Novel monofocal intraocular lens for expanding macular vision for macular degeneration patients

Abstract

An intraocular lens system comprising a single lens comprising two optical surfaces selected to maintain image quality at the center of the fovea while reducing image aberration at a preferred retinal site location outside the fovea region.

Description

[0001] This application is a divisional application of the PCT international patent application with application number 201980077013.X, filing date November 21, 2019, and invention title "Novel Single-Focal Intraocular Lens for Extended Macular Vision in Patients with Macular Degeneration".

[0002] Cross-reference to related applications

[0003] This PCT patent application claims the priority benefit of U.S. Provisional Patent Application No. 62 / 770,999, filed November 23, 2018. The disclosure of this provisional application is hereby incorporated by reference in its entirety and priority is claimed from each of the details, features, and / or technical background, where appropriate to teach additional or alternative details, features, and / or technical background. Background art

[0004] For decades since the first introduction of intraocular lenses (IOLs), the main focus has been on optimizing the visual prognosis of normal vision individuals undergoing phacoemulsification 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 counteract age-related corneal positive spherical aberration. Currently, standard soft acrylic intraocular lenses can provide a tightly focused image at the fovea and a consistent high-quality visual prognosis for otherwise eye-healthy patients. However, the image quality provided by such lenses drops significantly just a few degrees outside the center of the fovea, and this can have a significant impact on the visual prognosis of patients with macular disease, who typically use eccentric fixation to utilize the healthier retina outside the center of the fovea. Eyes with age-related macular degeneration have poor contrast sensitivity and scotomas (usually central), making them particularly sensitive to a decrease in retinal image quality. Patients with central macular disease can expect reduced visual quality with standard intraocular lenses, which exacerbates the reduced contrast sensitivity and local 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 sites to deteriorate as more of the macula is affected.

[0005] The surgical options for patients with macular lesions undergoing cataract extraction and intraocular lens implantation are extremely limited. To date, surgeons have widely used standard single-focal IOLs with the goal of achieving emmetropia and tightly focusing the image at the center of the fovea in such patients; however, although the cone density is still relatively high at a retinal eccentricity of only 4 degrees (about 1.15 mm), approximately 20,000 / mm 2 , the image quality provided by standard IOLs drops rapidly in this region13 。

[0006] Alternative methods include implanting an intraocular telescope to provide a magnified image or using a prism device to target a single PRL. Some devices employ a combination approach. AMD patients often rely on multiple preferred retinal loci to perform activities of daily living, and thus a drawback of targeting a specific PRL is that it can compromise the image quality at other retinal loci used for activities of daily living. If the patient begins to rely on another PRL as the disease progresses, any image optimization at the specific PRL may also become completely redundant.

[0007] Intraocular telescopes attempt to capitalize on the advantages of hand-held magnifiers by conferring an optical advantage of intraocular magnification and eliminating the need for hand-eye coordination. Compared to standard IOLs, such devices are generally relatively large and complex and are more difficult to implant safely. Depending on the magnification, the main drawback of intraocular telescopes is that they result in a reduced peripheral visual field. For some devices, the peripheral visual field may be so restricted that implantation can only be performed in one eye. Intraocular telescopes also spread a limited amount of light over a wider area of the retina and thus inevitably reduce the contrast of the resulting image. Thus, both intraocular telescopes and prism devices can compromise the patient's natural mechanisms for coping with central field defects and thus affect visual function, since 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, since this compromises binocular summation and affects the image scanning across the macula that occurs during reading.

[0008] The evolution of a single injectable soft polymer (e.g., acrylic) intraocular lens for implantation in the capsular bag herein, i.e., the optics being uniquely configured to provide a focused image to all regions of the macula extending from the foveal center to 10 degrees, is an advancement over the prior art. The optics are designed to maintain the image quality at the foveal center for patients with early disease. By correcting for the optical aberrations generated when the patient fixates eccentrically up to a retinal eccentricity of 10 degrees, the IOLs of the embodiments optimize the visual potential in macular diseases and prevent progressive vision loss. It is estimated that the +2D to +3.5D target using this new type of intraocular lens can also provide 10% to 20% magnification using glasses, but this is not necessary for the mechanism of action. SUMMARY OF THE INVENTION

[0009] In an embodiment of the present invention, there is provided a one-piece, injectable, soft, hydrophobic polymer (e.g., acrylic) intraocular lens (IOL) that is designed to be placed in the capsular bag. The lens optics are uniquely optimized to provide enhanced image quality at any position in the macula for eccentric fixation from 0 to 10 degrees in any direction from the foveal center. The embodiment lens achieves its effect by being shaped to minimize the optical aberrations that would be generated by a standard lens in the case where the patient is to fixate eccentrically. The embodiment lens is designed to have such a radius and conic constant that it provides a focused image at the foveal center and reduces higher-order aberrations over the entire region extending from the focus center in all fixation directions up to (but not necessarily limited to) 10 degrees.

[0010] Compared to a standard single-focus IOL, the novel lens provides better image quality at increased retinal eccentricities, with potential benefits for patients with macular disease. The IOL of the embodiment can be used to target post-aphakic refraction: a target of +2D to +3.5D can provide 10% to 20% magnification using glasses. Emmetropic or myopic outcomes can be targeted in individuals with better visual potential, or postoperative anisometropia (as in the case of standard single-focus IOLs) can be avoided.

[0011] The IOL of the embodiment can have refractive powers of 11, 13, 15, 17, 19, 21, 23, and 25 D, but the IOL of the embodiment is not limited to this range of refractive powers. The appropriate IOL refractive power for an individual eye can be estimated in a manner similar to that for a standard IOL implanted during cataract surgery, using the SRK / T (or similar) biometric formula and an A constant of 119.2.

[0012] The IOL of the embodiment provides significant advantages over existing intraocular telescopes in the treatment of macular disease. In contrast, intraocular telescopes such as the Implantable Miniature Telescope (IMT) and the Intraocular Lens for the Visually Impaired (IOL-VipTM) are expensive and complex devices that, relatively speaking, have a less attractive risk-benefit profile due to the need for large incisions in the eye, reduced field of view, the risk of corneal decompensation, and the need for postoperative visual rehabilitation 11,12 , and their risk-benefit characteristics become less appealing.

[0013] In an embodiment, the present invention is a one-piece, injectable, soft, hydrophobic polymer (e.g., acrylic) IOL that is 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 foveal center, and the device thus constitutes a new class of IOL.

[0014] As described in Example 1, compared to a standard monofocal IOL, the lens provides better image quality at increased retinal eccentricities, with potential benefits for patients with macular disease. The IOL embodiments of the present invention can also be used to target refractive outcomes after hyperopia surgery. For example, a +2.00 to +3.50 diopter target can provide a 10% to 20% magnification using glasses, but depending on the severity of the macular disease and the patient's preference or adaptation to this method, the degree of hyperopia may increase or decrease. Emmetropic or myopic outcomes can be targeted in individuals with better visual potential, or postoperative anisometropia (as in the case of standard monofocal IOLs) can be avoided.

[0015] In an embodiment, there is provided an intraocular lens system for improving a patient's vision to enhance image quality across the entire macular region extending 10% from the center of the fovea, 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 optic zone diameter (D) and a central thickness (T); the first surface being a spherical surface having a first radius of curvature (R 1 ) and the second surface being a rotationally symmetric conical surface having a second radius of curvature (R 2 ) and having a surface sag (z coordinate) given as a function of the radial coordinate (r) by:

[0016]

[0017] where: c = 1 / R 2

[0018] k = constant.

[0019] In a particular embodiment, preferred variables are P = 11 diopters, D = 6.00 mm, T = 0.7 mm, R 1 = 19.99 mm, R 2 = -143.7 mm, and k = -12.7. In another particular embodiment, preferred variables are P = 17 diopters, D = 6.00 mm, T = 0.7 mm, R 1 = 110.53 mm, R 2 = -12.96 mm, and k = -12.7. In yet another particular embodiment, preferred variables are P = 25 diopters, D = 6.00 mm, T = 0.7 mm, R 1 = -45.52 mm, R 2 in the range from -6 mm to -19 mm, and k = -12.7. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Embodiments of the present invention are illustrated in the accompanying drawings, wherein:

[0021] Figure 1 is a schematic diagram of the design process.

[0022] Figure 2 is a side view of an IOL of an embodiment providing a refractive power of 17 diopters.

[0023] Figure 3 is a side view of an IOL of an embodiment providing a refractive power of 19 diopters.

[0024] Figure 4 is a side view of an IOL of an embodiment providing a refractive power of 21 diopters.

[0025] Figure 5 is a side view of an IOL of an embodiment providing a refractive power of 23 diopters.

[0026] Figure 6 is a side view of an IOL of an embodiment providing a refractive power of 25 diopters. Detailed Description

[0027] The standard monofocal IOL provides a focused image to the fovea. In patients with dry AMD, central GA typically results in loss of functional vision 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.

[0028] As disclosed herein in the IOL of the embodiment, the present invention is designed to maintain the image quality at the center of the fovea, but correct for the optical aberrations that would be generated by a standard monofocal IOL when the eye is tilted to adopt eccentric fixation. This optimizes the image quality in any area within 10 degrees of the center of the fovea, thus helping to use these areas as PRLs and improving the functional outcome after implantation. The aim is to provide a good retinal image at an eccentricity of up to 10 degrees, while having the option of an appropriate magnification when combined with external glasses for correction of the maximum +3D refractive target.

[0029] The IOL design of the embodiment can be implemented in an eye model describing the average eye obtained from the literature (Liou - Brennan: Liou HL, Brennan NA. Anatomically accurate, finite model eye for optical modelling. J Opt Soc Am A. 1997;14(8):1684 - 1695.) using commercially available ray - tracing software (Zemax OpticStudio, Zemax LLC, USA). Figure 1It is a schematic diagram of an implementation manner of the design process.

[0030] Ray tracing technology can be used to optimize the optical performance of different IOLs within the previously described eye model. Optical design software (Zemax OpticStudio, Zemax LLC, USA) can be employed. Once the material is selected, a merit function can be developed to design the IOL of the implementation manner. Generally, parameters can be selected among those 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 minimizes the merit function. Ideally, this process ends with finding the global or absolute minimum rather than a local minimum. The generated merit function includes constraints on the geometric parameters of the IOL to keep it within a physiologically compatible range. In this example, the variable parameters for optimization are the thickness of the lens, the position of the lens within the capsule, the radius of curvature, and the asphericity of different surfaces. Three configurations are included simultaneously in the merit function, corresponding to the incident beam on the axis in the horizontal direction, an eccentricity of 5 degrees, and an eccentricity of 10 degrees.

[0031] The IOLs of each implementation manner have the following common characteristics:

[0032] The front surface is a standard sphere with a curvature range or radius of curvature. The rear surface is a rotationally symmetric conical surface.

[0033] The surface depression (z - coordinate) as a function of the radial coordinate r is given by:

[0034]

[0035] where c is the reciprocal of the radius of curvature R: c = 1 / R

[0036] For a specific non - restrictive 17D version of the lens, the relevant parameters are:

[0037] Optical zone diameter: 6.00 mm

[0038] Central thickness: 0.7 mm

[0039] First (front) surface:

[0040] Standard sphere

[0041] Radius of curvature is 110.53 mm

[0042] Second (rear) surface:

[0043] Rotationally symmetric conical surface. The surface depression (z - coordinate) as a function of the radial coordinate r is given by:

[0044]

[0045] where c is the reciprocal of the radius of curvature R: c = 1 / R

[0046] The specific parameters are as follows:

[0047] R = -12.96 mm

[0048] k = -12.7

[0049] Using these values and units, z in mm was obtained.

[0050] For the standard IOL reference in the design, the same eye model (Liou - Brennan cornea, axial length 23.5 mm) can be used, 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 sphere (the radii of curvature of the front and rear surfaces are 27.51 mm and -14.59 mm respectively), a refractive index of 1.54, and a thickness of 0.70 mm is used.

[0051] To evaluate the image quality of the IOL of the embodiment, a NIMO instrument (LAMBDA - X, Nivelles, Belgium) is used, which includes an optical bench and its software version is 4.5.15. The working principle of this 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 the beam deviation, which can be used to calculate the wavefront analysis considering 36 Zernikes coefficients. This technique has been proven to effectively measure 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 salt solution with a composition of 0.154 milliequivalents of NaCl per milliliter (Laboratoires Sterop SA, Anderlecht, Belgium). The cuvette or wet cell used to hold the IOL and the salt solution in place during the measurement has been verified using an interferometer; and it has been proven that the refractive power is <0.005 D. This additional cross - check of the wet cell is performed to exclude potential interference with the measurement. In addition, 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.

[0052] In Example 1 described in detail below, the axial length of the eye model is set to 23.5 mm. The corneal parameters (curvature, asphericity, thickness, and refractive index) are taken from the Liou-Brennan eye model (reference). The retina is simulated as a sphere of -12 mm, and the anterior IOL surface is axially set 4.16 mm from the second surface of the cornea.

[0053] The external spectacle lens is modeled using a refractive index of 1.585 (polycarbonate) and a central thickness of 5 mm, set 12 mm (vertex distance) from the corneal apex. The radius of curvature of the anterior and posterior surfaces is 32 mm and 36 mm (+3 diopters), respectively. Additionally, a +6D spectacle lens (with the object set 33 cm from the cornea) is simulated, which has the same anterior curvature but a posterior radius of curvature of 44.7 mm. All calculations are performed at a wavelength of 550 nm and a pupil diameter of 3 mm.

[0054] The IOL lens of the 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.

[0055] This optimization process is repeated for different models with a specified axial length value. This provides lenses of different optimized refractive powers. Figures 2 to 6 The actual shapes of the IOLs of the optimized embodiments of different refractive powers are shown. The corresponding emmetropic targets are located at the bottom of each lens. For these non-limiting examples, these methods are used for setting and alignment: as the refractive power of the IOL increases, the posterior surface of the lens becomes more curved, while the anterior surface changes the sign of its curvature, from positive curvature to a flatter curvature, and then to negative curvature. This is the result of the shape factor optimization process for each model.

[0056] Example 1

[0057] Research

[0058] A study was designed and conducted to evaluate the safety and preliminary outcomes after implantation of this new 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 phacoemulsification and IOL implantation with a hyperopic postoperative refractive target. The amount of targeted postoperative hyperopia was determined after careful discussion with the patients regarding the potential benefits of using glasses for magnification with this approach while balancing the drawbacks of increased dependence on glasses for activities of daily living. All operated eyes of the patients had moderate to severe visual loss, and thus a hyperopic outcome of 1.5D to 4.5D was chosen depending on the individual case (including consent for surgery on the second eye if necessary). Initial follow-up and evaluations were performed at baseline, 1 week, 1 month, and 2 months.

[0059] The following examinations were performed at baseline and 1 week, 1 month, and 2 months postoperatively: full subjective refraction, corrected near vision (N-point, at 30 cm, with LogMAR conversion), corrected distance vision (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). The lens opacity was graded according to the LOCSIII system. The visual field was evaluated by a full-threshold 80-point test. After refractive correction of the operated eye at 1 month postoperatively, the MNREAD chart was used to evaluate reading acuity, critical print size, and reading speed. Microperimetry was performed using a Macular Integrity Assessment Instrument (MAIA, Ellex Medical Lasers Ltd.) at baseline and from 1 to 2 months postoperatively; additional microperimetry assessments were performed at 1- to 3-month intervals to confirm any observed changes. Microperimetry was performed using the "expert" algorithm under mesopic conditions without mydriasis to evaluate macular threshold sensitivity and fixation stability (testing 37 points in a 10-degree area centered on the preferred retinal locus; 4-2 strategy; stimulus size Goldmann III, duration 200 ms). Exclusion criteria included: active choroidal neovascularization (CNV) treated within 6 months after recruitment; axial length >24.5 mm or <20.5 mm; uncontrolled glaucoma and intraocular surgery within 6 months after recruitment.

[0060] The mean age of the patients was 77 ± 16 years (range 43 to 91), and the male-to-female ratio was 5:3. The 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) was used to perform a 5-mm capsulotomy and phacoemulsification, and the WHITESTAR phacoemulsification system (Abbot Medical Optics, Abbot Laboratories Inc., Illinois, USA) was used to complete lens removal through a standard 2.6-mm corneal incision located at 100°. The capsular bag was filled with a viscous ophthalmic viscoelastic device (OVD), and then the lens was loaded into a syringe barrel and subsequently injected into the capsular bag through the main wound, centered the lens, and performed an 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).

[0061] Results

[0062] Specular microscopy showed a mean endothelial cell count reduction of 13% ± 14% (range 0% - 37%) postoperatively. Two eyes had reductions 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 the results were in line with the expected reduction (4% - 13%) after standard phacoemulsification cataract surgery 8 Pre- and post-operative 80-point visual field test results were similar (mean number of points seen preoperatively was 50 ± 31 and postoperatively was 53 ± 27), and anterior segment and macular OCT imaging showed a well-centered IOL and a stable macula postoperatively. Intraocular pressure remained stable in all subjects postoperatively - mean preoperative intraocular pressure and postoperative intraocular pressure at 2 months were 16 ± 2.8 mmHg and 14 ± 2 mmHg, respectively.

[0063] Postoperative MN reading data were not available for one subject. In the remaining subjects, a modest improvement in mean reading acuity was observed from 1.07 ± 0.31 LogMAR to 0.9 ± 0.37 LogMAR, and a modest improvement in critical print size from 1.04 ± 0.25 to 0.95 ± 0.27. The mean reading speed was observed to increase from 28 ± 19 words per minute to 44 ± 31 words per minute, a 57% increase.

[0064] Microperimetry data were obtained at approximately 1 month and / or 2 months postoperatively in all subject eyes except one. A mean improvement in microperimetry threshold sensitivity was observed from 8.2 ± 4.6 dB to 12.0 ± 5.6 dB. The mean percentage of fixation points within the 4-degree circle increased from 77% ± 17% to 91% ± 11%. Although postoperative microperimetry data were not available for one subject, vision improved significantly in this individual during the late postoperative period. Minimal changes in microperimetry testing were observed postoperatively in three eyes, and signs of progressive improvement were seen at 1 month and 2 months in the remaining eyes.

[0065] Further microperimetry tests were performed on three eyes in the operated eyes, and the data indicated that visual function gradually improved after the two-month time point. It was observed that the preferred retinal loci in these eyes gradually shifted from the areas of geographic atrophy. In the subject's Eye 1, the mean threshold sensitivity increased from 0 dB to 16.6 dB at 5 months, and the mean percentage of fixation points within the 4-degree circle increased concomitantly from 64% to 94%. For the subject's second eye, the tests performed 4 months postoperatively showed that the mean threshold sensitivity decreased slightly from 4.2 dB to 3 dB, but the mean percentage of fixation points within the 4-degree circle increased from 57% to 93%, and these points were concentrated in the narrow channel between the optic disc and the large area of geographic atrophy. The tests performed on the third subject at 4 months showed that the threshold sensitivity increased from 12.9 dB to 27 dB, and the mean percentage of fixation points within the 4-degree circle decreased slightly from 99% to 83%.

[0066] No symptoms of aniseikonia were reported, but all subjects subsequently went on to implant the device in their other eye.

[0067] The visual prognosis of subjects with moderate to severe age-related macular degeneration was consistent with the results of laboratory simulations, corresponding to an average improvement of 18 ETDRS letters in both distance and near vision, and an average increase in reading speed of 57% was observed. These results are very favorable compared to the reported outcomes of cataract surgery in published AMD patients (including those treated for CNV) - a recent meta-analysis showed that AMD subjects who underwent cataract surgery and received a standard monofocal IOL could expect an improvement in visual acuity of 6.5 to 7.5 ETDRS letters after a 6- to 12-month follow-up 9,10 。

[0068] Statement regarding the preferred embodiment

[0069] Although the invention has been described with respect to the foregoing, those skilled in the art will readily appreciate that various changes and / or modifications can be made to the invention without departing from the spirit or scope of the invention as defined by the appended claims.

[0070] Abbreviations and Acronyms

[0071] Age-related Macular Degeneration (AMD)

[0072] Binary Contour Ellipse Area Analysis (BCEA)

[0073] Confidence Interval (CI)

[0074] Corrected Distance Visual Acuity (CDVA)

[0075] Corrected Near Visual Acuity (CNVA)

[0076] Choroidal neovascularization (CNV)

[0077] Early Treatment Diabetic Retinopathy Study (ETDRS)

[0078] Implantable Miniature Telescope (IMT)

[0079] Intraocular lens (IOL)

[0080] Intraocular pressure (IOP)

[0081] Logarithm of the Minimum Angle of Resolution (LogMAR)

[0082] Macular Integrity Assessment (MAIA)

[0083] Ophthalmic viscosurgical device (OVD)

[0084] Optical Coherence Tomography (OCT)

[0085] Preferred retinal locus (PRL)

[0086] Standard error of the mean (SEM)

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[0118] 25. Qureshi MA, Robbie SJ, Hengerer FH, Auffarth GU, Conrad-Hengerer I, Artal P. Consecutive Case Series of 244 Age-Related Macular Degeneration Patients Undergoing Implantation with an Extended Macular Vision IOL. Eur J Ophthalmol. 2018;5(0):ejo.5001052. doi:10.5301 / ejo.5001052.

[0119] 26. Hengerer FH, Auffarth GU, Robbie SJ, Yildirim TM, Conrad-Hengerer I. First Results of a New Hyperaspheric Add-on Intraocular Lens Approach Implanted in Pseudophakic Patients with Age-Related Macular Degeneration. Ophthalmol Retin. July 2018. doi:10.1016 / j.oret.2018.02.003.

Claims

1. An intraocular lens system for improving a patient's vision, the intraocular lens system comprises: 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 (D) and a central thickness (T); The first surface is a spherical surface having a first radius of curvature (R 1 ). The second surface is a rotationally symmetric conical surface having a second radius of curvature (R 2 ) and having a surface depression (z coordinate) that is a function of the radial coordinate (r) and is given by: where: c = 1 / R 2 , k = constant.

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

3. The intraocular lens system according to claim 1, wherein: P = 11 diopters D = 6.00 mm T = 0.7 mm R 1 = 19.99 mm R 2 = -143.7 mm k＝-12.7。 4. The intraocular lens system according to claim 1, wherein: P = 17 diopters D = 6.00 mm T = 0.7 mm R 1 = 110.53 mm R 2 = -12.96 mm k＝-12.7。 5. The intraocular lens system according to claim 1, wherein: P = 25 diopters D = 6.00 mm T = 0.7 mm R 1 = -45.52 mm R 2 = -6 mm to -19 mm k＝-12.7。

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