A state-of-the art intraocular lens (IOL) that uses one layer of diffractive optics often provides high diffractive efficiency only at or near its design wavelength. More specifically, for a state-of-the art IOL, diffractive efficiency often decreases as wavelength of light deviates from the design wavelength. An existing hybrid IOL having a refractive surface and a diffractive surface can compensate for the wavelength dependency of focal length, also referred to as achromatization. However, the achromatization is limited due to the low diffraction efficiency for the broadband spectrum. Such low diffraction efficiency causes light leakage to undesirable orders of diffraction and thus reduces image quality.
Therefore, there is a need for IOLs that compensate for the variation of the diffraction efficiencies throughout the entire visible light spectrum.
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, comprising a first biocompatible material, and a posterior diffractive optics layer, comprising a second biocompatible material that is different from the first biocompatible material. The anterior diffractive optics layer and the posterior diffractive optics layer are sealed in a peripheral non-optic portion of the lens body with a gap between the anterior diffractive optics layer and the posterior diffractive optics layer.
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 in a peripheral non-optic portion of the lens body. The lens body has diffractive efficiency of between 80% and 100% for the visible light spectrum.
Aspects of the present disclosure further provide a method for configuring multi-layer intraocular lens (IOL). The method includes computing a radial spacing and a 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 a 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 the IOL or causing the IOL to be formed based on the computed radial spacing and the computed step height of the first set of annular echelettes and the computed radial spacing and the computed step height of the second set of annular echelettes. The input parameters comprise 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.
So that the manner in which the above recited features of the present disclosure can be understood in detail, a more particular description of the disclosure, briefly summarized above, may be had by reference to embodiments, some of which are illustrated in the appended drawings. It is noted, however, that the appended drawings illustrate only some aspects of this disclosure and the disclosure may admit to other equally effective embodiments.
To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the figures. It is contemplated that elements and features of one embodiment may be beneficially incorporated in other embodiments without further recitation.
The embodiments described herein provide multi-layer intraocular lenses (IOLs). A multi-layer IOL includes two or more layers of diffractive optics and can achieve both achromatization (i.e., reducing or eliminating the wavelength dependence of focal length) and enhancement of diffractive efficiency throughout the entire visible light spectrum, as compared to a conventional single-layer IOL. A multi-layer IOL can further enhance the modulation transfer function (MTF) and visual acuity as compared to a conventional single-layer IOL.
The lens body 102 has a diameter of between about 4.5 mm and about 7.5 mm, for example, about 6.0 mm. The lens body 102 includes an anterior diffractive optics layer 102A having an anterior outer surface 106A with a radius of curvature R1, and a posterior diffractive optics layer 102P having a posterior outer surface 106P with a radius of curvature R2. In certain embodiments, as shown in
The annular echelettes 108A, 108B each form concentric circular gratings. The annular echelettes 108A have a radial spacing d1 between two adjacent annular echelettes and each have a step height h1. The annular echelettes 108B have a radial spacing d2 between two adjacent annular echelettes 108B and each have a step height h2. The step height h1 may be the same for all annular echelettes 108A or different for different annular echelettes 108A, and between about 1 μm and about 300 μm, for example, 35 μm.
The step height h2 may be the same for all annular echelettes 108B or different for different annular echelettes 108B, and between about 1 μm and about 300 μm, for example, 41 μm. The radial spacing d1 may be the same for all annular echelettes 108A or different for different annular echelettes 108A, and between about 10 μm and about 2000 μm, for example, 500 μm. The radial spacing d2 of the annular echelettes 108B may coincide with the radial spacing d1 of the annular echelettes 108A such that the annular echelettes 108A are proximate and opposed to the annular echelettes 108B.
Note that although in
Further, note that, although multi-layer IOL 100 is a multi-focal IOL, in some other embodiments (not shown), the multi-layer IOL 100 is a mono-focal IOL (with one focal point) without annular echelettes on the outer surfaces (not shown). In some other embodiments, the multi-layer IOL 100 is an extended depth of focus (EDOF) IOL (with elongated focus) having annular echelettes on the posterior outer surface 106P.
The diffractive optics layers 102A and 102P may be bonded together to make a seal in a peripheral non-optic portion of the lens body 102, by chemical bonding, thermal bonding, UV bonding or other appropriate types of bonding, with a gap 110 between the diffractive optics layers 102A and 102P. Thickness of the gap 110 may be between about 1 μm and about 1000 μm, for example, 20 μm. The gap 110 may be filled with air or water-like fluid similar to aqueous humor, for instance, balanced salt solution (BSS). In certain embodiments, the annular echelettes 108A, 108B are fabricated on the diffractive optics layers 102A, 102P, respectively, prior to the 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 appropriate techniques, subsequent to the bonding of the diffractive optics layers 102A and 102P having no annular echelettes.
The diffractive optics layers 102A, 102P may be each fabricated of a transparent, flexible, biocompatible material, such as a silicone polymeric material, acrylic polymeric material, hydrogel polymeric material. Young's Modulus, indicating stiffness and flexibility, of the two materials of which the diffractive optics layers 102A, 102P are fabricated may be between about 10 and about 300 MPa at dry 23° C. and between about 0.3 and about 100 MPa at hydrated 35° C., which are suitable for a multi-layer IOL 100 to be implemented inside a human eye. For example, the Young's Modulus of a first IOL material may be between about 140 MPa and 150 MPa at dry 18° C., between about 56 MPa and 66 MPa at dry 23° C., and between about 2.3 MPa and 2.5 MPa at hydrated 35° C. The Young's modulus of a second IOL material may be between about 130 MPa and 140 MPa MPa at dry 18° C., between about 60 MPa and 70 MPa at dry 23° C., and between about 2.0 MPa and 2.2 MPa at hydrated 35° C. Swelling factors (i.e., indication of expansion or shrinkage of the materials when immersed in the eye) of the two materials of which the diffractive optics layers 102A, 102P are fabricated may be similar, between 0% and 15%, for example, about 0.5% and 0.6%, having a difference less than about 5%, to ensure the seal between the diffractive optics layers 102A and 102P.
The diffractive optics layers 102A, 102P may have refractive indices nd1 and nd2, and different Abbe numbers νd1 and νd2, respectively. In certain embodiments, a difference between refractive indices nd1 and nd2 is between about 0 and 0.8. In some embodiments, Abbe numbers νd1 and νd2 may be between 25 and 50. In some embodiments, a difference between Abbe numbers νd1 and νd2 is between 5 and 60.0.
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 of a biocompatible material (e.g., polymethyl methacrylate (PMMA), stiffer than the material of the remaining portions of the diffractive optics layers 102A and 102P.
The haptic portion 104 includes radially-extending struts (also referred to as “haptics”) 104A and 104B. The haptics 104A and 104B may be fabricated of a biocompatible material, such as PMMA. The haptics 104A and 104B are coupled (e.g., glued or welded) to the peripheral portion of the lens body 102 or molded along with a portion of the lens body 102, and thus extend outwardly from the lens body 102 to engage the perimeter wall of the capsular sac of the eye to maintain the lens body 102 in a desired position in the eye. The haptics 104A and 104B typically have radial-outward ends that define arcuate terminal portions. The terminal portions of the haptics 104A and 104B may be separated by a length L of between about 6 mm and about 22 mm, for example, about 13 mm. The haptics 104A and 104B have a particular length so that the terminal portions create a slight engagement pressure when in contact with the equatorial region of the capsular sac after being implanted. While
As discussed below in detail, a conventional single-layer IOL inevitably exhibits wavelength dependence of diffractive efficiency. Thus, the diffractive efficiency decreases as the wavelength differs from the design wavelength at which the diffractive efficiency is optimized. Furthermore, the diffractive efficiency, in principle, cannot reach 100% at wavelengths that are different from the design wavelength. The multi-layer IOL 100, according to certain embodiments described herein, can achieve simultaneously the achromatization (i.e., reducing or eliminating the wavelength dependence of focal length) and high diffraction efficiency of close to 100%, for example, between 80% and 100%, at any wavelength over the entire visible wavelength, or at least over a larger wavelength range than just the design wavelength, by adjusting parameters related to the diffractive optics layers 102A and 102P described above, such as the step heights h1, h2 of the annular echelettes 108A, 1088, given the refractive indices of the diffractive optics layers 102A and 102P. In addition, the radial spacings d1, d2 of the annular echelettes 108A, 108B, together with the step heights h1, h2 are adjusted to optimize performance of the multi-layer IOL 100, which can be measured in through-focus modulation transfer function (MTF), also referred to simply as MTF, visual acuity, and aberration. The radii of curvature R1, R2 of the diffractive optics layers 102A and 102P are determined according to a desired lens base power.
For the purposes of comparison with the multi-layer IOL 100,
For a single-layer IOL, such as the single-layer IOL 120, having a refractive index n(λ) at a wavelength λ, the first order diffraction efficiency ηS(λ) at the wavelength can be calculated with a scaler diffraction theory known in the art, as
where sinc(x) is the sinc function,
and when the medium surrounding the IOL is air (i.e., n=1), ΦS(λ) is the phase function defined as
with the design wavelength λ0. The step height h may be chosen to optimize the first order diffraction efficiency ηS(λ0) at the design wavelength λ0. Since the phase function ΦS(λ) depends on the wavelength λ, the diffraction efficiency ηS(λ) varies as the wavelength varies λ.
Further, the diffraction efficiency ηS(λ) can reach 100% only when the phase function ΦS(λ) equals 2π (i.e., the argument of the sinc function is zero). This condition is equivalently
However, all known materials have a refractive index n(λ) that monotonically decreases as the wavelength λ increases, and thus the condition above cannot be not fulfilled at the wavelength λ, different from the design wavelength λ0. Consequently, the diffraction efficiency ηS(λ) cannot reach 100% at the wavelength λ, different from the design wavelength λ0.
For a multi-layer IOL, such as the multi-layer IOL 100, the first order diffraction efficiency ηM(λ) can be similarly calculated with the scaler diffraction theory, as
where ΦM(λ) is the phase function ΦM(λ) defined as
where n1(λ) and n2(λ) are the refractive indices of the diffractive optics layers 102A and 102P, respectively, and the refractive index of the gap 110 (e.g., air) is assumed to be 1. Since the two terms in the phase function ΦM(λ) have opposite signs, the dependency of the phase function ΦM(λ) on the wavelength λ can be reduced as compared to the phase function ΦS(λ) for the single-layer IOL 120, or eliminated, by appropriately adjusting the step heights h1, h2, given the refractive indices n1(λ) and n2(λ). Thus, high diffraction efficiency throughout the entire visible light spectrum can be achieved with the multi-layer IOL 100.
Further, the diffraction efficiency ηM(λ) can reach 100% when the phase function ΦM(λ) equals 2π. This condition is equivalently
h
1(n1(λ)−1)−h2(n2(λ)−1)=λ,
which can be fulfilled by appropriately adjusting the step heights h1, h2 at least at two different wavelengths λa, and λb, as
if the denominator is different from zero. The denominator is non-zero for real materials, if the two materials of which the diffractive optics layers 102A, 102P are fabricated are different.
It should be noted that these conditions for the step heights h1, h2 are tightly related to the Abbe numbers
of the diffractive optics layers 102A and 102P, defined using the refractive indices n1(λ), n2(λ) at three different wavelengths λF=486.1 nm (blue Fraunhofer F line from hydrogen), λD=589.2 nm (orange Fraunhofer D line from sodium), and λC=656.3 nm (red Fraunhofer C line from hydrogen).
In general, the step heights h1, h2 can be smaller when a difference between the Abbe numbers ν1, ν2 is larger. For instance, the step heights are h1=35.8 μm, h2=40.5 μm for a combination of Material A and Material B (νd1=39.5, νd2=52.8). The step heights are h1=317.0 μm, h2=312.2 μm for a combination of Material A and Material C (νd1=39.5, νd2=37.3).
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The control module 1202 includes a central processing unit (CPU) 1214, a memory 1216, and a storage 1218. The CPU 1214 may retrieve and execute programming instructions stored in the memory 1216. Similarly, the CPU 1214 may retrieve and store application data residing in the memory 1216. The interconnect 1208 transmits programming instructions and application data, among CPU 1214, the I/O device interface 1212, the user interface display 1204, the memory 1216, the storage 1218, output device 1210, etc. The CPU 1214 can represent a single CPU, multiple CPUs, a single CPU having multiple processing cores, and the like. Additionally, in certain embodiments, the memory 1216 represents volatile memory, such as random access memory. Furthermore, in certain embodiments, the storage 1218 may be non-volatile memory, such as a disk drive, solid state drive, or a collection of storage devices distributed across multiple storage systems.
As shown, the storage 1218 includes input parameters 1220. The input parameters 1220 include a lens base power, asphericity, toricity, refractive indices nd1 and nd2 of the two materials of which the diffractive optics layers 102A, 102P are fabricated, and a design wavelength λ0. The memory 1216 includes a computing module 1222 for computing control parameters such as the radial spacings d1, d2 and the step heights h1, h2 of the annular echelettes 108A, 108B. In addition, the memory 1216 includes input parameters 1224.
In certain embodiments, input parameters 1224 correspond to input parameters 1220 or at least a subset thereof. In such embodiments, during the computation of the control parameters, the input parameters 1224 are retrieved from the storage 1218 and executed in the memory 1216. In such an example, the computing module 1222 comprises 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 certain other embodiments, input parameters 1224 correspond to parameters received from a user through user interface display 1204. In such embodiments, the computing module 1222 comprises executable instructions for computing the control parameters, based on information received from the user interface display 1204.
In certain embodiments, the computed control parameters, are output via the output device 1210 to a lens manufacturing system that is configured to receive the control parameters and form a lens accordingly. In certain other embodiments, the system 1200 itself is representative of at least a part of a lens manufacturing systems. In such embodiments, the control module 1202 then causes hardware components (not shown) of system 1200 to form the lens according to the control parameters. The details and operations of a lens manufacturing system are known to one of ordinary skill in the art and are omitted here for brevity.
At step 1310, control parameters (e.g., the radial spacings d1, d2 and the step heights h1, h2 of the annular echelettes 108A, 108B) are computed based on input parameters (e.g., a lens base power, asphericity, toricity, refractive indices of the two materials of which the diffractive optics layers 102A, 102P are fabricated). The computations performed at step 1310 are based on one or more of the embodiments, including the formulas, described herein.
At step 1320, a multi-layer IOL (e.g., multi-layer IOL 100) having diffractive optics layers (e.g., diffractive optics layers 102A, 102P) based on the computed control parameters (e.g., the radial spacings d1, d2 and the step heights h1, h2 of the annular echelettes 108A, 108B) is formed, using appropriate methods, systems, and devices typically used for manufacturing lenses, as known to one of ordinary skill in the art.
The embodiments described herein provide multi-layer IOLs that can achieve both achromatization and high diffraction efficiency throughout the entire visible light spectrum, leading to significantly higher MTF and visual acuity, as compared to conventional single-layer IOLs. The enhancement of performance can be achieved with mono-focal IOLs, extended depth of focus (EDOF) multi-layer IOL, and tri-focal multi-layer IOLs.
While the foregoing 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, and the scope thereof is determined by the claims that follow.
This application claims the benefit of priority of U.S. Provisional Patent Application Ser. No. 63/284,318 titled “ACHROMATIC IOL WITH MULTIPLE LAYERS OF DIFFRACTIVE OPTICS,” filed on Nov. 30, 2021, whose inventors are Myoung-Taek Choi, Xin Hong, Shinwook Lee and Zhiguang Xu, which is hereby incorporated by reference in its entirety as though fully and completely set forth herein.
Number | Date | Country | |
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63284318 | Nov 2021 | US |