Methods for halting the progression of macular degeneration and treating macular degeneration using violet light and the instruments used for the same purpose.

Abstract

Invention details;

Description

Method for inhibiting progression of retinal degeneration and for treating it using violet light, and device used therefor

[0001] The present invention relates to a method for treating diseases using light stimulation and an apparatus used therefor, and more specifically to a method for treating retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration using light stimulation in which light in a specific wavelength range, such as violet light, is irradiated at a constant light level or at a specific flashing frequency, and an apparatus used therefor.

[0002] Causes of retinal degeneration include age-related macular degeneration (AMD) and hereditary retinal degeneration. Age-related macular degeneration (AMD) is a leading cause of blindness in developed countries and is classified into two types: exudative, characterized by choroidal neovascularization in the macula (the central part of the retina), and atrophic, characterized by geographic atrophy lesions in the macula and associated photoreceptor cell loss. For exudative AMD, intravitreal injection of anti-vascular endothelial growth factor (VEGF) antibodies is the standard treatment, but permanent cure is difficult and requires repeated administration over a long period of time. For exudative AMD, invasive treatment (intravitreal injection) and its associated complications (e.g., endophthalmitis) and side effects (e.g., cerebral infarction) have also become problematic. Meanwhile, no effective treatment has yet been established for atrophic AMD. Therefore, there is a need for a more non-invasive treatment for exudative AMD and an effective treatment for atrophic AMD. Examples of hereditary retinal degenerations include retinitis pigmentosa, macular dystrophies including Stargardt disease, cone-rod dystrophy, Leber congenital amaurosis, etc. Currently, gene replacement therapy is being attempted for some hereditary retinal degenerations, but no fundamental treatment exists for most hereditary retinal degenerations, and the development of new treatments is desired.

[0003] The present inventors have recently published interesting reports on the effects of violet light on the eyes. For example, Patent Document 1 and Non-Patent Document 1 propose that light in a specific wavelength range is effective in preventing and suppressing myopia, and great expectations are being placed on this, given the ongoing global increase in the number of people with myopia. The effects of light on the human body have been studied from various perspectives in recent years, and reports have been published based on new findings. For example, it has been reported that exposure to sunlight improves circadian rhythms (Non-Patent Document 2), and that light emitted from LED lighting and liquid crystal displays that use LEDs as backlights has a significant effect on the body and mind (Non-Patent Document 3).

[0004] Hidemasa Torii et al., EBioMedicine, "DOI: http: / / dx.doi.org / 10.1016 / j.ebiom.2016.12.007". Megumi Hatori, Kazuo Tsubota, Anti-Aging Medicine - Journal of the Japanese Society of Anti-Aging Medicine, Vol. 11, No. 3, 065(385)-072(392), (2015). Kazuo Tsubota, "Blue Light: A Threat to the Biological Clock", Shueisha, published November 20, 2013.

[0005] WO2015 / 186723A1

[0006] One of the objectives of the present disclosure is to provide a new method for treating retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration, and a device used therefor. Objectives of the present disclosure include providing a method for treating retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration that does not involve invasive treatment (intravitreal injection) and its associated complications (endophthalmitis, etc.) or side effects (cerebral infarction, etc.). In particular, one of the objectives of the present disclosure is to provide a method for treating atrophic age-related macular degeneration and hereditary retinal degeneration, for which no effective treatments yet exist.

[0007] The present inventors have discovered that retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration can be treated and / or prevented by irradiating a subject (e.g., an eye) with light in a specific wavelength range, and have completed the present invention. That is, the present disclosure provides a method for treating and / or preventing retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration by irradiating a subject with light in a specific wavelength range. Preferably, the present disclosure provides a method for treating and / or preventing retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration by irradiating a subject with constant light or violet light (VL) flashing at a specific wavelength.

[0008] In one aspect, the present disclosure provides a method for treating and / or preventing retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, by controlling a light irradiation device to irradiate a subject with light in a specific wavelength range. In some embodiments, the light irradiation device includes a light source capable of irradiating a living body with light in a specific wavelength range at a constant light level or at a specific flashing frequency, and a control unit that controls the irradiation of the light source, for example, by controlling the flashing frequency. The present disclosure also includes a method for treating and / or preventing symptoms of retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, in a subject, by irradiating a subject with light in a specific wavelength range using the light irradiation device.

[0009] In another aspect, the present disclosure relates to a method for treating and / or preventing symptoms of retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, in a subject in need thereof, the method comprising irradiating the subject with light in a particular wavelength range. The subject to which the method of the present disclosure is applied may be a patient with retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration.

[0010] In yet another aspect, the present disclosure provides methods for treating and / or preventing conditions associated with retinal degeneration, particularly age-related macular degeneration and inherited retinal degeneration.

[0011] In yet another aspect, the present disclosure provides a replaceable component that is incorporated into or attached to the device or instrument described above.

[0012] In yet another aspect, the present disclosure provides a method or system for replacing, repairing, or maintaining the above-described devices, instruments, or components.

[0013] That is, the present disclosure is as follows.

[0014] [Item 1] A method for treating and / or preventing retinal degeneration, comprising irradiating a subject with light in a specific wavelength range using a light irradiation device. [Item 2] The method of Item 1, wherein the retinal degeneration is age-related macular degeneration or hereditary retinal degeneration. [Item 3] The method of Item 2, wherein the age-related macular degeneration is exudative or atrophic. [Item 4] The method of Item 2, wherein the age-related macular degeneration is accompanied by at least one symptom selected from the group consisting of decreased visual acuity, metamorphopsia, central scotoma, and complete blindness. [Item 5] The method of Item 4, wherein the at least one symptom selected from the group consisting of decreased visual acuity, metamorphopsia, central scotoma, and complete blindness is caused by age-related macular degeneration. [Item 6] The method of Item 2, wherein the factor of age-related macular degeneration is at least one selected from the group consisting of neovascularization volume, subretinal fluid volume, intraretinal edema volume, extent of geographic atrophy, and extent of photoreceptor layer loss. [Item 7] The method of Item 2, wherein the age-related macular degeneration is a precursor lesion or advanced age-related macular degeneration. [Item 8] The method of Item 1, wherein the light irradiation device comprises a light source capable of irradiating the subject with light in a specific wavelength range at constant light or a specific flashing frequency, and a control unit that controls the irradiation of the light source. [Item 9] The method of Item 1, wherein the subject is undergoing or has previously undergone treatment and / or prevention of retinal degeneration. [Item 10] The method of Item 1, wherein the specific wavelength range includes 360 to 400 nm. [Item 11] The method of Item 1, wherein the light is flashed at a flashing frequency of 30 to 70 Hz. [Item 12] The method of Item 1, wherein the light is irradiated during the day. [Item 13] The method of Item 1, wherein the light is irradiated for one hour or more. [Item 14] The light is irradiated so that the irradiance of the light irradiating the subject's eye is 0.5 to 1000 μW / cm ２The method of item 1, wherein the light irradiation device is light-emitting eyeglasses or eyeglass frames, a desktop light source, a mobile terminal-mounted light source, a face-mounted or nearby light source, a portable light source, an indoor light source, or a desk lamp. [Item 16] A device for treating and / or preventing retinal degeneration by irradiating a subject with light in a specific wavelength range. [Item 17] The device of item 16, wherein the light in the specific wavelength range is irradiated as a constant light or at a flashing frequency. [Item 18] The device of item 16, characterized in that the device has a control unit that controls the light irradiation. [Item 19] The device of item 18, wherein the control unit changes and executes at least one irradiation condition selected from the group consisting of the flashing frequency of the specific wavelength range, irradiance, irradiation time, irradiation start time, and irradiation end time, by transmitting and receiving information to and from an isolated controller such as a mobile terminal. [Item 20] The device of item 16, characterized in that the device has a light source and a drive circuit that drives the light source. [Item 21] The device of Item 20, wherein the drive circuit includes: at least one processor communicatively connected to a light source and at least one memory; and at least one memory for storing processor-executable instructions. [Item 22] The device of Item 16, wherein the retinal degeneration is age-related macular degeneration or hereditary retinal degeneration. [Item 23] The device of Item 22, wherein the age-related macular degeneration is for treating and / or preventing wet or dry age-related macular degeneration. [Item 24] The device of Item 22, wherein the age-related macular degeneration is accompanied by at least one symptom selected from the group consisting of decreased visual acuity, metamorphopsia, central scotoma, and complete blindness. [Item 25] The device of Item 24, wherein the at least one symptom selected from the group consisting of decreased visual acuity, metamorphopsia, central scotoma, and complete blindness is caused by age-related macular degeneration. [Item 26] The device according to Item 22, wherein the element of age-related macular degeneration is at least one selected from the group consisting of neovascularization volume, subretinal fluid volume, intraretinal edema volume, extent of geographic atrophy, and extent of photoreceptor layer loss. [Item 27] ​​The device according to Item 22, wherein the age-related macular degeneration is a precursor lesion or advanced age-related macular degeneration.[Item 28] The device according to Item 16, wherein the subject is undergoing or has undergone a method for treating and / or preventing retinal degeneration. [Item 29] The device according to Item 16, wherein the specific wavelength range includes 360 to 400 nm. [Item 30] The device according to Item 17, wherein the flashing frequency is 30 to 70 Hz. [Item 31] The device according to Item 16, wherein the light is irradiated during the day. [Item 32] The device according to Item 16, wherein the light is irradiated for one hour or more. [Item 33] The light is irradiated such that the irradiance of the light irradiating the subject's eye is 0.5 to 1000 μW / cm. ２[Item 34] The device according to Item 16, wherein the device is light-emitting eyeglasses or eyeglass frames, a tabletop light source, a mobile terminal-mounted light source, a light source installed in front of or near the face, a portable light source, an indoor light source, or a table lamp. [Item 35] The device according to Item 16, wherein light of another wavelength, sound, vibration, magnetic field, or electric field is also applied in addition to the irradiation of light in the specific wavelength range. [Item 36] A non-transitory computer-readable medium having instructions stored thereon, which, when executed by a processor, can perform the following steps: for the device according to any one of Items 16 to 35, which includes a light source capable of irradiating a living organism with light in a specific wavelength range at constant light or a specific flashing frequency, and a control unit that controls the flashing frequency of the light source, the control unit operating the device so that the flashing frequency of the light source is controlled to 0 Hz or in a range of 30 to 75 Hz, and the light source operating the device so that the living organism is irradiated with light in a wavelength range of 360 to 400 nm. [Item 37] An instrument for treating and / or preventing retinal degeneration by photostimulation, comprising glass, eyeglass lenses, or contact lenses that transmit violet light. [Item 38] A replaceable part that is built into or attached to the device according to Item 16. [Item 39] A replaceable part that is built into or attached to the instrument according to Item 37. [Item 40] A system for replacing, repairing, or maintaining the device according to Item 16. [Item 41] A system for replacing, repairing, or maintaining the appliance according to Item 37. [Item 42] A system for replacing, repairing, or maintaining the part according to Item 38 or 39. [Item 43] A method for replacing, repairing, or maintaining the device according to Item 16. [Item 44] A method for replacing, repairing, or maintaining the appliance according to Item 37. [Item 45] A method for replacing, repairing, or maintaining the part according to Item 38 or 39.

[0015] In addition, the present disclosure also includes content relating to the following methods. A method for treating and / or preventing retinal degeneration, comprising irradiating a subject with light in a specific wavelength range using a light irradiation device. The above method, wherein the light is violet light. The above method, wherein the specific wavelength range includes light with a wavelength of approximately 380 nm. The above method, wherein the flashing frequency is 35 to 60 Hz. The above method, wherein the flashing frequency is 40 Hz. The above method, wherein the light is irradiated continuously for one hour or more. The above method, wherein the light is irradiated continuously for two hours or more. The above method, wherein the subject is a human.

[0016] The present disclosure also includes content relating to the following devices. - A device for treating and / or preventing retinal degeneration by irradiating a subject with light in the specific wavelength range at constant light or a specific flickering frequency, the device having a light source that irradiates light in the specific wavelength range at constant light or a specific flickering frequency. - The device in which the light is violet light. - The device in which the specific wavelength range includes light with a wavelength of approximately 380 nm. - The device in which the flickering frequency is 35 to 60 Hz. - The device in which the flickering frequency is 40 Hz. - The device in which the light is irradiated continuously for one hour or more. - The device in which the light is irradiated so that the irradiance of the light striking the subject's eye is 0.5 to 1000 μW / cm ２ The above device irradiates the light so that the light is within the range of 100 to 2000 nm. The above device irradiates the light continuously for one hour or more.

[0017] 1 is an example of violet light glasses that emit violet light. 2 is a graph showing the relationship between the spectral irradiance and wavelength of violet fluorescent light. 3 is the light spectrum of an LED with a peak wavelength of 375 nm. 4 is a block diagram of one embodiment of a biological function control device according to the present invention. 5 is a graph showing the volume of choroidal neovascularization (CNV) measured for a control group and a violet light group in a test using a mouse choroidal neovascularization model. 6 is a graph showing the electroretinogram measurement results at each irradiation intensity in a test using a mouse light damage model. 7 is a graph showing the measurement results of the thickness of the retinal outer nuclear layer (ONL) and the length of photoreceptor outer segments (OS) in a test using a mouse light damage model.

[0018] Retinal degenerations to be treated and / or prevented according to the present disclosure include age-related macular degeneration and hereditary retinal degenerations, such as retinitis pigmentosa, macular dystrophies including Stargardt's disease, cone-rod dystrophy, and Leber's congenital amaurosis.

[0019] Age-related macular degeneration (AMD) to be treated and / or prevented according to the present disclosure is a disease in which abnormal degeneration occurs with age in the central part of the retina called the macula, resulting in a decline in visual function (visual acuity and visual field). The AMD to be treated and / or prevented according to the present disclosure includes exudative AMD and atrophic AMD. In exudative AMD, new blood vessels develop in the choroid below the macula and grow toward the retina. These new blood vessels are abnormal blood vessels not present in a normal retina, and because their vascular walls are fragile, they are prone to leakage of blood components and bleeding. These exudates impair macular function and cause visual impairment. On the other hand, atrophic AMD is a phenomenon in which macular tissues (retinal pigment epithelium and photoreceptor cells) atrophy and degenerate with age.

[0020] Specific symptoms of exudative age-related macular degeneration that can be treated and / or prevented by the present invention include decreased vision, metamorphopsia, central scotoma, and complete blindness. Central scotoma is a symptom of advanced exudative age-related macular degeneration. Complete blindness is a symptom that can occur when neovascularization cannot be controlled.

[0021] Specific symptoms of atrophic age-related macular degeneration that can be treated and / or prevented by the present invention include decreased vision, metamorphopsia, central scotoma, etc. Central scotoma is a symptom of advanced age-related macular degeneration.

[0022] Specific examples of factors of age-related macular degeneration that can be treated and / or prevented by the present invention include neovascularization volume, subretinal fluid volume, intraretinal edema volume, geographic atrophy extent, and photoreceptor layer loss extent.

[0023] In the context of the present disclosure, patients with age-related macular degeneration are classified into precursor lesions such as drusen and advanced exudative and atrophic age-related macular degeneration in terms of severity, and may include any of these.

[0024] When applying the method according to the present disclosure, the subject may be a patient who is currently undergoing or has previously undergone at least one treatment and / or prophylaxis for retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration. Treatments for wet age-related macular degeneration include photodynamic therapy (PDT), which involves administering a photosensitizer (Visudyne) into the body and then irradiating the lesion with laser light. Antibody treatments against VEGF are also included. Other treatments for age-related macular degeneration that have been used in the past include direct laser photocoagulation and surgical removal of neovascularization, but these are no longer used.

[0025] In applying the methods of the present disclosure, the subject may be a patient who is currently receiving or has previously received at least one anti-retinal degeneration drug, such as an anti-age-related macular degeneration drug.

[0026] Anti-age-related macular degeneration drugs include anti-VEGF antibodies (anti-angiogenic drugs) that suppress the growth of new blood vessels, as well as antibodies that simultaneously inhibit VEGF and angiopoietin-2. Note that anti-vascular endothelial growth factor (VEGF) antibodies are administered, for example, by intravitreal injection.

[0027] In one aspect, the present disclosure relates to a method for treating and / or preventing retinal degeneration, the method comprising irradiating a subject with light in a specific wavelength range using a light irradiation device. More specifically, the present disclosure relates to a method for treating and / or preventing retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, in a subject in need of such treatment and / or prevention, the method comprising irradiating a subject with light in a specific wavelength range using a light irradiation device.

[0028] In one aspect, the present disclosure relates to a method for treating and / or preventing choroidal neovascularization in a patient with age-related macular degeneration in need of such treatment and / or prevention, the method comprising irradiating the patient with light in a specific wavelength range. In some embodiments, the present disclosure relates to a method for treating and / or preventing age-related macular degeneration in a subject in need of such treatment and / or prevention, the method comprising irradiating the subject with light in a specific wavelength range, thereby treating and / or preventing choroidal neovascularization in the subject, thereby treating and / or preventing age-related macular degeneration in the subject. It is known that age-related macular degeneration causes choroidal neovascularization in the choroid under the macula in the center of the retina, and therefore, the treatment and / or prevention of choroidal neovascularization is thought to be important for the treatment and / or prevention of age-related macular degeneration.

[0029] In some embodiments, the light irradiation device includes a light source capable of irradiating a target with light in a specific wavelength range at a constant light level or at a specific flashing frequency, and a control unit that controls the irradiation of the light source.

[0030] In some embodiments, the light used is violet light.

[0031] In some embodiments, the specific wavelength range used includes 360-400 nm, and in particular about 380 nm.

[0032] In some embodiments, the flashing frequency used may be 0 Hz or 30-70 Hz, particularly 0 Hz or 35-60 Hz, and more particularly, for example, 0 Hz or about 40 Hz.

[0033] In some embodiments, the irradiation conditions further include the irradiation time of the light source, specifically, irradiation for one hour or more.

[0034] In some embodiments, the light is administered to a subject such that the irradiance of the light impinging on the subject's eye is between 0.5 and 1000 μW / cm ２ Irradiate so that the radiation intensity is within the range of

[0035] In some embodiments, the light source may be light-emitting eyeglasses or eyeglass frames, a tabletop light source, a mobile terminal-mounted light source, a face-mounted or nearby light source, a portable light source, a room light, or a desk lamp. Preferred light sources include light-emitting eyeglasses or eyeglass frames, a tabletop light source, a mobile terminal-mounted light source, a face-mounted or nearby light source, a portable light source, or a desk lamp. More preferred light sources include light-emitting eyeglasses or eyeglass frames, a tabletop light source, a mobile terminal-mounted light source, or a face-mounted or nearby light source. Even more preferred light sources include light-emitting eyeglasses or eyeglass frames, or a desklight source. Most preferred light sources include light-emitting eyeglasses or eyeglass frames.

[0036] In some embodiments, the subject to which the methods of the present disclosure are applied is a human.

[0037] In one aspect, the present disclosure relates to an apparatus for treating and / or preventing retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, by irradiating a subject with light in a specific wavelength range. More specifically, the present disclosure relates to an apparatus for treating and / or preventing retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, by light stimulation, comprising at least one light source that emits light and a drive circuit that drives the light source, wherein the light emitted by the light source is light in a specific wavelength range that, when irradiated to a living body, produces a therapeutic and / or preventive effect for retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration.

[0038] In one aspect, the present disclosure relates to an apparatus for treating and / or preventing the symptoms and / or other factors by irradiating a living body with the light emitted by the light source, the apparatus comprising at least one light source that emits light and a drive circuit that drives the light source.

[0039] In some aspects, the devices of the present disclosure include a driver circuit that includes at least one processor communicatively connected to the light source and at least one memory, and at least one memory for storing instructions executable by the processor.

[0040] In one aspect, the present disclosure relates to a method of operating a device according to the present disclosure, the device comprising: a light source capable of irradiating a living organism with light in a specific wavelength range at constant light or at a specific flashing frequency; and a control unit that controls the irradiation of the light source, for example, controlling the flashing frequency, the method including a step in which the control unit controls the flashing frequency of the light source to 0 Hz or in a range of 30 to 75 Hz; and a step in which the light source irradiates the living organism with light having a wavelength in a range of 360 to 400 nm.

[0041] In one aspect, the present disclosure relates to a computer program that causes an apparatus including a light source capable of irradiating a living body with light in a specific wavelength range at a constant light level or at a specific flashing frequency, and a control unit that controls the irradiation of the light source, for example, controls the flashing frequency, to execute an operating method according to the present disclosure.

[0042] In the method and device according to the present disclosure, the light is, for example, violet light. According to this invention, violet light with a wavelength outside the visible light range can be irradiated onto a living organism, thereby affecting the living organism without the flickering or glare that white light can cause. Violet light has a wavelength of 360 to 400 nm, which has a lower visual sensitivity than white light and is a wavelength range that does not or is unlikely to cause discomfort to living organisms (especially humans). In the method and device according to the present disclosure, it is preferable to irradiate the light during the daytime.

[0043] In some embodiments of the present disclosure, light having a wavelength in the range of 350 to 400 nm may be used, for example, light having a wavelength of 350 nm, 360 nm, 370 nm, 380 nm, 390 nm, or 400 nm, or light having any wavelength included in a range defined by any of the above wavelengths (e.g., the range of 370 to 390 nm). In some embodiments of the present disclosure, the wavelength includes approximately 380 nm. Note that the term "about" as used herein means that the value modified by the term includes values ​​within 5% of the value.

[0044] In the method and apparatus of the present disclosure, the illumination state of the light is constant (i.e., 0 Hz) or a flashing frequency of greater than 0 Hz to 150 Hz.

[0045] In some embodiments of the present disclosure, a steady light (0 Hz) or a light with a flashing frequency in the range of 30-75 Hz may be used, for example, any of 30 Hz, 35 Hz, 40 Hz, 45 Hz, 50 Hz, 55 Hz, 60 Hz, 65 Hz, 70 Hz, or 75 Hz, or any flashing frequency within the range defined by any of the above flashing frequencies (e.g., the range of 35-45 Hz). In some embodiments of the present disclosure, the flashing frequency is about 40 Hz.

[0046] In the method and apparatus according to the present disclosure, the light is, for example, irradiance of the light incident on the subject's eye is 0.5 to 1000 μW / cm ２ or within 0.1 μW / cm ２ (0.001 W / m ２ )~5000μW / cm ２ (50W / m ２ The irradiance of the light incident on the subject's eye can be within the range of 100 μW / cm ２ ~1000 μW / cm ２ According to some embodiments, it is believed that the macula can be affected by irradiating it with violet light or the like within the above irradiance range. It has generally been confirmed that violet light can cause characteristic phenomena even when it is a particularly small amount of weak light (light with low photosensitivity).

[0047] In the method and device according to the present disclosure, the control unit of the device can change and execute the illumination conditions, such as the illumination state (including constant light or flashing frequency), irradiance, illumination time, illumination start time, illumination end time, constant light or flashing frequency, etc., of the light by transmitting and receiving information to and from an isolated controller such as a mobile terminal. According to some embodiments, the above-mentioned various illumination conditions are controlled in isolation, so that the illumination conditions can be arbitrarily set to be suitable for producing a therapeutic / preventive effect on at least one symptom selected from the group consisting of reduced visual acuity, metamorphopsia, central scotoma, and complete blindness, thereby achieving the desired effect.

[0048] In the method and apparatus according to the present disclosure, the light source may be a light source installed in front of or near the face, such as light-emitting glasses (see, for example, FIG. 1 ), a spectacle frame, a tabletop light source, a light source attached to a mobile terminal, etc. According to some embodiments, specific light can be emitted from a light source installed in front of or near the face, such as light-emitting glasses or a spectacle frame, which is easy to wear and comfortable to wear on a daily basis, and therefore is highly practical and can be constantly irradiated in a variety of situations and environments.

[0049] In the methods and devices disclosed herein, the light source may be a non-stationary light source, such as a portable light source, or a stationary light source, such as a room lamp, a desk lamp, or a dedicated device. According to some embodiments, the device may have various light source forms depending on the environment in which it is used. For example, the light source may be used in combination with glass, eyeglass lenses, or contact lenses that transmit violet light. Alternatively, sunlight that has passed through glass, eyeglass lenses, or contact lenses that transmit violet light may be used as the light source.

[0050] The method of optical stimulation according to the present disclosure is a method for treating and / or preventing retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration by irradiating a living organism (e.g., a mammal, including a human) with light in a specific wavelength range at a constant light level or at a specific flashing frequency, and is characterized by controlling the emission of light that improves or suppresses symptoms in the living organism exposed to the light, i.e., at least one symptom selected from the group consisting of decreased vision, metamorphopsia, central scotoma, and complete blindness.

[0051] The device disclosed herein is a device for treating and / or preventing retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration by irradiating a living body with constant violet light, and is characterized by comprising a light source that emits the violet light, and an emission time control unit that irradiates the violet light for a specific time or for a specific period of time.

[0052] The present disclosure includes replaceable components built into or attached to a device or instrument. For example, the device or instrument of the present disclosure preferably maintains a consistent level of quality to effectively treat and / or prevent retinal degeneration. From the perspective of maintaining this quality, it is preferable to replace necessary components, preferably periodically. Examples of such components include a light source, a control unit that controls light emission, peripheral devices, and batteries. More specifically, examples of components include components whose performance or functionality deteriorates over time, such as an LED element as a light source, a control circuit, a memory, and a lithium secondary battery as a battery.

[0053] Furthermore, the present disclosure includes a maintenance method or system for replacing, repairing, or maintaining a device, instrument, or replaceable part. As described above, it is preferable that the device or instrument of the present disclosure always maintain a consistent quality so as to effectively treat and / or prevent retinal degeneration. Therefore, it is preferable to perform maintenance (checking the device or instrument), part replacement, or repair on the device or instrument, preferably periodic maintenance (checking the device or instrument), part replacement, or periodic repair. The present disclosure includes a method or system for performing such maintenance, part replacement, or repair, preferably periodic maintenance, part replacement, or repair. Such a method can include, for example, a method in which a sensor for sensing the condition of each part in the device or instrument is installed, and the maintenance, part replacement, or repair is performed according to the measurement results of the sensor.

[0054] Furthermore, as will be described below with reference to the drawings, some embodiments of the present disclosure provide a method for treating and / or preventing retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, in a subject in need of such treatment and / or prevention; a method for treating and / or preventing said symptoms, i.e., at least one symptom selected from the group consisting of decreased visual acuity, metamorphopsia, central scotoma, and complete blindness, in a subject in need of such treatment and / or prevention; a device for treating and / or preventing retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, by light stimulation; a device for treating and / or preventing said symptoms, i.e., at least one symptom selected from the group consisting of decreased visual acuity, metamorphopsia, central scotoma, and complete blindness by light stimulation; a method for operating the device; and a computer program for executing the operating method.

[0055] The present disclosure provides a method for treating and / or preventing retinal degeneration, such as age-related macular degeneration and hereditary retinal degeneration, in a subject in need of such treatment and / or prevention, a method for treating and / or preventing at least one symptom selected from the group consisting of decreased visual acuity, metamorphopsia, central scotoma, and complete blindness in a subject in need of such treatment and / or prevention, a device for treating and / or preventing retinal degeneration, such as age-related macular degeneration and hereditary retinal degeneration, using light stimulation, a device for treating and / or preventing at least one symptom selected from the group consisting of decreased visual acuity, metamorphopsia, central scotoma, and complete blindness, a method for operating the device, and a computer program for executing the method, which will be described with reference to the drawings. The present disclosure is not limited to the following embodiments and examples, and includes various modifications and applications within the scope of the gist of the present invention.

[0056] [Method for treating and / or preventing retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration] The method for treating and / or preventing retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration according to the present disclosure is characterized in that it includes irradiating a subject requiring treatment and / or prevention with light in a specific wavelength range.

[0057] The present inventors have discovered that irradiating a subject with light in a specific wavelength range can treat and / or prevent retinal degeneration, such as age-related macular degeneration and hereditary retinal degeneration, as indicated by, for example, a reduction in CNV (choroidal neovascularization) volume. Accordingly, one aspect of the present disclosure relates to a method for treating and / or preventing retinal degeneration, such as age-related macular degeneration and hereditary retinal degeneration, in a subject in need of such treatment and / or prevention, the method comprising irradiating the subject with light in a specific wavelength range. In some embodiments, irradiating the subject with light in a specific wavelength range inhibits CNV (choroidal neovascularization). Accordingly, one aspect of the present disclosure relates to a method for inhibiting CNV (choroidal neovascularization) in a subject in need of such treatment and / or prevention, the method comprising irradiating the subject with light in a specific wavelength range. Here, the subject may be a human suffering from retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, or at risk of developing retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration.

[0058] As mentioned above, symptoms of age-related macular degeneration include decreased visual acuity, metamorphopsia, central scotoma, and complete blindness.

[0059] In diagnosing age-related macular degeneration, a comprehensive assessment is made by combining fundus examination, optical coherence tomography (OCT), and fluorescein angiography to distinguish between age-related macular degeneration and other diseases.

[0060] Patients with age-related macular degeneration can be classified into precursor lesions such as drusen and progressive exudative and atrophic age-related macular degeneration based on severity. Age-related macular degeneration is evaluated by a comprehensive assessment combining fundus examination, optical coherence tomography (OCT), and fluorescein angiography, with optical coherence tomography (OCT) being the most commonly used method due to its minimal invasiveness and excellent quantitative properties.

[0061] As described above, one aspect of the present disclosure relates to a method for treating and / or preventing retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, in a subject in need thereof, the method comprising irradiating the subject with light in a specific wavelength range, and the method may comprise irradiating the subject with light in a specific wavelength range to improve or prevent the symptom in the subject, i.e., at least one symptom selected from the group consisting of reduced visual acuity, metamorphopsia, central scotoma, and complete blindness, thereby treating and / or preventing retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, in the subject.

[0062] Currently, the main treatment for exudative age-related macular degeneration is intravitreal injection of anti-vascular endothelial growth factor (VEGF) antibodies. Drugs used include anti-VEGF antibodies (anti-angiogenic drugs) that suppress the growth of new blood vessels, as well as VEGF and angiopoietin-2 co-inhibitory antibodies. Therefore, the therapeutic and / or preventive methods according to the present disclosure can be performed on patients who are currently receiving or have previously received these drugs. The therapeutic and / or preventive methods according to the present disclosure may also be performed in combination with the administration of these drugs.

[0063] It has been revealed that CNV (choroidal neovascularization) is observed in the choroid under the macula in the central part of the retina in patients with age-related macular degeneration. The present inventors have found that CNV (choroidal neovascularization) in the choroid under the macula in the central part of the retina can be suppressed by irradiating a subject with light in a specific wavelength range. Therefore, one aspect of the present disclosure relates to a method for suppressing or ameliorating CNV (choroidal neovascularization) in the choroid under the macula in the central part of the retina in patients with age-related macular degeneration, the method comprising irradiating a subject with light in a specific wavelength range.

[0064] In some embodiments of the method according to the present disclosure, the light used may be violet light. Furthermore, in some embodiments of the method according to the present disclosure, specific wavelengths used may include 360 ​​to 400 nm, and particularly approximately 380 nm. The flashing frequency may be, for example, 0 Hz or 30 to 70 Hz, and particularly 0 Hz or 35 to 60 Hz. The flashing frequency may particularly be 0 Hz or approximately 40 Hz. The illumination conditions may further include the duration of illumination of the light source. The light source may be, but is not limited to, light-equipped eyeglasses or eyeglass frames, a tabletop light source, such as a bedside table lamp or reading lamp, a desk lamp, a mobile terminal-mounted light source, a face-mounted or near-face light source, a portable light source, room lighting, a wall lamp, a ceiling light, or a desk lamp.

[0065] In some embodiments of the present disclosure, the specific time for light irradiation can be any time in a range of 10 seconds to 24 hours per day, for example, 10 seconds, 30 seconds, 45 seconds, 1 minute, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, 12 hours, 18 hours, 24 hours, or any time included in a range defined by any of the above times (e.g., a range of 1 to 12 hours). The specific period for which light irradiation is continued can be, for example, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 2 years, 3 years, or longer.

[0066] In some embodiments of the present disclosure, in addition to irradiating the light in the specific wavelength range, irradiation with light from a fluorescent lamp or the like may be performed. The color temperature of the light irradiated by the fluorescent lamp or the like is, for example, 2600 to 7100 Kelvin, such as 4600 to 5500 Kelvin. The time period during which irradiation with light from the fluorescent lamp or the like is performed is, for example, 7:00 AM to 9:00 PM, 8:00 AM to 8:00 PM, or 9:00 AM to 7:00 PM. The time period during which irradiation with light from the fluorescent lamp or the like is performed is, for example, 9 to 15 hours, 10 to 14 hours, or 11 to 13 hours per day. The time period during which both the light in the specific wavelength range and the light from the fluorescent lamp or the like are irradiated is, for example, 1 to 5 hours, or 2 to 4 hours per day. For each day, irradiation with light from the fluorescent lamp or the like may be performed before irradiating the light in the specific wavelength range per day. The duration of light irradiation by a fluorescent lamp or the like before irradiation with light in the specific wavelength range per day is, for example, 6 to 12 hours, 7 to 11 hours, or 8 to 10 hours per day. For each day, light irradiation by a fluorescent lamp or the like may be performed after completion of irradiation with light in the specific wavelength range per day, but does not have to be performed after completion of irradiation with light in the specific wavelength range per day. The duration of light irradiation by a fluorescent lamp or the like after completion of irradiation with light in the specific wavelength range per day is, for example, 0 minutes to 1 hour, 0 minutes to 30 minutes, or 0 minutes to 15 minutes per day.

[0067] One aspect of the present disclosure relates to a method for treating and / or preventing retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, in a subject in need of such treatment and / or prevention, the method comprising controlling a light irradiation device to irradiate the subject with light in a specific wavelength range, thereby improving or suppressing at least one symptom selected from the group consisting of decreased visual acuity, metamorphopsia, central scotoma, and complete blindness, thereby treating and / or preventing retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, in the subject. In some embodiments, the light irradiation device is capable of irradiating violet light. In some embodiments, the light irradiation device is capable of irradiating light with a wavelength of 360 to 400 nm, particularly light with a wavelength of approximately 380 nm. The light irradiation device may have a flashing frequency that is controllable to, for example, 0 Hz or 30 to 70 Hz, particularly 0 Hz or 35 to 60 Hz, and the flashing frequency may be particularly 0 Hz or approximately 40 Hz. The light irradiation device may also have a controllable irradiation duration. The light source may be in the form of, but is not limited to, lighted eyeglasses or eyeglass frames, a tabletop light source, a mobile device mounted light source, a face-mounted or near-face mounted light source, a portable light source, a room light, or a desk lamp.

[0068] [Device] One aspect of the present disclosure relates to a device for treating and / or preventing retinal degeneration by irradiating a subject with light in a specific wavelength range. More specifically, the present disclosure relates to a device for treating and / or preventing retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, through light stimulation. In some embodiments, a device for treating and / or preventing retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, according to the present disclosure may include at least one light source that emits light and a drive circuit that drives the light source. Here, the light emitted by the light source is light in a specific wavelength range that, when irradiated to a living body, produces a therapeutic and / or preventive effect for retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration.

[0069] Furthermore, one aspect of the present disclosure relates to a device for treatment and / or prevention using light stimulation. In some embodiments, the device for treatment and / or prevention of at least one symptom selected from the group consisting of reduced visual acuity, metamorphopsia, central scotoma, and complete blindness according to the present disclosure may include at least one light source that emits light and a drive circuit that drives the light source. Here, the light emitted by the light source is light in a specific wavelength range that, when irradiated onto a living body, produces an effect of promoting the improvement or suppression of at least one symptom selected from the group consisting of reduced visual acuity, metamorphopsia, central scotoma, and complete blindness.

[0070] In this specification, devices for the treatment and / or prevention of retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration caused by light stimulation, and devices for the treatment and / or prevention of at least one symptom selected from the group consisting of light-induced visual acuity loss, metamorphopsia, central scotoma, and complete blindness may be collectively referred to as "biofunction control devices" or simply "devices."

[0071] These devices are thought to be able to stimulate the macula, which is the central part of the retina, particularly the choroid below the macula, by controlling the illumination state of light. As described above, patients who receive light stimulation will experience an improvement or suppression of at least one symptom selected from the group consisting of decreased visual acuity, metamorphopsia, central scotoma, and complete blindness, leading to the treatment and / or prevention of retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration.

[0072] In some embodiments, the device according to the present disclosure is a device for treating and / or preventing retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration by irradiating a living body with violet light at constant light or at a specific flashing frequency, as described above, to promote the improvement or suppression of at least one symptom selected from the group consisting of decreased vision, metamorphopsia, central scotoma, and complete blindness, and is characterized in that it comprises a light source that emits the violet light, a light emission cycle controller that sets the violet light to constant light or at a specific flashing frequency, and a light emission time controller that irradiates the violet light at a specific time or for a specific period of time, and is used for treating and / or preventing the disease.

[0073] In addition, in some embodiments, the device according to the present disclosure is a device that controls biological functions related to retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration by irradiating a living body with constant violet light, and is characterized by comprising a light source that emits the violet light, and an emission time control unit that irradiates the violet light for a specific time or for a specific period of time.

[0074] In some embodiments, the present disclosure relates to a device for treating and / or preventing the above-mentioned diseases through light stimulation, the device comprising: at least one light source that emits light; and a drive circuit that drives the light source, wherein the light emitted by the light source is light of a specific wavelength range that produces the effect when irradiated to a living body. Accordingly, one aspect of the present disclosure relates to a device for treating and / or preventing retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, through light stimulation, the device comprising: at least one light source that emits light; and a drive circuit that drives the light source, the drive circuit including at least one processor communicably connected to the light source and at least one memory, and at least one memory for storing instructions executable by the processor, the light source being configured to emit light of a specific wavelength range that produces a therapeutic and / or preventive effect on retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, when irradiated to a living body. Furthermore, one aspect of the present disclosure relates to a device for treating and / or preventing at least one symptom selected from the group consisting of visual acuity loss, metamorphopsia, central scotoma, and complete blindness caused by light stimulation, the device comprising at least one light source that emits light and a drive circuit that drives the light source, the drive circuit including at least one processor communicatively connected to the light source and at least one memory, and at least one memory for storing instructions executable by the processor, wherein the light source is configured to emit light in a specific wavelength range that, when irradiated onto a living body, produces a therapeutic and / or preventive effect for at least one symptom selected from the group consisting of visual acuity loss, metamorphopsia, central scotoma, and complete blindness.

[0075] (Light Source) The wavelength of light emitted by the light source is not particularly limited, but in some embodiments, violet light defined as 360 to 400 nm is used.

[0076] A light source capable of oscillating at a frequency between 0 (normal light, DC light) and 150 Hz can be preferably used. The frequency can be adjusted in 0.5 Hz or 1 Hz increments by setting the control unit, making it possible to generate light with any desired blinking frequency. Increasing the blinking frequency has the advantage that the blinking becomes less noticeable, although this will vary from person to person. The blinking frequency is not limited to the 10 Hz or 60 Hz used in the experimental example.

[0077] The irradiance from the light source may be variable or constant. In some embodiments, the maximum output is 310 μW / cm ２ For example, a value of 0.1 μW / cm is used, but is not limited to this. ２ (0.001 W / m ２ )~5000μW / cm ２ (50W / m ２ ) or, for example, 1 μW / cm ２ (0.01 W / m ２ )~1000μW / cm ２ (10 W / m ２ ) or, for example, 0.5 μW / cm ２ (0.005 W / m ２ ) ~ 500 μW / cm ２ (5 W / m ２ ) and those in the range of 0.5 to 1000 μW / cm ２ The light source can be configured to have any irradiance, such as within the range of 1000 to 15000 rad / s. Furthermore, a light source with such irradiance can be easily applied to eyeglasses or eyeglass frames, or other portable irradiation devices, so that it can be worn in daily life. It has been confirmed that even a small amount of weak light (light with low photosensitivity) produces characteristic phenomena, and it is expected to have an effect on various parts of the body, including the choroid under the macula in the center of the retina, and on cell activity (this term also includes gene expression control).

[0078] The light may be specified by the relative luminous efficiency. Since the features of the present invention can be realized even with a low relative luminous efficiency, it is possible to perform flashing irradiation of violet light that stimulates the living body even with a low relative luminous efficiency, and to stimulate the desired area without burdening the living body.

[0079] The light irradiation time is preferably set arbitrarily depending on the purpose, and may be short or long. The light can be set intermittently (at regular or irregular intervals) or continuously. The light irradiation time can be set, for example, during the daytime hours between 4:00 PM and 9:00 PM, between 5:00 PM and 8:00 PM, or between 6:00 PM and 7:00 PM, and the period can be at least 10 minutes, at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, at least 2 hours, at least 3 hours, at least 4 hours, or 5 hours. In some embodiments, 5 hours of irradiation are applied between 4:00 PM and 9:00 PM, 3 hours of irradiation between 5:00 PM and 8:00 PM, or 1 hour of irradiation between 6:00 PM and 7:00 PM. A timer function can be used when setting the irradiation time in this manner.

[0080] The light source may be light-emitting eyeglasses or eyeglass frames. Such eyeglasses or eyeglass frames are easy to wear and comfortable to wear on a daily basis, and therefore have a light source that emits a flashing frequency attached to them. This makes them highly practical and allows them to be worn constantly in a variety of situations and environments. The light source may be a light source installed in front of or near the face, such as a desktop light source or a light source attached to a mobile terminal, or a non-installed light source, such as a portable light source, or a fixed light source, such as a room light, a desk lamp, or a dedicated device. Various light source forms can be used depending on the usage environment.

[0081] (Controller) The controller is a part that controls the illumination state of the light from the light source (constant light or flashing frequency). The controller may be equipped with a power source for supplying power to the light source, and such a power source may be a battery, or may be a power source that is connected to a battery installed in another location via a cable. Furthermore, if the controller is not movable in one place, it may be configured to be connected to a household power source or the like.

[0082] The control unit preferably changes the irradiation conditions, such as the light flashing frequency, irradiance, irradiation time, irradiation start time, irradiation end time, and flashing frequency, by transmitting and receiving information to and from an isolated controller such as a mobile terminal. Since such a control unit controls the various irradiation conditions described above in isolation, it is possible to arbitrarily set irradiation conditions suitable for causing the desired biological function control, thereby obtaining the desired effect.

[0083] Furthermore, the control unit may have a light source controller or timer function. Examples of the controller include functions to vary the frequency and irradiance, and to set the irradiation time. Examples of the timer function include a function to set the irradiance time of the light. Such a controller or timer function may be provided integrally with the device or may be a separate component.

[0084] FIG. 4 shows a simplified block diagram of an example of a device that can be used for the above-described biological function control, etc., as one embodiment of the device according to the present disclosure. The device shown in FIG. 4 may include various functions of the devices described herein for treating and / or preventing retinal degeneration, such as age-related macular degeneration and hereditary retinal degeneration, and for treating and / or preventing at least one symptom selected from the group consisting of light-induced visual acuity loss, metamorphopsia, central scotoma, and complete blindness (which may be collectively referred to simply as "biological function control devices"). Accordingly, all of the devices described herein can be represented by the block diagram of FIG. 4. The biological function control device may include a light source 10 and a control unit 20. The light source 10 emits light in a specific wavelength range. The wavelength of the light emitted by the light source 10 preferably includes the VL described above or 360 to 400 nm, and more preferably includes 380 nm. The light source 10 may be any light source, and a light-emitting diode (LED) is preferably used from the viewpoints of compact size, long life, ease of on / off control, etc. (See FIG. 2 for an example of the spectrum of a purple fluorescent lamp, and FIG. 3 for an example of the spectrum of an LED.) The number of light sources 10 may be one or more depending on the desired irradiation intensity and irradiation range of the light source, etc.

[0085] The control unit 20 is connected to the light source 10 by wire or wirelessly and is configured to control the illumination conditions of the light source 10. The illumination conditions can include at least one of the blinking frequency and illumination time of the light source 10, and therefore the control unit 20 can include at least one of a blinking frequency control unit 20a and an illumination time control unit 20b. The blinking frequency can be preferably 0 Hz or 30 to 75 Hz, more preferably 0 Hz or 35 to 45 Hz, and particularly preferably 0 Hz or 40 Hz. A blinking frequency of 0 Hz means constant illumination. The illumination time can be set arbitrarily, for example, within a range of 10 seconds to 24 hours per day, and the specific period of continuous illumination can also be set arbitrarily, for example, from one day to several years or longer.

[0086] The control unit 20 may include a processor such as a CPU (Central Processing Unit) and executes processing to control the irradiation conditions of the light source 10. The processing performed by the control unit 20 may be implemented by a computer program or by hardware using logic circuits. The computer program may be stored in a computer-readable recording medium. The recording medium storing the computer program may be a non-transitory recording medium. The non-transitory recording medium is not particularly limited and may be, for example, a memory card, a CD-ROM, or other recording medium. The computer program stored in the recording medium can be installed in the computer unit via an appropriate reader. Examples of the appropriate reader include a card reader if the recording medium is a memory card, and a CD drive if the recording medium is a CD-ROM. Alternatively, the computer program may be downloaded to the computer unit from an external server via a communication network.

[0087] In an apparatus according to the present disclosure, the drive circuitry may include at least one processor communicatively connected to the light source and at least one memory, and at least one memory for storing instructions executable by the processor.

[0088] 4 may be light-emitting eyeglasses or eyeglass frames, a desktop light source, a mobile terminal-mounted light source, a face-mounted or nearby light source, a portable light source, a room light, or a desk lamp. The biofunction control device may also be provided as a light-emitting product, including eyeglasses or eyeglass frames, a desk lamp, a mobile terminal, a mobile terminal case, a head-mounted item (such as a hat or earphone headphones), a portable light, a room light, or a desk lamp, to which at least the light source 10 of the light source 10 and the control unit 20 is attached.

[0089] As described above, the biological function control device using optical stimulation according to the present disclosure can irradiate a living organism with light in a specific wavelength range, such as violet light, at a constant light level or at a specific flashing frequency, thereby leading to the treatment and / or prevention of retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration, as well as the treatment and / or prevention of at least one symptom selected from the group consisting of decreased vision, metamorphopsia, central scotoma, and complete blindness.

[0090] Another aspect of the present invention relates to a method for operating a biological function control device using optical stimulation. Accordingly, some embodiments of the present disclosure relate to a method for operating a device for use in controlling the above-mentioned biological functions, i.e., treating and / or preventing retinal degeneration such as age-related macular degeneration and hereditary retinal degeneration, and treating and / or preventing at least one symptom selected from the group consisting of decreased visual acuity, metamorphopsia, central scotoma, and complete blindness, the device comprising: a light source capable of irradiating a living body with light in a specific wavelength range at constant light or a specific flashing frequency; and a control unit for controlling the irradiation of the light source, for example, controlling the flashing frequency, wherein the device irradiates the living body with light in the specific wavelength range at constant light or the specific flashing frequency. Here, the flashing frequency of the light source may be controlled to 0 Hz or in a range of 30 to 75 Hz, and the light source may irradiate the living body with light in a wavelength range of 360 to 400 nm. In addition, one aspect of the present invention relates to a computer program that causes an apparatus including a light source capable of irradiating a living body with light in a specific wavelength range at a constant light level or at a specific flashing frequency, and a control unit that controls the irradiation of the light source, for example, controls the flashing frequency, to execute the above-mentioned operating method.

[0091] A computer program according to the present disclosure may have instructions stored on a non-transitory computer-readable medium. When the instructions are executed by a processor, the computer program according to the present disclosure can perform predetermined steps. Thus, one aspect of the present disclosure also relates to a non-transitory computer-readable medium on which instructions are stored, which, when executed by a processor, can cause a device including a light source capable of irradiating a living organism with light in a specific wavelength range at constant light or a specific flashing frequency, and a controller that controls the irradiation of the light source, for example, the flashing frequency, to operate the device such that the controller controls the flashing frequency of the light source to 0 Hz or in a range of 30 to 75 Hz, and to operate the device so that the light source irradiates the living organism with light having a wavelength in the range of 360 to 400 nm.

[0092] Furthermore, one aspect of the present invention relates to an apparatus for treating and / or preventing retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration, by light stimulation, which may include glass, eyeglass lenses, or contact lenses that transmit violet light. Use of such an apparatus can have a beneficial effect on the living body, such as improving or suppressing at least one symptom selected from the group consisting of decreased visual acuity, metamorphopsia, central scotoma, and complete blindness. Use of such an apparatus may enable the treatment and / or prevention of retinal degeneration, such as age-related macular degeneration or hereditary retinal degeneration.

[0093] [Components] Furthermore, one aspect of the present invention relates to replaceable components that are built into or attached to the device or instrument described above. Examples of components include a light source, a control unit that controls light emission, peripheral devices, and a battery.

[0094] [Method or System for Replacement, Repair, or Maintenance] Furthermore, one aspect of the present invention relates to a method or system for replacing, repairing, or maintaining the above-mentioned device, instrument, or component.

[0095] Example 1. Volume measurement test of CNV (choroidal neovascularization) For the control group, 6-week-old mice (C57BL6 / J, CLEA Japan, Inc.) were exposed to a 5000 Kelvin fluorescent lamp with a background light of approximately 50 Lux from 8:00 AM to 8:00 PM every day. For the violet light group, in addition to the background light, 400 μW / cm at wavelengths of 360 to 400 nm was used. ２ Violet light (LED light source: Nichia Corporation, model number: NSPU510CS, peak wavelength: 375 nm) was additionally irradiated from 5:00 pm to 8:00 pm every day.

[0096] Seven days after the start of violet light irradiation, mice were anesthetized by intraperitoneal injection of a triple-anesthesia mixture (Domitor, midazolam, and betolfar (0.75 mg / kg, 4 mg / kg, and 5 mg / kg)), and the pupils were dilated with 5% tropicamide and 5% phenylephrine hydrochloride. Three to five laser spots (170 mW, 75 μm, 100 ms) were irradiated in each eye surrounding the optic nerve to create a CNV (choroidal neovascularization) mouse model, an animal model of exudative age-related macular degeneration. The appearance of bubbles during laser irradiation confirmed rupture of Bruch's membrane. After laser photocoagulation, the mice were awakened by administration of antisedan and returned to their cages. Violet light irradiation was continued under the same conditions.

[0097] Fourteen days after the start of violet light irradiation, mice were euthanized, and the eyeballs were enucleated and fixed in 4% paraformaldehyde for 1 hour. After removing the anterior segment and neural retina, radial incisions were made, and the retinal pigment epithelium-choroid complex was flattened to prepare choroidal flat mounts. The flat mounts were incubated for 15 minutes in PBS containing 0.05% Triton® X-100, followed by incubation in 5% BSA. They were then incubated overnight at 4°C with fluorescently labeled isolectin-B4. The choroidal flat mounts were observed using a confocal laser scanning microscope (SP5, Leica), and the CNV volume was measured from the captured images using image analysis software IMARIS (Oxford Instruments). The CNV volume measurements are shown in Figure 5. The vertical axis represents CNV volume. As shown in Figure 5, the CNV volume was significantly reduced in the violet light group (VL) mice irradiated with violet light compared to the control group (control) mice not irradiated with violet light. This demonstrates that violet light irradiation can treat age-related macular degeneration, particularly exudative age-related macular degeneration. Furthermore, the CNV volume was significantly reduced in the violet light group that had been irradiated with violet light before the CNV (choroidal neovascularization) model mice were generated, demonstrating that violet light irradiation before the onset of age-related macular degeneration can prevent age-related macular degeneration, particularly exudative age-related macular degeneration. This demonstrates that violet light irradiation can treat and / or prevent age-related macular degeneration, particularly exudative age-related macular degeneration.

[0098] Example 2. Test using a mouse light damage model Ten-week-old mice (BALB / c, CLEA Japan, Inc.) were exposed to a 5000 Kelvin fluorescent lamp with approximately 50 lux as background light from 8:00 am to 8:00 pm every day. The violet light group was exposed to 400 μW / cm at wavelengths of 360 to 400 nm in addition to the background light. ２Violet light (LED light source: Nichia Corporation, model number: NSPU510CS, peak wavelength: 375 nm) was additionally irradiated from 5:00 PM to 8:00 PM every day. On the seventh day after the start of violet light irradiation, the mouse cage was moved to a dark place at 8:00 PM. After 14 hours of dark adaptation, the pupils were dilated using 5% tropicamide and 5% phenylephrine hydrochloride under red light. The mouse cage was placed under a 2500 lux white LED and irradiated for 1 hour. After the light irradiation, the mouse was returned to a breeding cage under a normal light source of 50 lux. Violet light irradiation was continued under the same conditions as above. On the 10th day after the start of violet light irradiation, the mouse cage was moved to a dark place at 8:00 PM. After 14 hours of dark adaptation, mice were anesthetized by intraperitoneal injection of a triple-anesthesia mixture (Domitor, midazolam, and betolfar (0.75 mg / kg, 4 mg / kg, and 5 mg / kg)) under red light, and the pupils were dilated with 5% tropicamide and 5% phenylephrine hydrochloride. After pupil dilation, electroretinograms were measured using a small animal full-field light stimulator and evoked response recording device (PuRec, Mayo) (Figure 6). After measurement, mice were euthanized, and the eyes were enucleated and embedded in OCT compound to prepare frozen blocks. 10-μm-thick frozen sections were prepared from the right eye blocks of each mouse, with the cross section including the optic disc. Fluorescent immunostaining was then performed using anti-rhodopsin antibody and DAPI. The sections were photographed under a fluorescence microscope (BZ9000, Keyence), and the thickness of the outer nuclear layer (ONL) and the length of the photoreceptor outer segment (OS) were measured from the photographed images using image analysis software Leica Application Suite X version 3.7.4.23463 (Figure 7).

[0099] 0.5, 2, 10cd. s / m ２The electroretinogram measurement results at each illumination intensity are shown in Figure 6. The left panel shows the a-wave amplitude, and the right panel shows the b-wave amplitude. The light irradiation group showed a decrease in amplitude compared to the control group, but the light irradiation + VL group, which was irradiated with violet light, showed a tendency for the decrease in amplitude to recover. The control group was a group that was not irradiated with either background light or violet light. The measurements of the thickness of the retinal outer nuclear layer (ONL) and the length of the photoreceptor outer segment (OS) are shown in Figure 7. The light irradiation group showed a decrease in ONL thickness compared to the control group, but the decrease in ONL thickness recovered in the light irradiation + VL group, which was irradiated with violet light. Similarly, the light irradiation group showed a decrease in OS length compared to the control group, but the decrease in OS length tended to recover in the light irradiation + VL group, which was irradiated with violet light. The mouse light damage model used in this example is a model in which photoreceptor degeneration is induced by irradiating the mouse retina with intense visible light, and is widely used as a model for retinal degeneration (photoreceptor degeneration) such as atrophic age-related macular degeneration and hereditary retinal degeneration. The fact that a certain degree of improvement was observed with violet light using this model indicates that it can be applied as a treatment for retinal degenerative diseases such as atrophic age-related macular degeneration and hereditary retinal degeneration.

[0100] Example 3 Clinical Trial for Prevention of Age-Related Macular Degeneration A clinical trial for prevention of age-related macular degeneration is conducted by having patients with drusen, which are considered to be precursor lesions of age-related macular degeneration, wear violet light glasses and comparing the rate of progression to advanced age-related macular degeneration (exudative or atrophic) with that of a control group.

[0101] Example 4 Clinical Trial for Patients with Exudative Age-Related Macular Degeneration Clinical trials for patients with exudative age-related macular degeneration are conducted by having patients diagnosed with exudative age-related macular degeneration wear violet light glasses, and comparing subretinal fluid, intraretinal edema, and the like with a control group using optical coherence tomography (OCT) or the like.

[0102] Example 5 Clinical Trial on Patients with Atrophic Age-Related Macular Degeneration Clinical trials on patients with atrophic age-related macular degeneration are conducted by having patients diagnosed with atrophic age-related macular degeneration wear violet light glasses, and comparing the extent of geographic atrophy, the extent of photoreceptor layer loss, and the like with a control group using optical coherence tomography (OCT) or the like.

[0103] All publications, applications, standards, and patents mentioned herein are incorporated by reference in their entirety, and in the event of a conflict, the present specification controls. The present invention should not be limited in scope by the specific embodiments described herein. Indeed, various modifications of the present invention in addition to those described herein will become apparent to those skilled in the art from the foregoing description and accompanying drawings. Such modifications are intended to fall within the scope of the appended claims. Some or all of the above embodiments may also be described as follows, but the disclosure of this application is not limited to the following supplementary notes.

Claims

DEPCT6813 / 06 / 25681. Methods for the treatment and / or prevention of macular degeneration, methods which include: irradiation of the target with specific wavelengths of light using a photoreceptor.

2. Methods under claim 1 where macular degeneration is either age-related macular degeneration or hereditary macular degeneration.

3. Methods under claim 2 where macular degeneration is either viscous macular degeneration or dry macular degeneration.

4. Methods under claim 2 where macular degeneration is associated with at least one symptom selected from a group consisting of low visual acuity, visual acuity, central vision loss, and complete vision loss.5.Claim 4: At least one symptom selected from a group comprising hypovisibility, visual aberration, central macular degeneration, and complete vision loss is attributed to age-related macular degeneration.

6. Claim 2: At least one component of age-related macular degeneration is selected from a group comprising neovascularization volume, subretinal fluid volume, retinal edema volume, macular degeneration region, and photoreceptor cell loss region.

7. Claim 2: Age-related macular degeneration is either a preclinical lesion or an invasive form of age-related macular degeneration.

8. Claim 1: The photoreceptor device includes a light source capable of continuously or pulsed irradiation of the target with a specific wavelength range at a specific frequency, and a controller that regulates the irradiation of the light source. 9.

10. A method under Claim 1 in which the target is already receiving or has received treatment and / or prevention of macular degeneration.

11. A method under Claim 1 in which a specific wavelength region includes the wavelength range of 360 nm to 400 nm.

12. A method under Claim 1 in which light is generated to be emitted in pulses at a flashing frequency in the range of 30 Hz to 70 Hz.

13. A method under Claim 1 in which light is emitted during daylight hours.

14. A method under Claim 1 in which light is emitted for one hour or more.

15. A method under Claim 1 in which light is emitted in such a manner that the incidence of light on the target's eye is in the range of 0.5 µW / cm² to 1000 µW / cm².

16. An instrument for the treatment and / or prevention of macular degeneration by irradiating a target with light of a specific wavelength region.

17. An instrument under claim 16 in which the instrument continuously irradiates a specific wavelength region or at a flashing frequency.

18. An instrument under claim 16, which includes: a controller that controls the emission of the irradiated light. 19.

20. An instrument under claim 16, in which the controller, by transmitting to and from a separate controller such as a portable terminal, performs control by changing at least one of the irradiation conditions selected from a group of irradiation conditions consisting of the flash frequency of a specific wavelength region, the amount of light intensity, the irradiation time, the start time of irradiation, and the end time of irradiation.

21. An instrument under claim 20, in which the drive circuit includes at least one processor unit which is communicatively connected to the light source and at least one memory unit and at least one memory unit for storing the instructions executable by the processor unit.

22. An instrument under claim 16, in which macular degeneration is either age-related macular degeneration or hereditary macular degeneration. 23.

24. An instrument under Claim 22 in which age-related macular degeneration is linked to at least one symptom selected from a group comprising hypoviscosity, visual aberration, central ocular necrosis, and complete vision loss.

25. An instrument under Claim 24 in which at least one symptom selected from a group comprising hypoviscosity, visual aberration, central ocular necrosis, and complete vision loss is caused by age-related macular degeneration. 26.

27. An instrument under claim 22 where at least one component of age-related macular degeneration is selected from a group comprising neovascularization volume, subretinal fluid volume, retinal edema volume, macular degeneration area, and photoreceptor cell loss area.

28. An instrument under claim 16 where the target is either a preclinical lesion or an invasive age-related macular degeneration lesion.

29. An instrument under claim 16 where the target is either receiving or has already received treatment and / or prevention of macular degeneration.

30. An instrument under claim 16 where the specific wavelength region includes the wavelength range of 360 nm to 400 nm.

31. An instrument under claim 16 where the blink frequency is in the range of 30 Hz to 70 Hz.

31. An instrument under claim 16 where light is emitted during the daytime. 32.

33. An instrument under claim 16 in which light is emitted for one hour or more.

34. An instrument under claim 16 in which light is emitted in such a way that the incidence of light on the target's eye is in the range of 0.5 microwatts / cm² to 1000 microwatts / cm².

35. An instrument under claim 16 in which the instrument is eyeglasses with a light source or eyeglass frames with a light source, a fixed benchtop light source, a light source mounted on a mobile terminal, a light source mounted near or in front of the face, a portable light source, an indoor lighting source or a desk lamp.

36. An instrument under claim 16 in which light of other wavelengths, sound, vibration, magnetic or electric fields are applied in addition to the emission of light of a specific wavelength region.A computer-readable medium, which is a permanent computer-readable medium containing stored instructions and which has the capability to enable an instrument according to any of the claims 16 through 35, including a light source which has the capability to continuously illuminate a living body with light of a specific wavelength range or at a specific flashing frequency, and a controller which controls the flashing frequency of the light source, to perform the following steps when an instruction is executed by the processor: the procedure of operation in such an instrument is that the controller controls the flashing frequency of the light source to 0 Hz or to a frequency range of 30 Hz to 75 Hz; and the procedure of operation in such an instrument is that the light source illuminates a living body with light of a wavelength range of 360 nm to 400 nm.

37. An instrument for the treatment and / or prevention of macular degeneration by photo-stimulation, which includes: glass, lenses, eyeglasses or contact lenses which allow violet light to pass through. 38.

39. Components which are built-in or attached to the instrument under Claim 16 and are replaceable.

40. Systems which replace, repair or perform maintenance on the instrument under Claim 16.

41. Systems which replace, repair or perform maintenance on the equipment under Claim 37.

42. Systems which replace, repair or perform maintenance on the components under Claim 38 or Claim 39.

43. Methods for replacing, repairing or performing maintenance on the instrument under Claim 16.

44. Methods for replacing, repairing or performing maintenance on the equipment under Claim 37.

45. Methods for replacing, repairing or performing maintenance on the components under Claim 38 or Claim 39.

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