Projecting a defocused image on the peripheral retina to treat refractive errors

Abstract

An apparatus for treating refractive error of an eye includes one or more optical elements configured to project a stimulus including a defocused image onto a peripheral retina outside the macula. While the stimulus can be configured in a variety of ways, in some embodiments the stimulus is arranged to reduce interference with central vision, such as macular vision. The stimulus can be a defocused image, can include an amount of defocus in a range of about 3 diopters ("D") to about 6 D. In some embodiments, the stimulus is of a brightness that is a suitable amount greater than the brightness of background illumination, such as at least 3 times the background brightness. In some embodiments, each of a plurality of stimuli includes a spatial frequency distribution having an amplitude profile, the spatial frequency distribution having a spatial frequency in a range of about 1 x 10 ‑1 cycles per degree to 2.5 x 10 1 cycles per degree.

Description

[0001] Related applications

[0002] This PCT application claims priority to the following provisional patent applications: Provisional Patent Application No. 63 / 036,226, filed June 8, 2020, entitled “PROJECTION OF DEFOCUSED IMAGES ON THE PERIPHERAL RETINA TO TREAT REFRACTIVE ERROR”; Provisional Patent Application No. 62 / 706,153, filed August 3, 2020, entitled “PROJECTION OF DEFOCUSED IMAGES ON THE PERIPHERAL RETINA TO TREAT REFRACTIVE ERROR”; and Provisional Patent Application No. 62 / 706,456, filed August 18, 2020, entitled “PROJECTION OF DEFOCUSED IMAGES ON THE PERIPHERAL RETINA TO TREAT REFRACTIVE ERROR”, the entire disclosure of which is incorporated herein by reference.

[0003] The subject matter of this application relates to PCT / US2019 / 043692, filed on July 26, 2019, entitled “ELECTRONIC CONTACT LENS TODECREASE MYOPIA PROGRESSION” (published on February 6, 2020 as WO2020028177A1), the entire disclosure of which is incorporated herein by reference.

[0004] background

[0005] Existing methods for treating refractive errors (such as myopia) are less than ideal in at least some respects. Spectacular lenses, contact lenses, and refractive surgery can be used to treat refractive errors in the eye. However, to correct the error, lenses must be worn, and uncorrected refractive errors can affect a person's ability to achieve and fully participate in school activities, sports, and other activities. While surgery can reduce refractive errors, it carries risks, at least in some cases, such as infection and decreased vision. Furthermore, these methods do not address the underlying changes in eye length associated with refractive errors (such as myopia).

[0006] Work related to this disclosure shows that the retina in many species, including humans, responds to defocused images and repositions itself through scleral remodeling to reduce blur caused by defocus. The mechanisms of growth signal generation are still under investigation, but one observable phenomenon is an increase in choroidal thickness. Defocused images cause changes in choroidal thickness, which is related to the axial length of the eye. Changes in axial length can modify refractive errors by altering the position of the retina relative to the cornea. For example, an increase in axial length increases myopia by increasing the distance between the cornea and retina.

[0007] While image defocusing can play a role in changes in choroidal thickness and axial length of the eye, existing methods are not well-suited for addressing refractive errors related to axial length. Although drug therapies have been proposed for treating myopia associated with axial length growth, these treatments may not yield ideal results, and in some cases have not yet been shown to safely treat refractive errors. While light has been proposed as a stimulus to alter eye growth, at least some existing devices may provide less-than-ideal results. Furthermore, treatment may take longer than ideal, and at least some existing methods may be more complex than ideal.

[0008] Therefore, new methods are needed to improve upon at least some of the aforementioned limitations of existing methods for treating refractive errors of the eye.

[0009] Overview

[0010] The currently disclosed methods, apparatus, and devices provide improved treatment of refractive errors with reduced treatment time. In some embodiments, the stimulus includes one or more of a spatial frequency distribution or a ratio of stimulus intensity to background illumination intensity to enhance the improved response. In some embodiments, the stimulus is presented at an appropriate time of day to enhance the response.

[0011] An apparatus for treating refractive errors of the eye includes one or more optical elements configured to project a stimulus, including a defocused image, onto the peripheral retina outside the macula. While the stimulus can be configured in various ways, in some embodiments, the stimulus is arranged to reduce interference with central vision, such as macular vision. The stimulus can be a defocused image and can include an amount of defocus ranging from about 2 diopters (“D”) to about 6D, and this range can be from about 3D to about 6D. In some embodiments, the brightness of the stimulus is appropriately greater than the brightness of the background illumination, such as being at least 3 times the background brightness. In some embodiments, each of the plurality of stimuli includes a spatial frequency distribution having an amplitude profile having a frequency of 1 × 10⁻⁶ ppm per degree. -1 One cycle to 1×10 1A large number of spatial frequencies within a range of cycles. In some embodiments, the size and shape of each stimulus are configured to have an intensity profile distribution in order to provide spatial frequencies to enhance the response to the stimulus. Each stimulus may include one or more local intensity peaks near a region of reduced illumination. In some embodiments, the region of reduced illumination lies between multiple peaks, although the region of reduced illumination may be defined by ring-shaped peaks.

[0012] By incorporating references

[0013] All patents, applications and publications cited and confirmed in this document are incorporated herein by reference, and any references made elsewhere in the application shall be deemed to be incorporated by reference in their entirety. Brief description of the attached diagram

[0015] A better understanding of the features, advantages, and principles of this disclosure will be obtained by referring to the following detailed description of illustrative embodiments and the accompanying drawings, in which:

[0016] Figure 1A A retinal stimulation device according to some embodiments is shown;

[0017] Figure 1B A spectacle-based retinal stimulation device according to some embodiments is shown, the device including a display and a housing housing electronics for operating the near-eye display;

[0018] Figure 1C Examples of some embodiments are shown. Figure 1B The retinal stimulation device shown is based on eyeglass lenses, in which the eye has moved and different display elements have been activated in response to eye movement;

[0019] Figure 2A A soft contact lens according to some embodiments is shown;

[0020] Figure 2B A soft contact lens according to some embodiments is shown, which has an embedded light source, optical elements and electronics for projecting a defocused image onto the periphery of a user's retina;

[0021] Figure 3 As shown Figure 2A and Figure 2B A system diagram showing the functions of the components of a contact lens;

[0022] Figure 4A An optical configuration according to some embodiments is shown, wherein the optical path length is increased by folding the optical path with two mirrors;

[0023] Figure 4B Examples of some embodiments are shown. Figure 4AThe optical configuration that projects light into the eye;

[0024] Figure 5A An optical configuration according to some embodiments is shown, including a lens that focuses light onto the retina;

[0025] Figure 5B Examples of some embodiments are shown. Figure 5A The optical configuration that projects light into the eye;

[0026] Figure 6A An optical tube for increasing the optical path length is shown according to some embodiments;

[0027] Figure 6B Examples of some embodiments are shown. Figure 6A The optical configuration that projects light into the eye;

[0028] Figure 7 Multiple stimuli and images, as seen by a user, are illustrated according to some embodiments;

[0029] Figure 8A The image shows a stimulation on a screen that provides myopic defocus stimulation to the retina according to some embodiments;

[0030] Figure 8B The corresponding dimensions of myopic defocusing stimuli on the retina are shown in degrees according to some embodiments;

[0031] Figure 9 The illustration depicts stimuli that portray natural scenes, such as circular floral patterns, according to some embodiments;

[0032] Figure 10 The illustration shows a method for targeting according to some embodiments. Figures 8A to 9 The image contrast of the stimulus shown is illustrated with histograms of red (R), blue (B), and green (G) values.

[0033] Figure 11 Images suitable for modification and incorporation as stimuli described herein are shown according to some embodiments;

[0034] Figure 12 Similar to some embodiments are shown. Figure 11 The image is an image that has been processed to provide improved stimulation;

[0035] Figure 13 Illustrations are shown according to some embodiments Figure 11 The spatial frequency distribution of the image;

[0036] Figure 14 Illustrations are shown according to some embodiments Figure 12The image of the spatial frequency distribution of the image (which is used as a stimulus);

[0037] Figure 15 The illustration shows a method for targeting according to some embodiments. Figure 8B and Figure 9 The graph shows the spatial frequency of the stimulus image in units of number of cycles per degree and the logarithm of the energy at each frequency.

[0038] Figure 16 A system for treating refractive errors of the eye, according to some embodiments, is shown;

[0039] Figure 17 A method for treating refractive errors of the eye according to some embodiments is shown;

[0040] Figure 18A Stimulus with 6D myopic defocus (“6D stimulus”) and another stimulus with 3D myopic defocus (“3D stimulus”) according to some embodiments are described.

[0041] Figure 18B Stimuli with 25% coverage (“25% stimulus”) and stimuli with 50% coverage (“50% stimulus”) are depicted according to some embodiments;

[0042] Figure 18C Stimuli with a luminance ratio of 0.1:1 and stimuli with a luminance ratio of 1:1 are described according to some embodiments;

[0043] Figure 18D Black and white stimuli and red stimuli are depicted according to some embodiments;

[0044] Figure 19 An optical system for projecting stimuli onto the retina according to some embodiments is described;

[0045] Figure 20A The image shows the focal point of the central entertainment area and the background pattern for the control eye (e.g., the left eye) according to some embodiments;

[0046] Figure 20B The image shows a myopic defocus, a central recreation area, and a background pattern for the tested eye (e.g., the right eye) according to some embodiments.

[0047] Figure 21 Clinical results similar to those in Table 1 are shown according to some embodiments;

[0048] Figure 22Aggregated data from 5x, 10x, and 20x brightness tests according to some embodiments are presented, showing that after a 1-hour defocusing session, the mean change in central axis length (in micrometers) of the test eyes was significantly smaller than the mean change in central axis length of the control eyes (p<0.025); and

[0049] Figure 23 The mean changes (mean ± SEM) in axial length and choroidal thickness according to some embodiments are shown: for the aggregation of all trials, after a one-hour defocusing period, the axial length change in the test eyes was significantly smaller than that in the control eyes.

[0050] Detailed description

[0051] The following detailed description provides a better understanding of the features and advantages of the invention described in this disclosure according to embodiments disclosed herein. Although the detailed description includes many specific embodiments, these embodiments are provided by way of example only and should not be construed as limiting the scope of the invention disclosed herein.

[0052] The methods and apparatus disclosed herein can be configured in a variety of ways to provide retinal stimulation as described herein. The methods and apparatus disclosed herein are well-suited for combination with a wide range of existing devices, such as ophthalmic devices, TV screens, computer screens, virtual reality (“VR”) displays, augmented reality (“AR”) displays, handheld devices, mobile computing devices, tablet computing devices, smartphones, wearable devices, eyeglass frames, eyeglass lenses, near-eye displays, head-mounted displays, goggles, contact lenses, implantable devices, corneal inlays, corneal implants, corneal prostheses, or intraocular lenses, or one or more. Although specific references are made to eyeglass lenses and contact lenses, the methods and apparatus disclosed herein are well-suited for use with any of the foregoing devices, and based on the teachings provided herein, those skilled in the art will readily understand how one or more of the components disclosed herein can be interchanged between devices.

[0053] Figure 1AA retinal stimulation device is illustrated for reducing or at least partially reversing one or more of the progressions of myopia. The device includes a lens 10 to support a plurality of light sources. The plurality of light sources may be coupled to one or more optical components to provide stimulation to the retina as described herein. In some embodiments, the lens 10 includes spectacle lens 74. In some embodiments, the lens 10 is shaped to correct spherical and cylindrical refractive errors in a user to provide corrected visual acuity through the lens. The plurality of light sources may include one or more of a projection unit 12 or a display 72 (such as a near-eye display). The plurality of light sources are arranged around a central portion of the lens to provide light stimulation to locations outside the retina, such as the peripheral retina as described herein. In some embodiments, the light sources are located in a near-annular region to provide stimulation to the peripheral retina. The light sources may be arranged in a generally annular pattern, e.g., in a quadrant, to correspond to a quadrant of the peripheral retina outside the macula. Each of the plurality of light sources may be configured to project a pattern onto the front of the retina using an appropriate stimulation pattern as described herein. In some embodiments, light from the light sources crosses the optical axis of the eye to stimulate the retina at a location on the side of the retina opposite to the light source.

[0054] In some embodiments, the projection unit 12 is configured to emit light to enter the pupil of the eye without substantial aliasing. In some embodiments, the pupil of the eye may be dilated by the application of an appropriate amount of light or a mydriatic agent, so that a larger area of ​​the retinal surface may be reached by the stimulus projected by the projection unit 12.

[0055] In some embodiments, multiple light sources are configured to remain static while a user views an object. Alternatively, the light sources can be configured to move in response to eye movements, for example, by utilizing selective activation of pixels as described herein.

[0056] Although reference is made to multiple light sources supported on a lens, the light source can be supported on any suitable optical transmission substrate (such as a beam splitter or a substantially flat optical component), and the light source can include the light source of a pixel display (such as an AR or VR display). In some embodiments, display 72 includes pixels 94 that are selectively activated to provide stimulation to the retina as described herein. Alternatively or in combination, projection unit 12 may include shaped structures to provide stimulation to the retina as described herein.

[0057] In some embodiments, for example, pixels are configured to emit multiple colors, thereby allowing the projected light to be combined to produce any suitable color or hue, such as white light.

[0058] In some embodiments, multiple light sources are supported on a head support, such as an eyeglass frame 76 on eyeglasses 70.

[0059] Figure 1B and Figure 1C Glasses 70 for treating refractive errors of the eye (e.g., spherical refractive errors) are depicted, although any suitable visual device as described herein may be appropriately modified according to embodiments disclosed herein. Multiple light sources may be coupled to one or more optical components to provide stimulation to the retina as described herein. Glasses 70 may include one or more components of commercially available augmented reality glasses. Glasses 70 may include one or more displays 72 for retinal stimulation. Near-eye displays 72 may be mounted to lenses 74. Lens 74 may be spectacle lenses supported by spectacle frames 76. Lens 74 may be corrective or uncorrective lenses. Lens 74 may be a plano lens, a spherical corrective lens, an astigmatic corrective lens, or a prism corrective lens. In some embodiments, the near-eye displays are positioned away from the optical zone to provide clear central vision. The optical axis may extend along the line of sight from the object of the patient's attention through lens 74 to the fovea of ​​the eye. In some embodiments, glasses 70 includes an eye tracker suitable for integration according to this disclosure. As described herein, near-eye displays 72 may be programmed to selectively activate pixels 94 to provide peripheral stimulation to the retina. In some embodiments, a plastic substrate carrying the microlens is attached to a microdisplay to generate a desired level of defocus and stimulation at the retina. Selectably activatable pixels may include groups of pixels that can be selectively activated together, such as a first pixel group 94a, a second pixel group 94b, a third pixel group 94c, and a fourth pixel group 94d. The pixel groups may be arranged to provide an appropriate degree of eccentricity relative to the patient's line of sight in order to provide peripheral retinal stimulation as described herein.

[0060] In some embodiments, the near-eye display 72 includes a combination of a microdisplay and microoptics. In some embodiments, the microoptics are configured to collect, substantially collimate, and focus light emitted from the microdisplay. In some embodiments, as described herein, the microoptics are configured to form an image in front of or behind the retina. In some embodiments, the near-eye display is located at a distance from the entrance pupil of the eye ranging from about 10 mm to about 30 mm, for example, about 15 mm. The microdisplay may be placed on a transparent substrate, such as on the front or rear surface of the lens 74 of the eyeglasses 70. When the microdisplay is placed on the front surface of the lens 74, the focus of the microdisplay may be affected by cylindrical correction on the rear surface of the lens 74.

[0061] In some embodiments, the focal point of the pixels in the microdisplay may vary based on their position on lens 74 and the refractive correction provided by the lens in that region. In some embodiments, the focal point of the pixels may be fixed. In some embodiments, the focal point of the pixels may vary based on the sensing position of the cornea to take into account the refractive properties of the cornea and lens of the eye. In some embodiments, the pixels are defocused to produce a defocused spot with a diameter of about 1 mm on the retina.

[0062] Light emitted from pixels 94 in the microdisplay of the near-eye display can be one or more of substantially collimated or focused light before being guided to the pupil of the eye. In some embodiments, the microlens array is aligned with the pixels of the near-eye display such that light from the near-eye display can enter the pupil and form an image in front of or behind the retina. In some embodiments, the width of the near-eye display corresponds to the patient's field of vision. In some embodiments, the range of the near-eye display can be substantially similar to the range of the lens 74 of the eyeglasses 70.

[0063] In some embodiments, the device provides unimpaired central vision so that the user's quality of life and visual quality are not adversely affected. In some embodiments, central vision includes a field of view of + / - 5 degrees or greater, preferably + / - 7.5 degrees or greater, such as + / - 12.5 degrees, covering the macula, while the fixed foveal vision has a field of view of + / - 1.0 degrees. In some embodiments, the defocused image is, for example, in the range of 15 degrees (full angle, or + / - 7.5 degrees) to 40 degrees (full angle, or + / - 20 degrees) off-center from the fovea, and may be projected toward the periphery of the retina at the outer portion of the retina in the range of 20 degrees to 40 degrees, for example, in the range of 20 degrees to 30 degrees. In some embodiments, the microdisplay 72 does not obstruct the central visual field of view. In some embodiments, the pixel 94 does not obstruct the central visual field of view.

[0064] In some embodiments, the microdisplay and optics are configured to project light onto an outer region of the retina sufficiently far from the fovea, such that illumination remains substantially constant even in the presence of eye movement. In some embodiments, the point of interest is monitored and (e.g., calculated using a processor) the desired location of pixels to be activated on the microdisplay, thereby projecting an image onto the desired location on the retina to allow for continuous stimulation at the same retinal location. In some embodiments, the point of interest on the spectacle plane or microdisplay plane is calculated by monitoring the horizontal, vertical, and torsional displacement of the eye relative to the dominant position.

[0065] Points of interest can be determined in many ways, such as using eye position sensors (e.g., magnetic or optical sensors). In some embodiments, a search coil embedded in the eyeglass frame is used to track eye movements. The coil embedded in the eyeglass frame can be coupled to one or more magnetic structures placed on the eye, such as coils on contact lenses, coils implanted in the eye, magnetic materials on contact lenses, or magnetic materials implanted in the eye. In some embodiments, the sensor includes an optical sensor, such as a position-sensitive detector or an array sensor, to optically measure the position of the eye. The optical sensor can be configured to measure the position of the eye in a variety of ways, such as being configured to measure the position of one or more of a light source, the pupil, the limbus, or the sclera. The eyeglass frame can support an additional light source to illuminate the eye, for example, to generate a corneal reflection. Data from the sensor can provide the position of the coaxial visible corneal light reflection (“CSCLR”), thereby providing the orientation of the visual axis and the position of the fovea. Srinivasan, S., describes the point of interest, visual axis, optical axis, nodal point of the eye, and CSCLR in “Ocular axes and Angels: time for Goodering Generation” (J CATARACT REFRACT SURG - Vol. 42, March 2016). In some embodiments, a processor using an eye position sensor can be configured to adjust optical elements, such as pixels in a microdisplay, to reduce movement of the stimulated position of the retina in response to eye movements. In some embodiments, a target position of the peripheral image is calculated from the position of the fovea based on information from the eye position sensor, and real-time ray tracing calculations provide the position of the pixels to be activated in the microdisplay. The time for selectively switching to multiple second pixels in response to eye movements can be less than 100 milliseconds, for example, less than 20 milliseconds.

[0066] In some embodiments, the positions of pixels in the microdisplay to be activated to form an external image toward the periphery of the retina are referenced to the optical center of the spectacle lens, as this optical center is the point of attention during the primary gaze. In some embodiments, the position of the point of attention is calculated by taking into account eye movements relative to the eye's position during the primary gaze, and the positions of the pixels to be activated are calculated with reference to the new point of attention. For example, Figure 1B The active pixel 94 is shown when the patient is looking straight ahead (i.e., the so-called dominant gaze), while Figure 1C The active pixel 94 is shown when the patient looks up and to the left. In this case, the shape of the pixel array can be the same, but shifted up and to the left, or the shape of the array can be changed.

[0067] In some embodiments, the device is bi-purpose and includes microdisplays and optical elements for each of the user's eyes. The microdisplays may be optically coupled to one or more microoptical elements designed to substantially collimate the converging light generated and presented by the pixels of the microdisplays before it enters the pupil.

[0068] In some embodiments, the display 72 is mounted on the outer side of the spectacle lens and aligned with the spectacle lens optics, such that the near-eye display can provide a field of view of + / -40 degrees or greater. This allows the microdisplay to continue providing peripheral retinal stimulation for eye movements within a normal range, typically + / -15 degrees laterally and +10 to -20 degrees vertically, including downward gaze when reading or viewing nearby objects. In some embodiments, light from the microdisplay is transmitted through the spectacle lens optics and provides refractive correction for the user.

[0069] In some embodiments, the optical system is configured to form an image in front of the retina and includes one or more of a single microlens (microlens), a plurality of microlenses (microlens array), a compound lens (such as a Gabor lens), a microprism, or a micromirror, or a combination thereof. In some embodiments, the light-blocking plate and the micromirrors are arranged to ensure that the amount of light not captured by the micro-optical elements is significantly reduced, for example minimized, in order to reduce stray light and light escaping from the front side of the display.

[0070] In some embodiments, a pixel fill factor of less than 10% (0.1) is sufficiently sparse to provide a clear view of the foveal and macular images. In some embodiments, the fill factor is in the range of 0.01 to 0.3, and may be in the range of 0.05 to 0.20. For example, a pixel array with a pixel size of 5 micrometers and a pixel pitch of 20 micrometers results in a fill factor of 0.06. A low fill factor can also reduce the complexity of the manufacturing process and lower the cost of such micro-optical displays.

[0071] In some embodiments, the micro-optical element array is designed to be optically aligned with the display so that light from one or more pixels 94 can be collected, collimated, and focused to be guided to the user's pupil during primary gaze. The density of these micro-optical elements can control the overall visibility of the near-eye display. In some embodiments, the micro-optical elements have a low fill factor (preferably equal to or less than 0.1) so that the total light transmission through the near-eye display is acceptable to the user and allows the patient to view objects.

[0072] In some embodiments, the device includes a switchable micro-optical element array that can be switched between a flat (no optical focus) state and an active state via electro-optic components, for example using liquid crystal or LC-based materials, which can, for example, switch from one refractive index to another, or from one polarization to another. In some embodiments, when the micro-optical element array is not activated, it does not scatter light or distort real-world images.

[0073] In some embodiments, the location of pixels in the microdisplay to be activated to form an external image toward the periphery of the retina is referenced to the optical center of the spectacle lens, since this optical center is the point of attention during the primary gaze. In some embodiments, the location of the point of attention is calculated by taking into account eye movements relative to the eye's position during the primary gaze, and the location of the pixels to be activated is calculated with reference to the new point of attention.

[0074] In some embodiments, multiple pixels are activated to form a light source imaged by micro-optical elements. The optical design of the micro-optical elements and their separation from the microdisplay can be configured to provide the focal length of the image transmission system, image magnification of the image projected onto the retina, and blurring caused by diffraction, such as the blurring measured by the Airy disc diameter of the optical transmission system.

[0075] Work relating to this disclosure shows that the retina perceives changes in image blur caused by higher-order aberrations present in a defocused image (as an addition to spherical defocus), including longitudinal chromatic aberration (LCA), higher-order spherical aberrations, astigmatism, etc., which are sign-sensitive to defocus. Based on the teachings provided herein, those skilled in the art can perform experiments to determine whether the retina can distinguish between myopic and hyperopic blur when the depth of focus of the device is greater than or nearly equal to the defocus amplitude. The device described herein can be suitably configured to provide, for example, an appropriate amount of defocus at appropriate locations.

[0076] The device can be configured to provide appropriate image magnification, limiting diffraction and depth of focus for image resolution, which is related to the magnitude of the applied myopic defocus and the rate of change of image blur or image sharpness gradient as a function of the defocus magnitude.

[0077] In some embodiments, the near-eye display is configured to provide a clear, substantially undistorted field of view for comfortable vision of the foveal and macular images. In some embodiments, for example, the field of view of the central image is at least + / - 5 degrees, and can be larger (e.g., + / - 12 degrees) to account for, for example, differences in interpupillary distance (IPD) among different users. The image quality and field of view of the true image can be provided using a substantially transparent near-eye display, and can be provided by reducing the fill factor of the luminescent pixels in the microdisplay. In some embodiments, a fill factor of less than 10% (0.1) is sufficiently sparse to provide a clear view of the foveal and macular images. In some embodiments, the fill factor is in the range of 0.01 to 0.3, and can be in the range of 0.05 to 0.20. For example, a pixel array with a pixel size of 5 micrometers and a pixel pitch of 20 micrometers would result in a fill factor of 0.06. A low fill factor can also reduce the complexity of the manufacturing process and reduce the cost of such micro-optical displays.

[0078] In some embodiments, the micro-optical element array is designed to be optically aligned with the display so that light from one or more pixels can be collected, collimated, and focused to be guided to the user's pupil during primary gaze. The arrangement density of these micro-optical elements can control the overall visibility of the near-eye display. In some embodiments, the micro-optical elements have a low fill factor (preferably equal to or less than 0.1) so that the total light transmission through the near-eye display is acceptable to the user.

[0079] In some embodiments, the device includes a switchable micro-optical element array that can be switched between a flat (no optical focus) state and an active state via electro-optic components, for example using liquid crystal or LC-based materials, which can, for example, switch from one refractive index to another, or from one polarization to another. In some embodiments, when the micro-optical element array is not activated, it does not scatter light or distort real-world images.

[0080] Figure 2A and Figure 2BA contact lens 10 is depicted, comprising a plurality of light sources configured to project a defocused image onto the retina, away from the central field including the macula, to stimulate changes in choroidal thickness. The plurality of light sources may be coupled to one or more optical components to provide stimulation of the retina as described herein. Although referenced to a contact lens, lens 10 may include one or more of a projector, ophthalmic device, TV screen, computer screen, augmented reality display, virtual reality display, handheld device such as a smartphone, wearable device such as eyeglasses, near-eye display, head-mounted display, goggles, contact lens, corneal inlay, corneal implant, corneal prosthesis, or intraocular lens.

[0081] The contact lens 10 includes a base or carrier contact lens, which includes embedded electronics and optical elements. The base soft contact lens 10 is made of a biocompatible material, such as a hydrogel or silicone hydrogel polymer, designed for continuous wear. The contact lens includes a maximum total span distance, for example, a diameter of 13. The biocompatible material may encapsulate components of the soft contact lens 10. In some embodiments, the contact lens 10 has a central optical zone 14 designed to cover the pupil of the user's eye under various lighting conditions. In some embodiments, the optical zone includes a circular area defined by a radius of 15. In some embodiments, a plurality of projection units 12 are located at a distance 17 from the center of the optical zone. Each of the plurality of projection units 12 includes a span distance 19. In some embodiments, the distance between the projection units is set to place the projection units outside the optical zone to stimulate a peripheral area of ​​the retina, although, as described herein, the projection units may also be placed inside the optical zone to stimulate the peripheral retina.

[0082] The optical zone 14 can be appropriately sized according to the pupil size of the eye and the lighting conditions during treatment. In some embodiments, such as when the contact lens is configured for daytime use, the optical zone includes a diameter of 6 mm. The optical zone 14 can have a diameter ranging from 6 mm to 9 mm, for example, from 7.0 mm to 8.0 mm. The central optical zone 14 is designed to provide the user with normal refractive correction or other suitable correction, and can provide both spherical correction and astigmatism correction. The central optical zone 14 is defined by an outer annular zone (such as a peripheral zone 16 with a width ranging from 2.5 mm to 3.0 mm). The peripheral zone 16, sometimes referred to as the hybrid zone, is primarily designed to provide a good fit to the cornea, including good centralization and minimal off-centering. The outer annular zone is surrounded by an outermost edge zone 18 with a width ranging from 0.5 mm to 1.0 mm. The optical zone 14 is configured to provide refractive correction and can be spherical, curved, or multifocal in design, for example, with a visual acuity of 20 / 20 or better. The outer annular region surrounding the optical zone 14 is configured to adapt to the corneal curvature and may include a rotational stabilization zone for translational and rotational stabilization while allowing the contact lens 10 to move across the eye with blinking. The edge region 18 may include a thickness ranging from 0.05 mm to 0.15 mm and may end in a wedge shape. The total diameter 13 of the soft contact lens 10 may range from 12.5 mm to 15.0 mm, for example, from 13.5 mm to 14.8 mm.

[0083] The contact lens 10 includes a plurality of embedded projection units 12. Each of the plurality of projection units 12 includes a light source and one or more optical elements to focus light in front of the retina, as described herein. Each optical element may include one or more of a mirror, a plurality of mirrors, a lens, a plurality of lenses, a diffractive optical element, a Fresnel lens, a light tube, or a waveguide. The contact lens 10 may include a battery 20 and a sensor 22. The contact lens 10 may include a flexible printed circuit board (PCB) 24, and a processor may be mounted on the flexible PCB 24. The processor may be mounted on the PCB 24 and coupled to the sensor 22 and the plurality of light sources 30. The soft contact lens 10 may also include wireless communication circuitry and one or more antennas 41 for electronic communication and inductive charging of the battery 20 of the contact lens 10. Although reference is made to the battery 20, the contact lens 10 may include any suitable energy storage device.

[0084] As described herein, projection unit 12 can be configured to provide a defocused image to a peripheral portion of the retina and can include a light source and projection optics. In some embodiments, one or more projection optics are configured with a light source to project the defocused image from the light source onto the peripheral retina, away from the central field of vision including the macula, to stimulate changes in choroidal thickness, such as an increase or decrease in choroidal thickness. One or more projection units 12 can be configured to stimulate the retina without degrading central vision and the quality of the corresponding image formed on one or more of the fovea or macular regions of the retina. In some embodiments, one or more projection optics do not degrade the image-forming characteristics of visual correction optics prescribed for correcting a user's refractive errors. As described herein, this configuration allows the user to have good visual acuity when receiving treatment from the defocused image.

[0085] In some embodiments, light from the light source of projection unit 12 is substantially collimated and focused by one or more projection optics, as described herein. The function of the light source and the projection optics is to substantially collimate the light emitted by the light source and guide the light to a focal point designed to be in front of or behind the retina to provide appropriate defocus, thereby stimulating changes in choroidal thickness. For example, for myopic defocus, the focused image may appear about 1.5 mm to 2.5 mm in front of the peripheral retina, and the myopia is about 2.0D to 5.0D, for example 2.0D to 4.0D, or preferably 2.5D to 3.5D. For example, for hyperopic defocus, the focused image may appear about 1.5 mm to 2.5 mm behind the peripheral retina, so that the hyperopia is about -2.0D to -5.0D, for example -2.0D to -4.0D, or preferably -2.5D to -3.5D.

[0086] Multiple stimuli and clear zones can be arranged to allow eye movement relative to the projection optics and clear zones. This is well-suited for use in embodiments where the eye moves relative to the projection optics, such as glasses, AR, and VR applications. According to some embodiments, light from the projection unit can be directed at an oblique angle relative to the optical axis of the eye to enter the pupil while maintaining a clear central visual area significantly larger than the pupil, thus providing a large field of view, e.g., a large viewing window. The size of the clear zone can be set in various ways and can include circular, elliptical, square, or rectangular areas. In some embodiments, the viewing window can be 5.0 mm × 4.0 mm. In some embodiments, the clear zone includes a viewing window that can be 15 mm × 4.0 mm. For example, a larger clear viewing area, such as a larger viewing window, allows for a greater degree of eye movement so that the stimulus is not blocked by the pupillary margin when the eye changes its gaze direction and the clear viewing area defined by the viewing window remains stationary. In some embodiments, the oblique angle at which the stimulus is projected into the eye depends on the size of the viewing window.

[0087] According to some embodiments, lens 10 or other suitable optical support structure includes a projection unit comprising projection optics and a microdisplay as a light source. The microdisplay may include an OLED (Organic Light Emitting Diode) or an array of microLEDs. The light emitted by these displays may be Lambertian. In some embodiments, the microdisplay is optically coupled to a micro-optical array that substantially collimates and focuses the light emitted from the microdisplay. The microdisplay may include one or more miniaturized pixels. In some embodiments, the microdisplay forms an extended pixel array characterized by pixel size and pixel pitch, wherein the pixel size and pixel pitch together correspond to a fill factor of the microdisplay. As described herein, for example, the size of each pixel may range from about 2 micrometers to about 100 micrometers, and the pixel pitch may range from 10 micrometers to 1.0 mm. The corresponding fill factor may range from 0.1% to 10% or greater. In some embodiments where real-world viewing is desired, a smaller fill factor blocks less light from the real environment and provides a higher level of comfort and vision. Alternatively or in combination, a larger fill factor can enhance the overall brightness of the stimulus and may be well-suited for applications that do not rely on real-world viewing and all surrounding vision. In some embodiments, the pixel array is optically coupled to the micro-optical element array in order to substantially collimate and focus the light from the pixels.

[0088] The images produced by these displays are defocused and can be symmetrically placed in the field of view or the four quadrants of the eye (e.g., nasal-inferior, nasal-superior, temporal-inferior, and temporal-superior). The microdisplays can be located at a distance of 1.5 mm to 4.0 mm, preferably 2.5 mm to 3.5 mm, from the optical center of the lens. The central optic of the contact lens can be selected to normalize the user's refractive power, and the diameter of this central optic can range from 3.0 mm to 5.0 mm. In some embodiments, each microdisplay can be circular, rectangular, or arc-shaped, and its area is less than 0.01 mm². 2 Up to 8.0mm 2 Within a range, for example, within 0.04mm 2 Up to 8.0mm 2 Within a range, for example, within 1mm 2 Up to 8mm 2 Within the range, or preferably within 1.0 mm 2 Up to 4.0mm 2 Within the range.

[0089] For example, a microdisplay may be coupled to and supported by a body of corrective optics such as a contact lens or eyeglass lens, an augmented reality (“AR”) head-mounted device, or a virtual reality (“VR”) head-mounted device. In some embodiments, the microdisplay is coupled to and supported by one or more of an intraocular lens, a corneal prosthesis, a corneal inlay, or a corneal inlay. For example, the optical configuration described herein with reference to contact lenses can be similarly used for one or more of an intraocular lens, a corneal prosthesis, a corneal inlay, or a corneal inlay.

[0090] In some embodiments, a microdisplay and an array of microoptical elements are mounted adjacent to each other on the same corrective optics, spaced at a fixed distance, to project a beam of light onto the pupil of the eye in an orientation that forms a defocused image at a desired location on the retina, as described herein. In some embodiments, one or more projection optics are mounted on or within one or more corrective optics such that light from the projection optics is refracted through the corrective optics. The corrective optics refract the light from the projection optics to converge or diverge to contribute to clear vision, thereby allowing the microoptical array to provide a desired magnitude of additional optical power, which can be positive or negative depending on the magnitude and sign of the desired defocus. The microdisplay can be, for example, monochrome or multicolor.

[0091] In some embodiments, the projected defocused image may be provided by a microdisplay comprising a screen, including one or more of an LCD screen, an OLED (organic light-emitting diode) driven screen, a TOLED driven screen, an AMOLED driven screen, a PMOLED driven screen, or a QLED driven screen.

[0092] Figure 3 Retinal stimulation devices (such as) are shown Figures 1A to 2BThe diagram shows the system functionality of the components of lens 10. These components can be supported by PCB 24. For example, a power source such as battery 20 can be mounted on PCB 24 and coupled to other components to provide power function 21. Sensor 22 can be configured to provide activation function 23. Sensor 22 can be coupled to a processor mounted on PCB 24 to provide control function 25 for lens 10. Control function 25 may include light intensity setting 27 and light switch 29. The processor can be configured to detect signals from sensor 22 corresponding to intensity increase, intensity decrease, or on / off signals from sensor 22, such as a sequence of encoded signals from sensor 22. The processor is coupled to light projection unit 12, which may include light source 30 and optical elements 32 to provide projection function 31. For example, the processor may be coupled to multiple light sources 30 (e.g., projection unit 12 or one or more displays 72) to control each light source 30 in response to user input to sensor 22.

[0093] Retinal stimulation devices may include Global Positioning System (GPS) circuitry for determining the user's location and an accelerometer for measuring body movements such as head movements. The retinal stimulation device may include a processor coupled to one or more of the GPS or accelerometer to receive and store measurement data. In some embodiments, the processor uses GPS and a local clock (a clock that maintains local time) to calculate the occurrence of diurnal variation in the wearer's eye's axial length. In some embodiments, the application of stimulation may coincide with the occurrence of maximum axial length under diurnal variation. The retinal stimulation device may include communication circuitry, such as wireless communication circuitry like Bluetooth or Wi-Fi, or wired communication circuitry like USB, to transfer data from the device to a remote server (such as a cloud-based data storage system). This data transfer to the remote server can allow for remote monitoring of the user's treatment and adherence. In some embodiments, the processor includes a graphics processing unit (GPU). The GPU can be used to efficiently and quickly process content from the web to utilize that content when formulating stimulation as described herein.

[0094] The methods and apparatus for retinal stimulation described herein can be configured in a variety of ways and can include one or more attributes that encourage a user to receive treatment. For example, retinal stimulation as described herein can be combined with the display of a game to encourage a user to wear the treatment device. In some embodiments, retinal stimulation can be combined with another stimulus (such as an emoji) to encourage a user to wear the device for treatment. Components of the system can communicate with or receive information from games or other stimuli to promote retinal stimulation with the game or stimulus.

[0095] Reference Figure 4A The optical configuration 32 includes multiple mirrors configured to collect light emitted by the microdisplay and then guide the beam to the pupil of the eye 11 to form an off-center retinal image, such as... Figure 4B As shown. The mirror can substantially collimate the beam, or guide the beam to the retina 33 with appropriate vergence so as to focus the beam onto the retina 33.

[0096] although Figure 4A and Figure 4B The optical configuration shown refers to a lens such as a contact lens, but similar optical configurations can be used in projectors, ophthalmic devices, TV screens, computer screens, handheld devices such as smartphones, wearable devices such as eyeglass lenses, near-eye displays, head-mounted displays, helmet-mounted displays, AR displays, VR displays, goggles, contact lenses, corneal inlays, corneal implants, corneal prostheses, or intraocular lenses, or one or more of these lenses. Furthermore, although myopic astigmatism is referenced, this astigmatism can include, for example, hyperopic astigmatism, astigmatic astigmatism, or an image focused on the retina, or other astigmatism used to correct refractive errors, as described herein.

[0097] Figure 4A The mirror assembly shown can be configured to achieve a depth of focus of less than 1D, such that the applied defocus of 2.0D–4.0D can be clearly perceived by the peripheral retina 33 at a specified radial eccentricity (e.g., in the range of 5 to 30 degrees, or in the range of 20 to 30 degrees).

[0098] like Figure 5A and Figure 5B As shown, another embodiment includes an optical element 32 comprising a converging or collimating lens optically coupled to a light source 30. In this configuration, a lens 34, which may include a single lens, may be used to substantially collimate light output from a stimulus source and guide the light to the cornea 37 via a lens such as contact lens 10. Although referenced to contact lenses, lenses may include one or more of the following: projectors, ophthalmic devices, TV screens, computer screens, handheld devices such as smartphones, wearable devices such as eyeglass lenses, near-eye displays, head-mounted displays, VR displays, and AR displays, goggles, contact lenses, corneal inlays, corneal implants, corneal prostheses, or intraocular lenses.

[0099] The effectiveness of the collimating lens 34 depends on its refractive index, and its refractive index should be high enough to create a significant refractive index difference between the lens material and the material of the contact lens 10 used as a substrate. In this example, it is assumed that the refractive index of the embedded lens 34 is 2.02 (e.g., the refractive index of lanthanum fluorosilicate glass LaSF5), although other materials can be used.

[0100] Another embodiment includes a light tube 36 to increase the optical path length, such as Figure 6A and Figure 6B As shown. The light tube 36 can provide an increased optical path length to provide appropriate image magnification (e.g., 0.5x to 8x, preferably 1x to 3x) and retinal image size.

[0101] Although reference is made to the light tube 36 on the cornea 37, as would occur with the use of contact lenses, the lens combined with the light tube 36 may include one or more of the following: a projector, an ophthalmic device, a TV screen, a computer screen, a handheld device such as a smartphone, a wearable device such as an eyeglass lens, a near-eye display, a head-mounted display, a VR display, an AR display, goggles, a contact lens, a corneal inlay, a corneal inlay, a corneal prosthesis, or an intraocular lens.

[0102] Many other optical configurations can be used, including using microlens arrays with point sources, using diffractive optical elements to use thinner lenses, and using a single point source and optical processing unit to generate multiple retinal images.

[0103] Figure 7 Multiple stimuli 702 and an image 704 on a display 706 are shown as seen by the user. The stimuli 702 are located around the display 706, where the display corresponds to a clear central visual area, and the stimuli correspond to the user's peripheral vision, such as vision outside the macula. The multiple stimuli can be imaged in front of the retina with myopic defocus in order to provide stimulation to increase choroidal thickness and reduce the growth of eye axial length.

[0104] The stimuli can be configured in a variety of ways as described herein. In some embodiments, the stimuli include a bright pattern 708 on a dark background 710, such as a black and white pattern. In some embodiments, the stimuli include a multicolor pattern on a darker background, such as a white or nearly white stimuli on a gray or substantially black background. In some embodiments, each stimuli includes a dark inner region on a dark background and one or more bright outer regions, such as a dark cross through a white circular region on a dark background. The stimuli can be selected based on their global contrast factor and their polarity (e.g., white or multicolor on a black background, or vice versa, black on a white or multicolor background). The stimuli can be configured in a variety of ways and can include multiple repeating icons displayed on the display. The stimuli can be arranged in a circular or toroidal pattern of repeating icons. For example, the stimuli can include any suitable global contrast factor, such as a global contrast factor of at least 0.5, at least 0.7, or at least 0.8.

[0105] Figure 8AStimulus 702 on screen 800 is shown to provide a myopic defocus stimulus to the retina, and Figure 8B The corresponding size of the myopic defocus stimulus on the retina is shown in degrees. The size of the stimulus on the display is related to the distance between the user and the display, and the size can be varied depending on the viewing distance to provide an appropriate angular subtense to the retina. Those skilled in the art can readily perform calculations to determine the size of the stimulus on the display to provide an appropriate angular size setting for the defocused projected image.

[0106] As in Figure 8A and Figure 8B As shown, each stimulus includes a span distance 802, such as 18 mm, which corresponds to angular illumination 812 on the retina, such as 3.3 degrees. The stimuli are arranged on the display to provide a clear central field of view 804 with a span distance 806, such as 70 mm, thereby providing an undisturbed central field of view 804 with a span distance 814 of 15 degrees. Multiple stimuli include a maximum span distance 815, such as 178 mm, which corresponds to an opposing angle 816 of 35 degrees. The stimuli can be arranged to have any suitable object size to provide an appropriate image size on the retina. Although a specific size is referenced, any suitable size can be used, for example, by varying the distance to the eye and the corresponding opposing angle. In some embodiments, the stimuli are arranged to provide a clear central field of view, such as spanning 15 mm, to provide an undisturbed central field of view of 15 degrees. In some embodiments, multiple stimuli include a maximum span distance, such as 70 mm, which corresponds to an opposing angle of 35 degrees.

[0107] Figure 9 Stimulus 702 depicting a natural scene 900 is shown, such as a circular flower pattern. Although a flower pattern is shown, any image can be used. For example, the stimulus can be... Figure 8A and Figure 8B The stimuli 702 shown are provided on the display alternately or in combination. Figure 9 The size and angle of the stimulus shown can be set to be similar to Figure 8A and Figure 8BThe stimulus shown is illustrated. For example, the central field of view 814, shown as a dark circle, may include a span distance corresponding to, for example, about 15 degrees, and the maximum distance 806 spanning the annular region may be about 35 degrees. Work related to this disclosure shows that multicolored natural scenes, such as floral patterns, may be more pleasing to the user. Work related to this disclosure also shows that, in some embodiments, multicolored floral scenes may be less effective as a stimulus than an annular array of white circles on a black background with black crosses dividing the circular icons, although other stimuli may be used.

[0108] Figure 10 Showing the target Figures 8A to 9 The image contrast of the stimulus shown is illustrated with histograms of red (R), blue (B), and green (G) values. For example... Figure 8A and Figure 8B The circular pattern shown in the histogram indicates an intensity value of approximately 255, approximately 3.5 × 10⁻⁶. 5 The pixel count of each stimulus pixel. Black pixels are excluded from the histogram to increase the sharpness of the graphic representation (intensity = 0). For Figure 9 The flower pattern shown has a blue intensity distribution with a peak at approximately 50, a red peak at approximately 110, and a green peak at approximately 120. The counts at these peaks are less than 0.5 × 10⁻⁶. 5 .

[0109] In some embodiments, contrast is defined as the difference between the lowest and highest intensities of an image. The global contrast factor (GCF) can also be used to define the contrast of the stimulus image. The GCF measures the richness of detail perceived by a human observer. In some embodiments, as described in Global contrast factor—a new approach to image contrast (by Matkovic, Kresimir et al., 2005; Computational Aesthetics in Graphics, Visualization and Imaging (2005); L. Neumann, M. Sbert, B. Gooch, W. Purgathofer (eds.)), the GCF of the stimulus is determined.

[0110] The obtained GCF values ​​are as follows:

[0111] Flowers: 6.46

[0112] Circular pattern (b / w): 9.94

[0113] Work related to this disclosure suggests that, due to a higher GCF, white circles on a black background may be preferred over flowers in a field.

[0114] Figure 11 An image 1100 suitable for modification and incorporation as a stimulus described herein is shown. Image 1100 may include a processed image to provide a suitable spatial frequency distribution as described herein. The image may include a natural image or a computer-generated image. The image may be masked to define, for example, a similar... Figure 9 Circular stimulation. Figure 12 It shows something similar to Figure 11 Image 1200, which has been processed to provide improved stimulation. This processed image can be digitally masked to form, for example... Figure 9 The circular stimulus shown has appropriate spatial frequency and contrast.

[0115] While images can be processed in various ways, in some embodiments, the image is processed with a digital spatial frequency filter and contrast is adjusted to provide an image with an appropriate spatial frequency distribution, thereby generating an improved response to the eye. At one step of the processing, the image is processed with a moving average filter of a length, for example, a filter with a length of 400 pixels. At another step, the RGB image is converted to a grayscale image. At yet another step, the RGB image is adjusted based on the moving average image. At yet another step, the moving average filter is reapplied to the new image. In some embodiments, the moving average of brightness is smoothed. For example, the initial image may have a 100% brightness difference, while the adjusted image has a 25% brightness difference.

[0116] Figure 13 It shows Figure 11 Image 1300 shows the spatial frequency distribution of the image.

[0117] Figure 14 It shows Figure 12 Image 1400, spatial frequency distribution of the image. Figure 12 Images can be used as Figure 9 Stimulation within.

[0118] Figure 15 Showing the target Figure 8B and Figure 9 The stimulus image shown is a graph of the spatial frequency of the image, expressed as the number of cycles per degree, and the logarithm of the energy at each frequency. Figure 15 The graph shown illustrates the average radial profile of the spatial spectrum, where the magnitude logarithm (in arbitrary units, "au") relates to the number density of the characteristics for a specific spatial frequency. For reference, the graph shows lines 1 / f, 1 / f... 2and 1 / f 0.5 .include Figure 9 The processed image shown has a circular flower pattern and... Figures 7 to 8B The white circular pattern with a black cross shown exhibits similar frequency dependence. These graphs show that both the flower pattern and the circular pattern show a slope dependence of approximately 1 / f at frequencies in the middle (e.g., the middle range) of approximately 2 to 10 cycles per degree. In some embodiments, for frequencies in the range of approximately 2 to 10 cycles per degree, the stimulus includes variations in intensity (energy, au), where the frequency dependence is between 1 / f and 1 / f. 2 Within the range of frequency dependence.

[0119] The stimuli can be configured in a variety of ways using an appropriate spatial frequency distribution (e.g., a contour of the spatial frequency distribution). In some embodiments, each of the plurality of stimuli includes a length, edge, and intensity contour distribution to generate a 1×10-1 frequency distribution per degree when imaged into the eye in front of or behind the retina. -1 One cycle up to 2.5×10 1 Within a period of time and optionally within 1×10⁻⁶ degrees. -1 One cycle to 1×10 1 Spatial frequencies within a range of cycles. In some embodiments, the multiple stimuli imaged in the eye include a spatial frequency distribution of approximately 1 × 10⁻⁶ per degree. -1 One cycle to approximately 5×10 0 A spatial frequency range spanning several periods, this spatial frequency distribution provides a decrease in spatial frequency amplitude as the spatial frequency increases. In some embodiments, for any unit spatial frequency amplitude, the decrease in spatial frequency intensity is between 1 / (spatial frequency) and 1 / (spatial frequency). 2 Within the range. In some embodiments, the spatial frequency range is from approximately 3 × 10⁻⁶ per degree. -1 One cycle to approximately 1.0 × 10⁻⁶ degrees. 1 One cycle, and optionally approximately 3 × 10 per degree. -1 One cycle to approximately 2.0 × 10⁻⁶ degrees. 0 Within a period of time, and optionally within approximately 3 × 10⁻⁶ per degree. -1 One cycle to approximately 1.0 × 10⁻⁶ degrees. 0 Within the range of a cycle.

[0120] Alternatively, or in combination with spatial frequency characteristics, the stimulus can be configured to have an appropriate ratio of stimulus intensity to background intensity. In some embodiments, the brightness of the plurality of defocused stimulus images is at least 3 times that of ambient light illumination, optionally at least 5 times that of background light illumination, optionally in the range of 3 to 20 times that of background light illumination, and further optionally in the range of 5 to 15 times that of background light illumination.

[0121] In some embodiments, stimuli comprising spatial frequency and intensity characteristics are presented at appropriate ratios to one or more of the background or ambient illumination. In some embodiments, each of the plurality of stimuli imaged in the eye is overlaid on a substantially uniform gray background. In some embodiments, each of the plurality of stimuli includes a multicolored icon, such as a white icon, on a darker background to provide contrast, such that the icon has an edge outline or the total length of the edge to generate a spatial frequency primarily at 1 × 10⁻⁶ degrees. -1 One cycle to 2.5 × 10⁻⁶ degrees 1 Within a period of 1 × 10⁻⁶ cycles, and optionally within 1 × 10⁻⁶ degrees. -1 One cycle to 1×10 per degree 1 Features within a range of periods.

[0122] Figure 16 A system 1600 for treating refractive errors of the eye is illustrated. System 1600 includes a treatment device 1602, such as a user device operably coupled to a server 1604 using a secure bidirectional communication protocol. Server 1604 is configured to communicate with a treatment specialty device 1608 using a secure bidirectional communication protocol 1606. In some embodiments, server 1604 is coupled to a care device 1610 using the secure bidirectional communication protocol 1606. In some embodiments, system 1600 includes a treatment database 1612 that stores treatment parameters and results from multiple treatments. Treatment database 1612 may be configured to communicate with server 1604 using the secure bidirectional communication protocol 1606. In some embodiments, treatment system 1600 includes one or more clinical measurement devices 1614 configured to communicate with the server using the secure bidirectional communication protocol 1606. Each of these devices is operably coupled to another device using the secure bidirectional communication protocol 1606. Secure communication can include any suitable secure communication protocol for transmitting encrypted data, and the data can be stored in any suitable encrypted format. For example, as those skilled in the art will understand, Figure 16 The device shown can be configured to comply with HIPAA and GDPR. Server 1604 may include any suitable server, such as a cloud-based server comprising multiple servers that may be located in different geographical locations. Although treatment database 1612 is shown separately, it may include components of a server.

[0123] As described herein, the treatment device 1602 can be configured in a variety of ways and may include a user device, which may include one or more of the following: ophthalmic equipment, TV screen, computer screen, virtual reality (“VR”) display, augmented reality (“AR”) display, handheld device, mobile computing device, tablet computing device, smartphone, wearable device, eyeglass frame, eyeglass lens, near-eye display, head-mounted display, goggles, contact lens, implantable device, corneal inlay, corneal implant, corneal prosthesis, or intraocular lens. For example, the treatment device 1602 may include an optical system with a beam splitter, as described herein. In some embodiments, for example, the treatment device 1602 includes a user device, such as a smartphone or tablet. The display 1620 of the user device may be configured to provide a plurality of stimuli 702, as described herein. In some embodiments, the user device 1602 includes a microlens array 1622 positioned above the plurality of stimuli 702 to provide an image of the stimuli 702 in front of or behind the retina. In some embodiments, each microlens in the microlens array is aligned with one of the plurality of stimuli. As described herein, the user equipment may be configured with a clear viewing area 804, for example, without a microlens array extending into the clear viewing area. The clear viewing area 804 may be configured to allow the user to view images, such as video, and to allow the user to use the device in a substantially normal manner, such as using a web browser, playing video games, sending and receiving text and emails, etc. The microlens array 1622 may be positioned at a distance from the pixels to provide an appropriate amount of defocus as described herein. In some embodiments, the treatment system 1600 includes one or more clinical measurement devices 1614.

[0124] Therapeutic device 1608 can be configured to enable a therapeutic professional to receive data, such as treatment data, from user device 1602. Treatment data may include any suitable treatment data, such as daily treatment duration, daily usage, screen time, and screen time during which stimulation is activated. Therapeutic device 1608 can also be configured to send and receive data from ophthalmic instruments, such as refractive data as described herein, to assess the effectiveness of treatment. Therapeutic device 1608 can be configured to send treatment instructions to user device 1602. For example, treatment instructions may include any suitable parameters as described herein and may include the duration and duration of treatment. Work relating to this disclosure shows that circadian rhythms can play a role in the effectiveness of treatment, and treatment instructions may include instructions for the user to perform treatment at a certain time of day or within a certain time range (e.g., in the morning, such as within the range of approximately 6 a.m. to approximately 9 a.m. local time at the patient's location).

[0125] For example, clinical measurement device 1614 may include any suitable clinical measurement device, such as one or more of an automated refractometer or OCT system. Alternatively or in combination, patient records, such as those for manifest refractive errors, may be stored at the clinic site and transmitted to a server.

[0126] The care device 1610 may include any suitable device with a display, such as a smartphone or tablet. The care device 1610 may be configured to send and receive data related to the user's treatment. The care device 1610 may be configured to enable caregivers (such as parents) to monitor treatment and promote adherence to treatment protocols. For example, the server 1604 may be configured to send notifications to the care device 1610, such as notifications that a user has been scheduled for treatment, and caregivers may interact with the user to encourage them to receive treatment.

[0127] The treatment database 1612 can be configured to store treatment-related data. For example, treatment-related data may include treatment data and efficacy data. Efficacy data may include one or more of refractive data and axial length data. Refractive data may include refractive data of the user's eye at multiple time points (e.g., longitudinal data), such as spherical, cylindrical, and axial data. Axial length data may include data such as OCT data collected at multiple time points. Treatment data may include data related to stimulation parameters as described herein, and may include, for example, daily treatment duration, stimulation intensity, stimulation type, and defocus data.

[0128] In some embodiments, algorithms such as artificial intelligence, machine learning, neural networks, or convolutional neural networks are used to process data to determine improved treatment parameters, such as treatment duration, treatment time of day, defocus, stimulus shape and intensity, amount of defocus, spatial frequency of the stimulus, stimulus-to-ambient light ratio, stimulus background, or any other parameters related to the treatment. These parameters can be adjusted to provide improved treatment and can be suggested to treatment professionals on specialized treatment equipment so that they can push instructions to user equipment.

[0129] While the therapeutic device 1602, such as a user device, can be configured in a variety of ways, in some embodiments, the device 1602 includes sensors 1624, such as photometric sensors or spectrophotometers, for detecting one or more of luminosity or spectral data. Sensors 1624 can be configured to measure and detect ambient light exposure of a subject, such as a wearer or user. In some embodiments, the sensors are supported (e.g., mounted) on a therapeutic device as described herein, such as on eyeglasses, wearable devices, or user devices.

[0130] For example, Figure 16 The system is well-suited for clinical trials, enabling the execution of clinical trials and the generation of efficacy data.

[0131] Figure 17 A method for treating refractive errors of the eye is shown 1700.

[0132] At step 1705, refractive data is received. This refractive data may include any suitable refractive data, such as one or more of manifest refraction, retinoscopy, cycloplegic refraction, or autorefraction. The refractive data may include one or more components of the refraction at the time of measurement, such as spherical, cylindrical, or axial components.

[0133] At step 1710, axial length data is received. The axial length data may include axial length data from the treated eye or the contralateral eye, and may include, for example, OCT data.

[0134] At step 1715, the treatment time is determined. This treatment time may include one or more of a series of treatment times, such as times in the morning. For example, the treatment time may be based on the patient's circadian rhythm.

[0135] At step 1720, a treatment instruction is received from the healthcare provider. This treatment instruction may include any suitable parameters as described herein. For example, the treatment instruction may include one or more of the following: duration of treatment, intensity of the stimulus, shape of the stimulus, background of the stimulus, chrominance of the stimulus, ratio of stimulus intensity to central viewing area, ratio of stimulus intensity to ambient light, shape profile of the stimulus, defocusing of the stimulus, or spatial frequency profile of the stimulus.

[0136] At step 1725, the user is instructed to receive treatment. This can be done in various ways, such as by prompting the user to begin treatment, which the user can accept when ready to begin. The prompt may also include instructions to begin treatment in a suitable environment, such as an indoor environment. The prompt may provide the user with the option to delay treatment for a period of time, such as five minutes, and to prompt the user again at an appropriate time.

[0137] At step 1730, the caregiver is instructed that the user will receive treatment, for example, when it is time for the user to receive treatment. This allows caregivers, such as parents, to encourage the user to receive treatment.

[0138] At step 1735, the user begins treatment. The user can initiate treatment in various ways (e.g., by inputting to user device 1602). For example, input may include input to a touchscreen display. Alternatively or in combination, the user may respond to prompts to receive treatment.

[0139] At step 1740, a stimulus is provided to the user. The stimulus may include any suitable stimulus, such as stimulus 702 as described herein.

[0140] At step 1745, the user is allowed to view the central clear area 804 on the display. When stimuli (e.g., multiple stimuli) are provided, the user can view the data on the central clear area.

[0141] At step 1750, the treatment ends. The user can be notified that the treatment is complete. The caregiver can also be notified.

[0142] At step 1755, the treatment data is sent to server 1604. For example, the data can be sent to healthcare provider 1608 or treatment database 1612.

[0143] At step 1760, the steps are repeated as appropriate. For example, follow-up treatment may be provided to the user, and the user and caregiver may be informed of the follow-up treatment. Additional refractive data may be measured. Alternatively or in combination, additional OCT data may be measured.

[0144] although Figure 17 Methods for treating refractive errors according to some embodiments are illustrated, but those skilled in the art will recognize many adaptations and variations. For example, steps may be performed in any order, some steps may be omitted, and some steps may be repeated. Furthermore, some steps may include sub-steps of other steps.

[0145] Any computing device, processor, or combination thereof can be configured to perform Figure 17 One or more of the steps.

[0146] Experimental research

[0147] Clinical studies were conducted on human subjects to evaluate the efficacy. These studies involved a clinical testing instrument in which subjects were given a stimulus, and the efficacy and related parameters of various stimuli were assessed.

[0148] Clinical research

[0149] The following research parameters were evaluated in the clinical study.

[0150] 1) The magnitude of myopic astigmatism. Myopic astigmatism values ​​of 6D, 4.5D, and 3D were evaluated. Figure 18AStimulus 702 is depicted having a region 1802 with myopic defocus of 6D (“6D stimulus”) and another region 1804 with myopic defocus of 3D (“3D stimulus”).

[0151] 2) Retinal Coverage. Coverage corresponds to a percentage of the ring having an inner diameter 1806 corresponding to 15 degrees (full angle) and an outer diameter 1808 corresponding to approximately 35 degrees (full angle). The percentage areas listed below correspond to the percentage coverage of this ring. The stimulus 702 tested included segmented rings 1814, which comprised 70%, 50%, and 25% of the entire ring. Figure 18B Stimulus 702 is depicted, which has a region 1810 with a coverage of 25% (“25% stimulus”) and a region 1812 with a coverage of 50% (“50% stimulus”).

[0152] 3) Brightness of the background image. The brightness (cd / m²) of the stimulus compared to indoor lighting conditions was compared using ratios of 1.0, 3.0, 5.0, 10.0, and 20.0. 2 An assessment will be conducted. Figure 18C Stimulus 702 is depicted, which has a region 1820 with a brightness ratio of 0.1:1 and a region 1822 with a brightness ratio of 1:1.

[0153] 3) Chromaticity. Studies were conducted to determine the relationship between the effect of monochromatic light and the effect of white light, and the following chromaticity parameters were tested: white, green, and red. Figure 18D Stimulus 702 was depicted with a black-and-white stimulation region 1830 and a red stimulation region 1832.

[0154] 4) Changes in stimulus spatial frequency content. The spatial frequency content of the stimuli was assessed to determine how stimulus patterns affect stimulus efficiency. Various patterns were tested, including: Figure 9 Natural patterns in, such as Figures 18A to 18D The test circle included those with brighter intensity discs, and such as... Figures 8A to 8B The cross-shaped dots in the image.

[0155] Figure 19An optical system 1900 is depicted that projects a stimulus 702 onto the retina 33. In the study conducted, system 1900 includes a desktop system. The system is configured to receive the left and right eyes of a subject for testing purposes. The test eye 1902 is placed in front of a first beam splitter 1906, and the control eye 1904 is placed in front of a second beam splitter 1908. The test eye 1902 and the control eye 1904 are allowed to view a central display 1910 in front of a passive background 1912 similarly. The display 1910 may include a clear central visual zone and display appropriate content, and may include a computer screen. In some embodiments, central vision includes an entertainment area as seen by the patient through the clear central visual zone, which has entertainment content displayed on the display. The active stimulation system includes a desktop-mounted device with a headrest or chin rest. The system is configured to provide a background image for both eyes at optical infinity and to provide video for central (foveal) vision. Stimulus 702 is shown on display 1920, which is positioned in front of lens 1922 (e.g., an achromatic lens) to provide a superimposed image of the stimulus with myopic defocus to the test eye. The myopic stimulus is projected in front of the retina of the eye. The distance between the displayed stimulus and lens 1922 and the optical power of lens 1922 are configured to provide an appropriate amount of defocus. Stimulus 702 is superimposed on a central display 1910 and a passive background 1912 using a first beamsplitter 1906. A second beamsplitter 1908 is similar to the first beamsplitter, and the background light is blocked by a blocker 1924. The beamsplitters include a 50 / 50 reflectance to transmit ratio for each eye, thus transmitting 50% of the light and coupling 50% of the light to the stimulus. The stimulus is provided on a screen, such as display 1920, at an appropriate distance from the achromatic lens.

[0156] As described herein, the following parameters are adjusted, including the magnitude of defocus, the coverage of the stimulus on the retina (e.g., retinal image shell), dominance relative to the background image (e.g., contrast and brightness), and chromaticity (e.g., wavelength distribution).

[0157] Background patterns were also considered in these experiments. Background patterns could include uniform patterns 1930a or patterned backgrounds 1930b, such as grid patterns. The background pattern was projected onto the peripheral retina with hyperopic defocus. In some embodiments, this hyperopic defocus is provided to push the focus of distant objects to optical infinity rather than a hyperfocal point. Work related to this disclosure shows that, according to some embodiments, patterned backgrounds may compete with myopic defocus stimuli, and uniform background patterns may be preferred. While the background can be presented in various ways, it was presented as a poster with an appropriate test pattern.

[0158] Camera 1926 was used to observe one or more eyes. In the experiments conducted, the right eye was the test eye 1902, and the left eye was the control eye 1904. Although Figure 19 The left eye is shown as the test eye and the right eye as the control eye, but this can be easily changed by coupling an achromatic lens and display to the right eye and providing an occluder to the left eye. For example, the position of the display with the stimulus pattern and the achromatic lens can be placed on the right side, while the occluder is moved to the left side.

[0159] Figure 20A A clear focal point of the central visual area 804 (e.g., the entertainment area) and a background pattern 1930 for the control eye (e.g., the left eye) are shown. The central area displayed to both eyes on the monitor is presented to the user at optical infinity without significant refractive error. The background pattern 1930 is also presented to the user at infinity. A retinal image shell 2002 is also shown. Even though central vision is corrected for objects at infinity (computer monitors), the background pattern is still projected onto the peripheral retina with hyperopic defocus.

[0160] Figure 20B The image shows the myopic defocus of stimulus 702, the video displayed in the central clear visual area 804, and the background pattern for the tested eye (e.g., the right eye). The optical configuration shows the stimulus, as described herein, being imaged in front of the retina with myopic defocus.

[0161] These studies were conducted against a passive background consisting of a substantially uniform gray paper. The gray paper was illuminated by adjustable lamps mounted on a ceiling. The luminance level was measured to be 9–11 cd / m². 2 The active display area, including the central entertainment area, is equipped with a television (“TV”). The brightness level of the TV is measured to be between 10 and 11 cd / m². 2 .

[0162] Although the ambient light in the room was measured to be between 500 and 700 lux, these values ​​were controlled and reduced during the experimental testing.

[0163] During the measurement, the axial length and choroidal thickness of the eye were measured under ambient light of approximately 5–6 lux. The axial length and choroidal thickness were measured using a commercially available biometer and an optical coherence tomography (“OCT”) system, respectively.

[0164] During the test, the background illumination was 9-10 lux, and the TV screen illumination was 9-10 lux.

[0165] The tests were conducted in the morning (typically from 8:30 AM to 12:00 PM). The study was performed on the same subjects, followed by a one-hour washout period. In other words, subjects typically arrived at the office between 7:30 and 7:45 AM, spent 30-45 minutes relaxing (drinking water, using the restroom, but without sweet snacks, coffee, or caffeinated beverages), and then underwent the first test (one-hour stimulation), followed by a 60-minute washout period during which they relaxed in their room before proceeding to the next stimulation step. All axis length measurements were based on measurements taken at the start of the day.

[0166] In these studies, ambient stimuli were provided as variables.

[0167] Table 1. Experimental results of white stimulation against a black background.

[0168] brightness of surrounding stimuli The axial length decreased after 1 hour of stimulation (test eye - control eye). 9-10 Lux (1x) <1 micrometer (not significant) 27-30 Lux (3x) 1 micrometer (not significant) 45-50 lux (5x) 1-2 micrometers (not significant) 90-100 lux (10x) 10 micrometers (significant at p = 0.05) 180-200 lux (20x) 10-12 micrometers (significant at p<=0.05)

[0169] These studies show a reduction in retinal thickness as measured by OCT. The brightness of peripheral stimuli can be interpreted as the ratio of the brightness of the defocused stimulus to ambient light (e.g., the center display of a television screen or a background such as gray paper). These studies indicate that when the ratio is at least 3 times, the axial length decreases and the choroidal thickness increases, with a statistically significant change observed when the ratio is at least 10 times. These data suggest a stimulus-to-ambient-light ratio in the range of 3 to at least 20 times, for example, in the range of 5 to 15 times, such as 10 times.

[0170] Figure 21 Clinical results similar to those in Table 1 are presented. As described herein, these data demonstrate the effect of actively stimulating the peripheral retina with a projected image that is defocused by myopia. As described herein, results were obtained by stimulating the peripheral retina for 1 hour with a projected image that included a white target on black. As described herein, subjects viewed a TV screen 20 feet away through a clear central area. Axial length (corneal apex to retinal pigment epithelium “RPE”) was measured without moving the subjects. 192 data points were taken for each measurement. Variations in axial length due to diurnal fluctuations were compensated for by measuring the change in the test eye relative to the control eye in pairs. These results show the nominal change in the test eye (shown on the left) relative to the control eye (shown on the right) at 5x stimulation light. However, when the stimulation-to-environment ratio was 10x, the axial length of the test eye shown was significantly smaller than that of the control eye. For 20x stimulation light, this difference of approximately 15 micrometers was statistically significant, with a p-value of 0.0016.

[0171] The above results were obtained using white stimuli on a black background, with a black cross extending through the white stimuli, as shown in the reference. Figure 8A and Figure 8B As shown. The stimulus includes a spatial frequency distribution defined by a basic linear relationship between amplitude and reciprocal spatial frequency, which is in the spatial frequency range of about 0.1 cycles to about 25 cycles per degree, for example about 0.3 cycles to about 10 cycles per degree, and optionally about 0.1 cycles to 5 cycles per degree.

[0172] Although the equipment used in these experiments includes monocular stimulation devices, in some embodiments of this disclosure, the equipment includes binocular stimulation devices.

[0173] Additional clinical study results

[0174] The main objective of this study is to measure the degree of axial length reduction and central choroidal thickening after the defocusing stage using the proposed system under controlled conditions.

[0175] Twelve participants aged 21–32 years with normal vision (9 men, 3 women) participated in this study (7 Asians, 4 Caucasians, and 1 Hispanic). The spherical equivalents of the participants ranged from 0.00 to -3.50D, with a mean of -0.70D. Participants experienced two defocusing periods under photopic indoor light conditions, with a one-hour interval between the two periods without defocusing. We projected digital defocus onto the peripheral retina using a non-wearable, augmented reality-based device, as described herein. The projected annular peripheral defocus stimulus extended outward from approximately a 15-degree diameter in the field of view to a 35-degree diameter in the right eye, as described herein.

[0176] Refer again Figure 8A and Figure 8B These figures are in millimeters ( Figure 8A ) and degree ( Figure 8B The range of stimuli is shown in units of ).

[0177] The system described in this paper has easily programmable control over important stimuli used to control eye growth, including the size of peripheral defocused stimuli, retinal position, brightness, chromaticity, activation duration, and refractive amplitude.

[0178] Refer again Figure 7 The image shows the subject's view through the device as described in this article, viewed through the test eye.

[0179] The left eye served as a control and did not receive any of the projected peripheral defocus. A gray background screen served as the background for the defocused stimuli projected at a diameter exceeding 15 degrees for both eyes. The content of the central aperture was a color film displayed on an HD television located 4 meters away, which was used as the fixation zone. We set the test conditions for the digital projected stimuli to be 5 times (5X), 10 times (10X), and 20 times (20X) the brightness of the gray poster background and the central 15-degree window (both with equal brightness). The test conditions for the brightness ratio were randomized for each subject. Before and after each defocusing period, axial length measurements of the posterior pole or macula were obtained using a Haag-Streit Lenstar APS900 and optical coherence tomography (Heidelberg Spectralis SD-OCT).

[0180] The brightness ratios of 5x, 10x, and 20x under gray poster background testing conditions were tested 8, 9, and 7 times respectively, for a total of 24 tests.

[0181] Figure 22 Figure 2200, showing aggregated data from the 5x, 10x, and 20x luminance tests, illustrates that after a 1-hour defocusing period, the mean change in central axis length (in micrometers) in the test eyes was significantly smaller than the mean change in central axis length in the control eyes (p < 0.025). Similarly, aggregated data from all tests reveal that after the same defocusing period, the mean change in subfoveal choroidal thickness in the test eyes was significantly greater than the mean change in subfoveal choroidal thickness in the control eyes (p < 0.025). Both p-values ​​correspond to two-tailed t-test comparisons, where α = 0.025 (Bonferroni correction).

[0182] Figure 23 Graph 2300 (mean ± SEM) shows the average changes in axial length and choroidal thickness: For the aggregation of all trials, the change in axial length in the test eyes was significantly smaller than that in the control eyes after the one-hour defocusing period. Similarly, the relative increase in the thickness of the subfoveal choroid in the test eyes was also significantly greater than that in the control eyes after the defocusing period (asterisk "*" indicates a p-value less than or equal to 0.025, also known as "* = p < 0.025").

[0183] For the control eye, exactly the opposite behavior was observed in both parameters. The axial length decreased by an average of approximately 1 μm in the test eye, while it increased by an average of approximately 7 μm in the control eye. The subfoveal choroidal thickness increased by an average of approximately 4 μm from baseline in the test eye, while it decreased by an average of approximately 2 μm in the control eye. The average relative effect in the test eye compared to the control eye was a decrease in axial length of approximately 8 μm and an increase in central choroidal thickness of approximately 6 μm. For all comparisons made before and after the defocusing period, the mean changes in central choroidal thickness measurements performed at 0.50 mm (subfoveal), 1.00 mm (parafoveal), and 1.50 mm (perifoveal) eccentricities were significantly different in the test eye relative to the control eye (p < 0.025). The central choroid in the control eye thinned in each region and thickened significantly after a one-hour peripheral defocusing period of projection, as shown in the figure. Figure 23 As shown.

[0184] Figure 23 The relative thickening of the choroid behind the retina was also shown (mean ± SEM): the choroid was significantly thickened after one hour of projective defocus at 0.50 mm (subfoveal), 1.00 mm (parafoveal), and 1.50 mm (perifoveal) eccentric to the retina in the posterior pole (* = p < 0.025).

[0185] When considering the luminance ratio for each test, the 20x condition was the only one that showed statistical significance for the change in mean axial length between the test and control eyes (p = 0.02) (independent t-test, two-tailed, uncorrected). Although the 20x luminance defocused stimulus condition was more robust than the 5x or 10x stimulus conditions, the difference between the test and control eyes tended to increase with increasing stimulus luminance relative to background.

[0186] Statistically, our results show that, compared to the control eye, the test eye exhibited a significant decrease in axial length and an increase in choroidal thickness after a one-hour defocusing period. Furthermore, the central choroidal layer thickened significantly after one hour of projective defocusing. A significant advantage of this augmented reality-based system compared to traditional or multifocal defocusing systems is that it allows for easily programmable control over important stimulus aspects. In testing peripheral projective stimuli of several different intensities, we found an inverse correlation between increased intensity and decreased axial length, and a positive correlation between increased intensity and increased choroidal thickness. The control eye under the 20x test condition showed a greater change in mean axial length after defocusing compared to the mean changes in the control eye under the other two brightness test conditions. This is likely due to normal variability in the control eye, which occurs naturally without defocusing. It may also be due to the monocular coupling effect of projective defocusing, the binocular effect of which remains to be understood. This exploratory study successfully demonstrates the concept of using augmented reality-based peripheral defocusing optics to physiologically influence ocular biomarkers.

[0187] Our results and the versatility of the proposed method demonstrate the promise of this concept for projective and programmable peripheral myopic defocus, which could contribute to a better understanding of the role of peripheral stimulation in modulating eye growth and finding the fastest and most effective treatment strategies. Furthermore, it can be applied to augmented and virtual reality devices, office therapy, eyeglasses, and contact lenses.

[0188] Refer again Figures 1A to 3 , Figure 16 and Figure 19 The stimulation device can be configured to stimulate the eye by pupil dilation. Work related to this disclosure shows that an increase in pupil diameter, such as pupil dilation, can allow an increased amount of light to be delivered to the peripheral portion of the retina. An increase in pupil diameter facilitates increased illumination decentering away from the fovea, thus illuminating retinal areas farther from the fovea, and also facilitates increased illumination to the peripheral retinal region. Work related to this disclosure shows that the surface area of ​​the stimulated region of the retina may be related to the effectiveness of the response. Furthermore, by providing stimulation to the peripheral retinal region while maintaining a substantially low amount of light to the fovea and macula during stimulation, pupillary constriction can be reduced.

[0189] While the stimulation device can be configured in a variety of ways, in some embodiments, one or more optical elements are arranged to project multiple stimuli toward the peripheral portion of the retina when the pupil of the eye has already dilated. The pupil can dilate in a variety of ways, such as by dilating with reduced light intensity to include the natural pupil, or by dilating with a mydriatic agent such as a cycloplegic agent to include a pharmacologically dilated pupil.

[0190] While one or more stimuli, such as multiple stimuli, may be arranged to illuminate the retina in a variety of ways during pupil dilation, in some embodiments, the one or more stimuli are arranged to illuminate the peripheral portion of the retina at an angle of at least 35 degrees to the visual axis of the eye.

[0191] In some embodiments, the stimulation device includes a sensor for measuring pupil size and a processor configured with instructions to direct optical stimulation to the eye in response to pupil size. This can allow for increased light output to the peripheral retinal region and, in some cases, more accurate delivery and estimation of the amount of light delivered to the peripheral retinal region. While pupil size can be measured in various ways, in some embodiments, the measured pupil size includes the diameter of the pupil. In some embodiments, the processor is configured to adjust one or more of the intensity or duration of the optical stimulation in response to pupil size. For example, a larger diameter pupil may receive stimulation for a shorter duration or at a lower intensity, while a smaller diameter pupil may receive stimulation for an increased amount of time or at an increased intensity. While the sensor for measuring pupil size can be configured in any suitable manner that a person skilled in the art would know, in some embodiments, the sensor includes a sensor array. For example, the sensor may include a sensor array of a camera. The camera may include any suitable device, such as a patient mobile device, like a smartphone, or a measurement sensor built into a testing and measurement device as described herein.

[0192] In some embodiments, multiple stimuli are configured to allow the natural pupil to dilate upon illumination with the multiple stimuli. Work relating to this disclosure has shown that illumination of the peripheral portion of the retina has a less significant effect on pupil diameter than illumination of the fovea or macula. In some embodiments, the multiple stimuli are configured to, when stimulation is provided, cause pupil constriction of no more than one millimeter (mm) compared to the pupil diameter when no stimulation is provided.

[0193] In some embodiments, when the eye is exposed to multiple stimuli, the pupil includes the stimulus diameter, and when the eye is exposed to a photopic viewing condition without multiple stimuli, the eye includes the photopic diameter. In some embodiments, the photopic diameter is at least one millimeter smaller than the stimulus diameter. In some embodiments, the photopic viewing condition includes per square meter (m²) 2 At least 3 candela (cd) of brightness.

[0194] In some embodiments, the stimulus is configured to illuminate a peripheral portion of a retina having an eccentricity greater than 35 degrees, wherein when the stimulus is provided to a peripheral retina having an eccentricity greater than 35 degrees, the pupil of the eye is dilated by at least about 1 millimeter compared to photopic illumination.

[0195] In some embodiments, no more than 10% of the total energy of the plurality of stimuli, and optionally no more than 5% and optionally no more than 1% of the total energy, is directed to the fovea of ​​the eye to reduce pupillary constriction in response to the plurality of stimuli.

[0196] In some embodiments, the stimulation includes photopic stimulation directed to the peripheral region of the retina, and illumination of one or more of the fovea or macula includes one or more of mesopic or scotopic illumination to reduce pupil size. The device can be configured in a variety of ways to provide this stimulation. In some embodiments, the device includes a display configured to provide one or more of mesopic or scotopic illumination, and the plurality of stimuli are configured to provide photopic illumination in any suitable manner as described herein.

[0197] In some embodiments, a method for treating refractive errors of the eye includes dilating the pupil of the eye and providing optical stimulation to a peripheral portion of the retina to reduce the refractive error of the eye. The stimulation may include any suitable stimulation as described herein, and may include multiple stimuli.

[0198] While pupils can be dilated in a variety of ways, in some embodiments, a mydriatic agent is used to dilate the pupil. While any suitable mydriatic agent can be used to pharmacologically increase pupil size, in some embodiments, mydriatic agents include cycloplegic agents.

[0199] In some embodiments, the cycloplegic agent is selected from the group consisting of atropine, cyclovalerate, homatropine, scopolamine, and tropicamide. For example, the cycloplegic agent may include an appropriate percentage of atropine. In some embodiments, the weight percentage is in the range of 0.025% to 0.2% and optionally in the range of 0.05% to 0.1%.

[0200] In some embodiments, the size of the pupil is measured, and optical stimuli are directed to the eye in response to the size of the pupil, and one or more of the intensity or duration of the optical stimuli are adjusted in response to the size of the pupil. For example, in some embodiments, the size of the pupil is measured using a sensor such as a sensor array, and the sensor array includes a sensor array of a camera.

[0201] In some embodiments, the pupil includes the natural pupil of the eye, which is dilated by an appropriate amount of light illuminating the peripheral retina and light passing through the natural pupil from other sources, such that the natural pupil is able to contract and dilate in response to light illuminating the eye.

[0202] In some embodiments, the natural pupil is dilated using intermediate background lighting or scotopic background lighting.

[0203] In some embodiments, when stimulation is provided, the natural pupil constricts by no more than one millimeter (mm) compared to the natural pupil diameter when no stimulation is provided.

[0204] In some embodiments, the natural pupil includes the stimulus diameter when the eye is exposed to a stimulus, and wherein the natural pupil includes the visual diameter when the eye is exposed to a photopic viewing condition. In some embodiments, the visual diameter is at least one millimeter smaller than the stimulus diameter.

[0205] In some embodiments, the stimulus is configured to illuminate a peripheral retina with an eccentricity greater than 35 degrees, wherein when the stimulus is provided to a peripheral retina with an eccentricity greater than 35 degrees, the pupil is dilated by at least about 1 mm compared to photopic illumination.

[0206] While stimuli can be configured in a variety of ways to reduce pupillary constriction, in some embodiments, no more than 10% of the total energy of the multiple stimuli, and optionally no more than 5% and optionally no more than 1% of the total energy, is directed to the fovea of ​​the eye to reduce pupillary constriction in response to the multiple stimuli.

[0207] In some embodiments, the stimulation includes a photopic stimulus directed to the peripheral region of the retina, and wherein illumination of one or more of the fovea or macula includes one or more of mesopic or scotopic illumination to reduce pupil size.

[0208] As described herein, the computing devices and systems described and / or illustrated herein broadly refer to any type or form of computing device or system capable of executing computer-readable instructions, such as those included in the modules described herein. In its most basic configuration, the computing device may each include at least one memory device and at least one physical processor.

[0209] As used herein, the term "memory" or "memory device" generally refers to any type or form of volatile or non-volatile storage device or medium capable of storing data and / or computer-readable instructions. In one example, a memory device may store, load, and / or maintain one or more modules described herein. Examples of memory devices include, but are not limited to, random access memory (RAM), read-only memory (ROM), flash memory, hard disk drive (HDD), solid-state drive (SSD), optical disk drive, cache, variations or combinations thereof, or any other suitable memory for storage.

[0210] Furthermore, as used herein, the term "processor" or "physical processor" generally refers to a processing unit of any type or form of hardware implementation capable of interpreting and / or executing computer-readable instructions. In one example, a physical processor may access and / or modify one or more modules stored in the aforementioned memory devices. Examples of physical processors include, but are not limited to, microprocessors, microcontrollers, central processing units (CPUs), field-programmable gate arrays (FPGAs) implementing soft-core processors, application-specific integrated circuits (ASICs), portions of one or more of these, variations or combinations thereof, or any other suitable physical processor. The processor may include distributed processor systems, such as those running parallel processors or remote processors (e.g., servers), and combinations thereof.

[0211] Although shown as separate elements, the method steps described and / or illustrated herein may represent parts of a single application. Furthermore, in some embodiments, one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, enable the computing device to perform one or more tasks, such as the method steps.

[0212] Furthermore, one or more devices described herein can convert data, physical devices, and / or representations of physical devices from one form to another. Additionally or alternatively, one or more modules described herein can convert a processor, volatile memory, non-volatile memory, and / or any other part of a physical computing device from one form of computing device to another by executing on a computing device, storing data on a computing device, and / or otherwise interacting with a computing device.

[0213] As used herein, the term "computer-readable medium" generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media include, but are not limited to, transport media such as carrier waves and non-transient media such as magnetic storage media (e.g., hard disk drives, magnetic tape drives, and floppy disks), optical storage media (e.g., optical discs (CDs), digital video disks (DVDs), and Blu-ray disks), electronic storage media (e.g., solid-state drives and flash memory media) and other distribution systems.

[0214] Those skilled in the art will recognize that any process or method disclosed herein can be modified in various ways. The process parameters and sequence of the steps described and / or illustrated herein are given by way of example only and can be changed as needed. For example, while the steps shown and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order shown or discussed.

[0215] The various exemplary methods described and / or illustrated herein may omit one or more steps described or illustrated herein, or include additional steps in addition to those disclosed. Furthermore, the steps of any method disclosed herein may be combined with any one or more steps of any other method disclosed herein.

[0216] The processor described herein can be configured to perform one or more steps of any of the methods disclosed herein. Alternatively or in combination, the processor can be configured to combine one or more steps of one or more methods disclosed herein.

[0217] Unless otherwise stated, the terms “connected to” and “coupled to” (and their derivatives) as used in the specification and claims shall be interpreted as allowing direct and indirect (i.e., through other elements or components) connections. Furthermore, the terms “a” or “an” as used in the specification and claims shall be interpreted as meaning “at least one”. Finally, for ease of use, the terms “including” and “having” (and their derivatives) as used in the specification and claims may be used interchangeably with the word “comprising” and shall have the same meaning as the word “comprising”.

[0218] The processor disclosed herein may be configured with instructions to perform any one or more steps of any of the methods disclosed herein.

[0219] It will be understood that although the terms “first,” “second,” “third,” etc., may be used herein to describe various layers, elements, components, regions, or sections, they do not imply any particular order or sequence of events. These terms are used only to distinguish one layer, element, component, region, or section from another. The first layer, element, component, region, or section described herein may be referred to as the second layer, element, component, region, or section without departing from the teachings of this disclosure.

[0220] As used herein, the term "or" is used inclusively to refer to both alternatives and combinations.

[0221] As used in this article, characters such as numbers refer to similar elements.

[0222] This disclosure includes entries numbered as follows.

[0223] Item 1. An apparatus for treating refractive errors of the eye, the apparatus comprising: a plurality of stimuli; and one or more optical elements for imaging the plurality of stimuli in front of or behind a peripheral portion of the retina to form a plurality of defocused images on the peripheral portion of the retina; wherein the plurality of stimuli and one or more optical elements are arranged to reduce interference with central vision of the eye.

[0224] Item 2. The apparatus according to Item 1, wherein the plurality of defocused images are defocused by an amount in the range of 3.0D to 6.0D, optionally by myopic defocus, and optionally by an amount in the range of 3.5D to 5.0D.

[0225] Item 3. The apparatus according to Item 1, wherein the brightness of the plurality of defocused images is at least 3 times higher than the background illumination, optionally at least 5 times higher than the background illumination, optionally in the range of 3 to 20 times the background illumination, and further optionally in the range of 5 to 15 times the background illumination.

[0226] Item 4. The apparatus according to Item 1, wherein each of the plurality of defocused images includes an intensity profile distribution comprising one or more peaks distributed around an inner portion having a reduced intensity relative to the one or more peaks.

[0227] Item 5. The apparatus according to Item 4, wherein one or more peaks comprise a plurality of peaks, and wherein an inner portion is located between the plurality of peaks.

[0228] Item 6. The apparatus according to Item 5, wherein the plurality of peaks comprises four peaks, and an internal portion is located between the four peaks.

[0229] Item 7. The apparatus according to Item 6, wherein the internal portion includes a cross extending between four peaks.

[0230] Item 8. The apparatus according to Item 4, wherein one or more peaks include a ring-shaped peak, and wherein an inner portion is located within the ring-shaped peak.

[0231] Item 9. The apparatus according to Item 1, wherein each of the plurality of defocused images includes a multicolored icon on a darker background to provide contrast, and optionally, wherein the multicolored icon includes a white icon and the darker background includes a substantially black background.

[0232] Item 10. The apparatus according to Item 1, wherein each of the plurality of stimuli includes a length, edge, and intensity profile distribution to generate a spatial frequency when imaged into the eye in front of or behind the retina, the spatial frequency being at 1 × 10⁻⁶ degrees. -1 One cycle up to 2.5×10 1 Within a period of 1 × 10⁻⁶ cycles, and optionally within 1 × 10⁻⁶ degrees. -1 One cycle to 1×10 1 Within the range of a cycle.

[0233] Item 11. The apparatus according to Item 1, wherein the plurality of stimuli imaging in the eye comprises a spatial frequency distribution at approximately 1 × 10⁻⁶ per degree. -1 One cycle to approximately 2.5 × 10 1 Within the spatial frequency range of one period and optionally within 1×10 per degree -1 One cycle to approximately 5×10 0 Within a spatial frequency range of one cycle, it provides a decrease in spatial frequency amplitude as the spatial frequency increases.

[0234] Item 12. The apparatus according to Item 11, wherein, for any unit of spatial frequency amplitude, the decrease in spatial frequency intensity is from 1 / (spatial frequency) 0.5 Up to 1 / (spatial frequency) 2 Within the range, and optionally, for any unit of spatial frequency amplitude, the decrease in spatial frequency intensity is from 1 / (spatial frequency) to 1 / (spatial frequency). 2 Within the range.

[0235] Item 13. The apparatus according to Item 11, wherein the spatial frequency ranges from approximately 3 × 10⁻⁶ per degree. -1 One cycle to approximately 1.0 × 10⁻⁶ degrees. 1 One cycle, and optionally approximately 3 × 10 per degree. -1 One cycle to approximately 2.0 × 10⁻⁶ degrees. 0 Within a period of time, and optionally, from approximately 3 × 10⁻⁶ per degree. -1 One cycle to approximately 1.0 × 10⁻⁶ degrees. 0 One cycle.

[0236] Item 14. The apparatus according to Item 1, wherein the apparatus is configured to provide monocular stimulation to a patient’s eye.

[0237] Item 15. The apparatus according to Item 1, wherein the apparatus is configured to provide eye stimulation to a patient.

[0238] Item 16. The apparatus according to Item 15 further includes: a plurality of second stimuli for stimulating the contralateral eye of the patient; and one or more second optical elements for imaging the plurality of second stimuli in front of or behind a peripheral portion of the retina of the contralateral eye to form a plurality of second defocused images on the peripheral portion of the second retina; wherein the plurality of second stimuli and the one or more second optical elements are arranged to reduce interference with the central vision of the contralateral eye.

[0239] Item 17. The apparatus according to Item 1, wherein a plurality of stimuli and one or more optical elements are arranged to provide a substantially undisturbed field of view in the range of 10 to 30 degrees, optionally in the range of 10 to 20 degrees, and optionally in the range of 12 to 18 degrees, and optionally, wherein each of the plurality of defocused images is projected onto a retina outside the field of view.

[0240] Item 18. The apparatus according to Item 1, wherein each of a plurality of stimuli imaged in the eye is superimposed on a substantially uniform gray background, each of the plurality of stimuli including a white icon such that the icon has a total edge length to generate a value primarily at 1 × 10⁻⁶ per degree. -1 One cycle to 2.5 × 10⁻⁶ degrees 1 Within a period of 1 × 10⁻⁶ cycles, and optionally within 1 × 10⁻⁶ degrees. -1 One cycle to 1×10 per degree 1 The characteristics of spatial frequency within a period range.

[0241] Item 19. The apparatus according to Item 1, wherein each of a plurality of stimuli imaged in the eye includes a multicolor icon having an edge outline on a background, the multicolor icon being generated primarily at 1 × 10⁻⁶ degrees. -1 One cycle to 2.5 × 10⁻⁶ degrees 1 Within one cycle, and optionally within 1×10 per degree. -1 One cycle to 1×10 per degree 1 The spatial frequency characteristics within a period range.

[0242] Item 20. The apparatus according to Item 1, wherein each of the plurality of stimuli includes a global contrast factor greater than 0.7 and optionally greater than 0.8.

[0243] Item 21. The apparatus according to Item 1, wherein one or more optical elements comprise one or more of a hologram, a waveguide, a mirror, a lens, a spectacle lens, or a contact lens.

[0244] Item 22. The device according to Item 1 further includes a support member coupled to a user to support one or more optical elements, the support member including components of one or more of a head-mounted device, spectacle lenses, spectacle frames, goggles, AR display, contact lenses, or VR display.

[0245] Item 23. The apparatus according to Item 1 further includes a lens for correcting refractive errors of the eye.

[0246] Item 24. The apparatus according to Item 1, wherein one or more optical elements are arranged to project multiple stimuli toward the peripheral portion of the retina when the pupil of the eye has been dilated with a mydriatic agent.

[0247] Item 25. The apparatus according to Item 24, wherein a plurality of stimuli are arranged to illuminate a peripheral portion of the retina at an angle of at least 35 degrees to the visual axis of the eye.

[0248] Item 26. The apparatus according to Item 1 further includes a sensor for measuring the size of the pupil, and the apparatus further includes a processor configured with instructions to direct optical stimulation to the eye in response to the size of the pupil, and optionally, wherein the size of the pupil includes the diameter of the pupil.

[0249] Item 27. The apparatus according to Item 26, wherein the processor is configured to adjust one or more of the intensity or duration of an optical stimulus in response to the size of the pupil.

[0250] Item 28. The apparatus according to Item 26, wherein the sensor comprises a sensor array, and optionally, wherein the sensor array comprises a sensor array of a camera.

[0251] Item 29. The apparatus according to Item 26, wherein a plurality of stimuli are configured to allow the natural pupil to dilate when irradiated by the plurality of stimuli.

[0252] Item 30. The apparatus according to Item 1, wherein a plurality of stimuli are configured to cause the pupil to constrict by no more than one millimeter (mm) when the stimulus is provided, compared to the diameter of the pupil before the stimulus is provided.

[0253] Item 31. The apparatus according to Item 1, wherein when the eye is exposed to multiple stimuli, the pupil includes a stimulus diameter, and wherein when the eye is exposed to a photopic viewing condition without multiple stimuli, the eye includes a photopic diameter, and wherein the photopic diameter is at least one millimeter smaller than the stimulus diameter, and optionally, wherein the photopic viewing condition includes a diameter per square meter (m²). 2 At least 3 candela (cd) of brightness.

[0254] Item 32. The apparatus according to Item 1, wherein the stimulus is configured to illuminate a peripheral portion of a retina having an eccentricity greater than 35 degrees, wherein when the stimulus is provided to the peripheral retina having an eccentricity greater than 35 degrees, the pupil of the eye dilates by at least about 1 millimeter compared to photopic illumination.

[0255] Item 33. The apparatus according to Item 1, wherein no more than 10% of the total energy of the plurality of stimuli and optionally no more than 5% and optionally no more than 1% of the total energy are directed to the fovea of ​​the eye in order to reduce pupillary constriction in response to the plurality of stimuli.

[0256] Item 34. A method for treating refractive errors of the eye, the method comprising: providing stimulation to a peripheral area of ​​the retina of the eye, wherein the stimulation is provided in the morning.

[0257] Item 35. The method according to Item 34, wherein the stimulus is provided by the means described in any of the preceding items.

[0258] Item 36. The method according to Item 34, wherein the stimulus is provided between 6 a.m. and 10 a.m.

[0259] Item 37. The method according to Item 34, wherein the stimulation is provided to the eye on the morning of multiple consecutive days, and wherein the total treatment time per day includes no more than one hour.

[0260] Item 38. A tangible medium configured with instructions to be executed by a processor, the tangible medium being configured to perform the method described in any one of Items 34 to 37.

[0261] Item 39. A patient database comprising: treatment data corresponding to multiple retinal stimulation treatments for multiple patients; and efficacy data for multiple patients, the efficacy data including refractive data for the multiple treatments.

[0262] Item 40. A method for conducting a clinical trial, the method comprising: providing peripheral retinal stimulation to a test eye but not a control eye on each of multiple days; measuring the axial length of the test eye and the control eye before and after treatment on each of the multiple days; and comparing the axial length of the test eye with the axial length of the control eye to determine the efficacy of the peripheral retinal stimulation.

[0263] Item 41. A method for treating refractive errors of the eye, the method comprising: dilating the pupil of the eye; and providing optical stimulation to a peripheral portion of the retina to reduce the refractive error of the eye.

[0264] Item 42. The method according to Item 41, wherein the stimulus comprises a plurality of stimuli as described in any of the preceding items.

[0265] Item 43. The method according to Item 41, wherein the pupil is dilated with a mydriatic agent.

[0266] Item 44. The method according to Item 43, wherein the mydriatic agent optionally includes a cycloplegic agent, wherein the cycloplegic agent is selected from the group consisting of atropine, cyclovalerate, homatropine, scopolamine and tropicamide.

[0267] Item 45. The method according to Item 44, wherein the cycloplegic agent comprises atropine, the weight percentage of which is in the range of 0.025% to 0.2%, and optionally in the range of 0.05% to 0.1%.

[0268] Item 46. The method according to Item 41, wherein the size of the pupil is measured and an optical stimulus is directed to the eye in response to the size of the pupil, and optionally, wherein the size of the pupil includes the diameter of the pupil.

[0269] Item 47. The method according to Item 46, wherein one or more of the intensity or duration of the optical stimulus are adjusted in response to the size of the pupil.

[0270] Item 48. The method according to Item 46, wherein the size of the pupil is measured with a sensor, and optionally, wherein the sensor comprises a sensor array, and optionally, wherein the sensor array comprises a sensor array of a camera.

[0271] Item 49. The method according to Item 41, wherein the pupil comprises the natural pupil of the eye, wherein the natural pupil is dilated by an appropriate amount of light from the peripheral retina and light passing through the natural pupil from other sources, and optionally, wherein the natural pupil is capable of contracting and dilating in response to light exposure to the eye.

[0272] Item 50. The method according to Item 49, wherein natural pupil dilation is achieved using intermediate or scotopic background illumination, and optionally, wherein the intermediate background illumination comprises 0.01 candela (cd / m²) per square meter. 2 Up to 3 cd / m 2 The quantity within the range.

[0273] Item 51. The method according to Item 50, wherein, when a stimulus is provided, the natural pupil constricts by no more than one millimeter (mm) compared to the diameter of the natural pupil when no stimulus has been provided.

[0274] Item 52. The method according to Item 50, wherein when the eye is exposed to a stimulus, the natural pupil includes the stimulus diameter, and wherein when the eye is exposed to a clear vision condition, the natural pupil includes a clear vision diameter, and wherein the clear vision diameter is at least one millimeter smaller than the stimulus diameter.

[0275] Item 53. The method according to Item 41, wherein the stimulus is configured to illuminate a peripheral retina having an eccentricity greater than 35 degrees, wherein when the stimulus is provided to a peripheral retina having an eccentricity greater than 35 degrees, the pupil dilates by at least about 1 mm compared to photopic illumination.

[0276] Item 54. The method according to Item 41, wherein no more than 10% of the total energy of the plurality of stimuli, and optionally no more than 5% and optionally no more than 1% of the total energy, is directed to the fovea of ​​the eye in order to reduce pupillary constriction in response to the plurality of stimuli.

[0277] Item 55. The method according to Item 41, wherein the stimulus comprises a photopic stimulus directed to a peripheral region of the retina, and wherein illumination of one or more of the fovea or macula comprises one or more of intermediate illumination or scotopic illumination in order to reduce the size of the pupil.

[0278] Embodiments of this disclosure have been shown and described herein and are provided by way of example only. Those skilled in the art will recognize many adaptations, changes, modifications, and substitutions without departing from the scope of this disclosure. Several alternatives and combinations of the embodiments disclosed herein may be used without departing from the scope of this disclosure and the invention disclosed herein. Therefore, the scope of the invention currently disclosed is defined only by the scope of the appended claims and their equivalents.

Claims

1. A device for treating refractive errors of the eye, the device comprising: Multiple light sources, the multiple light sources being configured to provide multiple stimuli; as well as One or more optical elements, said one or more optical elements for imaging the plurality of stimuli in front of or behind a peripheral portion of the retina to form a plurality of defocused images on the peripheral portion of the retina; The plurality of stimuli and the one or more optical elements are arranged to reduce interference with central vision of the eye, and the plurality of stimuli imaging in the eye include a spatial frequency distribution at 1 × 10⁻⁶ ppm. -1 One cycle up to 2.5×10 1 Within a range of spatial frequencies over a period of time, the amplitude of the spatial frequency decreases as the spatial frequency increases.

2. The apparatus according to claim 1, wherein, The amount of defocusing of the plurality of defocused images is in the range of 3.0D to 6.0D.

3. The apparatus according to claim 1, wherein, The brightness of the plurality of defocused images is at least three times higher than the brightness of the background light.

4. The apparatus according to claim 1, wherein, Each of the plurality of defocused images includes an intensity profile distribution comprising one or more peaks distributed around an inner portion having a reduced intensity relative to the one or more peaks.

5. The apparatus according to claim 4, wherein, The one or more peaks include a plurality of peaks, and wherein the inner portion is located between the plurality of peaks.

6. The apparatus according to claim 5, wherein, The plurality of peaks includes four peaks, and the inner portion is located between the four peaks.

7. The apparatus according to claim 6, wherein, The internal portion includes a cross extending between the four peaks.

8. The apparatus according to claim 4, wherein, The one or more peaks include ring-shaped peaks, and wherein the inner portion is located within the ring-shaped peaks.

9. The apparatus according to claim 1, wherein, Each of the multiple defocused images includes a multicolored icon on a darker background to provide contrast.

10. The apparatus according to claim 1, wherein, Each of the plurality of stimuli includes a length, edge, and intensity contour distribution to generate a spatial frequency when imaged into the eye in front of or behind the retina, the spatial frequency being 1 × 10⁻⁶ per degree. -1 One cycle up to 2.5×10 1 Within the range of a cycle.

11. The apparatus according to claim 1, wherein, The spatial frequency distribution is at 1×10⁻¹⁰ per degree. -1 One cycle to 5×10 0 Within a spatial frequency range of one cycle, it provides a decrease in spatial frequency amplitude as the spatial frequency increases.

12. The apparatus according to claim 11, wherein, For any unit of spatial frequency amplitude, the decrease in spatial frequency intensity is from 1 / (spatial frequency) 0.5 Up to 1 / (spatial frequency) 2 Within the range.

13. The apparatus according to claim 11, wherein, The spatial frequency range is from 3 × 10⁻⁶ per degree. -1 One cycle to 1.0 × 10⁻¹⁰ degrees 1 One cycle.

14. The apparatus according to claim 1, wherein, The device is configured to provide monocular stimulation to the patient's eye.

15. The apparatus according to claim 1, wherein, The device is configured to provide eye stimulation to a patient.

16. The apparatus of claim 15, further comprising: Multiple secondary stimuli, said multiple secondary stimuli being used to stimulate the patient's contralateral eye; as well as One or more second optical elements are used to image the plurality of second stimuli in front of or behind the peripheral portion of the retina of the contralateral eye to form a plurality of second defocused images on the peripheral portion of the second retina. The plurality of second stimuli and the one or more second optical elements are arranged to reduce interference with the central vision of the contralateral eye.

17. The apparatus according to claim 1, wherein, The plurality of stimuli and the one or more optical elements are arranged to provide a substantially undisturbed field of view, which is in the range of 10 to 30 degrees.

18. The apparatus according to claim 1, wherein, Each of the plurality of stimuli imaged in the eye is superimposed on a substantially uniform gray background, and each of the plurality of stimuli includes a white icon such that the white icon has a total edge length to generate a value primarily 1×10 at each degree. -1 One cycle to 2.5 × 10⁻⁶ degrees 1 The spatial frequency characteristics within a period range.

19. The apparatus according to claim 1, wherein, Each of the plurality of stimuli imaged in the eye includes a multicolor icon with an edge outline on a background, the multicolor icon being generated primarily at 1×10⁻⁶ per degree. -1 One cycle to 2.5 × 10⁻⁶ degrees 1 The spatial frequency characteristics within a period range.

20. The apparatus according to claim 1, wherein, Each of the plurality of stimuli includes a global contrast factor greater than 0.

7.

21. The apparatus according to claim 1, wherein, The one or more optical elements include one or more waveguides, mirrors, or lenses.

22. The device of claim 1, further comprising a support member coupled to a user to support the one or more optical elements, the support member comprising one of an eyeglass lens, an eyeglass frame, goggles, an AR display, a contact lens, or a VR display.

23. The apparatus of claim 1 further includes a lens for correcting refractive errors of the eye.

24. The apparatus according to claim 1, wherein, The one or more optical elements are arranged to project the plurality of stimuli toward the peripheral portion of the retina when the pupil of the eye has been dilated with a mydriatic agent.

25. The apparatus according to claim 24, wherein, The plurality of stimuli are arranged to illuminate the peripheral portion of the retina at an angle of at least 35 degrees to the visual axis of the eye.

26. The apparatus of claim 1, further comprising a sensor for measuring pupil size, and the apparatus further comprising a processor configured with instructions to direct optical stimulation to the eye in response to the pupil size.

27. The apparatus according to claim 26, wherein, The processor is configured to adjust one or more of the intensity or duration of the optical stimulus in response to the size of the pupil.

28. The apparatus according to claim 26, wherein, The sensor includes a sensor array.

29. The apparatus according to claim 26, wherein, The multiple stimuli are configured to allow the natural pupil to dilate when exposed to the multiple stimuli.

30. The apparatus according to claim 1, wherein, Multiple stimuli are configured to cause the pupil to constrict by no more than one millimeter (mm) when the stimulus is provided, compared to the diameter of the pupil before the stimulus is provided.

31. The apparatus according to claim 1, wherein, When the eye is exposed to the plurality of stimuli, the pupil includes the stimuli diameter, and wherein, when the eye is exposed to a clear vision condition without the plurality of stimuli, the eye includes a clear vision diameter, and wherein the clear vision diameter is at least one millimeter smaller than the stimuli diameter.

32. The apparatus according to claim 1, wherein, The stimulus is configured to illuminate the peripheral portion of the retina having an eccentricity greater than 35 degrees, wherein when the stimulus is provided to the peripheral retina having an eccentricity greater than 35 degrees, the pupil of the eye dilates by at least 1 millimeter compared to photopic illumination.

33. The apparatus according to claim 1, wherein, No more than 10% of the total energy of the plurality of stimuli is directed to the fovea of ​​the eye in order to reduce pupillary constriction in response to the plurality of stimuli.

34. The apparatus according to claim 1, wherein, The multiple defocused images are defocused due to myopia.

35. The apparatus according to claim 1, wherein, The amount of defocusing of the plurality of defocused images is in the range of 3.5D to 5.0D.

36. The apparatus according to claim 1, wherein, The brightness of the plurality of defocused images is at least 5 times higher than the brightness of the background light.

37. The apparatus according to claim 1, wherein, The brightness of the multiple defocused images is in the range of 3 to 20 times that of the background light intensity.

38. The apparatus according to claim 1, wherein, The brightness of the multiple defocused images is in the range of 5 to 15 times the background light intensity.

39. The apparatus according to claim 9, wherein, The multi-colored icons include white icons, and the darker backgrounds include substantially black backgrounds.

40. The apparatus according to claim 10, wherein, The spatial frequency is 1×10 per degree. -1 One cycle to 1×10 1 Within the range of a cycle.

41. The apparatus according to claim 11, wherein, For any unit of spatial frequency amplitude, the decrease in spatial frequency intensity ranges from 1 / (spatial frequency) to 1 / (spatial frequency). 2 Within the range.

42. The apparatus according to claim 11, wherein, The spatial frequency range is 3 × 10⁻⁶ per degree. -1 One cycle to 2.0 × 10⁻⁶ degrees 0 Within the range of a cycle.

43. The apparatus according to claim 11, wherein, The spatial frequency range is from 3 × 10⁻⁶ per degree. -1 One cycle to 1.0 × 10⁻¹⁰ degrees 0 One cycle.

44. The apparatus according to claim 17, wherein, The field of view is in the range of 10 to 20 degrees.

45. The apparatus according to claim 17, wherein, The field of view is in the range of 12 to 18 degrees.

46. ​​The apparatus according to claim 17, wherein, Each of the plurality of defocused images is projected onto the retina outside the field of view.

47. The apparatus according to claim 1, wherein, Each of the plurality of stimuli imaged in the eye is superimposed on a substantially uniform gray background, and each of the plurality of stimuli includes a white icon such that the white icon has a total edge length to generate a value primarily 1×10 at each degree. -1 One cycle to 1×10 per degree 1 The spatial frequency characteristics within a period range.

48. The apparatus according to claim 1, wherein, Each of the plurality of stimuli imaged in the eye includes a multicolor icon with an edge outline on a background, the multicolor icon being generated primarily at 1×10⁻⁶ per degree. -1 One cycle to 1×10 per degree 1 The spatial frequency characteristics within a period range.

49. The apparatus according to claim 1, wherein, Each of the plurality of stimuli includes a global contrast factor greater than 0.

8.

50. The apparatus according to claim 26, wherein, The size of the pupil includes the diameter of the pupil.

51. The apparatus according to claim 28, wherein, The sensor array includes the camera's sensor array.

52. The apparatus according to claim 31, wherein, The viewing conditions include per square meter (m 2 At least 3 candela (cd) of brightness.

53. The apparatus according to claim 1, wherein, No more than 5% of the total energy of the plurality of stimuli is directed to the fovea of ​​the eye in order to reduce pupillary constriction in response to the plurality of stimuli.

54. The apparatus according to claim 1, wherein, No more than 1% of the total energy of the plurality of stimuli is directed to the fovea of ​​the eye in order to reduce pupillary constriction in response to the plurality of stimuli.

55. The apparatus according to claim 21, wherein, The lens includes spectacle lenses or contact lenses.

56. The apparatus of claim 1 further includes a support member coupled to a user to support the one or more optical elements, the support member comprising a head-mounted device.

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