Classifications

• • 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
  • G02C7/06—Lenses; Lens systems ; Methods of designing lenses bifocal; multifocal ; progressive
  • G02C7/061—Spectacle lenses with progressively varying focal power
• • 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
  • G02C7/16—Shades; shields; Obturators, e.g. with pinhole, with slot
• • 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 is a major problem worldwide with the prevalence in the US estimated to have increased to over 40% by 2004 (see, e.g ., Vitale et al, 2009 Arch Ophthalmol. 127: 1632- 9). It is well established that patients with myopia have an elevated risk of developing sight- threatening conditions (see, e.g., Jones et el., 2012 Eye Contact Lens. 38: 188-96), and currently it is believed that there are no known therapies in the United States approved to reduce or control the progression of myopia.
• a myopia control spectacle lens also can correct for refractive error.
• a myopia control spectacle lens can contain light scattering features (e.g ., light scattering dots on a lens surface and/or light scattering inclusions in the bulk of the lens).
• a myopia control spectacle lens also can contain one or more defocus elements (e.g., microlenses).
• a myopia control spectacle lens can contain a clear center, free of said scattering features or defocus elements. Treating children having, or suspected of having, myopia by having the children wear spectacles with myopia control lenses provides a safe, efficient, and non-invasive method for reducing the progression of juvenile myopia.
• one aspect of this document features methods for reducing progression of myopia in a human child having, or suspected of having, myopia.
• the methods can include, or consist essentially of, identifying a human child having, or suspected of having, myopia; and treating the human child with spectacles containing at least one myopia control spectacle lens, where the myopia control spectacle lens reduces myopia progression in the human child by 0.4 D or more after three years of treatment compared to a control group.
• the myopia control spectacle lens can provide normal visual acuity to the human child when viewed through a central region of the lens and reduced visual acuity when viewed through a peripheral region of the lens.
• the reduced visual acuity can be provided by a dot pattern in the peripheral region of the lens.
• the scattering centers can have a volume that varies randomly from a nominal volume, VN, the random variation being equal to or less than a jitter amplitude.
• the jitter amplitude times the nominal volume can be 0.5 x VN or less.
• the annular region can correspond to an area of 20% or more of the lens surface (e.g., 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, e.g., up to 90%).
• the average jitter amplitude of all the dots on a lens can be 0.05 or more (e.g., 0.1 or more, 0.15 or more, 0.2 or more, 0.25 or more, 0.3 or more, 0.35 or more, such as 0.4 or less).
• At least 10% of the dots on the lens can be jittered (e.g., 20% or more, 30% or more, 40% or more, 50% or more 60% or more, 70% or more, 80% or more, 90% or more, such as 100% of the dots).
• the myopia control spectacle lens can contain regions having an optical power different from an optical power of the central region. range from 2 mm to 8 mm.
• the central region can be aligned to be in front of the human’s pupil when in distance gaze.
• the myopia control spectacle lens can reduce an image contrast of an object viewed through the peripheral region by at least 20% compared to an image contrast of the object viewed through the central region.
• the reduction in myopia progression can be measured based on a change in spherical equivalent refraction compared to the control group.
• the myopia control spectacles can reduce myopia progression by at least 0.46 D compared to the control group.
• the myopia control spectacles can reduce myopia progression by at least 0.46 D as measured by autorefraction change from baseline.
• FIG. 4A and 4B show a lens blank with a dot pattern that has a transition zone between a clear aperture and the dot pattern.
• FIG. 5F shows a further exemplary dot pattern with a transition zone and dots with a random displacement from uniform spacing.
• FIG. 6A shows an exemplary lens having a graded dot pattern with different spacing between adjacent dots.
• FIG. 6B shows an exemplary lens having a graded dot pattern with varying dot size.
• Figure 7 is an output summary of a table of 30% reduction in myopia progression in a fast progressor group treated with a myopia control spectacle lens relative to patients treated with a control lens.
• Figures 8A and 8B are plots based on the simulated numbers shown in Figure 7.
• Figure 8A is a plot showing a 30% reduction in SER in patients in a fast progressor group treated with a myopia control spectacle lens relative to patients treated with a control lens.
• Figure 8B is a plot showing a 30% reduction in axial length in patients in a fast progressor group treated with either a myopia control spectacle lens or a control lens.
• Figure 18 contains a table and a plot showing a 30% reduction in SER distribution in patients in a COMET-like population treated with either a myopia control spectacle lens relative to patients treated with a control lens.
• Figure 19 is an output summary of a table of 40% reduction in myopia progression in a COMET-like population treated with a myopia control spectacle lens relative to patients treated with a control lens.
• Figures 20A and 20B are plots based on the simulated numbers shown in Figure 19.
• Figure 20A is a plot showing a 40% reduction in SER in patients in a COMET-like population treated with either a myopia control spectacle lens relative to patients treated with a control lens.
• Figure 20B is a plot showing a 40% reduction in axial length in patients in a COMET-like population treated with either a myopia control spectacle lens relative to patients treated with a control lens.
• Figure 21 contains a table and a plot showing a 40% reduction in SER distribution in patients in a COMET-like population treated with either a myopia control spectacle lens relative to patients treated with a control lens.
• Figure 22 is an output summary of a table of 50% reduction in myopia progression in a COMET-like population treated with a myopia control spectacle lens relative to patients treated with a control lens.
• Figures 23 A and 23B are plots based on the simulated numbers shown in Figure 22.
• Figure 23 A is a plot showing a 50% reduction in SER in patients in a COMET-like population treated with either a myopia control spectacle lens relative to patients treated with COMET -like population treated with either a myopia control spectacle lens relative to patients treated with a control lens.
• Figure 24 contains a table and a plot showing a 50% reduction in SER distribution in patients in a COMET-like population treated with either a myopia control spectacle lens relative to patients treated with a control lens.
• Figure 25A is a table showing change in SER (in D) for a treatment group compared to baseline.
• example control outcomes are shown in the first row, and reduction in myopia from 40-75% compared to those control outcomes, are shown for comparison.
• Figure 25B is a table showing the difference in SER change from baseline between two groups, one treated group and one control group.
• example control group outcomes are shown in the first row, and the difference between groups is shown for a reduction in myopia from 40-75%.
• Figure 26A is a table showing change in SER (in D) for a treatment group compared to baseline.
• example control outcomes are shown in the first row, and reduction in myopia from 40-75% compared to those control outcomes, are shown for comparison.
• Figure 26B is a table showing the difference in SER change from baseline between two groups, one treated group and one control group.
• example control group outcomes are shown in the first row, and the difference between groups is shown for a reduction in myopia from 40-75%.
• Figure 27A is a table showing change in SER (in D) for a treatment group compared to baseline.
• example control outcomes are shown in the first row, and reduction in myopia from 40-75% compared to those control outcomes, are shown for comparison.
• Figure 27B is a table showing the difference in SER change from baseline between two groups, one treated group and one control group.
• example control group outcomes are shown in the first row, and the difference between groups is shown for a reduction in myopia from 40-75%.
• Figure 28B is a table showing the difference in axial length change from baseline between two groups, one treated group and one control group.
• example control group outcomes are shown in the first row, and the difference between groups is shown for a reduction in myopia from 40-75%.
• myopia control spectacle lenses can be worn by a child having, or suspected of having, myopia to treat the child.
• methods for treating a human having, or suspected of having, myopia can include identifying such an individual, fitting the individual for one or more myopia control spectacle lenses, having the individual wear the one or more myopia control spectacle lenses for an change in myopia progression. The fitting, wearing, and assessing can be repeated over the course of treatment.
• the terms “lenses” and“ophthalmic lenses” are used to mean spectacle lenses, such as spectacle lenses that would be used to control myopia progression.
• the term“myopia control spectacle lenses” refers to any spectacle lenses that can be used to control myopia or reduce myopia progression, including peripheral diffusion lenses (also called dot lenses) or lenses containing optical defocusing power.
• defocus regions may comprise one or more defocusing centers in the periphery of the lens, where each defocus center forms a“lenslet” providing plus power to that region.
• Defocus spectacle lenses are known in the art to reduce myopia progression, but have shown limited reduction in myopia progression of 0.2 D over 3 years (see, e.g, Gwiazda et al, 2003 Invest
• DIMS Incorporated Multiple Segments
• races that can be treated using the methods and devices described herein include, without limitation, White (e.g ., person having origins in any of the original peoples of Europe, the Middle East, or North Africa), Asian (e.g., a person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, e.g., for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam), Black or African American (e.g, person having origins in any of the Black racial groups of Africa), and American Indian or Alaska Native (e.g, a person having origins in any of the original peoples of North and South America (including Central America) and who maintains tribal affiliation or community attachment), or Native Hawaiian or other Pacific Islander (e.g, a person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands).
• White e.g ., person having origins in any of the original peoples of Europe, the Middle East,
• “races” are defined as per the 1997 Office of Management and Budget standards on race and ethnicity, which permits the reporting of more than one race. Ethnicity determines whether a person is of Hispanic origin or not.
• a White child having, or suspected of having, myopia can be treated as described herein.
• an Asian child having, or suspected of having, myopia can be treated as described herein.
• a child having, or suspected of having, myopia that is not Asian e.g, White, Black or African American, American Indian or Alaska Native, or Native Hawaiian or Other Pacific Islander
• a human treated as described herein e.g., by having the human wear one or more (e.g, one or two) myopia control spectacle lenses
• can be, or can be suspected of being, a COMET-like human see, e.g., Gwiazda et al, 2003 Invest Ophthalmol Vis Sci 44: 1492-500).
• a human having, or suspected of having, myopia can have a refractive error of from about -0.75 D to about -4.50 D.
• a human having, or suspected of having, myopia can have a refractive error of about -4.50 D.
• Myopia also includes syndromic myopia, where humans may have high myopia together with other visual symptoms, such as nystagmus and reduced cone ERG.
• syndromic myopia is Bornholm Eye Disease (BED).
• BED Bornholm Eye Disease
• a myopia can be caused by any appropriate type of mechanism.
• a myopia can be an axial myopia or a refractive myopia (e.g, a curvature myopia or an index myopia).
• methods of treating a human having, or suspected of having, myopia as described herein also can include determining a genetic haplotype (e.g., an opsin gene haplotype) of that human.
• a genetic haplotype e.g., an opsin gene haplotype
• a human can be identified as having a genetic haplotype indicative of a myopia and can be treated by having that human wear one or more myopia control spectacle lenses.
• a genetic haplotype indicative of a myopia can be any appropriate genetic haplotype.
• a genetic haplotype indicative of a myopia, or likelihood of developing a myopia can be an opsin gene haplotype as described in, e.g., for example, WO 2012/097213 or WO 2016/138512.
• a genetic variant e.g, a SNP or a haplotype
• a genetic variant indicative of a myopia, or likelihood of developing a myopia can be as described elsewhere (see, e.g, Zhang, 2015 Progress in Molecular Biology and Translational Science 134: 269-279; and Tedja el al,
• an amount of opsin gene exon skipping indicative of a myopia, or likelihood of developing a myopia can be an amount of opsin gene exon skipping as described in, e.g., for example, WO 2016/138512.
• methods of treating a human having, or suspected of having, myopia as described herein also can include determining the L:M cone ratio in that human.
• a human can be identified as having a L:M cone ratio indicative of a myopia and can be treated by having that human wear one or more myopia control spectacle lenses.
• a L:M cone ratio indicative of a myopia can be any appropriate L:M cone ratio.
• a L:M cone ratio indicative of a myopia, or likelihood of developing a myopia can be a L:M cone ratio as described in, e.g., for example, WO 2012/097213.
• a peripheral region of the ophthalmic lens can have optical properties different from the optical properties of a central region of the ophthalmic lens (e.g, an aperture).
• a myopia control spectacle lens can include one or more features that allow a user (e.g, a human) reduced visual acuity for the same eye through a peripheral region of the ophthalmic lens (e.g., having one or more scattering centers) and normal visual acuity (e.g, 20/20 or better) for an eye through a central region of the ophthalmic lens (e.g, an aperture).
• myopia-reducing eyeglasses 100 are disclosed which allow treatment of both eyes simultaneously without substantially compromising clear vision.
• the eyeglasses are sufficiently robust and inconspicuous as to allow a wearer to engage in the same day-to-day activities without the eyeglasses failing and without feeling self-conscious about their appearance, which is especially desirable because the eyeglasses are typically used to arrest eye-lengthening in children.
• the dots shown in FIG. 1B are arranged on a square grid, spaced apart by a uniform amount in each direction. This is shown by D y in the y-direction and D x in the x-direction.
• contrast reduction is produced by other diffusing structures, such as a roughened surface.
• Holographic diffusers or ground glass diffusers may be used.
• Transition zone 420 features a dot pattern that scatters incident light less than the dot pattern in scattering zone 430, providing a transition in the scattering properties of the lens from the clear aperture to the scattering zone.
• Such a transition may be advantageous in that it reduces scattering into the fovea compared to scattering that would be provided if the scattering zone extended to the clear aperture.
• a further advantage is that the transition zone may reduce the visibility of the dot pattern to the user, providing a more comfortable wearing experience. This can be particularly important for children, where the likelihood that a child will regularly wear eyeglasses featuring such lenses for extended periods depends on the child’s comfort level.
• the dot diameter can increase linearly from a first value (e.g., 0.05 mm) to a second value (e.g., 0.17 mm) as the radial distance from the lens axis increases from R410 to R420.
• the dot spacing can decrease monotonically (e.g., linearly) from R410 to R420.
• R410 is in a range from about 1 mm to about 3 mm (e.g., 1.0 mm to 1.1 mm, 1.1 mm to 1.2 mm, 1.2 mm to 1.3 mm, 1.3 mm to 1.4 mm, 1.4 mm to 1.5 mm, 1.5 mm to 1.6 mm, 1.6 mm to 1.7 mm, 1.7 mm to 1.8 mm, 1.8 mm to 1.9 mm, 1.9 mm to 2.0 mm, 2.0 mm to 2.1 mm, 2.1 mm to 2.2 mm, 2.2 mm to 2.3 mm, 2.3 mm to 2.4 mm, 2.4 mm to 2.5 mm, 2.5 mm to 2.6 mm, 2.6 mm to 2.7 mm, 2.7 mm to 2.8 mm, 2.8 mm to 2.9 mm, 2.9 mm to 3.0 mm).
• R420 can be in a range from about 2 mm to about 6 mm (e.g., 2.0 mm to 2.2 mm, 2.2 mm to 2.4 mm, 2.4 mm to 2.6 mm, 2.6 mm to 2.8 mm, 2.8 mm to 3.0 mm, 3.0 mm to 3.2 mm, 3.2 mm to 3.4 mm, 3.4 mm to 3.6 mm, 3.6 mm to 3.8 mm, 3.8 mm to 4.0 mm, 4.0 mm to 4.2 mm, 4.2 mm to 4.4 mm, 4.4 mm to 4.6 mm, 4.6 mm to 4.8 mm, 4.8 mm to 5.0 mm, 5.0 mm to 5.2 mm, 5.2 mm to 5.4 mm, 5.4 mm to 5.6 mm, 5.6 mm to 5.8 mm, 5.8 mm to 6.0 mm).
• the dot pattern includes randomly displacing dots with respect to a regular array. Introducing random displacements can reduce optical effects associated with regularly spaced scattering centers, such as starburst-like glare. See, e.g.,
• random displacements in dot patterns can provide the user with a more comfortable experience compared with similar dot patterns in which the scattering centers are uniformly spaced.
• randomization of the dot pattern can reduce the optical effects (e.g., diffractive or interference effects) that manifest in reflected light, reducing the noticeability of the dot patterns to observers.
• Dot size can also vary randomly, which can reduce optical effects associated with an array of uniformly sized dots, such as glare.
• the radial dimension of each dot can vary from a nominal dot radius, ro.
• dot 40 ld has nominal dot radius ro
• dots 40 lb and 40 le have radii i3 ⁇ 4 and r e , respectively that are both larger than ro and i3 ⁇ 4 1 r e.
• the dot pattern features a gradient in, e.g., dot size and/or spacing.
• Dot patterns can feature a gradient in scattering efficiency of the dots (e.g., due to a gradient in the refractive index mismatch and/or shape of each dot).
• Graded dot patterns can reduce the conspicuity of the pattern. For example, a graded transition from the clear portions of the lens to the scattering portion can be less conspicuous than a sharp transition.
• a lens in another example, can have a graded dot pattern with both varying dot size and dot-to-dot distance.
• the shape and/or composition of dots can also vary radially, yielding a graded pattern.
• a graded pattern can be provided by forming scatter centers with a lower refractive index mismatch compared to the lens bulk material closer to the edges of the dot pattern compared to scatter centers in the center of the dot pattern.
• dots are formed on one or both surfaces of a lens by exposing a lens surface to laser radiation.
• the laser radiation locally ablates the lens material at the surface, leaving a small depression, small bumps and/or roughened patch.
• a dot pattern can be formed on the surface.
• the laser’s beam can be moved relative to the surface while the beam is pulsed. Relative motion between the beam and the lens surface can be caused by moving the beam while leaving the surface fixed, moving the surface while leaving the beam fixed, or moving both the beam and the surface.
• a dot pattern can include dots having a diameter of from about 0.10 mm to about 0.20 mm (e.g, from about 0.10 mm to about 0.17 mm, from about 0.10 mm to about 0.15 mm, from about 0.10 mm to about 0.14 mm, from about 0.10 mm to about 0.13 mm, from about 0.10 mm to about from about 0.12 mm to about 0.20 mm, from about 0.13 mm to about 0.20 mm, from about 0.14 mm to about 0.20 mm, from about 0.15 mm to about 0.20 mm, from about 0.16 mm to about 0.20 mm , from about 0.18 mm to about 0.20 mm , from about 0.11 mm to about 0.17 mm , from about 0.12 mm to about 0.15 mm, from about 0.13 mm to about 0.14 mm, or from about 0.12 mm to about 0.16 mm).
• a dot pattern can include dots having a diameter of about 0.14 mm.
• a dot pattern can include any appropriate dot spacing. In some cases, dot spacing in a dot pattern can be even. In some cases, dot spacing in a dot pattern can be variable. In some cases, dots in a dot pattern can have a dot spacing of ( e.g ., be spaced apart by) from about 0.2 mm to about 0.4 mm (e.g., from about 0.2 mm to about 0.38 mm, from about 0.2 mm to about 0.375 mm, from about 0.2 mm to about 0.35 mm, from about 0.2 mm to about 0.325 mm, from about 0.2 mm to about 0.3 mm, from about 0.2 mm to about 0.28 mm, from about 0.2 mm to about 0.24 mm, from about 0.25 mm to about 0.4 mm, from about 0.27 mm to about 0.4 mm, from about 0.29 mm to about 0.4 mm, from about 0.325 mm to about 0.4 mm, from about 0.35 mm to about 0.4 mm
• a dot pattern can include any appropriate dot density. In some cases, dot density in a dot pattern can be even. In some cases, dot density in a dot pattern can be variable. In some cases, dots in a dot pattern can have a dot density of from about 2 dots per mm 2 (dots/mm 2 ) to about 5 dots/mm 2 (e.g, from about 2 to about 4.75, from about 2 to about 4.5, from about 2 to about 4.25, from about 2 to about 4, from about 2 to about 3.75, from about 2 to about
• dots in a dot pattern can have an average dot density of from about 3.5 to about 3.65 dots/mm 2 ( e.g ., about 3.52, about 3.55, about 3.57, about 3.60, or about 3.62 dots/mm 2 ).
• dots in a dot pattern can have an average dot density of from about 4.1 to about 4.25 dots/mm 2 (e.g., about 4.12, about 4.15, about 4.17, about 4.2, or about 4.22 dots/mm 2 ).
• a dot pattern can include any appropriate combination of dot size, dot spacing, and/or dot density as described herein.
• dot size, dot spacing, and/or dot density in a dot pattern can be even.
• dot size, dot spacing, and/or dot density in a dot pattern can be variable.
• a plurality of dots can be attached in a dot pattern that includes random variation in dot size and/or random variation in spacing between adjacent dots.
• a plurality of dots in a dot pattern can be positioned relative to a regular array of lattice sites.
• each dot in a dot pattern positioned relative to a regular array of lattice sites can be displaced in at least one dimension (e.g, x- and/or y-) from a corresponding one of the lattice sites by an amount equal to or less than a jitter amplitude.
• the jitter amplitude can be a fraction of the distance between adjacent lattice sites.
• a jitter amplitude can be less than about 0.5 (e.g, 0.4, 0.35, 0.3, 0.25, 0.2, 0.18, 0.15, 0.12, 0.1, 0.8, 0.05 or less).
• a plurality of dots in a dot pattern can have a size (e.g, a dimension such as a maximum dimension and/or a volume) that varies randomly
• a jitter amplitude can be less than about 0.5 times the nominal value (e.g ., 0.4, 0.35, 0.3, 0.25, 0.2, 0.18, 0.15, 0.12, 0.1, 0.8, 0.05 times the nominal value).
• a jitter amplitude can be more than about 0.02 times the nominal value (e.g., 0.03, 0.04, 0.05, 0.08, 0.1, 0.12, 0.15, 0.18, 0.2, 0.25, 0.3, 0.35, 0.4 times the nominal value).
• a dot pattern can cover (e.g, can occupy) any appropriate amount of a lens surface.
• a dot pattern can cover a bulk of a peripheral diffusion lens. In some cases, a dot pattern can cover from about 10% to about 99% (e.g, from about 10% to about 90%, from about 10% to about 75%, from about 10% to about 60%, from about 10% to about 50%, from about 10% to about 40%, from about 10% to about 35%, from about 10% to about 30%, from about 10% to about 25% , from about 10% to about 20%, from about 10% to about 15%, from about 15% to about 99%, from about 20% to about 99%, from about 30% to about 99%, from about 40% to about 99%, from about 50% to about 99%, from about 60% to about 99%, from about 75% to about 99%, from about 12% to about 75%, from about 15% to about 50%, from about 20% to about 40%, from about 15% to about 25%, from about 20% to about 40%, from about 30% to about 50%, from about 40% to about 60%, or from about 50% to about 70%) of a lens surface.
• a lens surface e.g, from about 10% to about 90%, from
• a dot pattern can cover 50% or less (e.g, 40% or less, 30% or less, 20% or less) of a lens surface.
• a dot pattern can cover about 20% of a lens surface.
• a dot pattern can cover about 40% of a lens surface.
• a peripheral diffusion lens can include an aperture.
• an aperture can be aligned to be in front of a human’s pupil ( e.g ., when in distance gaze).
• an aperture can be a clear aperture (e.g., an aperture free of dots).
• an aperture can be on the viewing axis.
• An aperture can be any appropriate size.
• an aperture can have a size (e.g, a maximum dimension) of from about 0.2 mm to about 1.5 cm (e.g, from about 0.2 mm to about 1.2 cm, from about 0.2 mm to about 1 cm, from about 0.2 mm to about 8 mm, from about 0.2 mm to about 7 mm, from about 0.2 mm to about 6 mm, from about 0.2 mm to about 5 mm, from about 0.2 mm to about 4 mm, from about 0.2 mm to about 3 mm, from about 0.2 mm to about 2 mm, from about 0.2 mm to about 1 mm, from about 0.2 mm to about 0.5 mm, from about 0.5 mm to about 1.5 cm, from about 0.8 mm to about 1.5 cm, from about 1 mm to about 1.5 cm, from about 1.2 mm to about 1.5 cm, from about 1.5 mm to about 1.5 cm, from about 2 mm to about 1.5 cm, from about 2.5 mm to about 1.5 cm, from about 3 mm to about 1.5 cm, from about 5
• an aperture can be about 5 mm in size.
• An aperture can be any appropriate shape.
• an aperture can be circular.
• an aperture can be non-circular (e.g, elliptical or polygonal such as having 4, 6, or 8 sides).
• an aperture can be a circular aperture having a diameter of about 5 mm.
• a clear aperture located on a lens viewing axis can allows a user (e.g, a human) to experience maximal visual acuity when viewing on-axis objects, while objects in the periphery of the user’s visual field are viewed through a dot pattern (e.g, viewed with reduced contrast and acuity).
• the aperture may be a step-function aperture, where the lens transitions from a dot-free area to a dot-density area in a step-function fashion (i.e., from dot-free aperture directly to the dot density found in the periphery).
• the aperture may contain a transition zone, where between the dot- free area and the periphery there is a transition zone, where the density of dots is higher than the dot free area and lower than the peripheral area.
• a myopia control spectacle lens can be any appropriate type of spectacle lens.
• a lens can include flat or curved surfaces.
• a myopia control spectacle lens can be made from any appropriate material (e.g ., polycarbonate or Trivex ® ).
• spectacles can include a myopia control spectacle lens in a single (e.g., the left or the right) lens. In some cases, spectacles can include myopia control spectacle lenses in both (e.g, the left and the right) lenses. In some cases, when spectacles can include myopia control spectacle lenses in both (e.g, the left and the right) lenses, the myopia control spectacle lenses can be the same or different.
• a myopia control spectacle lenses can be as described elsewhere (see, e.g., Appendix A, WO 2018/026697, US 7,506,983, US 2011/0051079, and 2017/0131567).
• Defocus lenses include regions of the lens that provide“plus” power in order to move the focal plane from behind the retina to even with, or in front of, the retina (i.e., inside the eye). Such defocus regions may be applied to various regions of the spectacle lens. For example they may be in the bottom half or bottom third of the lens (e.g, a progressive or bifocal), in the periphery of the lens, or in concentric rings around the center of the lens. Alternatively, defocus regions may comprise one or more defocusing centers in the periphery of the lens, where each defocus center forms a“lenslet” providing plus power to that region.
• Defocus lenses may provide optical power in the range of +1.0 D to +6.0 D.
• defocus lenses may provide optical power in the range of +2.00 D to +5.00 D, or +2.00 D, +2.25D, +2.50 D, +2.75D, +3.00 D, +3.25 D, +3.50 D, +3.75 D, + 4.00 D, + 4.25 D, +4.50 D, +4.75 D, or +5.00 D.
• a spectacle lens may contain one or more lenslets, e.g, independent island shaped areas with a different optical power compared to the Rx for correcting the subject’s myopia.
• the shape and composition of such lenslets have been described previously, e.g., for example in US 2017/0131567. It may contain 10-1000 lenslets, e.g., for example between 100-500 lenslets, or about 200-400, or about 350 lenslets. Lenslets may be from +2.00 D to +4.00 D, or about + 3.50 D.
• a child having, or suspected of having, myopia can be treated by having the juvenile human wear spectacles containing one or more (e.g ., one or two) spectacle lenses with a dot pattern having a dot diameter of 0.14 mm and a dot spacing of 0.24 mm covering about 20% of a lens surface, and a 5 mm clear aperture.
• one or more e.g ., one or two
• spectacle lenses with a dot pattern having a dot diameter of 0.14 mm and a dot spacing of 0.24 mm covering about 20% of a lens surface, and a 5 mm clear aperture.
• the human can wear one or more (e.g., one or two) myopia control spectacle lenses described herein for any appropriate amount of time.
• a human having, or suspected of having, myopia can wear one or more myopia control spectacle lenses for at least 12 months (e-g, at least 18 months, at least 24 months, at least 30 months, at least 36 months, at least 42 months, at least 48 months).
• a human having, or suspected of having, myopia can wear one or more myopia control spectacle lenses for at least 12 months.
• a human having, or suspected of having, myopia can wear one or more myopia control spectacle lenses for at least 24 months.
• a human having, or suspected of having, myopia can wear one or more myopia control spectacle lenses for at least 36 months.
• a human having, or suspected of having, myopia can wear one or more myopia control spectacle lenses for at least 6 hours (e.g, at least 7, at least 8, at least 9, at least 10, at least 11, at least 12, at least 13, at least 14, at least 15, at least 16, at least 17, or at least 18 hours) of each day that the one or more myopia control spectacle lenses are worn.
• a human having, or suspected of having, myopia can be treated by having the human wear one or more myopia control spectacle lenses for at least 10 hours of each day that the one or more myopia control spectacle lenses are worn.
• the human When treating a human having, or suspected of having, myopia as described herein, after the human has worn one or more (e.g., one or two) myopia control spectacle lenses described herein for an appropriate amount of time, the human can be assessed for any change in visual acuity. Visual acuity can be determined using any appropriate methods and/or instruments.
• Examples of methods and/or instruments that can be used to determine visual acuity in at least one eye of a human include, without limitation, visual acuity tests (e.g, using logMAR charts, Snellen charts, or ETDRS charts), contrast sensitivity tests (e.g, high contrast or low contrast vision charts to establish contrast sensitivity thresholds), charts, or ETDRS charts in a peripheral region of specified eccentricity(ies) to fixation (e.g., 25 degrees) and of specified location(s) (e.g., superonasal visual quadrant) to assess the ability of the human to distinguish the letters and/or symbols of the charts), or peripheral contrast (e.g., by fixating gaze in one place and using high contrast or low contrast vision charts in a peripheral region).
• visual acuity tests e.g, using logMAR charts, Snellen charts, or ETDRS charts
• contrast sensitivity tests e.g, high contrast or low contrast vision charts to establish contrast sensitivity thresholds
• charts or ETDRS charts in a peripheral region of specified
• the peripheral region can be more than about 5 degrees, more than about 10 degrees, more than about 20 degrees, or more than about 24 degrees of eccentration from the point of fixation.
• the peripheral visual acuity or peripheral contrast can be tested in one or more (e.g, one, two, three, or all 4) quadrants of vision (e.g, superonasal, superotemporal, inferonasal, and/or inferotemporal fields), and can be measured, e.g., for example, in logMAR.
• a human can be selected for continued wear of (e.g, another cycle of wearing) one or more myopia control spectacle lenses (e.g, one or more second myopia control spectacle lenses).
• a human can be fitted for one or more second myopia control spectacle lenses.
• One or more myopia control spectacle lenses (e.g, one or more second myopia control spectacle lenses) for continued wear can include the same myopia control spectacle lenses or different myopia control spectacle lenses (e.g, as compared to one or more first myopia control spectacle lenses).
• a human when visual acuity is reduced after having worn one or more myopia control spectacle lenses for an appropriate period of time, a human can be fitted for one or more new myopia control spectacle lenses (e.g, myopia control spectacle lenses having a different degree of correction, different peripheral diffusion or light scattering features, or different amounts of optical defocus).
• a human when visual acuity is unchanged after having worn one or more myopia control spectacle lenses for an appropriate period of time, a human can be fitted for one or more different myopia control spectacle lenses (e.g, myopia control spectacle lenses having a higher or lower dot pattern density, higher or lower defocus power, or higher or lower reduction in visual acuity or contrast).
• a human when visual acuity is improved after having worn one or more myopia control spectacle lenses for an appropriate period of time, a human can be fitted for one or more higher or lower dot pattern density, higher or lower defocus power, or higher or lower reduction in visual acuity or contrast) or can terminate wearing one or more myopia control spectacle lenses. After having worn one or more second myopia control spectacle lenses for an appropriate period of time, a human can be assessed for any change in visual acuity.
• This cycle (e.g ., repeating a method including determining a visual acuity in at least one eye of a human identified as having myopia or as being likely to develop myopia can be determined, fitting that human for one or more peripheral diffusion lenses, having the human wear the one or more myopia control spectacle lenses for an appropriate period of time, and assessing the human for any change in visual acuity) can be repeated any appropriate number of times (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or more times).
• the treatment can be effective to correct the myopia or to reduce/eliminate progression of the myopia (e.g, as compared to a control).
• treating a human having, or suspected of having, myopia as described herein can be effective to correct the myopia or to reduce/eliminate progression of the myopia (by greater than 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, or 60%) after having the human wear the one or more myopia control spectacle lenses for an appropriate period of time (e.g, about 3 years).
• a control can include, without limitation, measurements (e.g, axial lengths and/or SER errors) taken from a human prior to treatment, an untreated human, a human treated with one or more control lenses (e.g, lacking a dot pattern or optical defocus as described herein), such as a standard single vision lens, a lens with an optical tint, a standard contact lens, etc.
• measurements e.g, axial lengths and/or SER errors
• a control can include a single human or a group of humans (e.g, a control group).
• treating a human having, or suspected of having, myopia as described herein can be effective to reverse or partially reverse the myopia.
• wearing one or more (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce an axial length in at least one eye (e.g, one eye or both eyes) of that human.
• wearing one or more (e.g ., one or two) myopia control spectacle lenses described herein can be effective to increase a SER error in at least one eye (e.g., one eye or both eyes) of that human.
• This reversal could be measured at any time point, e.g., for example, 30 days or 6, 12, 18, 24, 30, or 36 months.
• treating a human having, or suspected of having, myopia as described herein can be effective to reduce/eliminate progression of the myopia compared to a control.
• wearing one or more (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce/eliminate an increase in axial length (e.g, reduce/eliminate axial lengthening) in at least one eye (e.g, one eye or both eyes) of that human.
• wearing one or more (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce/eliminate a change in SER (e.g, reduce/eliminate a decrease of a SER) in at least one eye (e.g, one eye or both eyes) of that human.
• SER e.g, reduce/eliminate a decrease of a SER
• wearing one or more (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce progression of the myopia by at least 0.45 D (e.g, 0.46 D, 0.5 D, 0.55 D, 0.56 D, 0.6 D, 0.65 D, 0.7 D, or 0.75 D, or more).
• wearing one or more (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce progression of the myopia by at least 0.45 D after three years of treatment.
• wearing one or more (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce progression of the myopia by at least 0.45 D as compared to a control group.
• treating a human having, or suspected of having, myopia as described herein can be effective to shorten an axial length of at least one eye (e.g, one eye or both eyes) of that human and/or to reduce/eliminate a change in axial length (e.g, reduce/eliminate axial lengthening) in at least one eye (e.g, one eye or both eyes) of that human.
• Axial length can be measured using any appropriate methods and/or machines. Examples of methods and/or machines that can be used to evaluate axial length include, without limitation, interferometry, such as an IOLMaster or Lenstar system. Axial length can masked observer).
• treating a human having, or suspected of having, myopia as described herein can be effective to shorten an axial length ( e.g ., by about 0.01, 0.02,
• a human having, or suspected of having, myopia has, prior to a treatment described herein, an axial length of from about 20 mm to about 30 mm in each eye
• wearing myopia control spectacle lenses as described herein can be effective to shorten an axial length (e.g., by about 0.01, 0.02, 0.03, 0.04, 0.05, 0.1, or 0.15 mm) in at least one eye of that human.
• treating a human having, or suspected of having, myopia as described herein can be effective to reduce (e.g, slow) a change (e.g, an increase) in axial length.
• a human having, or suspected of having, myopia has, prior to a treatment described herein, an axial length of from about 20 mm to about 30 mm in each eye
• wearing myopia control spectacle lenses as described herein can be effective to reduce a change in the axial length (e.g, to slow (e.g, retard) axial length increase such that the axial length growth is not greater than about 0.1, 0.2, or 0.3 mm) in at least one eye of that human over a period of time (e.g, 1, 2, or 3 years).
• treating a human having, or suspected of having, myopia as described herein can be effective to maintain an axial length.
• an axial length of from about 20 mm to about 30 mm in each eye wearing myopia control spectacle lenses as described herein can be effective to eliminate a change of > 0.1 mm in axial length (e.g, to maintain the axial length) in at least one eye of that human. Changes in axial length could be compared to a particular subject’s baseline (i.e., starting measurement before treatment) or compared to a control group of patients.
• treating a human in a fast progressor group having, or suspected of having, myopia as described herein can be effective to reduce axial length growth by at least 30% (e.g, at least 40%, at least 50%, at least 60%, or more).
• treating a human in a fast progressor group with at least one (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce axial length growth by about 30% as compared to a human treated with at least one (e.g, one or two) control lenses (see, e.g, Figure 8B).
• treating a human in a fast progressor group with at least one (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce axial length control lenses (see, e.g, Figure 11B).
• treating a human in a fast progressor group with at least one (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce axial length growth by about 50% as compared to a human treated with at least one (e.g, one or two) control lenses (see, e.g, Figure 14B).
• treating a human in a COMET-like population having, or suspected of having, myopia as described herein, can be effective to reduce axial length growth by at least 30% (e.g, at least 40%, at least 50%, at least 60%, or more).
• treating a human in a COMET-like population with at least one (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce axial length growth by about 30% as compared to a human treated with at least one (e.g, one or two) control lenses (see, e.g, Figure 17B).
• treating a human in a COMET-like population with at least one (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce axial length growth by about 40% as compared to a human treated with at least one (e.g., one or two) control lenses (see, e.g, Figure 20B).
• treating a human in a COMET-like population with at least one (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce axial length growth by about 50% as compared to a human treated with at least one (e.g, one or two) control lenses (see, e.g, Figure 23B).
• treating a human having, or suspected of having, myopia as described herein can be effective to increase a SER in at least one eye (e.g, one eye or both eyes) of that human and/or to reduce/eliminate a worsening in SER (e.g, reduce/eliminate a decrease in SER) in at least one eye (e.g, one eye or both eyes) of that human.
• SER can be evaluated using any appropriate methods and/or machines.
• SER error examples include, without limitation, auto-refractors (e.g, an open field autorefractor such as a Grand Seiko WR-5100K, Shin-Nippon, or equivalent).
• SER can be evaluated at any appropriate time.
• SER can be measured when a human having, or suspected of having, myopia is in a cycloplegic state.
• SER can be evaluated by any appropriate human (e.g, an ophthalmic clinician or an observer such as a masked observer).
• SER SER of between about -0.75 D and about -4.50 D in each eye
• wearing myopia control spectacle lenses as described herein can be effective to increase the SER (e.g ., to between about -0.25 D and about -4.25 D) in at least one eye of that human.
• treating a human having, or suspected of having, myopia as described herein can be effective to reduce (e.g., slow) a change (e.g, a decrease) in SER error.
• wearing myopia control spectacle lenses as described herein can be effective to reduce a change in the SER compared to a control in at least one eye of that human, so that on average, patients wearing myopia control spectacle lenses may have reduced progression by greater than or equal to 0.3 D, 0.4 D, 0.46 D, 0.5 D, 0.56 D, 0.6 D, 0.7 D, 0.73 D, 0.75 D, or more.
• treating a human having, or suspected of having, myopia as described herein can be effective to maintain SER.
• SER between about - 0.75 D and about -4.50 D in each eye
• wearing myopia control spectacle lenses as described herein can be effective to eliminate a change in SER error (e.g, to maintain the SER error at between about -0.75 D and about -4.50 D) in at least one eye of that human.
• Changes in SER could be compared to a particular subject’s baseline (i.e., starting measurement before treatment) or compared to a control group of patients.
• treating a human in a fast progressor group having, or suspected of having, myopia as described herein can be effective to reduce SER progression and/or SER distribution by at least 30% (e.g, at least 40%, at least 50%, at least 60%, or more).
• treating a human in a fast progressor group with at least one (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce SER progression and/or SER distribution by about 30% as compared to a human treated with at least one (e.g, one or two) control lenses (see, e.g, Figure 8A and Figure 9).
• treating a human in a fast progressor group with at least one (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce SER progression and/or SER distribution by (see, e.g, Figure 11 A and Figure 12).
• treating a human in a fast progressor group with at least one (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce SER progression and/or SER distribution by about 50% as compared to a human treated with at least one (e.g, one or two) control lenses (see, e.g, Figure 14A and Figure 15).
• treating a human in a COMET-like population can be effective to reduce SER progression and/or SER distribution by at least 30% (e.g, at least 40%, at least 50%, at least 60%, or more).
• treating a human in a COMET-like population with at least one (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce SER progression and/or SER distribution by about 30% as compared to a human treated with at least one (e.g, one or two) control lenses (see, e.g, Figure 17A and Figure 18).
• treating a human in a COMET-like population with at least one (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce SER progression and/or SER distribution by about 40% as compared to a human treated with at least one (e.g, one or two) control lenses (see, e.g, Figure 20A and Figure 21).
• treating a human in a COMET-like population with at least one (e.g, one or two) myopia control spectacle lenses described herein can be effective to reduce SER progression and/or SER distribution by about 50% as compared to a human treated with at least one (e.g, one or two) control lenses (see, e.g, Figure 23 A and Figure 24).
• treating a human having, or suspected of having, myopia as described herein can be effective to reduce progression of the myopia by 40% to 75% in a treatment group compared to a control group whose SER progresses -0.6 D to -1 D after having the treatment group wear the one or more myopia control spectacle lenses for 12 months.
• the myopia control spectacle lenses can be peripheral diffusion lenses such as those shown in Figures 5A-5F, described above, or having other appropriate dot patterns.
• the myopia control spectacle lenses can be myopic defocus lenses.
• SER change from baseline for the treatment group for percentage reductions from 40% to 75% are shown in the table in Figure 25A for control group progression from -0.60 D to -1.00 D in -0.05 D increments.
• outcomes can vary from -0.15 D (75% reduction vs. control progression of -0.60 D) to -0.60 D (40% reduction vs. control progression of -1.00 D) after 12 months.
• Outcomes can vary from -0.15 D to -0.36 D, e.g., for -0.60 D control group progression.
• Outcomes can vary from -0.16 D to -0.39 D, e.g., for -0.65 D control group progression.
• Outcomes can vary from -0.18 D to -0.42 D, e.g., for -0.70 D control group progression.
• Outcomes can vary from -0.19 D to -0.45 D, e.g., for -0.75 D control group progression. Outcomes can vary from -0.20 D to -0.48 D, e.g., for -0.80 D control group progression. Outcomes can vary from -0.21 D to -0.51 D, e.g., for -0.85 D control group progression. Outcomes can vary from -0.23 D to -0.54 D, e.g., for -0.90 D control group progression. Outcomes can vary from -0.24 D to -0.57 D, e.g., for -0.95 D control group progression. Outcomes can vary from -0.25 D to -0.60 D, e.g., for -1.00 D control group progression.
• outcomes can vary from 0.24 D (40% reduction vs. control progression of -0.60 D) to 0.75 D (75% reduction vs. control progression of -1.00 D) after 12 months.
• Outcomes can vary from 0.24 D to 0.45 D, e.g., for -0.60 D control group progression.
• Outcomes can vary from 0.26 D to 0.49 D, e.g., for -0.65 D control group progression.
• Outcomes can vary from 0.28 D to 0.53 D, e.g., for -0.70 D control group progression.
• Outcomes can vary from 0.30 D to 0.56 D, e.g., for -0.75 D control group progression. Outcomes can vary from 0.32 D to 0.60 D, e.g., for -0.80 D control group progression. Outcomes can vary from 0.34 D to 0.64 D, e.g., for - 0.85 D control group progression. Outcomes can vary from 0.36 D to 0.68 D, e.g., for -0.90 D control group progression. Outcomes can vary from 0.38 D to 0.71 D, e.g., for -0.95 D control group progression. Outcomes can vary from 0.40 D to 0.75 D, e.g., for -1.00 D control group progression.
• treating a human having, or suspected of having, myopia as described herein can be effective to reduce progression of the myopia by 40% to 75% in a treatment group compared to a control group whose SER progresses - l.l5 D to -l.55 D after having the treatment group wear the one or more myopia control spectacle lenses for 24 months.
• the myopia control spectacle lenses can be peripheral diffusion lenses such as those shown in myopia control spectacle lenses can be myopic defocus lenses.
• SER change from baseline for the treatment group for percentage reductions from 40% to 75% are shown in the table in Figure 26A for control group progression from -1.15 D to -1.55 D in -0.05 D increments.
• outcomes can vary from -0.29 D (75% reduction vs. control progression of -1.15 D) to -0.93 D (40% reduction vs. control progression of -1.55 D) after 24 months.
• Outcomes can vary from -0.29 D to -0.69 D, e.g., for -1.15 D control group progression.
• Outcomes can vary from -0.30 D to -0.72 D, e.g., for -1.20 D control group progression.
• Outcomes can vary from -0.31 D to -0.75 D, e.g., for -1.25 D control group progression.
• Outcomes can vary from -0.33 D to -0.78 D, e.g., for -1.30 D control group progression. Outcomes can vary from -0.34 D to -0.81 D, e.g., for -1.35 D control group progression. Outcomes can vary from -0.35 D to -0.84 D, e.g., for -1.40 D control group progression. Outcomes can vary from -0.35 D to -0.87 D, e.g., for -1.45 D control group progression. Outcomes can vary from -0.38 D to -0.90 D, e.g., for -1.50 D control group progression. Outcomes can vary from -0.39 D to -0.93 D, e.g., for -1.55 D control group progression.
• outcomes can vary from 0.46 D (40% reduction vs. control progression of -1.15 D) to 1.16 D (75% reduction vs. control progression of -1.55 D) after 24 months.
• Outcomes can vary from 0.46 D to 0.86 D, e.g., for -1.15 D control group progression.
• Outcomes can vary from 0.48 D to 0.90 D, e.g., for -1.20 D control group progression.
• Outcomes can vary from 0.50 D to 0.94 D, e.g., for -1.25 D control group progression.
• Outcomes can vary from 0.52 D to 0.98 D, e.g., for -1.30 D control group progression. Outcomes can vary from 0.54 D to 1.01 D, e.g., for -1.35 D control group progression. Outcomes can vary from 0.56 D to 1.05 D, e.g., for - 1.40 D control group progression. Outcomes can vary from 0.58 D to 1.09 D, e.g., for -1.45
• Outcomes can vary from 0.60 D to 1.13 D, e.g., for -1.50 D control group progression. Outcomes can vary from 0.62 D to 1.16 D, e.g., for -1.55 D control group progression.
• treating a human having, or suspected of having, myopia as described herein can be effective to reduce progression of the myopia by 40% to 75% in a treatment treatment group wear the one or more myopia control spectacle lenses for 36 months.
• the myopia control spectacle lenses can be peripheral diffusion lenses such as those shown in Figures 5A-5F, described above, or having other appropriate dot patterns.
• the myopia control spectacle lenses can be myopic defocus lenses.
• SER change from baseline for the treatment group for percentage reductions from 40% to 75% are shown in the table in Figure 27A for control group progression from -1.70 D to -2.10 D in -0.05 D increments.
• outcomes can vary from -0.42 D (75% reduction vs. control progression of -1.70 D) to -1.26 D (40% reduction vs. control progression of -2.10 D) after 36 months.
• Outcomes can vary from -0.42 D to -1.02 D, e.g., for -1.70 D control group progression.
• Outcomes can vary from -0.44 D to -1.05 D, e.g., for -1.75 D control group progression.
• Outcomes can vary from -0.45 D to -1.08 D, e.g., for -1.80 D control group progression.
• Outcomes can vary from -0.46 D to -1.11 D, e.g., for -1.85 D control group progression. Outcomes can vary from -0.47 D to -1.14 D, e.g., for -1.90 D control group progression. Outcomes can vary from -0.49 D to -1.17 D, e.g., for -1.95 D control group progression. Outcomes can vary from -0.50 D to -1.20 D, e.g., for -2.00 D control group progression. Outcomes can vary from -0.51 D to -1.23 D, e.g., for -2.05 D control group progression. Outcomes can vary from -0.52 D to -1.26 D, e.g., for -2.10 D control group progression.
• outcomes can vary from 0.68 D (40% reduction vs. control progression of -1.70 D) to 1.58 D (75% reduction vs. control progression of -2.10 D) after 36 months.
• Outcomes can vary from 0.68 D to 1.28 D, e.g., for -1.70 D control group progression.
• Outcomes can vary from 0.70 D to 1.31 D, e.g., for -1.75 D control group progression.
• Outcomes can vary from 0.72 D to 1.35 D, e.g., for -1.80 D control group progression.
• Outcomes can vary from 0.74 D to 1.39 D, e.g., for -1.85 D control group progression. Outcomes can vary from 0.76 D to 1.43 D, e.g., for -1.90 D control group progression. Outcomes can vary from 0.78 D to 1.46 D, e.g., for - 1.95 D control group progression. Outcomes can vary from 0.80 D to 1.50 D, e.g., for -2.00 D control group progression. Outcomes can vary from 0.82 D to 1.54 D, e.g., for -2.05 D control group progression.
• Outcomes can vary from 0.84 D to 1.58 D, e.g., for -2.10 D
• treating a human having, or suspected of having, myopia as described herein can be effective to reduce progression of the myopia by 40% to 75% in a treatment group compared to a control group whose axial length increases 0.250 mm to 0.500 mm after having the treatment group wear the one or more myopia control spectacle lenses for 12 months.
• the myopia control spectacle lenses can be peripheral diffusion lenses such as those shown in Figures 5A-5F, described above, or having other appropriate dot patterns.
• the myopia control spectacle lenses can be myopic defocus lenses.
• Axial length change from baseline for the treatment group for percentage reductions from 40% to 75% are shown in the table in Figure 28 A for control group progression from 0.250 mm to 0.500 mm in 0.025 mm increments.
• outcomes can vary from 0.06 mm (75% reduction vs. control progression of 0.250 mm) to 0.30 mm (40% reduction vs. control progression of 0.500 mm) after 12 months.
• Outcomes can vary from 0.06 mm to 0.15 mm, e.g., for 0.250 mm control group progression.
• Outcomes can vary from 0.07 mm to 0.17 mm, e.g., for 0.275 mm control group progression.
• Outcomes can vary from 0.07 mm to 0.18 mm, e.g., for 0.300 mm control group progression.
• Outcomes can vary from 0.08 mm to 0.20 mm, e.g., for 0.325 mm control group progression.
• Outcomes can vary from 0.09 mm to 0.21 mm, e.g., for 0.350 mm control group progression. Outcomes can vary from 0.09 mm to 0.23 mm, e.g., for 0.375 mm control group progression. Outcomes can vary from 0.10 mm to 0.24 mm, e.g., for 0.400 mm control group progression. Outcomes can vary from 0.11 mm to 0.26 mm, e.g., for 0.425 mm control group progression. Outcomes can vary from 0.11 mm to 0.27 mm, e.g., for 0.450 mm control group progression.
• Outcomes can vary from 0.12 mm to 0.29 mm, e.g., for 0.475 mm control group progression. Outcomes can vary from 0.13 mm to 0.30 mm, e.g., for 0.500 mm control group progression.
• Outcomes can vary from -0.11 mm to -0.21 mm, e.g., for 0.275 mm control group group progression. Outcomes can vary from -0.13 mm to -0.24 mm, e.g., for 0.325 mm control group progression. Outcomes can vary from -0.14 mm to -0.26 mm, e.g., for 0.350 mm control group progression. Outcomes can vary from -0.15 mm to -0.28 mm, e.g., for 0.375 mm control group progression. Outcomes can vary from -0.16 mm to -0.30 mm, e.g., for 0.400 mm control group progression.
• Outcomes can vary from -0.17 mm to -0.32 mm, e.g., for 0.425 mm control group progression. Outcomes can vary from -0.18 mm to -0.34 mm, e.g., for 0.450 mm control group progression. Outcomes can vary from -0.19 mm to - 0.36 mm, e.g., for 0.475 mm control group progression. Outcomes can vary from -0.20 mm to -0.38 mm, e.g., for 0.500 mm control group progression.
• treating a human having, or suspected of having, myopia as described herein can be effective to reduce progression of the myopia by 40% to 75% in a treatment group compared to a control group whose axial length increases 0.500 mm to 0.750 mm after having the treatment group wear the one or more myopia control spectacle lenses for 24 months.
• the myopia control spectacle lenses can be peripheral diffusion lenses such as those shown in Figures 5A-5F, described above, or having other appropriate dot patterns.
• the myopia control spectacle lenses can be myopic defocus lenses.
• Axial length change from baseline for the treatment group for percentage reductions from 40% to 75% are shown in the table in Figure 29A for control group progression from 0.500 mm to 0.750 mm in 0.025 mm increments.
• outcomes can vary from 0.13 mm (75% reduction vs. control progression of 0.500 mm) to 0.45 mm (40% reduction vs. control progression of 0.750 mm) after 24 months.
• Outcomes can vary from 0.13 mm to 0.30 mm, e.g., for 0.500 mm control group progression.
• Outcomes can vary from 0.13 mm to 0.32 mm, e.g., for 0.525 mm control group progression.
• Outcomes can vary from 0.14 mm to 0.33 mm, e.g., for 0.550 mm control group progression.
• Outcomes can vary from 0.14 mm to 0.35 mm, e.g., for 0.575 mm control group progression.
• Outcomes can vary from 0.15 mm to 0.21 mm, e.g., for 0.600 mm control group progression. Outcomes can vary from 0.16 mm to 0.38 mm, e.g., for 0.625 mm control group progression. Outcomes can vary from 0.16 mm to 0.39 mm, e.g., for 0.650 mm control group progression. Outcomes can vary from 0.17 mm to 0.41 mm, e.g., for 0.675 mm control group progression. Outcomes can vary from from 0.18 mm to 0.44 mm, e.g., for 0.725 mm control group progression. Outcomes can vary from 0.19 mm to 0.45 mm, e.g., for 0.750 mm control group progression.
• Outcomes can vary from -0.21 mm to -0.39 mm, e.g., for 0.525 mm control group progression. Outcomes can vary from -0.22 mm to -0.41 mm, e.g., for 0.550 mm control group progression. Outcomes can vary from -0.23 mm to -0.43 mm, e.g., for 0.575 mm control group progression. Outcomes can vary from -0.24 mm to -0.45 mm, e.g., for 0.600 mm control group progression. Outcomes can vary from -0.25 mm to -0.47 mm, e.g., for 0.625 mm control group progression.
• Outcomes can vary from -0.26 mm to -0.49 mm, e.g., for 0.650 mm control group progression. Outcomes can vary from -0.27 mm to -0.51 mm, e.g., for 0.675 mm control group progression. Outcomes can vary from -0.28 mm to -0.53 mm, e.g., for 0.700 mm control group progression. Outcomes can vary from -0.29 mm to - 0.54 mm, e.g., for 0.725 mm control group progression. Outcomes can vary from -0.30 mm to -0.56 mm, e.g., for 0.750 mm control group progression.
• treating a human having, or suspected of having, myopia as described herein can be effective to reduce progression of the myopia by 40% to 75% in a treatment group compared to a control group whose axial length increases 0.800 mm to 1.050 mm after having the treatment group wear the one or more myopia control spectacle lenses for 36 months.
• the myopia control spectacle lenses can be peripheral diffusion lenses such as those shown in Figures 5A-5F, described above, or having other appropriate dot patterns.
• the myopia control spectacle lenses can be myopic defocus lenses.
• Axial length change from baseline for the treatment group for percentage reductions from 40% to 75% are shown in the table in Figure 30A for control group progression from 0.800 mm to 1.050 mm in 0.025 mm increments.
• Outcomes can vary from 0.23 mm to 0.54 mm, e.g., e.g., for 0.900 mm control group progression. Outcomes can vary from 0.23 mm to 0.56 mm, e.g., e.g., for 0.925 mm control group progression. Outcomes can vary from 0.24 mm to 0.57 mm, e.g., e.g., for 0.950 mm control group progression. Outcomes can vary from 0.24 mm to 0.59 mm, e.g., e.g., for 0.975 mm control group progression. Outcomes can vary from 0.25 mm to 0.60 mm, e.g., e.g., for 1.000 mm control group progression.
• Outcomes can vary from 0.26 mm to 0.62 mm, e.g., e.g., for 1.025 mm control group progression. Outcomes can vary from 0.26 mm to 0.63 mm, e.g., e.g., for 1.050 mm control group progression.
• outcomes can vary from -0.32 mm (40% reduction vs. control progression of 0.800 mm) to - 0.79 mm (75% reduction vs. control progression of 1.050 mm) after 36 months.
• Outcomes can vary from -0.32 mm to -0.60 mm, e.g., e.g., for 0.800 mm control group progression.
• Outcomes can vary from -0.33 mm to -0.62 mm, e.g., e.g., for 0.825 mm control group progression.
• Outcomes can vary from -0.34 mm to -0.64 mm, e.g., e.g., for 0.850 mm control group progression. Outcomes can vary from -0.35 mm -0.66 mm, e.g., e.g., for 0.875 mm control group progression. Outcomes can vary from -0.36 mm to -0.68 mm, e.g., e.g., for 0.900 mm control group progression. Outcomes can vary from -0.37 mm to -0.69 mm, e.g., e.g., for 0.925 mm control group progression.
• Outcomes can vary from -0.38 mm to - 0.71 mm, e.g., e.g., for 0.950 mm control group progression. Outcomes can vary from -0.39 mm to -0.73 mm, e.g., e.g., for 0.975 mm control group progression. Outcomes can vary from -0.40 mm to -0.75 mm, e.g., e.g., for 1.000 mm control group progression. Outcomes can vary from -0.41 mm to -0.77 mm, e.g., e.g., for 1.025 mm control group progression. Outcomes can vary from -0.42 mm to -0.79 mm, e.g., e.g., for 1.050 mm control group progression.
• the percentage by which the human’s myopic progression is reduced can increase (e.g., in proportion to) the average amount of time each day they wear the myopia control spectacle lenses.
• wearing the myopia control spectacle lenses for at least 6 hours can yield a greater reduction in myopia progression compared to wearing the myopia control spectacle lenses for 1 hour or more (e.g., 2 hours or more, 3 hours or more, 4 hours or more, 5 hours or more) less each day on average.
• the degree to which the treatment described above is effective to reduce progression of myopia does not vary depending on the average amount of time each day the human wears one or more (e.g., one or two) myopia control spectacle lenses during the treatment period.
• the percentage by which the human’s myopic progression is reduced can be substantially the same irrespective of the average amount of time each day they wear the myopia control spectacle lenses.
• wearing the spectacle lenses 6 hours a day on average can yield substantially the same reduction in myopia progression as 7 hours a day or more (e.g., 8 hours a day or more, 9 hours a day or more, 10 hours a day or more, 11 hours a day or more, 12 hours a day or more, 13 hours a day or more, 14 hours a day or more 15 hours a day or more).
• a region (e.g ., a peripheral region or a central region) of a lens can include one or more microlenses such that the optical power of the lens varies from each microlens and the regions of the lens between the microlenses.
• a region (e.g., a peripheral region or a central region) of a myopia control lens can include microlenses that are spaced apart from each other.
• lenses can have annular regions of increased or decreased optical power relative to the clear aperture of the lens.
• the methods and devices described herein can also be applied to any appropriate type of ophthalmic lens. Examples of ophthalmic lens which can contain a myopia control lens described herein include, without limitation, monocles, contact lenses, and intraocular lens implants.
• the treatment when treating a human having, or suspected of having, myopia as described herein (e.g ., by having the human wear one or more (e.g., one or two) myopia control spectacle lenses), the treatment also can include one or more additional myopia treatments.
• myopia treatments include, without limitation, medications (e.g, anti-muscarinic topical medications such as pirenzepine gel, cyclopentolate eye drops, and atropine eye drops or gel), surgery (e.g., scleral reinforcement surgery and refractive surgeries such as photorefractive keratectomy (PRK), LASIK, and phakic intra-ocular lens implantation), therapy (e.g, eye exercises and relaxation techniques), orthokeratology lenses, or defocus lenses such as spectacle or contact lenses.
• medications e.g, anti-muscarinic topical medications such as pirenzepine gel, cyclopentolate eye drops, and atropine eye drops or gel
• surgery e.g., scleral reinforcement surgery and refractive surgeries such as photorefractive keratectomy (PRK), LASIK, and phakic intra-ocular lens implantation
• therapy e.g, eye exercises and relaxation techniques
• orthokeratology lenses e.g, orthokeratology lenses,
• a model system can include any appropriate mammal having, or suspected of having, myopia.
• mammals that can be used in a model system utilizing the methods and devices described herein include, without limitation, non-human primates (such as monkeys) or chicks.
• the methods and devices herein can also be applied where they can control myopia without impacting the subject’s normal, corrected vision.
• peripheral vision, peripheral visual acuity, visual field, or peripheral contrast without impacting the subject’s peripheral vision, peripheral visual acuity, visual field, or peripheral contrast.
• the peripheral vision, peripheral visual acuity, visual field, or peripheral contrast could be impacted by less than 5%, less than 10%, less than 15%, less than 20%, or less than 25%, compared to baseline or compared to a control group.
• Example 1 Control of Myopia Using Peripheral Diffusion Lenses: Efficacy and Safety Study (CYPRESS)
• Subjects are masked to the treatment arm and masked observers are utilized for axial length and cycloplegic auto-refraction measurements.
• myopia control treatment e.g ., atropine, multifocal contact lenses, etc.
• SER Spherical equivalent refraction
• the main analysis of the primary efficacy outcome measures will be on the modified intent-to-treat (mITT) population, which is a subset of intent-to-treat subjects excluding those without a baseline value for either axial length or SER (as measured by cycloplegic auto- refraction).
• mITT modified intent-to-treat
• the study has an interim analysis (IA) on the 12-month and 24-month data.
• IA interim analysis

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