Achromatic IOLs with multiple layers of diffractive optics

Abstract

The multi-layer intraocular lens (IOL) includes a lens body including an anterior diffractive optics layer having a first biocompatible material and a posterior diffractive optics layer having a second biocompatible material different from the first biocompatible material, the anterior and posterior diffractive optics layers being sealed within a peripheral non-optical portion of the lens body with a gap between the anterior and posterior diffractive optics layers.

Description

[Technical field]

[0001] Claiming priority This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 284,318, entitled "ACHROMATIC IOL WITH MULTIPLE LAYERS OF DIFFRACTIVE OPTICS," filed November 30, 2021, whose inventors are Myoung-Taek Choi, Xin Hong, Shinwook Lee, and Zhiguang Xu, the contents of which are incorporated herein by reference in their entirety as if fully and completely set forth herein. [Background technology]

[0002] Prior art intraocular lenses (IOLs) using one layer of diffractive optics often provide high diffraction efficiency only at or near their design wavelength. More specifically, for prior art IOLs, the diffraction efficiency often decreases as the wavelength of light deviates from the design wavelength. Existing hybrid IOLs with refractive and diffractive surfaces can compensate for the wavelength dependence of focal length, which is also called anchromatization. However, anchromatization is limited due to low diffraction efficiency in a broadband spectrum. Such low diffraction efficiency creates an undesirable level of light leakage into diffraction and thus reduces image quality. Summary of the Invention [Problem to be solved by the invention]

[0003] Thus, a need exists for an IOL that compensates for variations in diffraction efficiency throughout the entire visible light spectrum. [Means for solving the problem]

[0004] Aspects of the present disclosure provide a multi-layer intraocular lens (IOL). The multi-layer IOL includes a lens body including an anterior diffractive optics layer having a first biocompatible material and a posterior diffractive optics layer having a second biocompatible material different from the first biocompatible material. The anterior and posterior diffractive optics layers are sealed within a peripheral non-optical portion of the lens body with a gap between the anterior and posterior diffractive optics layers.

[0005] Aspects of the present disclosure also provide a multi-layer intraocular lens (IOL). The multi-layer IOL includes a lens body including an anterior diffractive optics layer and a posterior diffractive optics layer bonded to the anterior diffractive optics layer within a peripheral non-optical portion of the lens body. The lens body has a diffractive efficiency of 80% to 100% in the visible light spectrum.

[0006] Aspects of the present disclosure further provide a method of constructing a multi-layer intraocular lens (IOL), the method including the steps of computing radial spacing and step height of a first set of annular echelettes on a posterior surface of an anterior diffractive optics layer of the IOL and radial spacing and step height of a second set of annular echelettes on an anterior surface of a posterior diffractive optics layer of the IOL based on input parameters, and forming or causing the IOL to be formed based on the computed radial spacing and step height of the first set of annular echelettes and the computed radial spacing and step height of the second set of annular echelettes. The input parameters include a first refractive index of a first biocompatible material associated with the anterior diffractive optics layer and a second refractive index of a second biocompatible material associated with the posterior diffractive optics layer.

[0007] So that the above-mentioned features of the present disclosure can be understood in detail, a more particular description of the present disclosure briefly summarized above can be had by reference to embodiments, some of which are illustrated in the accompanying drawings. It should be noted, however, that the accompanying drawings illustrate only some aspects of the present disclosure, which may be susceptible to other equally effective embodiments. [Brief description of the drawings]

[0008] [Figure 1A] 1 illustrates a top view of a multi-layer intraocular lens (IOL) according to certain embodiments. [Figure 1B] 1B illustrates a side view of a lens body of the IOL of FIG. 1A in accordance with certain embodiments. [Figure 1C] 1 illustrates a conventional single layer IOL according to certain embodiments. [Diagram 2] 4 shows the diffraction efficiency of a monofocal multi-layer IOL and a monofocal single layer IOL in accordance with certain embodiments. [Diagram 3] 1 depicts the modulation transfer function (MTF) of a monofocal multilayer IOL and a monofocal single layer IOL in accordance with certain embodiments. [Figure 4] 1 depicts the modulation transfer function (MTF) of a monofocal multilayer IOL and a monofocal single layer IOL in accordance with certain embodiments. [Diagram 5] 1 depicts the visual acuity of a monofocal multilayer IOL and a monofocal single layer IOL according to certain embodiments. [Figure 6] 1 depicts the MTF of an Enhanced Depth Of Focus (EDOF) multi-layer IOL and an EDOF single-layer IOL in accordance with certain embodiments. [Figure 7] 1 depicts the MTF of an Enhanced Depth Of Focus (EDOF) multi-layer IOL and an EDOF single-layer IOL in accordance with certain embodiments. [Figure 8] 1 depicts the visual acuity of an EDOF multi-layer IOL and an EDOF single-layer IOL according to certain embodiments. [Figure 9] 1 depicts the MTF of a trifocal multilayer IOL and a trifocal single layer IOL in accordance with certain embodiments. [Figure 10] 1 depicts the MTF of a trifocal multilayer IOL and a trifocal single layer IOL in accordance with certain embodiments. [Figure 11] 1 depicts the visual acuity of a trifocal multilayer IOL and a trifocal single layer IOL according to certain embodiments. [Figure 12]1 depicts an exemplary system for designing, constructing, and / or forming a multi-layer IOL in accordance with certain embodiments. [Figure 13] 1 depicts exemplary acts of forming a multi-layer IOL in accordance with certain embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] To facilitate understanding, the same reference numerals are used, wherever possible, to designate identical elements that are common to the various figures, and it is contemplated that elements and features of one embodiment may be beneficially incorporated in other embodiments without further reference.

[0010] The embodiments described herein provide a multi-layer intraocular lens (IOL). A multi-layer IOL includes two or more layers of diffractive optics and can provide both achromatization (i.e., reduction or elimination of the wavelength dependence of focal length) and improved diffractive efficiency throughout the entire visible light spectrum, as compared to conventional single-layer IOLs. A multi-layer IOL can further improve modulation transfer function (MTF) and visual acuity, as compared to conventional single-layer IOLs.

[0011] Multilayer IOLs FIG. 1A illustrates a plan view of a multi-layered intraocular lens (IOL) 100 according to certain embodiments. The multi-layered IOL 100 includes a lens body 102 and a haptic portion 104 coupled to a peripheral non-optical portion of the lens body 102. FIG. 1B illustrates a side view of the lens body 102. Note that the shape and curvature of the lens body 102 are shown for illustrative purposes only, and other shapes and curvatures are within the scope of the present disclosure. For example, the lens body 102 illustrated in FIG. 1A has a biconvex shape. In other examples, the lens body 102 can have a plano-convex, convex-concave, or plano-concave shape.

[0012] The lens body 102 has a diameter φ of about 4.5 mm to about 7.5 mm, such as about 6 mm. The lens body 102 has a radius of curvature R 1and a front diffractive optics layer 102A having a front outer surface 106A having a radius of curvature R 2 and a posterior diffractive optics layer 102P having a posterior outer surface 106P having a first set 108A of annular echelettes on the posterior surface (i.e., the surface opposite the anterior outer surface 106A) of the anterior diffractive optics layer 102A, and a second set 108B of annular echelettes on the anterior surface (i.e., the surface opposite the posterior outer surface 106P) of the posterior diffractive optics layer 102P, as shown in FIG. 1B. In certain embodiments, the multi-layer IOL 100 is a multifocal IOL (e.g., having multiple foci, such as bifocal and trifocal) having a first set 108A of annular echelettes on the posterior surface (i.e., the surface opposite the anterior outer surface 106A) of the anterior diffractive optics layer 102A, and a second set 108B of annular echelettes on the anterior surface (i.e., the surface opposite the posterior outer surface 106P) of the posterior diffractive optics layer 102P.

[0013] The annular echelettes 108A and 108B each form a concentric circular lattice. The annular echelettes 108A are spaced apart by a distance d between two adjacent annular echelettes. 1 and each has a step height h 1 The annular echelettes 108B have a spacing d between two adjacent annular echelettes 108B. 2 and each has a step height h 2 The step height h 1 may be the same for all annular echelettes 108A or may be different for different annular echelettes 108A and may be between about 1 μm and about 300 micrometers, such as, for example, 35 micrometers.

[0014] Step height h 2 may be the same for all annular echelettes 108B or may be different for different annular echelettes 108B and may be between about 1 μm and about 300 μm, such as about 41 μm. 1 may be the same for all annular echelettes 108A or may be different for different annular echelettes 108A and may be between about 10 μm and about 2000 μm, such as about 500 μm.2 is the radial spacing d between the annular echelettes 108A such that the annular echelettes 108A are adjacent to and opposite the annular echelettes 108B. 1 can be matched with

[0015] It should be noted that, in FIG. 1B, the first set of annular echelettes 108A are formed on the rear surface of the front diffractive optics layer 102A and the second set of annular echelettes 108B are formed on the front surface of the rear diffractive optics layer 102P, while in certain other embodiments not shown in FIG. 1B, the first set of annular echelettes 108A are formed on the front outer surface 106A and the second set of annular echelettes 108B are formed on the rear outer surface 106P.

[0016] It should further be noted that while multilayer IOL 100 is a multifocal IOL, in some other embodiments (not shown), multilayer IOL 100 is a monofocal (having one focus) IOL that does not have an annular echelette on its outer surface (not shown). In some other embodiments, multilayer IOL 100 is an extended depth of focus (EDOF) IOL that has an annular echelette on its posterior outer surface 106P.

[0017] The diffractive optics layers 102A and 102P can be bonded together by chemical, thermal, UV, or other suitable type of bonding with a gap 110 between the diffractive optics layers 102A and 102P to create a seal within the peripheral non-optical portion of the lens body 102. The thickness of the gap 110 can be from about 1 μm to about 1000 μm, such as, for example, 20 μm. The gap 110 can be filled, for example, with air or with a water-like fluid similar to aqueous humor, such as balanced saline solution (BSS). In certain embodiments, the annular echelettes 108A, 108B are fabricated on the diffractive optics layers 102A, 102P, respectively, prior to bonding of the diffractive optics layers 102A and 102P. In certain other embodiments, the annular echelettes 108A, 108B are fabricated by laser writing or other suitable techniques after bonding of the diffractive optics layers 102A and 102B, which do not have annular echelettes.

[0018] The diffractive optics layers 102A, 102P may each be made of a transparent, flexible, biocompatible material, such as a silicone polymer material, an acrylic polymer material, or a hydrogel polymer material. The Young's modulus, which indicates the stiffness and flexibility of the two materials from which the diffractive optics layers 102A, 102P are made, may be about 10 to about 300 MPa at 23° C. in a dry state, and about 0.3 to about 100 MPa at 35° C. in a hydrated state, suitable for the multi-layer IOL 100 to be implemented inside a human eye. For example, the Young's modulus of the first IOL material may be about 140 MPa to 150 MPa at 18° C. in a dry state, about 56 MPa to 66 MPa at 23° C. in a dry state, and about 2.3 MPa to 2.5 MPa at 35° C. in a hydrated state. The Young's modulus of the second IOL material may be about 130 MPa to 140 MPa at 18° C. in a dry state, about 60 MPa to 70 MPa at 23° C. in a dry state, and about 2.0 MPa to 2.2 MPa at 35° C. in a hydrated state. The expansion coefficients (i.e., a measure of the expansion or contraction of a material when immersed in an eye) of the two materials from which the diffractive optics layers 102A, 102P are fabricated may be similar, between 0% and 15%, with a difference of less than about 5%, for example, about 0.5% and 0.6%, to ensure a seal between the diffractive optics layers 102A and 102P.

[0019] The diffractive optics layers 102A and 102P each have a refractive index n d1 and n d2 and different Abbe numbers v d1 and v d2 In certain embodiments, the refractive index n d1 and n d2 In some embodiments, the difference between the Abbe number v d1 and v d2 may be 25 to 50. In some embodiments, the Abbe number v d1 and v d2 The difference between is 5 and 60.0.

[0020] The anterior outer surface 106A of the anterior diffractive optics layer 102A and / or the posterior outer surface 106P of the posterior diffractive optics layer 102P may be fabricated from a biocompatible material (e.g., polymethyl methacrylate (PMMA)) that has greater rigidity than the material of the remainder of the diffractive optics layers 102A and 102P.

[0021] Haptics 104 includes radially extending struts (also referred to as "haptics") 104A and 104B. Haptics 104A and 104B can be fabricated from a biocompatible material such as PMMA. Haptics 104A and 104B are bonded (e.g., glued or welded) to a peripheral portion of lens body 102 or are molded with a portion of lens body 102 and thereby extend outwardly from lens body 102 to engage the outer peripheral wall of the eye's capsular bag to maintain lens body 102 in a desired position within the eye. Haptics 104A and 104B typically have radially outward ends that define arcuate terminal portions. The terminal portions of haptics 104A and 104B may be separated by a length L of about 6 mm to about 22 mm, such as, for example, about 13 mm. Haptics 104A and 104B have a particular length such that the terminal portions generate a slight engagement pressure when in contact with the equatorial region of the lens capsule after implantation. Although FIG. 1A shows one example configuration of haptics 104A and 104B, any plate haptics or other types of haptics can be used.

[0022] Achromatization and improved diffraction efficiency As described in more detail below, conventional single-layer IOLs inevitably have a wavelength dependence of diffraction efficiency. Thus, the diffraction efficiency decreases as the wavelength differs from the design wavelength for which the diffraction efficiency is optimized. Moreover, the diffraction efficiency cannot in principle reach 100% at wavelengths other than the design wavelength. A multi-layer IOL 100 according to certain embodiments described herein has a step height h of the annular echelettes 108A, 108B given the refractive indices of the diffractive optic layers 102A and 102P. 1 , h>2 By adjusting the parameters associated with the diffractive optics layers 102A and 102P described above, such as the above, it is possible to simultaneously achieve achromatization (i.e., reduction or elimination of the wavelength dependence of the focal length) and a high diffraction efficiency close to 100%, e.g., 80% to 100%, at any wavelength over the entire visible wavelength range or at least in a wavelength range larger than just the design wavelength. In addition, the radial spacing d of the annular echelettes 108A, 108B can be adjusted to achieve a high diffraction efficiency of 100%, e.g., 80% to 100%, at any wavelength over the entire visible wavelength range or at least in a range of wavelengths larger than just the design wavelength. 1 , d 2 is the step height h 1 , h 2 The radii of curvature R of the diffractive optic layers 102A and 102P are adjusted to optimize the performance of the multi-layer IOL 100, which can be measured in terms of the modulation transfer function (MTF) through focus, also referred to simply as MTF, visual acuity, and aberrations. 1 , R 2 is determined according to the desired lens base power.

[0023] For purposes of comparison with the multi-layer IOL 100, FIG. 1C depicts a conventional single-layer IOL 120 having a single diffractive optics layer 122. As shown in FIG. 1C, the single-layer IOL 120 is a multifocal IOL having annular echelettes 128 on the anterior surface of the diffractive optics layer 122. The annular echelettes 128 have a radial spacing d between two adjacent annular echelettes, and each has a step height h. In other cases, the single-layer IOL 120 may be a monofocal IOL without annular echelettes (not shown). In still other cases, the single-layer IOL 120 is an extended depth of focus (EDOF) IOL having an annular echelette (not shown) on the posterior outer surface 126.

[0024] For a single layer IOL, such as single layer IOL 120, having a refractive index n(λ) at wavelength λ, the first order diffraction efficiency η S(λ) can be calculated by scalar diffraction theory, known in the art as:

number

number

number

[0025] Furthermore, the diffraction efficiency η S (λ) is the phase function Φ S 100% can only be reached when (λ) is equal to 2π (i.e., the argument of the sinc function is zero), which is equivalent to:

number

[0026] However, all known materials have refractive indices n(λ) that decrease monotonically with increasing wavelength λ, and therefore the above condition applies only to the design wavelength λ. 0 As a result, the diffraction efficiency η S (λ) is the design wavelength λ 0 cannot reach 100% at wavelengths λ different from

[0027] For a multi-layer IOL such as the multi-layer IOL100, the first-order diffraction efficiency η M (λ) can be calculated similarly using scalar diffraction theory as follows:

number

number

[0028] Furthermore, the diffraction efficiency η M >(λ) is the phase function Φ >M 100% can be reached when (λ) is equal to 2π. This condition is equivalent to: h 1 (n 1 (λ)-1)-h 2 (n 2 (λ)-1)=λ, This means that there are at least two different wavelengths, λ S and λ b At step height h1 , h 2 can be satisfied by appropriately adjusting the following formula:

number

[0029] Step height h 1 , h 2 These conditions for three different wavelengths λ F = 486.1 nm (blue Fraunhofer F line from hydrogen), λ D = 589.2 nm (orange Fraunhofer D line from sodium), and λ C = 656.3 nm (red Fraunhofer C line from hydrogen) 1 (λ), n 2 The Abbe number of the diffractive optic layers 102A and 102P defined using (λ)

number

[0030] In general, the step height h 1 , h >2 is the Abbe number v 1 , v 2 For example, the step height can be relatively small when the difference between the materials A and B (v d1 =39.5, v d2 = 52.8) 1 = 35.8 μm, h 2 = 40.5 μm. The step height is the same for the combination of material A and material C (v d1 =39.5, v d2 = 37.3) 1 = 317.0 μm, h 2 =312.2μm.

[0031] Figures 2-11 show three different examples of the differences between the optical performance of various types of multi-layer and single-layer IOLs. EXAMPLES

[0032] Example 1 FIG. 2 illustrates the diffraction efficiency, FIGS. 3 and 4 illustrate the MTF, and FIG. 5 illustrates the diffraction efficiency at a design wavelength λ of 0.55 μm. 0 1 depicts the visual acuity of an exemplary monofocal multilayer IOL according to certain embodiments, but without the annular echelette on the outer surface, in comparison to an exemplary monofocal single-layer IOL, such as the monolayer IOL 120 in FIG. 1. In the exemplary monofocal multilayer IOL, the anterior diffractive optics layer has an Abbe number v of 39.5. d1 and the rear diffractive optics layer is fabricated from material A having an Abbe number v of 52.8. d2 In the comparative monofocal single layer IOL, the diffractive optics layer is made from material A.

[0033] 2, it can be seen that the monofocal multilayer IOL provides a high diffraction efficiency 202 of about 98% to about 100% over the entire visible light spectrum at wavelengths from about 0.4 μm to about 0.7 μm. However, the monofocal single layer IOL has a diffraction efficiency 204 of about 98% to about 100% over the entire visible light spectrum at a design wavelength λ of 0.55 μm. 0 The diffraction efficiency 204 is designed to be 100% at the design wavelength λ 0 It decays rapidly as it deviates from

[0034] In FIG. 3, MTF mapping is generated by evaluating the MTF at different focal planes at a spatial resolution (also called "spatial frequency") of 50 lp / mm (line pairs per millimeter) using a 3 mm (photopic) aperture to determine the depth of focus (also called "defocus") of the IOL. In FIG. 3, it can be seen that the MTF 302 of the monofocal multilayer IOL has a narrower peak near the focus (i.e., at zero defocus) than the MTF 304 of the monofocal single layer IOL. Thus, the monofocal multilayer IOL has a larger focus than the monofocal single layer IOL. Also, in FIG. 4, it can be seen that the monofocal multilayer IOL has an improved MTF 402 in comparison to the MTF 404 of the monofocal single layer IOL at various spatial frequencies.

[0035] 5 shows simulated visual acuity 502, 504 of a monofocal multi-layered IOL and a monofocal single-layered IOL, respectively, in terms of LogMAR (Logarithm of Minimum Angle of Resolution) score. The simulated visual acuity 502 of the monofocal multi-layered IOL shows improvement at distance (0 diopters), intermediate (1.5 diopters), and near (2.5 diopters) compared to the simulated visual acuity 504 of the monofocal single-layered IOL.

[0036] Example 2 6 and 7 depict the MTF and FIG. 8 depicts the visual acuity of an exemplary EDOF multi-layer IOL in accordance with certain embodiments in comparison to an exemplary EDOF single-layer IOL, such as single-layer IOL 120.

[0037] In FIG. 6, MTF mappings are generated by evaluating the MTF at different focus planes at a spatial frequency of 100 lp / mm (line pairs per millimeter) using a 3 mm (photopic) aperture to determine the depth of focus (also called "defocus"). In FIG. 6, it can be seen that the MTF 602 of the EDOF multi-layer IOL has a narrower peak near focus (i.e., at zero defocus) than the MTF 604 of the EDOF single-layer IOL. Thus, the EDOF multi-layer IOL has a larger focus than the EDOF single-layer IOL. Also, in FIG. 7, it can be seen that the EDOF multi-layer IOL has an improved MTF 702 at far distance (0 diopters) compared to the MTF 704 of the EDOF single-layer IOL at various spatial frequencies.

[0038] 8 shows the visual acuity simulation results 802, 804 of an EDOF multi-layered IOL and an EDOF single-layered IOL, respectively, in terms of LogMAR. The visual acuity simulation result 802 of the EDOF multi-layered IOL shows an improvement in distance (0 diopters), intermediate (1.5 diopters), and near (2.5 diopters) compared to the visual acuity simulation result 804 of the EDOF single-layered IOL.

[0039] Example 3 9 and 10 depict the MTF and FIG. 11 depicts the visual acuity of an exemplary trifocal multilayer IOL according to certain embodiments in comparison to an exemplary trifocal single layer IOL such as single layer IOL 120.

[0040] In FIG. 9, MTF mapping is generated by evaluating the MTF at different focal planes at a spatial frequency of 100 lp / mm (line pairs per millimeter) using a 3 mm (photopic) aperture to determine the depth of focus (also called "defocus"). In FIG. 9, it can be seen that the MTF 902 of the trifocal multilayer IOL has a narrower peak near the focus (i.e., at zero defocus) than the MTF 904 of the trifocal monolayer IOL. Thus, the trifocal multilayer IOL has a larger focus than the trifocal monolayer IOL. Also, in FIG. 10, it can be seen that the trifocal multilayer IOL has an improved MTF 1002 at far distance (0 diopters) compared to the MTF 1004 of the trifocal monolayer IOL at various spatial frequencies.

[0041] 11 shows simulated visual acuity 1102, 1104 of a trifocal multilayered IOL and a trifocal single layered IOL, respectively, in terms of LogMAR. The simulated visual acuity 1102 of the trifocal multilayered IOL shows improvement at distance (0 diopters), intermediate (1.5 diopters), and near (2.5 diopters) compared to the simulated visual acuity 1104 of the trifocal single layered IOL.

[0042] A system for designing multi-layer IOLs 12 illustrates an example system 1200 for designing, constructing, and / or forming a multi-layer IOL 100. As shown, system 1200 includes, without limitation, a control module 1202, a user interface display 1204, an interconnect 1208, an output device 1210, and at least one I / O device interface 1212, which can allow for the connection of various I / O devices (e.g., a keyboard, a display, a mouse device, a pen input, etc.) to system 1200.

[0043] The control module 1202 includes a central processing unit (CPU) 1214, a memory 1216, and storage 1218. The CPU 1214 may read and execute programming instructions stored in the memory 1216. Similarly, the CPU 1214 may read and store application data in the memory 1216. The interconnect 1208 transmits programming instructions and application data between the CPU 1214, the I / O device interface 1212, the user interface display 1204, the memory 1216, the storage 1218, the output device 1210, and the like. The CPU 1214 may represent a single CPU, multiple CPUs, a single CPU with multiple processing cores, and the like. Additionally, in certain embodiments, the memory 1216 represents a volatile memory, such as a random access memory. Furthermore, in certain embodiments, the storage 1218 may be a collection of disk drives, solid state drives, or storage devices distributed across multiple storage systems.

[0044] As shown, the storage 1218 includes input parameters 1220. The input parameters 1220 include the lens base power, asphericity, toricity, refractive index n of the two materials from which the diffractive optics layers 102A, 102P are fabricated. d 1 and n d 2, and the design wavelength λ 0 The memory 1216 includes the radial spacing d between the annular echelettes 108A, 108B. 1 , d 2 and step height h 1 , h 2 The memory 1216 further includes a calculation module 1222 for calculating control parameters such as:

[0045] In certain embodiments, the input parameters 1224 correspond to the input parameters 1220 or at least a portion thereof. In such embodiments, during computation of the control parameters, the input parameters 1224 are retrieved from the storage 1218 and executed within the memory 1216. In one such example, the computation module 1222 has executable instructions (e.g., including one or more of the formulas described herein) for computing the control parameters based on the input parameters 1224. In other certain embodiments, the input parameters 1224 correspond to parameters received from a user through the user interface display 1204. In such embodiments, the computation module 1222 has executable instructions for computing the control parameters based on information received from the user interface display 1204.

[0046] In certain embodiments, the computed control parameters are output via output device 1210 to a lens manufacturing system configured to receive the control parameters and form a lens accordingly. In certain other embodiments, system 1200 itself represents at least a portion of a lens manufacturing system. In such embodiments, control module 1202 then causes hardware components (not shown) of system 1200 to form a lens in accordance with the control parameters. Details and operation of lens manufacturing systems are known to those skilled in the art and are omitted here for the sake of brevity.

[0047] How to design a multi-layer IOL 13 illustrates example operations 1300 for forming a multi-layer IOL. In some embodiments, step 1310 of operation 1300 is performed by one system (e.g., system 1200) while step 1320 is performed by a lens manufacturing system. In other embodiments, both steps 1310 and 1320 are performed by a lens manufacturing system.

[0048] In step 1310, a control parameter (e.g., the radial spacing d of the annular echelettes 108A, 108B) is 1 , d 2 and step height h 1 , h 2 ) is calculated based on input parameters (e.g., lens base power, asphericity, toricity, refractive index of the two materials from which the diffractive optics layers 102A, 102P are made). The calculations performed in step 1310 are based on one or more of the embodiments including the formulas described herein.

[0049] In step 1320, the calculated control parameters (e.g., the radial spacing d 1 , d 2 and step height h 1 , h 2 A multi-layer IOL (e.g., multi-layer IOL 100) having a diffractive optic layer (e.g., diffractive optic layers 102A, 102P) based on a reflective optics layer (e.g., reflective optics layers 102A, 102P) is formed using suitable methods, systems, and equipment typically used to manufacture lenses, as known to those of skill in the art.

[0050] The embodiments described herein provide multi-layer IOLs that can achieve both achromatization and greater diffusion efficiency throughout the entire visible light spectrum resulting in significantly greater MTF and visual acuity compared to conventional single-layer IOLs. Improved performance can be achieved with monofocal IOLs, extended depth of focus (EDOF) multi-layer IOLs, and trifocal multi-layer IOLs.

[0051] While the forgoing is directed to embodiments of the present disclosure, other and further embodiments of the disclosure may be devised without departing from the basic scope thereof, which scope is determined by the following claims.

Claims

1. 1. A multi-layer intraocular lens (IOL), comprising: A lens body is provided. The lens body includes: a front diffractive optics layer having a first biocompatible material; a rear diffractive optics layer having a second biocompatible material different from the first biocompatible material; and A multi-layer IOL, wherein the anterior diffractive optics layer and the posterior diffractive optics layer are sealed within a peripheral non-optical portion of the lens body with a gap between the anterior diffractive optics layer and the posterior diffractive optics layer.

2. the first biocompatible material has an expansion coefficient of 0 to 15%; the second biocompatible material has an expansion coefficient of 0-15%; and The multi-layer IOL of claim 1 , wherein the difference between the expansion coefficients of the first and second biocompatible materials is less than 5%.

3. the first biocompatible material has an Abbe number between 5 and 60; and The multi-layer IOL of claim 1 , wherein the second biocompatible material has an Abbe number between 5 and 60.

4. the front diffractive optics layer includes a first set of annular echelettes on a rear surface of the front diffractive optics layer; and The multi-layer IOL of claim 3 , wherein the posterior diffractive optics layer includes a second set of annular echelettes on an anterior surface of the posterior diffractive optics layer.

5. the step height of the first set of annular echelettes is between 1 μm and 300 μm; and The multi-layer IOL of claim 4, wherein the step height of the second set of annular echelettes is between 1 μm and 300 μm.

6. the radial spacing of the first set of annular echelettes is between 10 μm and 2000 μm; and The multi-layer IOL of claim 4, wherein the radial spacing of the second set of annular echelettes is between 10 μm and 2000 μm.

7. The multi-layer IOL of claim 1 , wherein the gap has a thickness of between 1 μm and 1000 μm.

8. The multi-layer IOL of claim 1 further comprising haptics coupled to said lens body, said haptics comprising a third biocompatible material.

9. 1. A multi-layer intraocular lens (IOL), comprising: A lens body is provided. The lens body includes: a front diffractive optics layer; and a rear diffractive optics layer bonded to the front diffractive optics layer within a peripheral non-optical portion of the lens body; and A multi-layer IOL, wherein the lens body has a diffraction efficiency of 80% to 100% in the visible light spectrum.

10. the anterior diffractive optics layer comprises a first biocompatible material; and The multi-layer IOL of claim 9 , wherein the posterior diffractive optics layer comprises a second biocompatible material that is different from the first biocompatible material.

11. the first biocompatible material has an expansion coefficient of 0 to 15%; the second biocompatible material has an expansion coefficient of 0-15%; and 11. The multi-layer IOL of claim 10, wherein the difference between the expansion coefficients of the first and second biocompatible materials is less than 5%.

12. the first biocompatible material has an Abbe number between 5 and 60; and The multi-layer IOL of claim 10, wherein the second biocompatible material has an Abbe number between 5 and 60.

13. the front diffractive optics layer includes a first set of annular echelettes on a rear surface of the front diffractive optics layer; and The multi-layer IOL of claim 12 , wherein the posterior diffractive optics layer includes a second set of annular echelettes on an anterior surface of the posterior diffractive optics layer.

14. the step height of the first set of annular echelettes is between 1 μm and 300 μm; and 14. The multi-layer IOL of claim 13, wherein the step height of the second set of annular echelettes is between 1 μm and 300 μm.

15. the radial spacing of the first set of annular echelettes is between 10 μm and 2000 μm; and 14. The multi-layer IOL of claim 13, wherein the radial spacing of the second set of annular echelettes is between 10 μm and 2000 μm.

16. 1. A method of constructing a multi-layer intraocular lens (IOL), comprising: calculating, based on the input parameters, a radial spacing and step height of a first set of annular echelettes on a posterior surface of an anterior diffractive optics layer of an IOL and a radial spacing and step height of a second set of annular echelettes on an anterior surface of a posterior diffractive optics layer of said IOL; forming the IOL or causing the IOL to be formed based on the calculated radial spacing and the calculated step height of the first set of annular echelettes and the calculated radial spacing and the calculated step height of the second set of annular echelettes; and The method, wherein the input parameters include a first refractive index of a first biocompatible material associated with the anterior diffractive optics layer and a second refractive index of a second biocompatible material associated with the posterior diffractive optics layer.

17. The step of forming the IOL or causing the IOL to be formed comprises: bonding the front and rear diffractive optics layers together within peripheral non-optical portions of the front and rear diffractive optics layers; forming, after the bonding step, a first set of annular echelettes on the rear surface of the front diffractive optics layer and a second set of annular echelettes on the front surface of the rear diffractive optics layer; 17. The method of claim 16, comprising:

18. The step of forming the IOL or causing the IOL to be formed comprises: forming a first set of the annular echelettes on the rear surface of the front diffractive optics layer and a second set of the annular echelettes on the front surface of the rear diffractive optics layer; after the forming step, bonding the front and rear diffractive optics layers within peripheral non-optical portions of the front and rear diffractive optics layers; 17. The method of claim 16, comprising:

19. The method of claim 16 , further comprising attaching haptics to peripheral non-optical portions of the anterior diffractive optics layer and the posterior diffractive optics layer.

20. the first biocompatible material has an Abbe number of 25 to 50; and The method of claim 16, wherein the second biocompatible material has an Abbe number of 25-50.

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