WO2024238255A2 - Lentilles de contact pour contrôle de la myopie avec des éléments de défocalisation et/ou d'induction de diffusion de sous-surface - Google Patents

Lentilles de contact pour contrôle de la myopie avec des éléments de défocalisation et/ou d'induction de diffusion de sous-surface Download PDF

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Publication number
WO2024238255A2
WO2024238255A2 PCT/US2024/028531 US2024028531W WO2024238255A2 WO 2024238255 A2 WO2024238255 A2 WO 2024238255A2 US 2024028531 W US2024028531 W US 2024028531W WO 2024238255 A2 WO2024238255 A2 WO 2024238255A2
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Prior art keywords
defocus
subsurface
elements
scatter
contact lens
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PCT/US2024/028531
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WO2024238255A3 (fr
Inventor
Leonard Zheleznyak
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Clerio Vision Inc
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Clerio Vision Inc
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Priority to CN202480040246.3A priority Critical patent/CN121336139A/zh
Publication of WO2024238255A2 publication Critical patent/WO2024238255A2/fr
Publication of WO2024238255A3 publication Critical patent/WO2024238255A3/fr
Anticipated expiration legal-status Critical
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    • G—PHYSICS
    • G02—OPTICS
    • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00—Optical parts
    • G02C7/02—Lenses; Lens systems ; Methods of designing lenses
    • G02C7/022—Ophthalmic lenses having special refractive features achieved by special materials or material structures
    • G—PHYSICS
    • G02—OPTICS
    • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00—Optical parts
    • G02C7/02—Lenses; Lens systems ; Methods of designing lenses
    • G02C7/04—Contact lenses for the eyes
    • G—PHYSICS
    • G02—OPTICS
    • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C2202/00—Generic optical aspects applicable to one or more of the subgroups of G02C7/00
    • G02C2202/24—Myopia progression prevention

Definitions

  • Myopia (aka nearsightedness) is an optical condition where close objects are seen clearly, and distant objects appear blurry. Myopia can be caused by the eyeball that is excessively long and/or the cornea that is excessively curved so that the light from a distant object is focused in front of the retina.
  • Myopia is the most common form of impaired vision under the age 40. The prevalence of myopia is growing at an alarming rate. It is estimated that about 25 percent of people in the world in the year 2000 were myopic. It is projected that about 50 percent of the people in the world in the year 2050 will be myopic.
  • myopia develops during childhood due, at least in part, to eye growth that occurs during childhood, and progresses until about age 20. Myopia may also develop after childhood due to visual stress or health conditions such as diabetes.
  • a person with myopia has increased risk of other optical maladies. For example, a myopic person has significantly increased risk of developing cataracts, glaucoma, and retinal detachment. Additionally, many people with high myopia are not well-suited for LASIK or other laser refractive surgery.
  • Embodiments described herein are directed to contact lenses with distributed subsurface defocus and/or scatter-inducing elements configured to reduce contrast and/or induce scatter to reduce myopia progression.
  • the subsurface defocus and/or scatter-inducing elements are formed by inducing subsurface changes in refractive index within the contact lens.
  • the configuration and distribution of the subsurface defocus and/or scatter-inducing elements can be selected to provide a suitable resulting level of scatter to reduce myopia progression while maintaining acceptable image contrast.
  • the use of subsurface defocus and/or scatter-inducing elements allows the exterior surfaces of the contact lens to have a smooth shape suitable for contacting the eye and eye lid as well as avoiding interaction between the defocus and/or scatter-inducing elements and a tear film to avoid tear film induced changes in optical correction produced by the contact lens.
  • a contact lens includes distributed subsurface defocus and/or scatter-inducing elements configured to reduce contrast and/or induce scatter to inhibit myopia progression.
  • the contact lens is formed from a transparent material having a lens material refractive index.
  • Each subsurface defocus and/or scatterinducing elements of the distributed subsurface defocus and/or scatter-inducing elements includes refractive indices that differ from the lens material refractive index.
  • the contact lens can have any suitable configuration.
  • the distributed subsurface defocus and/or scatter-inducing elements can be arranged in any suitable manner (e.g., in a hexagonal pattern, in a rectangular pattern, in a square pattern, in radially separated annular rings, arranged randomly and without overlap).
  • the distributed subsurface defocus and/or scatter-inducing elements can have any suitable configuration.
  • each of the distributed subsurface defocus and/or scatter-inducing elements can have an outer diameter in a range from 0.001 to 3 mm.
  • the distributed subsurface defocus and/or scatter-inducing elements have center-to-center separation distance in a range from 0.1 to 6 mm.
  • each of the distributed subsurface defocus and/or scatter-inducing elements has an outer diameter in a range from 0.5 to 0.9 mm. In some embodiments, the distributed subsurface defocus and/or scatter-inducing elements have center-to-center separation distance in a range from 0.5 to 0.9 mm.
  • the contact lens can include a central zone with none of the distributed subsurface defocus and/or scatter-inducing elements are disposed in the central zone.
  • the central zone can have any suitable outer diameter. In some embodiments, the central zone has an outer diameter in a range from 5 to 8 mm.
  • the distributed subsurface defocus and/or scatter-inducing elements can include lenslets with any suitable optical power.
  • one or more of the lenslets have an optical power of at least 1.0 diopter. In some embodiments, one or more of the lenslets have an optical power of at least 2.0 diopters. In some embodiments, one or more of the lenslets an optical power of at least 3.0 diopters.
  • the distributed subsurface defocus and/or scatter-inducing elements are configured to form at least one random pattern. In some embodiments, at least some of the distributed subsurface defocus and/or scatter-inducing elements are configured as spots. In some embodiments, at least some of the distributed subsurface defocus and/or scatter-inducing elements are configured as lines.
  • FIG. 1 shows an existing spectacle lens with distributed surface defocus elements configured to reduce contrast and/or induce scatter to slow myopia progression.
  • FIG. 2 and FIG. 3 illustrate the configuration of the distributed defocus elements of the spectacle lens of FIG. 1.
  • FIG. 4 shows a color contour plot of wavefront curvature in diopters for the distributed surface defocus elements of the spectacle lens of FIG. 1.
  • FIG. 5 shows a plot of mean and standard error of myopia progression observed during a 2-year clinical trial of the spectacle lens of FIG. 1.
  • FIG. 6 shows a plot of mean and standard error of eye axial elongation observed during the 2-year clinical trial of the spectacle lens of FIG. 1.
  • FIG. 7 illustrates the configuration of distributed surface defocus elements of another existing spectacle lens configured to reduce contrast and/or induce scatter to slow myopia progression.
  • FIG. 8 shows a color contour plot of wavefront curvature in diopters for the distributed surface defocus elements of the spectacle lens of FIG. 7.
  • FIG. 9 illustrates scatter induced by the spectacle lens of FIG. 7.
  • FIG. 10 shows a plot of myopia progression observed during a 1-year clinical trial of the spectacle lens of FIG. 7 with highly aspherical defocus elements and with slightly aspherical defocus elements compared to single-vision spectacle lenses.
  • FIG. 11 shows a plot of change in eye axial length observed during the 1-year clinical trial of the spectacle lens of FIG. 7 with highly aspherical defocus elements and with slightly aspherical defocus elements compared to single-vision spectacle lenses.
  • FIG. 12 shows plots of modulation transfer function for the spectacle lenses of FIG. 1 and FIG. 7 relative to the diffraction limit.
  • FIG. 13 shows a plot of the amount of myopia progression control produced as a function of induced scatter.
  • FIG. 14 and FIG. 15 illustrate geometrical differences between a contact lens and a spectacle lens relative to an eye.
  • FIG. 16, FIG. 17, FIG. 18, and FIG. 19 show example distribution of subsurface defocus and/or scatter-inducing elements that can be employed in a contact lens configured to reduce contrast and/or induce scatter to inhibit progression of myopia in an eye or reduce myopia in the eye, in accordance with embodiments.
  • FIG. 20, FIG. 21, FIG. 22, FIG. 23, and FIG. 24 show color contour plots of optical path length of different configurations of subsurface defocus and/or scatter-inducing elements, in accordance with embodiments.
  • FIG. 25 and FIG. 26 show plots of modulation transfer function showing loss in contrast for different defocus values, in accordance with embodiments.
  • FIG. 27 shows plots of modulation transfer function showing loss in contrast for the configurations of subsurface defocus and/or scatter-inducing elements of FIG. 20, FIG. 21, FIG. 22, and FIG. 23
  • FIG. 28 shows plots of modulation transfer function showing loss in contrast for two different defocus element diameters and two different optical powers.
  • FIG. 29 and FIG. 30 show color contour plots of optical path length of different configurations of subsurface defocus and/or scatter-inducing elements with added primary spherical aberration, in accordance with embodiments.
  • FIG. 31 shows plots of modulation transfer function showing loss in contrast for different configurations of subsurface defocus and/or scatter-inducing elements with added primary spherical aberration.
  • FIG. 32 is a schematic representation of a system that can be used to form subsurface optical elements within an ophthalmic lens, in accordance with embodiments.
  • FIG. 33 and FIG. 34 schematically illustrate another system that can be used to form subsurface optical elements within an ophthalmic lens, in accordance with embodiments.
  • FIG. 35 illustrates an example radial distribution of an optical correction for implementation via subsurface optical elements formed within an ophthalmic lens, in accordance with embodiments.
  • FIG. 36 illustrates a 1-wave phase wrapped distribution for the example optical correction of FIG. 35.
  • FIG. 37 illustrates a 1/3 wave ratio of the 1-wave phase wrapped distribution of FIG. 36
  • FIG. 38 graphically illustrates diffraction efficiency for near focus and far focus versus optical phase height.
  • FIG. 39 graphically illustrates an example calibration curve for resulting optical phase change height as a function of laser pulse train optical power.
  • FIG. 40 is a plan view illustration of an ophthalmic lens that includes subsurface optical structures, in accordance with embodiments.
  • FIG. 41 is a plan view illustration of subsurface optical structures of the ophthalmic lens of FIG. 40.
  • FIG. 42 is a side view illustration of the subsurface optical structures of the ophthalmic lens of FIG. 41.
  • FIG. 1 shows an existing spectacle lens 10 (i.e., a HOYA MiYOSMART DIMS spectacle lens as described in Lam et al.
  • FIG. 2 [Figure 1 from Lam et al., Br J Ophthalmol (2020)] and FIG. 3 [from Figure 1 of Javier Gantes-Nunez et al., “Optical characterisation of two novel myopia control spectacle lenses”, OPO Ophthalmol (2023)] illustrate the configuration of the spectacle lens 10 and the distributed surface defocus elements 12.
  • Each of the surface defocus elements 12 has a 1.03 mm outer diameter and provides +3.5 diopter of defocus.
  • FIG. 4 shows a color contour plot 14 of wavefront curvature in diopters for the distributed surface defocus elements 12.
  • FIG. 5 [from Lam et al., Br J Ophthalmol (2020)] shows plots 16, 18 of mean and standard error of myopia progression observed during the 2-year clinical trial of the spectacle lens 10.
  • Plot 16 is for subjects wearing the spectacle lens 10.
  • Plot 18 is for a control group.
  • the myopia progression with the spectacle lens 10 is less than half of the myopia progression of the control group.
  • FIG. 6 [from Lam et al., Br J Ophthalmol (2020)] shows plots 20, 22 of mean and standard error of eye axial elongation observed during the 2- year clinical trial of the spectacle lens 10.
  • Plot 20 is for the subjects wearing the spectacle lens 10.
  • Plot 22 is for the control group.
  • the eye axial elongation with the spectacle lens 10 is less than half of the eye axial elongation of the control group.
  • FIG. 7 [from Javier Gantes-Nunez et al., OPO Ophthalmol (2023)], FIG. 8 [from Javier Gantes-Nunez et al., OPO Ophthalmol (2023)], and FIG. 9 [from Bao J et al., “One- year myopia control efficacy of spectacle lenses with aspherical lenslets” OPO Ophthalmol (2022)] shows another existing spectacle lens 30 (i.e., an Essilor Stellest spectacle lens) with distributed surface defocus elements 32 configured to reduce contrast and/or induce scatter to slow myopia progression.
  • the surface defocus elements 32 are distributed in radially separated annular rings.
  • FIG. 8 shows a color contour plot 34 of wavefront curvature in diopters for the surface defocus elements 32 of the spectacle lens 30.
  • FIG. 9 illustrates scatter induced by the spectacle lens 30.
  • FIG. 10 shows plots 36, 38, 30 of changes in spherical equivalent refraction in diopters observed during the 12-month clinical trial of the spectacle lens 30.
  • Plot 40 is for a control group wearing single-vision lenses.
  • FIG. 11 [from Bao J et al., OPO Ophthalmol (2022)] shows plots 42, 44, 46 of changes in eye axial length observed during the 12-month clinical trial of the spectacle lens 30.
  • Plot 46 is for the control group wearing the single-vision lenses.
  • FIG. 12 shows plots 48, 50 of modulation transfer function for the spectacle lenses 10, 30 along with a plot 52 of the diffraction limit.
  • Plot 48 is for the spectacle lens 10.
  • Plot 52 is for the diffraction limit.
  • the spectacle lens 10 provides higher contrast than the spectacle lens 30 over most spatial frequencies except for spatial frequencies from just under 22 cycles per degree of visual angle (c/d) to just over 28 (c/d) while providing comparable reduction in myopia progression.
  • Contact lenses described herein include distributed subsurface defocus and/or scatter-inducing elements configured to reduce contrast and/or induce scatter to reduce myopia progression.
  • the distributed subsurface defocus and/or scatter- inducing elements are configured and distributed in view the location of the contact lens relative to the eye so that the contact lens provides a suitable distribution of defocus to the eye to provide a suitable reduction in myopia progression while maintaining acceptable image contrast.
  • FIG. 13 shows a plot 54 of the amount of myopia progression control produced as a function of induced scatter.
  • a target scatter range 56 that substantially maximizes the amount of myopia progression control produced.
  • Increases in the amount of induced scatter above the target scatter range 56 results in decreased myopia progression control with high levels of scatter corresponding to form deprivation resulting in substantial acceleration of myopia progression.
  • the distributed subsurface defocus and/or scatter-inducing elements are configured to produce scatter within the target scatter range 56.
  • the distributed subsurface defocus and/or scatter-inducing elements can be preferentially directed to the lower scatter end of the target scatter range 56 to provide increased image contrast relative to the higher scatter end of the target scatter range 56.
  • the subsurface defocus and/or scatter-inducing elements can have any suitable size (e.g., an outer diameter in a range from 0.001 to 3 mm).
  • the distributed subsurface defocus and/or scatter-inducing elements are configured based on the configuration and relative position of the contact lens relative to the eye.
  • FIG. 14 and FIG. 15 illustrate geometrical differences between a contact lens and a spectacle lens relative to an eye.
  • a spectacle lens 10, 30 is typically supported by a spectacle frame on a spectacle lens plane 58 offset from the retina 62 by a spectacle glass distance (Xi).
  • a contact lens is interfaced with the cornea of the eye on a contact lens plane 60 that is offset from the retina 62 by a contact lens distance (X2), which is shorter than the spectacle glass distance (Xi).
  • Each of the surface scatter-inducing elements 12 of the spectacle lens 10 has an outer diameter of 1.03 mm. Assuming the spectacle glass distance (Xi) is equal to 36 mm and the contact lens distance (X2) equal to 24 mm, the outer diameter of each of the subsurface defocus and/or scatter-inducing elements of the contact lens can be 0.7 mm to have the angular subtense of each of the subsurface defocus and/or scatter-inducing elements relative to the retina 62 be the same as for the surface scatter-inducing elements 12 of the spectacle lens 10.
  • the outer diameter of each of the subsurface defocus and/or scatter-inducing elements of the contact lens is within any suitable range (e.g., from 0.5 to 0.9 mm).
  • a similar scaling approach can be used to determine a candidate range for center- to-center separations distances (e.g., 0.5 to 0.9 mm) for the subsurface defocus and/or scatterinducing elements and candidate ranges (e.g., 5 to 8 mm) for a central zone of the contact lens in which none of the subsurface defocus and/or scatter-inducing elements are disposed.
  • the contact lens is configured to account for the contact lens staying substantially aligned with the optical axis of the eye in contrast to a spectacle lens that is substantially aligned with the wearer’s head instead of the optical axis of the eye. Accordingly, the contact lens does not need to include any subsurface defocus and/or scatterinducing elements beyond a suitable outer diameter around the optical axis of the eye.
  • the subsurface defocus and/or scatter-inducing elements of the contact lens can have any suitable distribution.
  • FIG. 16, FIG. 17, FIG. 18, and FIG. 19 show example distributions of subsurface defocus and/or scatter-inducing elements 66 that can be employed in a contact lens configured to reduce contrast and/or induce scatter to inhibit progression of myopia in an eye or reduce myopia in the eye, in accordance with embodiments.
  • the subsurface defocus and/or scatter-inducing elements 66 are arranged in a hexagonal pattern (similar to the hexagonal arrangement of the surface scatter-inducing elements 12 in the spectacle lens 10). As illustrated in FIG.
  • the subsurface defocus and/or scatter-inducing elements 66 can be arranged in a rectangular pattern or a square pattern.
  • the subsurface defocus and/or scatter-inducing elements 66 are arranged in radially separated annular rings (similar to the arrangement of the surface scatter-inducing elements 32 in the spectacle lens 30).
  • the subsurface defocus and/or scatterinducing elements 66 are arranged randomly and without overlap.
  • the subsurface defocus and/or scatter-inducing elements 66 can be configured to induce any suitable localized wavefront change to reduce contrast and/or induce scatter suitable to reduce myopia progression while still producing acceptable image contrast.
  • candidate configurations of the subsurface defocus and/or scatter-inducing elements 66 for example, diameter, spacing, and/or optical power can be evaluated to estimate resulting scatter and image contrast to generate performance data used to define the diameter, spacing, and/or optical power of the subsurface defocus and/or scatter-inducing elements 66. For example, FIG. 20, FIG. 21, FIG. 22, FIG. 23, and FIG.
  • FIG. 24 show color contour plots 68, 70, 72, 74, 76 of optical path length of different configurations of the subsurface defocus and/or scatter-inducing elements 66.
  • FIG. 25 and FIG. 26 show plots 78, 80, 82, and 84 of modulation transfer function showing loss in contrast for different defocus amounts relative to a plot 86 of the diffraction limit. As shown, increasing amounts of defocus decrease image contrast.
  • FIG. 27 shows plots 88, 90, 92, 94 of modulation transfer function showing loss in contrast for the configurations of 1.0 mm diameter subsurface defocus and/or scatter-inducing elements 66 configured to provide different optical powers (1.0 D, 2.0 D, 3.0 D, 4.0 D) relative to a plot 86 of the diffraction limit.
  • FIG. 28 shows plots 96, 98, 100, 102 of modulation transfer function showing loss in contrast for two different defocus element diameters (1.0 mm and 2.0 mm) and two different optical powers (1.0 D and 2.0 D) relative to a plot 86 of the diffraction limit.
  • FIG. 29 and FIG. 30 show color contour plots 104, 106 of optical path length of different configurations of the subsurface defocus and/or scatter-inducing elements 66 with added primary spherical aberration.
  • FIG. 31 shows plots 108, 110, 112, 114 of modulation transfer function showing loss in contrast for different configurations of subsurface defocus and/or scatter-inducing elements 66 with added primary spherical aberration relative to a plot 86 of the diffraction limit.
  • FIG. 32 is a schematic representation of the laser and optical system 300 that can be used to modify an ophthalmic lens to be configured to create high-quality vision for the patient and/or inhibit progression of myopia, in accordance with embodiments.
  • the system 300 includes a laser source that includes a Kerr-lens mode-locked Ti: Sapphire laser 312 (Kapteyn-Mumane Labs, Boulder, Colo.) pumped by 4 W of a frequency-doubled Nd: YVCh laser 314 .
  • the laser generates pulses of 300 mW average power, 30 fs pulse width, and 93 MHz repetition rate at wavelength of 800 nm.
  • the measured average laser power at the objective focus on the material is about 120 mW, which indicates the pulse energy for the femtosecond laser is about 1.3 nJ.
  • the pulse width can be preserved so that the pulse peak power is strong enough to exceed the nonlinear absorption threshold of the ophthalmic lens. Because a large amount of glass inside the focusing objective significantly increases the pulse width due to the positive dispersion inside of the glass, an extra-cavity, compensation scheme can be used to provide the negative dispersion that compensates for the positive dispersion introduced by the focusing objective.
  • Two SF10 prisms 324 and 328 and one ending mirror 332 form a two-pass one-prism-pair configuration. A 37.5 cm separation distance between the prisms can be used to compensate the dispersion of the microscope objective and other optics within the optical path.
  • a collinear autocorrelator 340 using third-order harmonic generation is used to measure the pulse width at the objective focus. Both 2nd and 3rd harmonic generation have been used in autocorrelation measurements for low NA or high NA objectives.
  • Third order surface harmonic generation (THG) autocorrelation was selected to characterize the pulse width at the focus of the high-numerical-aperture objectives because of its simplicity, high signal to noise ratio and sign of material dispersion that second harmonic generation (SHG) crystals usually introduce.
  • the THG signal is generated at the interface of air and an ordinary cover slip 342 (Corning No. 0211 Zinc Titania glass), and measured with a photomultiplier 344 and a lock-in amplifier 346.
  • a transform-limited 27-fs duration pulse was selected.
  • the pulse is focused by a 60X 0.70NA Olympus LUCPlanFLN long-working-distance objective 348.
  • a concave mirror pair 350 and 352 is added into the optical path in order to adjust the dimension of the laser beam so that the laser beam can optimally fills the objective aperture.
  • a 3D 100 nm resolution DC servo motor stage 354 (Newport VP-25XA linear stage) and a 2D 0.7 nm resolution piezo nanopositioning stage (Pl P-622.2CD piezo stage) are controlled and programmed by a computer 356 as a scanning platform to support and locate an ophthalmic lens 357.
  • the servo stages have a DC servomotor so they can move smoothly between adjacent steps.
  • An optical shutter controlled by the computer with 1 ms time resolution is installed in the system to precisely control the laser exposure time.
  • the optical shutter could be operated with the scanning stages to form the subsurface optical elements in the ophthalmic lens 357 with different scanning speed at different position and depth and different laser exposure time.
  • a CCD camera 358 along with a monitor 362 is used beside the objective 320 to monitor the process in real time.
  • the system 300 can be used to modify the refractive index of an ophthalmic lens to form subsurface optical elements that are configured to create high-quality vision for the patient and/or provide a myopia progression inhibiting optical correction for each of one or more locations in the peripheral retina.
  • FIG. 33 is a simplified schematic illustration of another system 430 used for forming one or more subsurface optical structures within an ophthalmic lens 410, in accordance with embodiments.
  • the system 430 includes a laser beam source 432, a laser beam intensity control assembly 434, a laser beam pulse control assembly 436, a scanning/interface assembly 438, and a control unit 440.
  • the laser beam source 432 generates and emits a laser beam 446 having a suitable wavelength for inducing refractive index changes in target sub-volumes of the ophthalmic lens 410.
  • the laser beam 446 has a 1035 nm wavelength.
  • the laser beam 446 can have any suitable wavelength (e.g., in a range from 400 to 1100 nm) effective in inducing refractive index changes in the target sub-volumes of the ophthalmic lens 410.
  • the laser beam intensity control assembly 434 is controllable to selectively vary intensity of the laser beam 446 to produce a selected intensity laser beam 48 output to the laser beam pulse control assembly 436.
  • the laser beam intensity control assembly 434 can have any suitable configuration, including any suitable existing configuration, to control the intensity of the resulting laser beam 448. In many instances, the laser beam intensity control assembly utilizes an acousto-optic modulator.
  • the laser beam pulse control assembly 436 is controllable to generate collimated laser beam pulses 450 having suitable duration, intensity, size, and spatial profile for inducing refractive index changes in the target sub-volumes of the ophthalmic lens 410.
  • the laser beam pulse control assembly 436 can have any suitable configuration, including any suitable existing configuration, to control the duration of the resulting laser beam pulses 450.
  • the scanning/interface assembly 438 is controllable to selectively scan the laser beam pulses 450 to produce XYZ scanned laser pulses 474.
  • the scanning/interface assembly 438 can have any suitable configuration, including any suitable existing configuration (for example, the configuration illustrated in FIG. 34) to produce the XYZ scanned laser pulses 474.
  • the scanning/interface assembly 438 receives the laser beam pulses 450 and outputs the XYZ scanned laser pulses 474 in a manner that minimizes vignetting.
  • the scanning/interface assembly 438 can be controlled to selectively scan each of the laser beam pulses 450 to generate XYZ scanned laser pulses 474 focused onto targeted sub-volumes of the ophthalmic lens 410 to induce the respective refractive index changes in targeted sub-volumes so as to form the one or more subsurface optical structures within an ophthalmic lens 410.
  • the scanning/interface assembly 438 is configured to restrain the position of the ophthalmic lens 410 to a suitable degree to suitably control the location of the targeted sub-volumes of the ophthalmic lens 410 relative to the scanning/interface assembly 438.
  • the scanning/interface assembly 438 includes a motorized Z-stage that is controlled to selectively control the depth within the ophthalmic lens 410 to which each of the XYZ scanned laser pulses 474 is focused.
  • the control unit 440 is operatively coupled with each of the laser beam source 432, the laser beam intensity control assembly 434, the laser beam pulse control assembly 436, and the scanning/interface assembly 438.
  • the control unit 440 provides coordinated control of each of the laser beam source 432, the laser beam intensity control assembly 434, the laser beam pulse control assembly 436, and the scanning/interface assembly 438 so that each of the XYZ scanned laser pulses 474 have a selected intensity and duration, and are focused onto a respective selected sub-volume of the ophthalmic lens 410 to form the one or more subsurface optical structures within an ophthalmic lens 410.
  • the control unit 440 can have any suitable configuration.
  • control unit 440 comprises one or more processors and a tangible memory device storing instructions executable by the one or more processors to cause the control unit 440 to control and coordinate operation of the of the laser beam source 432, the laser beam intensity control assembly 434, the laser beam pulse control assembly 436, and the scanning/interface assembly 438 to produce the XYZ scanned laser pulses 474, each of which is synchronized with the spatial position of the sub-volume optical structure.
  • FIG. 34 is a simplified schematic illustration of an embodiment of the scanning/interface assembly 438.
  • the scanning/interface assembly 438 includes an XY galvo scanning unit 442, a relay optical assembly 444, a Z stage 466, an XY stage 468, a focusing objective lens 470, and a patient interface/ophthalmic lens holder 472.
  • the XY galvo scanning unit 438 includes XY galvo scan mirrors 454, 456.
  • the relay optical assembly 440 includes concave mirrors 460, 461 and plane mirrors 462, 464.
  • the XY galvo scanning unit 442 receives the laser pulses 450 (e.g., 1035 nm wavelength collimated laser pulses) from the laser beam pulse control assembly 436.
  • the XY galvo scanning unit 442 includes a motorized X-direction scan mirror 454 and a motorized Y-direction scan mirror 456.
  • the X-direction scan mirror 454 is controlled to selectively vary orientation of the X-direction scan mirror 454 to vary direction/position of XY scanned laser pulses 458 in an X-direction transverse to direction of propagation of the XY scanned laser pulses 458.
  • the Y-direction scan mirror 456 is controlled to selectively vary orientation of the Y-direction scan mirror 456 to vary direction/position of the XY scanned laser pulses 458 in a Y-direction transverse to direction of propagation of the XY scanned laser pulses 458.
  • the Y-direction is substantially perpendicular to the X-direction.
  • the relay optical assembly 440 receives the XY scanned laser pulses 458 from the XY galvo scanning unit 442 and transfers the XY scanned laser pulses 458 to Z stage 466 in a manner that minimizes vignetting.
  • Concave mirror 460 reflects each of the XY scanned laser pulse 458 to produce a converging laser pulses incident on plane mirror 462.
  • Plane mirror 462 reflects the converging XY scanned laser pulse 458 towards plane mirror 464. Between the plane mirror 462 and the plane mirror 464, the XY scanned laser pulse 458 transitions from being convergent to being divergent.
  • the divergent laser pulse 458 is reflected by plane mirror 464 onto concave mirror 461.
  • Concave mirror 461 reflects the laser pulse 458 to produce a collimated laser pulse that is directed to the Z stage 466.
  • the Z stage 466 receives the XY scanned laser pulses 458 from the relay optical assembly 442.
  • the Z stage 466 and the XY stage 468 are coupled to the focusing objective lens 470 and controlled to selectively position the focusing objective lens 470 relative to the ophthalmic lens 410 for each of the XY scanned laser pulses 474 so as to focus the XYZ scanned laser pulse 474 onto a respective targeted sub-volume of the ophthalmic lens 410.
  • the Z stage 466 is controlled to selectively control the depth within the ophthalmic lens 410 to which the laser pulse is focused (i.e., the depth of the sub-surface volume of the ophthalmic lens 410 on which the laser pulse is focused to induce a change in refractive index of the targeted sub-surface volume).
  • the XY stage 468 is controlled in conjunction with control of the XY galvo scanning unit 442 so that the focusing objective lens 470 is suitably positioned for the respective transverse position of each of the XY scanned laser pulses 458 received by the Z stage 466.
  • the focusing objective lens 470 converges the laser pulse onto the targeted sub-surface volume of the lens 410.
  • the patient interface/ophthalmic lens holder 472 restrains the ophthalmic lens 410 in a fixed position to support scanning of the laser pulses 474 by the scanning/interface assembly 438 to form the subsurface optical structures within the ophthalmic lens 410.
  • FIG. 35 through FIG. 42 illustrate a process that can be used to define subsurface optical elements for a specified optical correction. While an optical correction configured to create high-quality vision for the patient and/or inhibit progression of myopia in a subject using the approaches described herein may be a combination of any suitable number of low- order optical corrections and/or any suitable number of high-order optical corrections, a single, simple 2 diopter optical correction is illustrated. The same process, however, can be used to define subsurface optical elements for an ophthalmic lens to configure the ophthalmic lens to provide an optical correction to create high-quality vision and/or to inhibit myopia progression (by utilizing any of the myopia inhibiting optical corrections described herein).
  • FIG. 35 shows a radial variation in units of optical waves of a 2.0 diopter refractive index distribution 510, in accordance with embodiments.
  • the optical waves in this curve correspond to a design wavelength of 562.5 nm.
  • the 2.0 diopter refractive index distribution 510 decreases from a maximum of 16.0 waves at the optical axis of an ophthalmic lens down to 0.0 waves at 3.0 mm from the optical axis.
  • FIG. 36 shows a 1.0 wave phase-wrapped refractive index distribution 512 corresponding to the 2.0 diopter refractive index distribution 510.
  • Each segment of the 1.0 wave phase-wrapped refractive index distribution 512 includes a sloped segment (512a through 512p).
  • Each of all the segments, except the center segment, of the 1.0 wave phasewrapped refractive index distribution 512 includes an optical phase discontinuity (514b through 514p) with a height equal to 1.0 wave.
  • Each of the sloped segments (512a through 512p) is shaped to match the corresponding overlying segment (510a through 51 Op) of the 2.0 diopter refractive index distribution 510.
  • sloped segment 512p matches overlying segment 51 Op; sloped segment 512o is equal to overlying segment 510o minus 1.0 wave; sloped segment 512n is equal to overlying segment 51 On minus 2.0 waves; sloped segment 512a is equal to overlying segment 510a minus 15.0 waves.
  • Each sloped segment corresponds to a Fresnel zone.
  • each of the optical phase discontinuities (514b through 514p) in the distribution 512 results in diffraction at the design wavelength that provides the same 2.0 diopter refractive correction as the 2.0 diopter refractive distribution 510 while limiting maximum optical phase equal to 1.0 wave.
  • the 1.0 wave phase-wrapped refractive index distribution 512 requires substantially lower total laser pulse energy to induce in comparison to the 2.0 diopter refractive index distribution 510.
  • the area under the 1.0 wave phase-wrapped refractive index distribution 512 is only about 5.2 percent of the area under the 2.0 diopter refractive index distribution 510.
  • FIG. 37 shows the 1.0 wave phase-wrapped refractive index distribution 512 and an example scaled phase-wrapped refractive index distribution (for a selected maximum wave value) corresponding to the 1.0 wave phase-wrapped refractive index distribution 512.
  • the example scaled phase-wrapped refractive index distribution has a maximum wave value of 1/3 wave.
  • Similar scaled phase-wrapped refractive index distributions can be generated for other suitable maximum wave values less than 1.0 wave (e.g., 3/4 wave, 5/8 wave, 1/2 wave, 1/4 wave, 1/6 wave).
  • the 1/3 optical wave maximum scaled phase-wrapped refractive index distribution 516 is equal to 1/3 of the 1.0 wave phase-wrapped refractive index distribution 512.
  • the 1/3 optical wave maximum scaled phase-wrapped refractive index distribution 516 is one substitute for the 1.0 wave phase-wrapped refractive index distribution 512 and utilizes a maximum refractive index value that provides a corresponding maximum 1/3 wave optical correction.
  • the 1/3 optical wave maximum scaled phase-wrapped refractive index distribution 516 requires less total laser pulse energy to induce in comparison with the 1.0 wave phasewrapped refractive index distribution 512.
  • the area under the 1/3 optical wave maximum scaled phase-wrapped refractive index distribution 516 is 1/3 of the area under the 1.0 wave phase-wrapped refractive index distribution 512.
  • Three stacked layers of the 1/3 wave distribution 516 can be used to produce the same optical correction as the 1.0 wave distribution 512.
  • FIG. 38 graphically illustrates diffraction efficiency for near focus 574 and far focus 576 versus optical phase change height.
  • the diffraction efficiency for near focus is only about 10 percent.
  • Near focus diffraction efficiency of substantially greater than 10 percent is desirable to limit the number of layers of the subsurface optical structures that are stacked to generate a desired overall optical correction.
  • Greater optical phase change heights can be achieved by inducing greater refractive index changes in the targeted sub-volumes of the ophthalmic lens 410.
  • Greater refractive index changes in the targeted sub-volumes of the ophthalmic lens 410 can be induced by increasing energy of the laser pulses focused onto the targeted sub-volumes of the ophthalmic lens 410.
  • FIG. 39 graphically illustrates an example calibration curve 578 for resulting optical phase change height as a function of laser pulse optical power.
  • the calibration curve 578 shows correspondence between resulting optical phase change height as a function of laser average power for a corresponding laser pulse duration, laser pulse wavelength, laser pulse repetition rate, numerical aperture, material of the ophthalmic lens 410, depth of the targeted sub-volume, spacing between the targeted sub-volumes, scanning speed, and line spacing.
  • the calibration curve 578 shows that increasing laser pulse energy results in increased optical phase change height.
  • Laser pulse energy may be limited to avoid propagation of damage induced caused by laser pulse energy and/or heat accumulation with the ophthalmic lens 410, or even between the layers of the subsurface optical elements. In many instances, there is no observed damage during formation of the first two layers of subsurface optical elements and damage starts to occur during formation of the third layer of subsurface optical elements. To avoid such damage, the subsurface optical elements can be formed using laser pulse energy below a pulse energy threshold of the material of the ophthalmic lens 410. Using lower pulse energy, however, increases the number of layers of the subsurface optical elements required to provide the desired amount of resulting optical phase change height, thereby adding to the time required to form the total number of subsurface optical elements 412 employed.
  • FIG. 40 is a plan view illustration of an ophthalmic lens 410 that includes one or more subsurface optical elements 412 with refractive index spatial variations, in accordance with embodiments.
  • the one or more subsurface elements 12 described herein can be formed in any suitable type of ophthalmic lens including, but not limited to, intra-ocular lenses, contact lenses, corneas, spectacle lenses, and native lenses (e.g., a human native lens).
  • the one or more subsurface optical elements 412 with refractive index spatial variations can be configured to provide a suitable refractive correction configured to create high-quality vision for the patient and/or inhibit progression of myopia as described herein.
  • the one or more subsurface optical elements 412 with refractive index spatial variations can be configured to provide a suitable refractive correction for each of many optical aberrations such as astigmatism, myopia, hyperopia, spherical aberrations, coma and trefoil, as well as any suitable combination thereof.
  • FIG. 41 is a plan view illustration of one of the subsurface optical elements 412 of the ophthalmic lens 410.
  • the illustrated subsurface optical elements 412 occupies a respective volume of the lens 410, which includes associated sub-volumes of the lens 410.
  • the volume occupied by one of the optical elements 412 includes first, second, and third portions 414.
  • Each of the first, second, and third portions 414 can be formed by focusing suitable laser pulses inside the respective portion 414 so as to induce changes in refractive index in sub-volumes of the lens 410 that make up the respective portion 414 so that each portion 414 has a respective refractive index distribution.
  • a refractive index distribution is defined for each portion 414 that forms the subsurface optical structures 412 so that the resulting subsurface optical structures 412 provide a desired optical correction.
  • the refractive index distribution for each portion 414 can be used to determine parameters (e.g., laser pulse power (mW), laser pulse width (fs)) of laser pulses that are focused onto the respective portions 414 to induce the desired refractive index distributions in the portions 414.
  • the portions 414 of the subsurface optical structures 412 have a circular shape in the illustrated embodiment, the portions 414 can have any suitable shape and distribution of refractive index variations.
  • a single portion 414 having an overlapping spiral shape can be employed.
  • one or more portions 414 having any suitable shapes can be distributed with intervening spaces so as to provide a desired optical correction for light incident on the subsurface optical structure 412.
  • FIG. 42 illustrates an embodiment in which the subsurface optical elements 412 are comprised of several stacked layers that are separated by intervening layer spaces.
  • the subsurface optical elements 412 have a spatial distribution of refractive index variations.
  • FIG. 42 is a side view illustration of an example distribution of refractive index variations in the subsurface optical elements 412.
  • the subsurface optical elements 412 can be formed using a raster scanning approach in which each layer is sequentially formed starting with the bottom layer and working upward. For each layer, a raster scanning approach can sequentially scan the focal position of the laser pulses along planes of constant Z-dimension while varying the Y- dimension and the X-dimension so that the resulting layers have the flat cross-sectional shapes shown in FIG.
  • timing of the laser pulses can be controlled to direct each laser pulse onto a targeted sub-volume of the ophthalmic lens 410 and not direct laser pulses onto non-targeted sub-volumes of the ophthalmic lens 410, which include sub-volumes of the ophthalmic lens 10 that do not form any of the subsurface optical elements 412, such as the intervening spaces between the adjacent stacked layers that can form the subsurface optical elements 412.
  • each of the illustrated subsurface optical elements 412 has a flat layer configuration and can be comprised of one or more layers. If the subsurface optical structures are comprised of more than one layer, the layers can be separated from each other by an intervening layer spacing. Each of the layers, however, can alternatively have any other suitable general shape including, but not limited to, any suitable non-planar or planar surface. In the illustrated embodiment, each of the subsurface optical elements 412 has a circular outer boundary. Each of the subsurface optical elements 412, however, can alternatively have any other suitable outer boundary shape. Each of the subsurface optical elements 412 can include two or more separate portions 414 with each covering a portion of the subsurface optical elements 412.

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Abstract

Des lentilles de contact comprennent des éléments de défocalisation et/ou de diffusion de sous-surface distribués conçus pour réduire le contraste et/ou induire une diffusion afin de réduire la progression de la myopie. La lentille de contact peut être formée à partir d'un matériau transparent ayant un indice de réfraction de matériau de lentille. Chacun des éléments de défocalisation et/ou d'induction de diffusion de sous-surface comprend des indices de réfraction qui diffèrent de l'indice de réfraction de matériau de lentille.
PCT/US2024/028531 2023-05-12 2024-05-09 Lentilles de contact pour contrôle de la myopie avec des éléments de défocalisation et/ou d'induction de diffusion de sous-surface Ceased WO2024238255A2 (fr)

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CN114630640A (zh) * 2019-07-19 2022-06-14 克莱里奥视觉股份有限公司 近视进展治疗
AU2021233235A1 (en) * 2020-03-11 2022-10-06 Brien Holden Vision Institute Limited Ophthalmic lenses and methods for correcting, slowing, reducing, and/or controlling the progression of myopia in conjunction with use of atropine or related compounds

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