Enhanced single-focus light-adjustable intraocular lens
By designing an enhanced monofocal intraocular lens, combining a basic optical power and a super-Gaussian zoom structure, the problem of uneven visual acuity at different distances in existing IOLs has been solved, achieving balanced visual improvement and glare reduction at far, medium, and near distances.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- RXSIGHT INC
- Filing Date
- 2024-10-30
- Publication Date
- 2026-05-12
AI Technical Summary
Existing intraocular lenses struggle to provide balanced visual acuity at different distances. In particular, multifocal IOLs improve visual acuity at near and far distances at the expense of visual acuity at intermediate distances, while EDOF IOLs improve visual acuity at intermediate distances at the expense of decreased visual acuity at near and far distances.
An enhanced monofocal (EMF) intraocular lens (IOL) is designed, whose optical power characteristics include a base optical power and a focal enhancement structure for near vision. The focal enhancement structure is characterized by a super-Gaussian wavefront. By introducing an axial focal power aperture and a central focal enhancement ring at the optical axis of the IOL, the optical path difference is composed of the base and focal enhancement wavefronts. The optical path difference is optimized to achieve balanced visual acuity.
While maintaining visual acuity at long distances, it significantly improves visual acuity at intermediate and near distances, reduces the risk of glare, and eliminates myopia-related glare through light modulation steps, providing a more balanced visual effect.
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Figure CN122028872A_ABST
Abstract
Description
[0001] John Kondis and Ilya Goldshleger
[0002] Cross-references to related applications
[0003] This application claims priority to U.S. Application No. 18 / 498,086, filed on October 31, 2023, entitled "Enhanced Monofocal Light Adjustable Intraocular Lens," the entire contents of which are incorporated herein by reference. Technical Field
[0004] This application relates to monofocal intraocular lenses, and more specifically to light-tunable enhanced monofocal intraocular lenses. Background Technology
[0005] Replacing the eye's cloudy natural lens with an intraocular lens (IOL) is a life-changing experience for patients, as these IOLs restore their visual acuity to the quality they enjoyed earlier in life. However, these IOLs are non-accommodative, so providing good vision at both near and far distances remains a challenge. Various solutions have been proposed to provide good vision at different distances, such as multifocal IOLs and depth-of-focus IOLs. Some of these ideas are achieved through diffractive optics designs, while others are achieved through partitioned or refractive designs. However, no single optical design is significantly superior to all others, thus there is an ongoing need to develop additional IOLs that can further enhance patients' visual acuity at different distances. Summary of the Invention
[0006] In some embodiments of enhanced monofocal (EMF) intraocular lenses (IOLs), the optical power of the EMF IOL is characterized by: a base optical power for distance vision, consistent with that of a monofocal lens; and an add-power structure for near vision, comprising a central add-power ring around the optical axis of the IOL and an axial power hole located at the optical axis of the IOL. In embodiments, this add-power structure is introduced by an approximately super-Gaussian optical path difference, the super-Gaussian having a power greater than two in its exponent on the radial coordinate.
[0007] In some embodiments of enhanced monofocal (EMF) intraocular lenses (IOLs), the optical path difference W(r) of the EMF IOL is characterized by: the base wavefront W for distance vision. b (r); and the additional focal length structural wavefront W for near vision. a(r), which is composed of supergaussian W sG (r) approximately characterizes the supergaussian as having a power greater than two in its exponent of the radial coordinate r. Attached Figure Description
[0008] Figure 1A -H shows the beam, logMAR, and MTF characteristics of the existing IOL.
[0009] Figure 2A -B illustrates an embodiment of the enhanced single-focus (EMF) IOL 100.
[0010] Figure 3 A super-Gaussian embodiment of the EMF IOL 100 with a zero additional paraxial zoom structure is shown.
[0011] Figure 4 A modified super-Gaussian embodiment of the EMF IOL 100 with a non-zero additional paraxial zoom structure is shown.
[0012] Figure 5 The diagram illustrates the root mean square difference between two wavefronts.
[0013] Figure 6 The diagram shows a comparison of defocus-dependent logMAR for different IOLs.
[0014] Figure 7 The MTF comparison charts for defocus dependence of different IOLs are shown. Detailed Implementation
[0015] The following describes a novel intraocular lens design that addresses the aforementioned challenges and provides significantly improved optical performance for the benefit of patients. Figure 1A -B illustrates the beam shape of a conventional multifocal intraocular lens 10 for both near and far objects. The multifocal intraocular lens has a central near supplementary region 12 for near vision and a remaining peripheral region 14 for far vision. Both regions have narrow beam waists, thus providing well-defined optical power, enabling high-quality imaging of near and far objects onto the retina 16, respectively.
[0016] Figure 1C -D shows two ways to characterize the imaging quality of IOL 10. Figure 1CVisual acuity is shown as a "logMAR" graph, representing the "logarithm of the minimum resolvable angle." The angle is measured in radians, and the logarithm is base 10. These graphs are typically determined by performing a vision test on a patient in the "lane" of an optometrist's office. A capital letter E is usually displayed, and the patient is asked to report the orientation of the E. Determining this orientation requires visually resolving three repeating lines of the E, thus indicating a threshold in the patient's ability to distinguish angular structures. Alternatively, a standard alphabetic vision chart is also widely used. This involves presenting the patient with letters of varying sizes at a fixed distance and determining the smallest letter size the patient can distinguish. The logMAR graph can also be estimated using only optical modeling and ray tracing without patient input. In this modeling approach, perceptual elements of visual performance can be represented by empirical functions.
[0017] Broadly speaking, logMAR 0.0 means that the patient can distinguish 1 arcminute at the channel distance. Better visual acuity means that the patient can distinguish features smaller than 1 arcminute. The logarithm of a number less than 1 is negative, so increasingly negative logMAR values represent increasingly better visual acuity (VA). Therefore, by convention, increasingly negative logMAR values are plotted in the +y direction on an xy-plot. Plotted on the horizontal axis is the negative reciprocal of the distance to the object (channel distance), in diopters D or 1 / meter, and is called defocus d, or simply defocus. In other words, the horizontal axis shows the optical power of the lens that replicates the focusing condition. For example, light from an object 1 meter away can be replicated by placing the object at infinity (0 D) and then placing a lens with a focal length of -1 meter in front of the eye. The optical power of this replicating lens is 1 / (-1m) = -1 D, so the focusing condition is represented on the horizontal defocus axis as d = -1 D. Defocus d becomes increasingly negative along the defocus axis in the +x direction. Finally, the industry standard also characterizes visual acuity at three distances: at far distance, corresponding to 0 D defocus; at a medium distance of 0.66 m, which is 1.5 D defocus; and at a close distance of 0.40 m, which is 2.5 D defocus. Conventionally, these three distances are simply referred to as far distance, medium distance, and close distance, completely omitting the word "distance".
[0018] Figure 1C The logMAR plot of the multifocal IOL 10 shows two or more distinct peaks: one at far distances with a defocus of 0 D, and one or more at near distances such as -2.5 D. The logMAR peaks at near distances allow the multifocal IOL 10 to alleviate visual acuity problems in hyperopic patients who experience near-field loss of accommodation. However, this high visual acuity at near and far distances comes at the cost of poorer visual acuity at intermediate distances (with a defocus of d = -1.5 D).
[0019] Figure 1D An alternative approach to characterizing visual acuity using the modulation transfer function (MTF) is presented. MTF determination does not involve patient feedback and can be accomplished through optical modeling of the IOL and the eye's optical system, particularly the cornea. MTF involves calculating the modulation amplitude of a periodic image in the IOL's focal plane when the IOL images an object with full (or 100%) modulation. A typical example of a periodic object is a set of repeating stripes or lines. Therefore, MTF is not a threshold criterion like logMAR.
[0020] MTF has several variables. One of them is ν, the spatial frequency of the periodic object, usually expressed in "line pairs / mm" or "lp / mm": how many line pairs are within one millimeter of the imaged object. MTF(ν) can be plotted based on the spatial frequency ν (in lp / mm). These MTF(ν) curves decrease as the object distance (for distance-corrected patients) decreases, i.e., the defocus becomes increasingly negative because the image is moving away from the focal plane. Figure 1D The MTF can also be drawn at a fixed spatial frequency ν (e.g., 25, 50, or 100 lp / mm) at the focal plane based on the defocus d. Figure 1D The MTF(d) at ν = 50 lp / mm is shown. As with the previous logMAR plot, increasingly negative defocus values correspond to closer objects. The MTF(d) shows that when the image is at the focal plane, the monofocal IOL 1 provides sharp visual acuity at d = 0 D, but this MTF(d) decreases as the object moves closer and the image thus moves further away from the focal plane. On the other hand, when the object moves very close to the multifocal IOL 10 such that the image formed by the central near-additional region 12 falls on the plane corresponding to the distant focal plane of the peripheral region 14, the multifocal IOL 10 has a second maximum MTF. This second maximum helps hyperopic patients see near objects with good acuity even with loss of their natural lenticule accommodation. It is evident that this benefit comes at a cost: providing good near MTF reduces distant MTF. Figure 1D In the multifocal IOL 10, the MTF (d=0) decreased from a typical 0.55 for the monofocal IOL 1 to approximately 0.25, a reduction of about 50%. Importantly, this reduction in visual acuity cannot be recovered by wearing glasses. Wearing glasses only shifts the MTF laterally along the defocus axis. Therefore, wearing glasses is only helpful if there is another, higher MTF peak at other defocus points. Figure 1DThe MTF of a multifocal IOL 10 does not show a higher peak than the peak at d=0 defocus. This makes the loss of visual acuity at distances irreversible. Furthermore, the visual acuity of a multifocal IOL 10 at intermediate distances is as low as that of a monofocal IOL 1—an additional problem for hyperopic patients. For completeness, it should be mentioned that there are different types of multifocal IOLs, sometimes called diffractive, refractive, or partitioned, and the MTF and logMAR curves of different types of IOLs can differ and exhibit variations.
[0021] Figure 1E -F illustrates an IOL design that provides improved visual acuity at mid-range distances. Figure 1E -F illustrates the beam shape of these extended depth-of-focus (or EDOF) IOLs 20 for both distant and near objects. In these EDOF IOLs 20, the optical power gradually varies from a higher value at the center to a lower value in the peripheral region, effectively smoothing out the abrupt change in optical power characteristic of multifocal IOLs 10 at the outer radius near the center of the additional region 12. This smoothing elongates the beam waist of these EDOF IOLs 20.
[0022] Figure 1G -H shows that the extended beam waist of EDOF IOL 20 improves visual acuity at intermediate distances, as evidenced by the higher logMAR(d) and MTF(d) values at d=-1.5D compared to the corresponding values for multifocal IOL 10. Furthermore, visual acuity at far / far distances d=0 remains essentially unchanged and is still significantly lower than that of monofocal IOL 1. However, it is evident that EDOF IOL 20 provides this significant improvement at intermediate distances by substantially reducing near visual acuity. Nevertheless, the benefit at intermediate distances is a major reason why EDOF IOL 20 has gained considerable attention and market share in recent years. Meanwhile, the decreased VA at near distances and the still relatively low acuity at far / far distances remain a source of persistent patient dissatisfaction.
[0023] Figure 2A -B illustrates an embodiment of an enhanced monofocal (EMF) IOL 100 that promises to overcome the aforementioned limitations. This EMF IOL 100 has a (total) optical power P(r) 110, which can be a base optical power P for distance vision. b (r) 120 (consistent with monofocal lenses) and an additional focusing structure P centered on the EMF IOL 100 optical axis 134 for near vision. a The sum of (r)130, this additional zoom structure includes a central zoom ring 132 surrounding the optical axis 134 of the EMF IOL 100, which surrounds the axial zoom aperture 136. In the formula:
[0024]
[0025] The total optical power P(r) 110 can be related to another important quantity, commonly known as the optical path difference OPD(r), optical path length, or wavefront W(r), which characterizes the length of the path traversed by the light rays multiplied by the refractive index of the medium they pass through. The two are closely related through the following relationship:
[0026]
[0027] The total wavefront W(r) 111 and the basic optical power wavefront W will be adopted. b (r) 121 and the zoom structure wavefront W a (r)131 notation.
[0028] In different EMF IOL 100 models, the basic optical power P b (r) can be aligned with a monofocal lens in a variety of ways. In some EMF IOL 100s, the base power P b (r) 120 can be characterized by radius-independent monofocal power: P b (r) = constant. In other embodiments, the base optical power P b (r) 120 can be characterized by a radius-dependent optical power with corrective aberrations that at least partially compensate for corneal aberrations. It is known that the cornea introduces aberrations into the wavefront. This spherical aberration is positive, and its value depends on the size / radius of the aperture at which the phase difference is measured. At a radius of 3 mm in the corneal plane, this corneal aberration is approximately 0.27–0.30 micrometers. Some EMF IOL100s can be designed by incorporating fourth / sixth-order Zernike polynomial terms that introduce compensating negative spherical aberrations into the fundamental optical power wavefront W. b (r) 121 partially or completely compensates for this aberration:
[0029]
[0030] Some EMF IOL 100 systems may even overcompensate corneal aberrations, resulting in negative spherical aberration in the corneal-plus-EMF IOL system. (The last sentence appears to be incomplete and unrelated to the preceding text. It likely refers to a specific optical power wavefront measurement.) b (r) Adding a negative spherical aberration term to 121 results in a fundamental optical power P b(r) 120 exhibits a moderate center-to-periphery change in optical power, which can range from a few tenths of a diopter, such as 0.2 D or 0.5 D, and may even rise to 1 D for EMF IOL 100 that fully or overcompensates corneal aberrations. Since this change in optical power is caused solely by aberration compensation, these EMF IOL 100s can still be cited as consistent with monofocal lenses.
[0031] Figure 2A It is a two-dimensional shaded plot of the total P(r) 110. Figure 2B The zoom structure P is an embodiment of EMF IOL 100. a (r) 130 radial section view—for simplicity, often simply referred to as the zoom structure P a (r) 130. In this zoom structure P a Figure 130 (r) shows that the central focusing ring 132 has focusing structure peaks 138 at some peak radii r (peaks) 133, while the axial focusing aperture 136 has a paraxial focusing structure 139 at the optical axis 134 (at r=0). The paraxial focusing structure 139 can be zero or a small value, as described below. As shown in the figure, the total optical power P(r) 110 and the focusing structure P a (r) 130 Both have a minimum value in the axial focal length aperture 136 at the optical axis 134 and a maximum focal length structure peak 138 in the central focal length ring 132.
[0032] In some embodiments, the zoom structure P a (r) 130’s central focusing ring 132 has a focusing structure peak 138 in the range of 1.0-4.0 diopter D; in other embodiments, the focusing structure peak 138 is in the range of 2.0-3.0 D. Figure 3 The zoom ratio structure P is shown. a (r) The embodiment with a focal length structure peak 138 of approximately 2.2 D is described. A higher focal length structure peak 138 (in the range of 2.5–4.0 D) provides better visual acuity at close range but is poorer at intermediate and distant ranges. A lower focal length structure peak 138 (in the range of 1.0–2.5 D) provides less satisfactory visual acuity at close range but better at intermediate and distant ranges. These competing design choices can be weighed and optimized based on physician judgment and patient preference.
[0033] Figure 3 The zoom ratio structure P is shown. a (r) 130 is the super-Gaussian zoom structure P sG (r) 140 embodiment, super-Gaussian zoom structure PsG (r) 140 is the super-Gaussian wave front W sG (r) 141 optical path difference W a (r) 131 introduces that this super-Gaussian has a k-th power (greater than two) of the lens radius r in its exponent:
[0034]
[0035] Figure 3 An example with k=4 is shown. The corresponding super-Gaussian zoom structure P sG (r) 140 is given by the following formula:
[0036]
[0037] It is evident that in this "super-Gaussian EMF IOL"100 where k>2, P a (r) 130 has a pre-exponential power-law term with an exponent of (k-2): ~r (k-2) This forced P a (r=0), the paraxial focusing power structure 139 is zero at r=0, thus forming a complete axial focusing aperture 136. Extensive optimization was performed on the weighting factors for various constraints. It was found that these super-Gaussian embodiments of EMFIOL 100 cause minimal distortion to the wavefront compared to monofocal IOL 1, thus making its MTF (d=0) and logMAR (d=0) at a distant defocus d=0 closest to the monofocal values. This is why EMF IOL 100 can be called an enhanced monofocal IOL.
[0038] Figure 4 As shown in other embodiments of the EMF IOL 100, the axial power aperture 136 can actually direct the paraxial fundamental power P. b (0) Add some paraxial power 139. In a general sense, the axial power aperture 136 can add non-zero paraxial power 139, which is less than the (maximum) peak power 138 of the central focusing ring 132. Therefore, the so-called axial power aperture 136: the paraxial power 139 of these EMF IOL 100s is still less than its peak power 138, so when the total power P(r) 110 is plotted according to radius r, P(r) 110 is not a monotonically decreasing function. Instead, the total power P(r) 110 exhibits a minimum power at r=0 and then a maximum power at the peak radius r=r(peak)>0 133. For r>r(peak), P a (r) 130 is a decreasing function that rapidly decays to zero, such that P(r) 110 will become equal to P b(r) 120. In some embodiments, the peak radius r (peak value) 133 does not exceed 0.5 mm; in other embodiments, the peak radius r (peak value) 133 does not exceed 0.75 mm. Therefore, EMF IOL 100 is clearly distinguished from some existing EDOF IOLs, whose optical power is a function that monotonically decreases as the radius r increases.
[0039] In some embodiments, the axial power aperture 136 can direct the paraxial base power P. b (0) Add a non-zero paraxial focusing power structure P with a diopter less than 1 diopter D. a (0) 139. In other embodiments, the axial power aperture 136 can direct the paraxial base power P. b (0) Add paraxial zoom structure P less than 0.5 D a (0) 139. Figure 4 The EMF IOL 100 embodiment shows an additional paraxial zoom structure 139P. a (0) = 1.5D. This design freedom of 139 independently controlled paraxial power enhancement structures is the reason why these EMF IOL 100s are called "paraxial power control". The advantages of these EMF IOL 100s will combine... Figure 6-7 Further analysis is needed. As mentioned earlier, the pure super-Gaussian wavefront W... sG (r) has a zero paraxial zoom structure 139. Therefore, the wavefront with a finite paraxial zoom structure 139 is a super-Gaussian wavefront corrected by a correction term that can generate a non-zero paraxial zoom structure 139.
[0040] It is worth noting that the techniques and equipment used to characterize IOLs (such as wavefront aberration meters) have limited spatial resolution, typically a few tenths of a millimeter. This resolution can be comparable to the minute spatial features of an EMF IOL 100 (such as the radius r(peak) 133 of the peak optical power), and in some embodiments it can be as small as r(peak) = 0.4 mm-0.5 mm. Therefore, for a structure with zero paraxial zoom 139 P a (0) = 0 D and therefore has a full-axis optical focal length aperture 136 and a significant focal length structure peak 138 P at r (peak) 133. aFor an EMF IOL 100 with (r(peak value)) (e.g., 2D), the following can occur. When characterizing such an EMF IOL 100 using a wavefront aberration meter with finite resolution, the measured finite resolution appears to "smear out" the axial optical power aperture 136 and the intensification structure peak 138. Furthermore, the 1 / r prefactor in the definition of optical power amplifies the measurement error as r approaches zero, which can have an additional blurring effect. Therefore, such a measurement may report a value with P... a (0)>0 indicates an incomplete axial focal length aperture 136 and a reduced focal length structure peak P. a (r(peak value)) < 2D, instead of P a (0) = 0D and P a (r(peak value)) = the true value of 2D. Therefore, in this finite resolution measurement, the EMF IOL 100 appears to have a finite paraxial zoom structure 139 P. a (0)>0, even if the high-resolution aberration meter will measure the true paraxial telephoto structure 139 P a (0) is zero.
[0041] Given the importance and practicality of characterizing EMF IOL 100 by its optical path distance / length or wavefront W(r), as just demonstrated, we can directly characterize EMF IOL 100 as having an optical path difference W(r) 111, which is determined by the basic wavefront W used for distance vision. b (r) 121 and the additional focal length enhancement structure wavefront W for near vision a (r) 131 characterization indicates that the wavefront of this zoom structure approximately follows a super-Gaussian W... sG (r) 141. Basic wavefront W b (r) 121 corresponds to the basic optical power P b (r) 120, additional zoom structure wavefront W a (r) 131 corresponds to the zoom structure P(r) 110. a (r) 130.
[0042] Figure 3 Display of super-Gaussian wavefront W sG (r) 141 can have a Gaussian exponential form, which has a power greater than two in the radial coordinate. The terms "radius" and "radial coordinate" will be used interchangeably.
[0043] The prime factor driving the superior depth-of-focus extension of these EMF IOL 100s is their intensification structure wavefront W. a (r) 131 and appropriately parameterized superGaussian wavefront W sG(r) 141 similarity. Therefore, in the above description, the embodiments are not limited to those that strictly follow a specific supergaussian form. Rather, their optical power P a (r) 130 and wavefront W a (r)131 approximately follows these forms. It has an approximation of the super-Gaussian wavefront W. sG (r) 141 wavefronts of this type of EMF IOL 100 also exhibit superior visual acuity and depth-of-focus characteristics. This approximation can be quantized in various ways, including the widely used quantization of two wavefronts W. A (r) and W B A method to determine the difference or similarity between (r) is through their root mean square difference D(AB). For example... Figure 5 As shown, D(AB) can be defined as:
[0044]
[0045] Since the unit of W(r) is length, the unit of D(AB) is also length. Given its universal relevance in calculating diffraction and wave propagation, it is customary to describe the wavefront W(r) and this optical path difference D(AB) as a fraction of the typical wavelength λ in the problem. For human vision, the relevant wavelength range is the visible spectrum of sunlight, with a maximum value of approximately λ = 550 nm. Therefore, D(AB) is conventionally discussed as, for example, "half a wavelength" (which could mean D(AB) = 0.5 * 550 nm), or any appropriately chosen "design wavelength". Thus, the dimensionless characterization of the root-mean-square difference between wavefronts A and B can be the ratio of D(AB) to the typical wavelength λ: D(AB) / λ.
[0046] Figure 5 Based on this preparation, the embodiment of EMF IOL 100 can have a super-Gaussian wavefront W with appropriate parameterization. sG (r) 141 is a good approximation of the zoom structure wavefront W a (r) 131, such that D(a,sG) / λ<δ, where in some embodiments δ can be 0.05, 0.1, or 0.2. Herein and below, “appropriate parameterization” means that the best approximation of the super-Gaussian wavefront W can be constructed. sG (r) 141, whose parameters make the best approximation super-Gaussian wavefront and the zoom structure wavefront W a The root mean square difference D(a,sG) between (r) is less than δ, in units of wavelength λ = 550 nm: D(a,sG) / λ < δ. Here δ is 0.05, 0.1, or 0.2. Informally, this means that the super-Gaussian wavefront W can be... sG (r) 141 Find parameters that align with the zoom structure wavefront W of EMF IOL 100. a(r) 131 is so close that D(a,sG) / λ<δ, where δ is 0.05, 0.1 or 0.2.
[0047] In some embodiments of EMF IOL 100, the zoom structure wavefront W a (r) 131 supergaussian W sG (r) 141 was modified to produce a non-zero paraxial zoom structure P(0) 139 in the range of 0 D - 1 D.
[0048] Our simulations show that very good visual acuity can be obtained in EMF IOL 100, with the power k in its super-Gaussian exponent in the range of 3.5-4.5.
[0049] Figure 6-7 This paper summarizes some of the significant advantages of the EMF IOL 100 in terms of the previously introduced visual acuity measurement metrics (logMAR and modulation transfer function MTF plot).
[0050] (1) As a result of extensive optimization of the constraint weighting factors, EMF IOL 100 achieves visual acuity at long distances / far distances very close to that of monofocal IOL 1, and is significantly enhanced compared to EDOF IOL 20. For example, Figure 7 MTF of EMF IOL100 EMF (d=0) is only compared to the MTF of the corresponding monofocal IOL 1 with the same base optical power. mono (d=0) 15% lower. In other embodiments, MTF EMF (d=0) can be found in MTF mono Within 30% of (d=0). This is much better than the optical performance of EDOF IOL 20, whose MTF is... EDOF (d=0) relative to long-distance monofocal MTF mono (d=0) can reduce it by 45%.
[0051] (2) Although EMF IOL 100 provides significantly better MTF than EDOF IOL 20 at far out-of-focus locations, its zoom ratio structure P a (r) 130 smooth super-Gaussian design and our extensive optimizations still achieve visual acuity comparable to EDOF IOL 20 in the middle and near. Figure 6 The logMAR of EMF IOL 100 is only about 0.05 lower than that of EDOF IOL 20 in the middle and near out-of-focus areas. Figure 7 The MTF of EMF IOL 100 is virtually indistinguishable from that of EDOF IOL 20 in the middle and near range.
[0052] (3) When compared with a single-focus IOL 1 at the intermediate and near points, relative to only having the corresponding basic optical power P b (r)120 single-focus IOL 1 depth of focus, zoom structure P a (r) 130 extends the depth of focus of the EMF IOL 100. One way to quantify this extension of depth of focus is compared to having only the corresponding base optical power P. b (r) 120 monofocal IOL 1, for a base optical power P b (r) 120 plus zoom structure P a (r) 130 of EMF IOL 100, in Figure 6 The negative logMAR of EMF IOL 100 exceeds 0.2 over a longer diopter range. Figure 6 In the EMF IOL 100, the negative logMAR exceeds 0.2 in the range of 0D-(-2.5D). However, only those with the corresponding basic optical power P... b (r) The negative logMAR of a single-focus IOL 1 at 120° only exceeds 0.2 in the range of 0D-(-1.8D). (Here we use "negative logMAR exceeds" to refer to logMAR values "above" 0.2 in the +y direction.)
[0053] (4) All these benefits are achieved while minimizing the risk of glare. Glare in the existing EDOF IOL20 can be generated by diffraction structures and sharp edges, which are absent in the EMF IOL 100. Furthermore, myopia-related glare can also be eliminated through the light conditioning steps discussed later.
[0054] These advantages are attributable to several design differences between the existing EDOF IOL 20 and EMF IOL 100, as described below.
[0055] (1) The broad category of EDOF IOL 20 has a central bulge, causing its optical power P(r) 110 to have a maximum value at r=0 and decrease monotonically as the radial coordinate r increases. In contrast, the optical power structure P of EMF IOL 100... a (r) 130 has an axial focal length aperture 136, therefore its focal length enhancement structure P aThe total optical power P(r) 110 has a minimum at r=0 and increases rather than decreases for small values of r. Therefore, the overall variation of the total optical power P(r) 110 is a non-monotonic function of the radial coordinate r of the EMF IOL 100, such that P(r) 110 has a minimum in the axial optical power aperture 136 and a maximum in the central focusing ring 132. Typically, P(r) 110 has its minimum at the center r=0, its maximum at the peak radius r (peak value) 133, and monotonically decreases as r > r (peak value).
[0056] (2) Other existing EDOF IOL 20 have more complex central additional structures 12, with phase-shifting structures whose optical power first decreases, then increases, and then decreases again with radial coordinate r. The optical power of these structures has a minimum value at a finite radial coordinate r. These structures have an optical power minimum value at a finite radial coordinate r. Their optical power enhancement structures P a (r) 130 is typically negative near this minimum. Some have annular or ring-shaped ridges on the surface of the lens itself, i.e., in W(r), rather than in the power P(r) as in EMF IOL 100. In contrast, EMF IOL 100 does not have a minimum power at a finite radial coordinate r. Their W(r) also does not have an annular shape: W(r) has a maximum value at r=0 and decreases monotonically as the radial coordinate r increases. Therefore, the power structure P of EMF IOL 100 is... a (r) 130 is non-negative in all radial coordinates: it has no region with negative optical power.
[0057] (3) Many of these phase-shift structures share linear variations in their wavefronts, some of which exhibit segmented, multi-regional patterns. In contrast, EMF IOL 100 lacks linear segments in its wavefront. Using the aforementioned characterization tool D(a,b), the zoom structure wavefront W... a (r) 131 and the best fit of the linear wavefront W with a central flat top and a decreasing linear segment lin The root mean square difference D(a,lin) between (r) exceeds The design wavelength is λ=550 nm. ,in =0.1, 0.2 or 0.5.
[0058] (4) The radii of the centrally attached phase-shifting structures in these existing EDOF IOL 20s typically exceed 1 mm. In contrast, EMF IOL 100 has a smaller characteristic peak radius r (peak) 133. Our simulations show that while such large-radius centrally attached structures 12 can provide good near vision, they impair distance vision to an uncomfortable degree. Inspired by these simulation results, the focal length enhancement structure P of EMF IOL 100... a (r) 130 is achieved with an exceptionally small feature radius, with its zoom structure peak 138 located at a peak radius 133 (r(peak) = 0.5 mm or less). Some embodiments have found benefits in r(peak) 133 being as large as 0.75 mm, but these values are still significantly below 1 mm.
[0059] (5) Total wavefront W(r) of EMF IOL 100 = W a (r)+ W b (r) differs significantly from most existing EDOF IOL 20. In fact, the wavefronts of most EDOF IOL 20 are characterized by Znick polynomials Zn(r), and their wavefronts W(r) are limited to the sum of a few leading Znick polynomials:
[0060]
[0061] N is typically 4 or 6, and does not exceed 10 or is at most 12. In contrast, the EMF IOL 100 features a super-Gaussian wavefront W... sG (r) 141 describes the zoom structure wavefront W a (r) 131. When people try to describe the zoom structure wavefront W of EMFIOL 100 using Zernike polynomials. a When (r) 131, N=20 or higher is typically required. This means that if one attempts to use the sum W of Zernike polynomials truncated at N=8, 10, or 12... ZN (r) describes the zoom structure wavefront W a (r) 131, then the residual difference not explained by the Zernike polynomial is still the zoom structure wavefront W in the region of EMF IOL 100. a (r) 131 is the substantive part. In some EMF IOL 100s, the wavefront difference measure defined above, i.e., W of EMF IOL 100, is... a (r) 131 and the sum of the Zernik polynomials with the best approximation at N-truncation W ZN The root mean square difference D(a,ZN) between (r) is still greater than In terms of wavelength λ: For λ = 550 nm and N = 8, 10, or 12, Greater than 0.1, 0.2, or 0.5. Here, N is the first index in the two-index notation of the Zernike polynomial. If a single-index notation is used for the Zernike polynomial, N in D(a,ZN) can be as high as 15 or even 20.
[0062] This incompatibility has a mathematical reason. As the index n increases, the Zernike polynomial Z... n The exponent n of radius r in (r) also increases. Therefore, they affect W. a The contribution of (r)131 increases significantly with r. In contrast, EMFIOL 100 exhibits a zoom structure wavefront W that decays exponentially at large r. a (r) 131. A large number of Zernike polynomials (increasing with r) are needed to finely cancel each other out in order to produce an exponentially decaying W of EMF IOL 100. a (r) 131.
[0063] (6) Another advantage of EMF IOL 100 is that many categories of EDOF IOL 20 are designed by optimizing their central focusing structure and peripheral base power separately and independently. Because the two regions are designed separately, mismatches often occur when their focusing structures and peripheral base power structures finally connect at a certain connection / matching radius r(con), i.e., a step in power, or a wavefront jump or kink. In these types of lenses, a key design step is to smooth this step, kink, or jump. This matching / smoothing step often reduces overall visual acuity. In contrast, the base power P in EMF IOL 100... b (r) 120 and zoom structure P a (r) 130 is simply additive. No matching or smoothing is needed at any radius because these lenses are designed to avoid any kinks, jumps, or steps between the central and peripheral regions from the outset. Basic wavefront W b (r) 121 and the zoom structure wavefront W a (r) 131 is defined over the entire radius range (from r=0 to typically 3 mm).
[0064] (7) Broad categories of IOLs achieve their design goals by using diffraction structures, gratings, grooves, or eddy gratings. In contrast, EMF IOL 100 does not have diffraction structures, grooves, or eddy gratings.
[0065] Finally, it is worth mentioning a new type of IOL known as the light-adjustable lens (or LAL). These are extensively described in several jointly owned patents, such as US 6,450,642, entitled "Lenses capable of post-fabrication power modification," by Jethmalani et al.; US 10,874,505, entitled "Using thelight adjustable lens (LAL) to increase the depth of focus by inducing targeted amounts of asphericity," by Sandstedt et al.; and US 11,191,637, entitled "Blended extended depth of focus light adjustable lens with laterally offsetaxes," all of which are incorporated herein by reference in their entirety. In this type of LAL, the focusing power structure P of the EMF IOL 100... a (r) 130 can be formed after implantation via a light-modulation step, or it can be pre-molded during its manufacturing process (before implantation).
[0066] This light-tunable capability offers additional benefits in the pursuit of optimized visual acuity. For example, certain types of glare formation are associated with implanted IOLs contributing to myopia, particularly in EDOF or multifocal IOLs. This can occur because the physician did not select the correct IOL or implant it in the optimal or planned location. In either case, eliminating the unintended myopic effect after implantation can significantly reduce or eliminate this type of glare formation. Among existing IOLs, only light-tunable IOLs or LALs allow physicians to correct this unintended myopia post-operatively.
[0067] While this document contains numerous specific details, nuances, and numerical ranges, these should not be construed as limiting the scope of the invention and the claims, but rather as descriptions of features specific to embodiments of the invention. Certain features described in the context of individual embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented individually in multiple embodiments or in any suitable sub-combination. Furthermore, although features may be described above as functioning in certain combinations or even initially claimed in this way, in some cases, one or more features from a claimed combination may be removed from that combination, and the claimed combination may refer to another sub-combination or a variation of a sub-combination.
Claims
1. An enhanced monofocal (EMF) intraocular lens (IOL), wherein: The optical power of the artificial lens is characterized by: The basic optical power used for distance vision is consistent with that of a monofocal lens; as well as Additional focusing structures for near vision include: A central zoom ring surrounding the optical axis of the IOL; as well as Axial focal length aperture located at the optical axis of the IOL.
2. The enhanced single-focus IOL according to claim 1, wherein: The basic optical power is characterized by one of the following: Radius-independent single-focal power; and A radius-dependent optical power with corrective aberrations that at least partially compensate for corneal aberrations.
3. The enhanced single-focus IOL according to claim 1, wherein: The optical power is a non-monotonic function of the radius of the IOL, such that the optical power has: The minimum value in the optical focal length aperture of the axis; and The maximum value in the central zoom ring.
4. The enhanced single-focus IOL according to claim 1, wherein: The central focusing ring produces a focusing structure with a maximum value in the range of 1.0-4.0 diopters.
5. The enhanced single-focus IOL according to claim 1, wherein: The central focusing ring produces a focusing structure with a maximum value in the range of 2.0-3.0 diopters.
6. The enhanced single-focus IOL according to claim 1, wherein: The zoom ratio structure is introduced by an approximate super-Gaussian optical path difference, where the super-Gaussian has a power greater than two in its exponent on the radial coordinate.
7. The enhanced single-focus IOL according to claim 1, wherein: The axial focal aperture produces a paraxial focal enhancement structure with a diopter of less than 1 diopter.
8. The enhanced single-focus IOL according to claim 1, wherein: The axial focal aperture produces a paraxial focal enhancement structure with a diopter of less than 0.5 diopters.
9. The enhanced single-focus IOL according to claim 1, wherein: The maximum value of the zoom structure generated by the central zoom ring is located at a radius not exceeding 0.5 mm.
10. The enhanced single-focus IOL according to claim 1, wherein: The focal depth of the EMF IOL is extended relative to that of an IOL with only the same base optical power.
11. The enhanced single-focus IOL according to claim 10, wherein: The negative logMAR of the EMF IOL having the base optical power plus the zoom capability structure exceeds 0.2 over a longer defocus diopter range than an IOL having only the same base optical power.
12. The enhanced single-focus IOL according to claim 1, wherein: The modulation transfer function of the EMF IOL at zero defocus is within 30% of the modulation transfer function of the corresponding monofocal IOL with only the same base optical power.
13. The enhanced single-focus IOL according to claim 1, wherein: The root mean square difference between the wavefront of the introduced zoom structure and the best fit of the Zernike polynomial truncated at N=8 exceeds 0.2, in wavelengths of 550 nm.
14. The enhanced single-focus IOL according to claim 1, wherein: The zoom ratio structure is non-negative across all radii.
15. The enhanced monofocal IOL according to claim 1, wherein: The IOL is light-tunable; and The zoom structure is pre-molded or formed through a light conditioning process.
16. An enhanced monofocal intraocular lens, wherein: The optical path difference W(r) of the enhanced monofocal intraocular lens (EMF IOL) is characterized by: Basic wavefront W for distance vision b (r); and Additional focal length enhancement structure wavefront W for near vision a (r), the additional zoom structure wavefront W a (r) is derived from the supergaussian W sG (r) approximately characterizes the supergaussian as having a power greater than two in its exponent of the radial coordinate r.
17. The enhanced monofocal IOL according to claim 16, wherein: The zoom structure wavefront W a (r) in the sense that the best approximation of the supergaussian W can be found. sG (r) approximates the optimal approximate super-Gaussian wavefront and the zoom structure wavefront W. a The root mean square difference D(a,sG) between (r) is less than δ=0.1, and in units of wavelength λ=550 nm: D(a,sG) / λ < δ.
18. The enhanced monofocal IOL according to claim 16, wherein: The power of the radius in the exponent of the super-Gaussian is between 3.5 and 4.
5.
19. The enhanced monofocal IOL according to claim 16, wherein: The focal enhancement structure wavefront is introduced to provide an additional focal enhancement structure for near vision, including: The central zoom ring surrounding the optical axis of the IOL; and Axial focal length aperture located at the optical axis of the IOL.
20. The enhanced monofocal IOL according to claim 19, wherein: The central focusing ring produces a focusing structure with a maximum value in the range of 1.0-4.0 diopters.
21. The enhanced monofocal IOL according to claim 16, wherein: The zoom structure wavefront W a The root mean square difference between (r) and the best fit of the Zernik polynomial truncated at N=8 exceeds In units of wavelength λ=550 nm: D(a,ZN) / λ > .
22. The enhanced monofocal IOL according to claim 16, wherein: The zoom structure wavefront W a (r) best fits the wavefront W with a central flat top and a decreasing linear segment. lin The root mean square difference between (r) exceeds In units of wavelength λ = 550 nm: D(a,lin) / λ > .
23. The enhanced monofocal IOL according to claim 16, wherein: The zoom structure wavefront W a The super-Gaussian of (r) is corrected to produce a non-zero paraxial zoom structure in the range of 0 D - 1 D.
24. The enhanced monofocal IOL according to claim 16, wherein: The entire zoom structure wavefront W a (r) is a decreasing function of radius r.
25. The enhanced monofocal IOL according to claim 16, wherein: The IOL is light-tunable; and The zoom structure wavefront W a (r) is pre-molded or formed through a light conditioning process.