Optical Coherence Tomography (OCT)

[0084] Preferred Retinal Site (PRL)

[0085] Standard error of the mean (SEM)

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Claims

1. An intraocular lens system for improving a patient's vision, the intraocular lens system comprising: a lens having a first surface and a second surface and providing a refractive power of P diopters; The lens is characterized by an optical zone diameter, denoted by D, and a central thickness, denoted by T; The first surface is a spherical surface having a first radius of curvature denoted by R1; The second surface is a rotationally symmetric conical surface having a second radius of curvature denoted by R2 and having a surface depression denoted by the z coordinate which is a function of the radial coordinate denoted by r and is given by: Where: c = 1 / R2, k＝-12.7； Where k is the cone constant, which remains constant as the refractive power increases beyond one diopter.

2. The intraocular lens system according to claim 1, wherein: As the optical power increases, the posterior surface of the lens becomes more curved, while the anterior surface changes the sign of curvature, from positive to flatter and then to negative.

3. The intraocular lens system of claim 1, wherein: P = 11 diopters D=6.00mm T=0.7mm R1=19.99mm R2=-143.7mm.

4. The intraocular lens system of claim 1, wherein: P = 17 diopters D=6.00mm T=0.7mm R1=110.53mm R2=-12.96mm.

5. The intraocular lens system of claim 1, wherein: P = 25 diopters D=6.00mm T=0.7mm R1=-45.52mm R2 = -6mm to -19mm.

Images