Apparatus and methods for controlling axial growth with application of white light

Abstract

Systems, devices, and methods for applying white light to a user's eyelids to control myopia are disclosed. In an example, a method for controlling an axial length of a user's eye includes applying white light to a user's eyelid; detecting the effect of the applied white light on the axial length of the user's eyes; and adjusting the applied white light based on the detected effect.

Description

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202480048195.9 (22) Application Date 2024.08.26 (30) Priority Data 63 / 578,934 2023.08.25 US (85) PCT International Application Entering National Phase Date 2026.01.20 (86) PCT International Application Application Data PCT / IB2024 / 000453 2024.08.26 (87) PCT International Application Publication Data WO2025 / 046290 EN 2025.03.06 (71) Applicant: Meritsu Co., Ltd. Address: Japan (72) Inventor: Stephen D. Newman (74) Patent Agency: Beijing J&J Intellectual Property Agency Co., Ltd. 11227 Patent Attorney: Chen Wei (51) Int.Cl. A61F 9 / 007(2006.01) (54) Title of Invention: Apparatus and Method for Controlling Axial Growth by Applying White Light (57) Abstract: A system, apparatus, and method for applying white light to a user's eyelids to control myopia are disclosed. In one example, a method for controlling the axial length of a user's eye includes applying white light to a user's eyelids; detecting the effect of the applied white light on the axial length of the user's eye; and adjusting the applied white light based on the detected effect. Claims 2 pages Description 12 pages Drawings 15 pages CN 121548399 A 2026.02.17 CN 1 21 54 83 99 A 1. A method for controlling the axial length of a user's eye, the method comprising: applying a dose of white light to a user's eyelids; detecting the effect of the applied white light on the user's eye; and adjusting the applied white light based on the detected effect. 2. The method of claim 1, wherein applying the dose of white light to the user's eyelid and applying a dose of red light to the user's eye, the red light having a wavelength in the range of 600 nm to 650 nm. 3. The method of claim 1, wherein the detection of the applied white light is performed on the axial length of the user's eye. 4. The method of claim 1, further comprising applying white light with a gradually increasing intensity before applying the dose of white light. 5. The method of claim 1, further comprising applying white light with a gradually decreasing intensity after applying the dose of white light. 6. The method of claim 1, further comprising detecting the pupil diameter of the user's other eye while the white light is applied to the user's eye. 7. The method of claim 6, further comprising adjusting the applied white light based on the detected pupil diameter of the user's eye.8. The method of claim 1, further comprising detecting pressure applied from the white light source to the user's eye during the application of the white light. 9. The method of claim 8, further comprising adjusting the tightness of a strip configured to hold the white light source on the user's head in response to the detected pressure. 10. The method of claim 1, wherein the white light is applied to the user while the user is asleep. 11. The method of claim 1, wherein the applied dose of white light has an illuminance in the range of 30,000 lux to 35,000 lux. 12. The method of claim 1, wherein the applied dose of white light is applied for a duration in the range of 2 minutes to 3 minutes. 13. A system configured to apply red light to a user's eye through the user's eyelids, the system comprising: a white light source; a sensor configured to detect the axial length of the user's eye; and a controller configured to change the white light source based on the detected axial length of the user's eye. 14. The system of claim 13, wherein the sensor uses optical low-coherence reflection measurement to detect the axial length of the user's eye. 15. The system of claim 13, wherein the sensor uses optical coherence tomography (OCT) to detect the axial length of the user's eye. 16. The system of claim 13, wherein the sensor is configured to direct infrared light toward the user's eye. 17. The system of claim 13, further comprising: a device housing housing the white light source, the sensor, and the controller; and a strip configured to hold the system on the user's head. 18. The system of claim 13, further comprising a pressure sensor configured to detect pressure applied to the user's eye by the device housing, wherein the strip is adjustable based on the pressure detected by the pressure sensor. 19. A device comprising: a device housing, the device housing including: a white light source configured to apply white light to a user's eyelids; and a sensor configured to detect characteristics of the eye; and a strip coupled to the device housing and configured to hold the device housing on the user's head. 20. The device of claim 19, wherein: the sensor is a pressure sensor; the sensor is configured to detect pressure applied to the eye by the device; and the strip is configured to adjust based on the detected pressure.Claims 2 / 2 Page 3 CN 121548399 A Apparatus and Method for Controlling Axial Growth with Application of White Light Cross-Reference to Related Applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 578,934, filed August 25, 2023, entitled “Apparatus and Methods for Controlling Axial Growth with Application of White Light,” the disclosure of which is incorporated herein by reference in its entirety. Background Art

[0002] Emmetropia is a visual state in which an observer can see objects clearly at both near and far distances. The cornea and lens work together to focus light entering the eye onto the central area of ​​the retina. Emmetropia is achieved when the combined refractive power of the cornea and lens focuses light precisely onto the central portion of the retina.

[0003] Myopia is a visual state in which objects near the observer appear clear, but objects further away from the observer gradually become blurry. Myopia is sometimes referred to as nearsightedness. Myopia can be caused by any number of diseases and causes. A significant factor in many cases of myopia is an excessively long axial length of the eye. Myopia occurs when the focal point of light entering the eye is formed in front of the retina. In other words, the focal point of light entering the eye converges in front of the retina.

[0004] Another condition affected by the axial length of the eye is hyperopia. This condition causes an observer to see objects at a certain distance clearly, while objects closer to the observer become increasingly blurry. Although this condition can occur for a variety of reasons, a person is usually hyperopic if the focal point of light entering the eye is formed behind the retina.

[0005] The axial length of the eye increases as children grow older. As teenagers enter adolescence, the eye typically stops growing and the axial length of the eye becomes more stable. Therefore, if the growth of the axial length of the eye can be controlled during childhood and adolescence, myopia or hyperopia can be reduced or even eliminated in adulthood. There is a need for devices, systems, and methods for controlling the growth of the axial length of the eye during any stage of life during which the axial length of the eye can increase.

[0006] Several devices, systems, and methods for controlling the growth of the axial length of the eye have been proposed. For example, systems and devices have been proposed that irradiate a subject's eyes directly or through the eyelids with red or near-infrared light. However, these methods for controlling the growth of the eye's axial length can lead to retinal burns, overexposure, light exposure shock, and require full-day user compliance (e.g., multiple times a day). Furthermore, there is a greater need for a safe and convenient device, system, and method for controlling the growth of the eye's axial length that provides improved efficacy and subject compliance.

[0007] Numerous representative embodiments are provided to illustrate various features, characteristics, and advantages of the disclosed subject matter. It should be understood that features, characteristics, advantages, etc., described in conjunction with one embodiment may be used alone or in various combinations and sub-combinations with other features described in conjunction with other embodiments.

[0008] According to an exemplary embodiment, a method for controlling the axial length of a user's eye may include: applying a dose of white light to a user's eyelid; detecting the effect of the applied white light on the user's eye; and adjusting the applied white light based on the detected effect.

[0009] In some examples, applying the dose of white light to the user's eyelid involves applying a dose of red light to the user's eye, the red light having a wavelength in the range of 600 nm to 650 nm. In some examples, the effect of the detection of the applied white light is the axial length of the user's eye. The method may include applying white light with gradually increasing intensity before applying the dose of white light. The method may further include applying white light with a gradually decreasing intensity after applying the dose of white light. In some examples, the method may further include detecting the pupil diameter of the user's other eye while the white light is applied to the user's eye, and may further include adjusting the applied white light based on the detected pupil diameter of the user's eye.

[0010] In some examples, the method may further include detecting pressure applied from the white light source to the user's eye during the application of the white light, and may include adjusting the tightness of a strip configured to hold the white light source on the user's head in response to the detected pressure. In some examples, the white light is applied to the user while the user is asleep. Additionally, the applied dose of white light may have an illuminance in the range of 30,000 lux to 35,000 lux. In some examples, the applied dose of white light is applied for a duration in the range of 2 to 3 minutes.

[0011] In another embodiment, a system configured to apply red light to a user's eye through the user's eyelids includes a white light source; a sensor configured to detect the axial length of the user's eye; and a controller configured to change the white light source based on the detected axial length of the user's eye. In some examples, the sensor uses optical low-coherence reflectance measurement to detect the axial length of the user's eye. In some examples, the sensor uses optical coherence tomography (OCT) to detect the axial length of the user's eye. In some examples, the sensor is configured to direct infrared light toward the user's eye.

[0012] In some examples, the system further includes: a device housing housing the white light source, the sensor, and the controller; and a strip configured to hold the system on a user's head. The system may also include a pressure sensor configured to detect pressure applied to the user's eyes by the device housing, wherein the strip is adjustable based on the pressure detected by the pressure sensor.

[0013] In other embodiments, a device includes: a device housing having a white light source configured to apply white light to a user's eyelids; and a sensor configured to detect characteristics of the eye. The device may also include a strip coupled to the device housing and configured to hold the device housing on a user's head.

[0014] In some examples of the device, the sensor may be a pressure sensor configured to detect pressure applied to the eyes by the device, and the strip may be configured to adjust based on the detected pressure.

[0015] The summary is provided to introduce, in a simplified form, a series of concepts further described below in the detailed description. The Summary of the Invention and the Background Art are not intended to point out key concepts or essential aspects of the disclosed subject matter, nor should they be used to constrain or limit the scope of the claims. For example, the scope of the claims should not be limited based on whether the enumerated subject matter includes any or all aspects mentioned in the Summary of the Invention and / or whether it solves any problems mentioned in the Background Art. Brief Description of the Drawings

[0016] The drawings illustrate various embodiments of the principles described herein and are part of the specification. The illustrated embodiments are merely examples and do not limit the scope of the claims.

[0017] FIG1 is a side view of a system for guiding white light into the eye through the eyelids.

[0018] FIG2 is a side view of a device mounted on a user's head for guiding white light through the user's eyelids into the user's eye.

[0019] FIG3 is a flowchart of a method for guiding white light through the user's eyelids into the user's eye.

[0020] FIG4 is a graph showing the light transmittance through the user's eyelids into the user's eye.

[0021] FIG5 is a graph showing the light transmittance through a 781 Terry Red filter.

[0022] Figure 6A is a graph showing the effect of the interaction between white light transmittance and intensity transmitted through the user's eyelids on pupil size changes.

[0023] Figure 6B is a graph showing the effect of the interaction between red light transmittance and intensity transmitted through the user's open eyes on pupil size changes.

[0024] Figure 7 is a graph showing the average axial length changes at three light intensity levels and at 0 minutes and 10 minutes after exposure.

[0025] Figure 8 is a graph showing the average axial length changes at 0 minutes and 10 minutes after exposure to white light (through the eyelids) and red light (broadband) with eyes open at low, medium, and high intensities.

[0026] Figure 9A is a graph showing the axial length changes at 0 minutes and 10 minutes after exposure to white light (through the eyelids) with eyes open at low, medium, and high intensities.

[0027] Figure 9B is a graph showing the axial length changes at 0 minutes and 10 minutes after exposure to red light (broadband) with eyes open at low, medium, and high intensities.

[0028] Figure 10 is a graph showing the average changes in subfoveal choroidal thickness (SFCT) at three intensities and at 0 minutes and 10 minutes after exposure to white light (through the eyelids) and red light (broadband).

[0029] Figure 11A is a graph showing the changes in subfoveal choroidal thickness (SFCT) for white light (through the eyelids) at three intensities and at 0 and 10 minutes after exposure.

[0030] Figure 11B is a graph showing the changes in subfoveal choroidal thickness (SFCT) for red light (broadband) at three intensities and at 0 and 10 minutes after exposure.

[0031] Figure 12 is a graph showing the average changes in foveal lumen thickness (FLT) for white light (through the eyelids) and red light (broadband) with the eyes open at three intensities and at 0 and 10 minutes after exposure.

[0032] Figure 13 is a graph showing the average changes in foveal lumen thickness (FST) for white light (through the eyelids) and red light (broadband) with the eyes open at three intensities and at 0 and 10 minutes after exposure.

[0033] Throughout the figures, the same reference numerals denote similar but not necessarily identical elements. Detailed Implementation

[0034] The growth of the axial length of the eye is affected by the light received in the retina. Specific wavelengths of light can be used to balance the axial length of the eye with the co-focusing ability of the cornea and lens. The eye uses the focal point of incident light focused on the retina to determine when the axial length of the eye reaches equilibrium. A focusing difference of 1.7–2 D exists across the entire visible spectrum, resulting in shorter wavelengths focusing in front of the retina and longer wavelengths focusing behind it. This focusing difference can be used to apply specific wavelengths of light to the eye to provide directional guidance to increase, stop, or even decrease the axial length of the eye. These changes in axial length may be accompanied by changes in choroidal thickness. For example, light received in the retina causing the eye to stop or decrease axial growth can lead to choroidal thickening, while light received in the retina causing the eye to continue axial growth can lead to choroidal thinning.

[0035] Multiple clinical trials have shown that exposure of the eyes to red or near-infrared light (e.g., light with wavelengths in the range of about 600 nm to about 680 nm) reduces axial elongation of the eyes in children. The mechanism of action of red light therapy can be related to the longitudinal color difference of the eye, where red light focused on the retina provides a signal that the axial length is already too long and thus provides a “stop” signal. Alternatively or additionally, red light therapy can stimulate increased blood flow to the choroid, resulting in a thicker choroid, which can produce a “stop” signal that reduces scleral hypoxia. Both mechanisms can be used to reduce myopia in subjects.

[0036] Red light can be applied to the user's eye by applying white light to the user's eyelids. When white light is applied to the user's eyelids, the transmittance through the user's eyelids is highest for wavelengths at the red end of the visible spectrum. The light transmittance through the eyelids is relatively consistent between wavelengths of 600 nm and 650 nm, while the transmittance in this red wavelength range is in the range of about 5% to about 10% of the incident light. Therefore, red light can be applied to the subject's eye by illuminating the user's eyelids with white light.

[0037] Applying white light to the user's eyelids, rather than applying red light directly to the user's eye, has several benefits. White light is cooler than red light, which reduces the possibility of retinal burns. In addition, the user's eyelids act to scatter the light incident on the user's eye, which also reduces side effects. This disclosure provides systems, devices, and methods for applying white light to a user's eyelids to control the axial length of the user's eye.

[0038] In addition to the benefits of using white light applied to the user's eyelids instead of applying red light directly to the user's eye, this disclosure also provides a ramp-up period before applying the full dose of white light to the user. The ramp-up period increases the intensity of the white light applied to the user's eye, thereby preventing the user from being subjected to light shock. The device and system may include a device housing and strip that are fixed to a user's head and can apply doses of white light to the user while the user is sleeping. This allows for a gradual increase in intensity during the day without additional use by the user, allows for multiple doses to be applied at night while the user is sleeping, and allows for measurements of the user's eyes before and after the application of a dose of white light. The housing may include a sensor that measures the user's eyes before, during, and after the application of the dose of white light, and the measurement results may be used to change the current and subsequent dose of white light applied to the user. The strip and / or housing may include a pressure sensor for adjusting the tightness of the strip to securely and comfortably hold the device on the user's head. The user only needs to wear the device once a day while they sleep, which is less required than previous devices, thus improving user compliance.

[0039] Figure 1 illustrates a system 100 for applying a dose of white light to a user.System 100 includes a white light source 102, an eyelid 106, and an eye 110. As illustrated in FIG1, white light 104 is generated by the white light source 102. When a certain dose of white light 104 is applied to the eyelid 106, some of the white light 104 is absorbed by the eyelid 106. Light with a red wavelength (e.g., light with a wavelength in the range of about 600 nm to about 650 nm or in the range of about 600 nm to about 680 nm) has the highest transmittance through the eyelid 106, where the transmittance is about 5%. Therefore, red light 108 is transmitted through the eyelid 106 to the eye 110.

[0040] The brightness of the red light 108 passing through the eyelid 106 may be about 5% of the brightness of the white light 104 applied to the eyelid. In some examples, white light 104 can be applied to the eyelid 106 at the following brightness levels: approximately 1,000 lux, approximately 10,000 lux, approximately 32,000 lux, approximately 1,000 lux to approximately 50,000 lux, approximately 1,000 lux to approximately 5,000 lux, approximately 5,000 lux to approximately 15,000 lux, approximately 25,000 lux to approximately 35,000 lux, etc. Red light 108 applied to the eye 110 can be applied at the following brightness levels: approximately 50 lux, approximately 500 lux, approximately 1,600 lux, approximately 50 lux to approximately 2,500 lux, approximately 50 lux to approximately 250 lux, approximately 250 lux to approximately 750 lux, approximately 1,250 lux to approximately 1,750 lux, etc. White light 104 can be applied to the eyelid 106 for a period of approximately 3 minutes, or for a period of approximately 2 minutes to approximately 3 minutes, etc.

[0041] FIG2 illustrates a device 200 for applying a dose of white light to a user's eyelid 212. As illustrated in FIG2, the device 200 includes a housing 202 and a strip 204. The housing 202 can accommodate various electronic components of the device 200, including a white light source 206, a sensor 208, a battery, control buttons, a controller, etc.

[0042] In the example of FIG2, a white light source 206 is provided adjacent to each of the user's eyelids 212. However, depending on the user's requirements, multiple white light sources 206 may be provided adjacent to each of the user's eyelids 212, or a single white light source 206 may be provided adjacent to a single user's eyelid 212. The white light source 206 may include a laser diode (LD), a light-emitting diode (LED), a bulb, etc. The controller can be connected to the white light source 206 to change the intensity, wavelength, bandwidth, application time, etc. of the white light source 206. The controller can also control the gradual increase, decrease, and white light exposure period of the white light source 206.

[0043] The sensor 208 can be located adjacent to each of the user's eyelids 212, or adjacent to one of the user's eyelids 212.Sensor 208 can be used to measure various characteristics of a user's eye, such as axial length, pupil diameter, choroid thickness, etc. The sensor can detect these characteristics using optical low-coherence reflectance measurement, optical coherence tomography (OCT), etc. The controller can adjust the white light source 206 based on the measurements detected by sensor 208, thereby customizing the white light dose applied to the user's eyelids 212 based on the effect of white light on the user's eyes.

[0044] Strip 204 is configured to hold housing 202 on the user's head 210 such that white light source 206 is held in a desired position adjacent to the user's eyelids 212. Strip 204 may include sensor 208, such as a pressure sensor, and the tension applied to the user's head and eyes can be adjusted based on measurements from the pressure sensor. The sensor 208 included in the device housing may also be a pressure sensor, and the tension in strip 204 can be adjusted based on the pressure applied to the user's eyes. The adjustable strip 204 can apply sufficient pressure to hold the device 200 on the user's head 210, even if the user moves during sleep, while still maintaining comfort.

[0045] In some examples, the device 200 of FIG. 2 can be a handheld device, a desktop device, etc., and the strip 204 can be omitted. In some examples, the device 200 can be used when the user is awake. In some examples, the device 200 can be a portable device that can be set on a desktop or other similar location. The user can point their eyes at the white light source 206, and the white light can be applied to the user's eyelids 212 when the user is awake.

[0046] In some examples, the white light source 206 can be provided adjacent to each of the user's eyes, or the white light source 206 can be provided adjacent to one of the user's eyes, and a sensor 208 can be provided adjacent to the user's other eye. One or more sensors 208 and / or white light sources 206 can be provided adjacent to each of the user's eyes.

[0047] In some examples, the sensor 208 can be used to detect the size of the user's pupils when the eyes are open. For example, white light can be applied to one of the user's closed eyelids 212 by a white light source 206 adjacent to the user's closed eyelid 212, and a sensor 208 adjacent to the user's other open eye can detect the pupil size of the user's open eye. The pupils of the user's eyes will constrict or dilate simultaneously, so that measuring the pupil size of one eye can approximately estimate the pupil size of the other eye.

[0048] FIG3 illustrates a method 300 for applying white light to a user's eyelids. Method 300 can be used to control the axial length of the user's eye. In some examples, in systems the same as or similar to the system 100 discussed above with respect to FIG1, method 300 can be used to indirectly apply red light to the user's eye by applying white light directly to the user's eyelids. The various steps of method 300 can be performed by devices the same as or similar to the device 200 discussed above with respect to FIG2.

[0049] Method 300 includes performing a white light intensification process at step 302. The intensity of white light applied to the user's eyelids during the white light intensification process may vary continuously (e.g., increase) or in a stepwise manner. During the white light intensification process, the intensity of white light applied to the user's eyelids increases over a period of time. The duration of the white light intensification process may range from about 1 minute to about 10 minutes, from about 2 minutes to about 5 minutes, about 2 minutes, about 3 minutes, or about 4 minutes, etc. In some examples, the wavelength of the white light applied to the user's eyelids may be changed during the white light intensification process at step 302. For example, a shorter wavelength of light may be applied at the beginning of the white light intensification process, and a longer wavelength of light may be applied at the end of the white light intensification process, and vice versa. The white light intensification process at step 302 is optional and may be omitted in some examples.

[0050] In some examples, method 300 may be performed on the user while the user is sleeping. Therefore, the white light intensification process at step 302 can be applied without requiring additional time investment from the user. This improves user compliance. The white light intensification process at step 302 allows the light intensity applied to the user's eyelids to increase over time, rather than increasing abruptly, thereby preventing the user from being subjected to light exposure shock. Furthermore, this can help prevent the user from waking up when receiving a dose of white light at step 304.

[0051] In step 304, a dose of white light is applied to the user's eyelids. When this dose of white light is applied to the user's eyelids, some of the white light is absorbed by the user's eyelids, and some of the white light is transmitted through the user's eyelids to the user's eyes. Light with red wavelengths (e.g., light with wavelengths in the range of about 600 nm to about 650 nm or in the range of about 600 nm to about 680 nm) has the highest transmittance through the human eyelids, where the transmittance is about 5%. Therefore, when this dose of white light is applied to the user's eyelids, a dose of red light is applied to the user's eyes.

[0052] The dose of white light applied to the user's eyelids may include a specific range of light wavelengths, which may be modifiable. As an example, different wavelength ranges of light may be applied to the user's eyelids based on the detected effect of the light on the user's eyes. The white light may be generated by a white LED or other light source, or a combination of colored light sources.

[0053] In some examples, white light may be applied to the user's eyelids at the following luminances: about 1,000 lux, about 10,000 lux, about 32,000 lux, about 1,000 lux to about 50,000 lux, about 1,000 lux to about 5,000 lux, about 5,000 lux to about 15,000 lux, about 25,000 lux to about 35,000 lux, etc.The brightness of the red light transmitted to the user's eye through the user's eyelids may be about 5% of the brightness of the white light applied to the user's eyelids. In some examples, the red light applied to the user's eye may be applied at the following brightness levels: about 50 lux, about 500 lux, about 1,600 lux, about 50 lux to about 2,500 lux, about 50 lux to about 250 lux, about 250 lux to about 750 lux, about 1,250 lux to about 1,750 lux, etc.

[0054] The duration of the white light application in step 304 may be in the range of about 2 minutes to about 3 minutes, about 3 minutes, etc. The duration of the white light application in step 304 may be in the range of about 2 minutes to about 4 minutes, about 150 seconds to about 210 seconds, about 1 minute to about 10 minutes, about 1 minute to about 3 minutes, about 2 minutes to about 5 minutes, or about 3 minutes.

[0055] Direct exposure of the eyes to red light may be associated with a variety of potential health problems. For example, direct exposure to red light can cause retinal burns. White light is cooler than red light, and therefore, applying white light instead of red light avoids problems such as retinal burns. Furthermore, the user's eyelids help scatter incident light, which also helps prevent retinal burns and associated health problems.

[0056] Method 300 includes performing a white light ramp-down process at step 306. The intensity of white light applied to the user's eyelids during the ramp-down process can vary continuously (e.g., decrease) or in a stepwise manner. During the ramp-down process, the intensity of white light applied to the user's eyelids decreases over a period of time. The duration of the ramp-down process can range from about 5 minutes to about 20 minutes, from about 8 minutes to about 12 minutes, from about 1 minute to about 30 minutes, and from about 5 minutes, about 10 minutes, about 15 minutes, etc. In some examples, the wavelength of the white light applied to the user's eyelids can be changed during the ramp-down process at step 306. For example, a shorter wavelength of light can be applied at the beginning of the white light fading process, and a longer wavelength of light can be applied at the end of the white light fading process, and vice versa. The white light fading process in step 306 is optional and can be omitted in some examples.

[0057] In some examples, method 300 can be performed on the user while the user is sleeping. Therefore, the white light fading process at step 306 can be applied without requiring additional time investment from the user. This improves user compliance. The white light fading process in step 306 allows the light intensity applied to the user's eyelids to decrease over time rather than immediately, thereby preventing the user from being exposed to light shock. Furthermore, this can encourage the user to continue sleeping after receiving that dose of white light at step 304.

[0058] In step 308, characteristics of the user's eyes are detected by a sensor. This sensor may be the same as or similar to the sensor 208 discussed above with respect to FIG. 2.Characteristics of the user's eye may include pupil diameter, choroidal thickness, axial length, scleral length, pressure applied to the eye by the white light therapy device, choroidal and retinal vascular characteristics, etc.

[0059] Although step 308 is illustrated as being performed after steps 302-306, step 308 may be performed at any appropriate time during the entire process of applying white light therapy to the user. For example, the measurement of step 308 may be performed before the gradual intensification process of step 302, during the gradual intensification process of step 302, after the gradual intensification process of step 302 and before the white light exposure of step 304, during the white light exposure of step 304, after the white light exposure of step 304 and before the gradual de-emergence process of step 306, during the gradual de-emergence process of step 306, after the gradual de-emergence process of step 306, or any combination thereof. The gradual increase in intensity of step 302, the white light exposure in step 304, the gradual decrease in intensity of step 306, the number of white light doses administered daily or weekly, etc., can all be varied based on the measurements determined in step 308. In a particular example, step 308 is used to measure the axial length of the user's eye, which is performed after the gradual increase in intensity of step 302 (referred to as the baseline axial length), before the white light exposure in step 304, at the end of the white light exposure in step 304, and from time to time during the gradual decrease in intensity of step 306 (e.g., at 3, 6, and 9 minutes into the gradual decrease in intensity of step 306).

[0060] In some examples, step 308 can be used to measure the user's pupil size. It has been found that a user's eyes respond synchronously to light, wherein both eyes contract and dilate to approximately the same degree when exposed to light. Therefore, one of the user's eyelids may be exposed to white light while the other eye remains open and not exposed to white light. The diameter of a user's open pupil can be detected and measured, thereby approximating the pupil size of the user's eyes exposed to white light. Therefore, the pupil size can be tracked when a user's eyes are exposed to white light.

[0061] In some examples, step 308 can be used to measure various eye characteristics while performing steps of method 300. In an example where step 308 is used to measure the pressure applied to the user's eye by the white light therapy device, a pressure sensor can be used to measure the pressure applied by the white light therapy device. The tightness of the strip of the white light therapy device can be adjusted based on the measured pressure applied to the user's eye. During method 300, and especially when performing steps of method 300 on a user, characteristics of the user's eye can be measured using optical coherence tomography (OCT), optical low coherence reflection measurement (OLCR), etc. For example, OCT or OLCR can be used to measure the axial length of the user's eye during method 300. In some examples, infrared light can be applied during detection in step 308 to aid in the detection of characteristics of the user's eye.

[0062] In step 310, the applied white light dose is adjusted in response to the eye characteristics detected in step 308. This may include changing the duration of steps 302-306, changing the wavelength of the white light applied during steps 302-306, changing the intensity of the white light applied during steps 302-306, changing the number of times method 300 is performed daily or weekly, stopping the performance of method 300, extending the performance of method 300 (e.g., for a longer period than initially suggested), etc. Step 310 may be used to change the performance of method 300 in the current round or to change the performance of method 300 in subsequent rounds.

[0063] Method 300 may be repeated a set number of times daily, weekly, etc. For example, method 300 may be repeated twice daily, five times weekly, for a period of at least one month. However, method 300 may be repeated more or less daily or weekly for a period sufficient to correct the user's eye condition (e.g., myopia). In some examples, all doses of white light applied by method 300 can be applied while the user is sleeping. For example, two doses of white light can be applied to the user while the user is sleeping, with a period of at least about 4 hours between the doses. This allows for the application of multiple doses with only a single wearing event by the user, and improves user compliance compared to methods that require the user to perform multiple actions. Furthermore, method 300 can be implemented while the user is sleeping without requiring the user to invest time, thereby further improving user compliance.

[0064] Examples Example 1 The transmittance of light through the eyelid at various wavelengths can be estimated experimentally. In a study using 27 subjects, an equation was derived to estimate the logarithmic transmittance through the eyelid: log(Tλ) = 0.739 xlog(Aλ) + 1.368 xlog(Bλ) + 2.643 xlog(Cλ) + dlog(Dλ) - log (0.828) Equation 1 Instruction Manual 7 / 12 Page 10 CN 121548399 A Where: Tλ is the transmittance value at wavelength λ; Aλ is the transmittance value of deoxyhemoglobin at wavelength λ; Bλ is the transmittance value of oxyhemoglobin at wavelength λ; Cλ is the transmittance value of melanin at wavelength λ. Furthermore, although melanin absorbance is the main cause of differences in external skin reflectance, its modeled effect on eyelid transmittance did not vary significantly among subjects; therefore, skin pigmentation had no significant effect on eyelid spectral transmittance. The last term of the equation, -log (0.828), represents the scattering constant of non-spectrally absorbing macromolecules.

[0065] This relationship provides a calculated average estimate of 9% for the transmittance through the eyelid at 630 nm, compared to 9% and 8.5% at 630 nm, respectively, as shown in Figure 4.In this study, it was assumed that the average transmittance level through the eyelid in the 600–650 nm range was approximately 5%.

[0066] Example 1: Irradiation with eyes open and closed For the purposes of this study, a clinical slit lamp was used to provide illumination. Since the slit lamp utilizes a halogen lamp to provide illumination, a high power setting was used and equilibrium was allowed to be reached in order to provide a stable luminous flux over time, and then a combination of neutral density filters was used to achieve the target illumination flux.

[0067] To ensure maximum eyelid light exposure, participants were instructed to gently keep their left upper eyelid closed by placing their fingers adjacent to the base of their eyelashes. Investigators then confirmed that the light source was not blocked by the participants' fingers and that the retina was filled with the brightest possible light. The white light intensity was estimated to be 5% of the light intensity in the 600–650 nm range illuminating the closed eyelid.

[0068] As shown in Figure 5, additional LEE 781 'Terry Red' filters were used on the neutral density filters to create red light-opening conditions. These filters remove almost all short-wavelength spectra and have relatively steep cutoff characteristics around 600 nm.

[0069] Table 1 Study subjects and test schemes: The following studies used six test subjects, four of whom had previously participated in separate red light studies. The participants' mean age was 33 ± 3 years, and their mean spherical equivalent (SER) measurements were: • 3 cases of emmetropia, with a mean SER of 0.16 ± 0.38 D (range -0.25 to 0.50 D) • 3 cases of myopia, with a mean SER of -2.04 ± 1.09 D (range -1.12 to -3.25 D) To match the commercially available RLRL treatment device, the participants' left eyes were exposed to either red light (eyes open) or white light (eyes closed, through the eyelids) test fields for 3 minutes. The right eye was then covered for both Lenstar and OCT measurements. The visit involved exposure to two different light conditions. To minimize potential cross-effects, a 30-minute interval was maintained between the last ocular measurement under the first light condition and the baseline measurement under the second light condition.

[0070] At baseline, and immediately after exposure to full-field light for 3 minutes and then for 10 minutes thereafter, the axial length (AxL) of the left eye was measured first, followed by the choroidal thickness (ChT). The axial length was determined using the Lenstar system, which uses optical low coherence tomography (OLCR) to determine various measurements of the ocular system to measure the axial length parameter of the eye. The choroidal thickness was determined by measuring the anterior anatomical features of the eye using optical coherence tomography (OTC). Baseline measurements were collected after a 10-minute washout period of watching a grayscale movie at a distance of 4 m.During ocular measurements, the right eye was covered, but the left eye remained open for pupillary recording while exposed to light.

[0071] Light conditions were tested on separate days in random order and included: • White light at low, medium, and high intensities through the eyelids • Broadband red light at low, medium, and high intensities through the open eye Example 2 Pupil constriction: Directly measuring the pupil size of the exposed eye behind the closed eyelids is problematic. Infrared backlighting through the skull has been effectively used in animals to measure pupil size through the eyelids, but there are no reports of this method being successfully tested in humans.

[0072] One way to obtain an accurate estimate of the direct pupil size behind the closed eyelids is to measure the pupil size of the contralateral eye, since the pupils of both eyes respond synchronously to light (i.e., both eyes constrict and dilate to approximately the same degree). The pupil size of the contralateral eye is measured using a handheld pupil meter as soon as light enters the closed eye. As part of the preliminary red light study, it was determined that for every millimeter decrease in pupil size in the exposed eye, there was a decrease of 0.93 millimeters in the contralateral eye.

[0073] The baseline pupil size of the contralateral eye was measured in the experimental setup before light stimulation. The pupil size of the contralateral eye was measured again using a handheld pupillometer as soon as light entered the eye. As expected, light intensity had a significant main effect on the percentage change in pupil size relative to baseline (p<0.001).

[0074] The degree of pupillary constriction was similar under both white light (through the eyelids) and red light with the eyes open, but the type of light had a significant main effect on pupillary constriction (p<0.001). This occurred because the overall constriction was greater under open-eye conditions than under white light with the eyelids through. This suggests that the initially estimated approximately 5% transmittance through the eyelids was too high (less light is transmitted through the eyelids), or that a slight difference in the wavelength reaching the retina (through the eyelids compared to a broadband red filter with the eyes open) affected pupillary constriction. Any one or two factors may cause differences in pupillary constriction (5% to 10%).

[0075] As shown in Figures 6A and 6B, for white light transmitted through the eyelids (low, medium, and high white light intensities), pupillary constriction was observed to be 9.2%, 20.8%, and 25.4% relative to its baseline value, respectively, while for open eyes under red light illumination (low, medium, and high red light intensities), pupillary constriction was observed to be 17.7%, 26.32%, and 28.5%, respectively.

[0076] Example 3 Axial length: The average baseline axial length (AxL) was 24.00 ± 0.58 mm. The baseline AxL did not change significantly with light conditions (p = 0.399) or light intensity (p = 0.942).Furthermore, no significant light-intensity interaction was observed in the baseline AxL measurement (p = 0.445), indicating that: ● AxL measurements were not confounded by the response to previous light conditions ● Potential light-induced AxL changes decayed within 40 minutes after 3 minutes of light exposure ● Light conditions had a significant effect on AxL changes (p = 0.016), while no significant effect was found on light intensity, time, or their interaction (all p > 0.05). The main effect of light (p = 0.016) is shown in Figure 7, which represents the average change at three light intensity levels and at 0 and 10 minutes post-exposure. For the average axial length change at 0 and 10 minutes post-exposure, the light-intensity interaction was p = 0.186 (see Figure 8), with the largest effect observed for moderate-intensity white light irradiation. The light-intensity-time interaction was not significant at 0 min and 10 min post-exposure, corresponding to p = 0.764 (Figs. 9A and 9B).

[0077] Example 4 Subfoveal choroidal thickness: The mean (±SEM) baseline subfoveal choroidal thickness (SFCT) was 287 ± 26 µm. Although the baseline SFCT did not change significantly with light conditions (p = 0.369), there was a significant main effect of intensity (p = 0.013) and a significant interaction between intensity and light (p = 0.04). Post-hoc testing revealed that the main reason for these significant effects was that the baseline SFCT under moderate white light conditions was significantly thinner than that under high white light conditions.

[0078] Given that the order of the test conditions was randomized and that for any participant, moderate white light conditions never preceded high white light conditions in a single trial, the significant light-intensity interaction is unlikely to be attributed to any residual effects. However, the statistical analysis incorporated both the absolute change in SFCT relative to baseline and the percentage change in SFCT to mitigate the potential impact of baseline SFCT variability on observed light-induced changes.

[0079] To assess these, a linear mixture model (LMM) statistical analysis was applied. A linear mixture model is an extension of the simple linear model to allow for both fixed and random effects, and is particularly useful when the data exhibit non-independence (such as that arising from hierarchical structures).

[0080] The LMM analysis of the absolute change in SFCT relative to baseline revealed a significant light-intensity interaction (p = 0.005). The LMM analysis of the percentage change in SFCT also revealed a significant main effect of intensity (p = 0.033) and a significant light-intensity interaction (p = 0.004).Given that the two statistical methods yielded similar findings, only the results of the absolute changes in SFCT are presented.

[0081] A significant light-intensity interaction was found for the average changes in SFCT at 0 and 10 minutes post-exposure (p = 0.005) (see Figure 10). The light-intensity-time interaction was not significant (p = 0.764) (see Figures 11A and 11B). LMM analysis of the percentage change in foveal lumen thickness (FLT) revealed a significant light-intensity interaction (p = 0.019) (see Figure 12).

[0082] LMM analysis of the percentage change in foveal lumen thickness (FLT) also revealed a near-significant light-intensity interaction (p = 0.139) (see Figure 12).

[0083] Examples Conclusion The aim of these studies was to investigate the short-term effects of white light exposure through the eyelids compared to direct broadband red light exposure on the axial length of the eye and changes in vascularity and thickness of the choroid.

[0084] The light levels used to deliver white light through the eyelids were selected to produce estimated light levels of 1600 lux (equivalent to eyeising), 500 lux, and 55 lux on the corneal plane. Broadband red light was used as a control condition with the eyes open, with light intensity levels similar to those of the white light condition through the eyelids (1600 lux, 500 lux, and 55 lux, see specification 10 / 12 pages 13 CN 121548399 A).

[0085] The change in pupil size was slightly greater under the open-eye condition compared to the broadband red light condition with the eyes open, when comparing the white light through the eyelids (measured from the contralateral eye). This indicates that the retinal illuminance level was slightly higher under the open-eye red filter condition.

[0086] The baseline axial length and choroidal thickness measured before each condition were similar and did not differ significantly over time. This indicates that the 40-minute delay used in the protocol between testing the six different light conditions was sufficient to allow the effects of the last tested light condition to dissipate.

[0087] Changes in axial length and subfoveal choroidal thickness after exposure to the six light conditions followed similar patterns and showed statistical correlation.

[0088] High-intensity and low-intensity white light passing through the eyelids, as well as all broadband (low, medium, and high) intensity red light, produced the smallest changes in axial length and choroidal thickness. However, medium-intensity white light passing through the eyelids (10,000 lux at the eyelids and approximately 500 lux at the cornea) was consistently the most effective in reducing axial length and thickening the choroid, producing a greater effect than that seen under open-eye red light irradiation as used in prior art devices.

[0089] Although the above embodiments have been described with reference to specific types of ophthalmic lenses, characteristic shapes, characteristic materials, layers, and other parameters, any suitable type of parameter can be incorporated into ophthalmic lenses according to the principles of this disclosure. Therefore, any number of features, shapes, or layers can be used according to the principles described herein. Furthermore, various types of materials with different optical refractive properties can be used to manufacture ophthalmic lenses. Additionally, ophthalmic lenses can be made from different materials to achieve optimal adhesion, spacing, attachment, optical properties, or other types of characteristics.

[0090] Terms referenced in the claims shall be given their usual and customary meaning, as determined by reference to relevant entries in widely used general dictionaries and / or relevant technical dictionaries, meanings generally understood by those skilled in the art, etc. It shall be understood that the claim terms shall be given the broadest meaning conferred by any one or combination of these sources (e.g., two or more relevant dictionary entries shall be combined to provide the broadest meaning of the combination of entries), subject only to the following exceptions: (a) if a term is used more broadly than its usual and customary meaning, then the term shall be given its usual and customary meaning plus an additional broad meaning; or (b) if a term has been explicitly defined to have a different meaning by reference to a term followed by the phrase “as used herein, shall mean” or similar language (e.g., “the term here means,” “as defined herein,” “for the purposes of this disclosure,” etc.).

[0091] Reference to specific examples, use of “that is,” use of the word “invention,” etc., are not intended to invoke exception (b) or otherwise limit the scope of the referenced claim terms. Except where exception (b) applies, nothing contained herein shall be construed as a waiver or denial of the scope of the claims.

[0092] The subject matter recited in the claims is not identical to any particular embodiment, feature, or combination of features shown herein, nor should it be construed as identical to any particular embodiment, feature, or combination of features shown herein. This conclusion still holds even if only a single embodiment having a particular feature or combination of features is illustrated and described herein. Therefore, the appended claims should be interpreted in the broadest possible sense in accordance with the meaning of the prior art and the terminology of the claims.

[0093] As used herein, spatial or directional terms such as “left,” “right,” “front,” “back,” etc., are related to the subject matter shown in the drawings. However, it should be understood that the subject matter described may present a variety of alternative orientations, and therefore such terms should not be considered restrictive.

[0094] Articles such as “the,” “an,” and “a” may imply singular or plural.Additionally, the word “or” should be interpreted as inclusive when used without preceding “or” (or other similar language indicating that “or” explicitly means exclusive – e.g., only one of x or y, etc.) (e.g., “x or y” means one or both of x or y).

[0095] The term “and / or” should also be interpreted as inclusive (e.g., “x and / or y” means one or both of x or y). Where “and / or” or “or” is used as a conjunction for a group of three or more items, the group should be interpreted as including a single item, all items together, or any combination of items or any number of items. Furthermore, terms such as have, having, include, and including as used in the specification and claims should be interpreted as synonymous with the terms comprise and comprising.

[0096] Unless otherwise specified, all numbers or expressions used in the specification (other than the claims), such as those describing dimensions, physical properties, etc., should be understood to be modified by the term "approximately" in all cases. To a minimum and without attempting to limit the application of the doctrine of equivalence to the claims, each numerical parameter described in the specification or claims that is modified by the term "approximately" should be interpreted at least according to the number of significant digits stated and by applying customary rounding.

[0097] All scopes disclosed herein should be understood to cover and support claims that state: any and all sub-scopes or any and all individual values ​​contained therein. For example, the enumerated range of 1 to 10 should be considered to include and support claims that state: any and all sub-scopes or individual values ​​between the minimum value 1 and the maximum value 10 and / or including end values; that is, all sub-scopes that begin with a minimum value 1 or greater and end with a maximum value 10 or less (e.g., 5.5 to 10, 2.34 to 3.56, etc.), or any value from 1 to 10 (e.g., 3, 5.8, 9.9994, etc.).Instruction manual, page 12 / 12, 15 CN 121548399 A, Figure 1, Figure 2; Instruction manual, Figure 1 / 15, page 16 CN 121548399 A, Figure 3; Instruction manual, Figure 2 / 15, page 17 CN 121548399 A, Figure 4; Instruction manual, Figure 3 / 15, page 18 CN 121548399 A, Figure 5; Instruction manual, Figure 4 / 15, page 19 CN 121548399 A, Figure 6A; Instruction manual, Figure 5 / 15, page 20 CN 121548399 A, Figure 6B; Instruction manual, Figure 6 / 15, page 21 CN 121548399 A, Figure 7; Instruction manual, Figure 7 / 15, page 22 CN 121548399 A, Figure 8; Instruction manual, Figure 8 / 15, page 23 CN 121548399 A, Figure 9A; Instruction manual, Figure 9 / 15, page 24 CN 121548399 A, Figure 9B. Figure 10 on page 10 / 15 of the instruction manual, CN 121548399 A; Figure 11A on page 11 / 15 of the instruction manual, CN 121548399 A; Figure 11B on page 12 / 15 of the instruction manual, CN 121548399 A; Figure 12 on page 13 / 15 of the instruction manual, CN 121548399 A; Figure 13 on page 14 / 15 of the instruction manual, CN 121548399 A; Figure 13 on page 15 / 15 of the instruction manual, CN 121548399 A.

Claims

1. A method for controlling an axial length of a user’s eye, the method comprising: applying a dose of white light to a user’s eyelid; detecting an effect of the applied white light on the user’s eye; and adjusting the applied white light based on the detected effect.

2. The method of claim 1, wherein applying the dose of white light to the user’s eyelid applies a dose of red light to the user’s eye, the red light having a wavelength in a range of 600 nm to 650 nm.

3. The method of claim 1, wherein the detected effect of the applied white light is the axial length of the user’s eye.

4. The method of claim 1, further comprising applying white light having a gradually increasing intensity prior to applying the dose of white light.

5. The method of claim 1, further comprising applying white light having a gradually decreasing intensity after applying the dose of white light.

6. The method of claim 1, further comprising detecting a pupil diameter of the user’s other eye while applying the white light to the user’s eye.

7. The method of claim 6, further comprising adjusting the applied white light based on the detected pupil diameter of the user’s eye.

8. The method of claim 1, further comprising detecting a pressure applied from a white light source to the user’s eye during the application of the white light.

9. The method of claim 8, further comprising adjusting a tightness of a strap configured to hold the white light source on a user’s head in response to the detected pressure.

10. The method of claim 1, wherein the white light is applied to the user while the user is in a sleep state.

11. The method of claim 1, wherein the applied dose of white light has an illuminance in a range of 30,000 lux to 35,000 lux.

12. The method of claim 1, wherein the applied dose of white light is applied for a duration in a range of 2 minutes to 3 minutes.

13. A system configured to apply red light through a user’s eyelid to a user’s eye, the system comprising: a white light source; a sensor configured to detect an axial length of a user’s eye; and a controller configured to vary the white light source based on the detected axial length of the user’s eye.

14. The system of claim 13, wherein the sensor detects the axial length of the user’s eye using optical low coherence reflectometry.

15. The system of claim 13, wherein the sensor detects the axial length of the user’s eye using optical coherence tomography (OCT).

16. The system of claim 13, wherein the sensor is configured to direct infrared light toward the user’s eye.

17. The system of claim 13, further comprising: a device housing that houses the white light source, the sensor, and the controller; and a strap configured to hold the system on a user’s head. ​ ​ ​ 18. The system of claim 13, further comprising a pressure sensor configured to detect a pressure applied by the device housing to the user’s eye, wherein the strap is adjustable based on the pressure detected by the pressure sensor.

19. A device, comprising: a device housing, the device housing comprising: a white light source configured to apply white light to a user’s eyelid; and a sensor configured to detect a characteristic of an eye; and a strap coupled to the device housing and configured to hold the device housing on a user’s head.

20. The device of claim 19, wherein: the sensor is a pressure sensor; the sensor is configured to detect a pressure applied by the device to an eye; and the strap is configured to adjust based on the detected pressure.

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