Eye disorder treatment device

Abstract

A device for treating eye disorders, particularly disorders of the internal tissues of the eye, comprises a mask and a plurality of light-emitting diodes (LEDs) arranged on the inner surface of the mask. The plurality of LEDs includes a matrix of at least one LED arranged in a region of the inner surface of the mask that is adapted to face the user's eyeball area when in use, and is configured to emit electromagnetic radiation adapted to stimulate the cellular function of retinal cells.

Description

Detailed Description of the Invention

[0001] (Technical Field) The present invention relates to an apparatus for the treatment of ocular disorders, particularly for the treatment of disorders of the internal tissues of the eye.

[0002] (Prior Art) The need to treat ocular disorders, particularly disorders of the internal tissues of the eye such as the retina (a thin membrane derived from nerves that covers the inner surface of the eye and extends from the optic nerve to the pupil opening), has been known for a long time.

[0003] Among the numerous retinal disorders are diabetic retinopathy, which damages the blood vessels of the retina, and age-related macular degeneration, a degenerative disease that affects retinal cells and causes loss of central vision.

[0004] Without appropriate treatment, both disorders can cause permanent damage to the retinal tissue, leading to a decrease in visual acuity and contrast sensitivity, and in the most severe cases, even loss of visual function.

[0005] In particular, age-related macular degeneration is caused by the progressive accumulation of mutations in mitochondrial DNA (mtDNA), which results in a decrease in the formation of ATP (adenosine triphosphate), the energy source for cell metabolism, an increase in the production of reactive oxygen species, induction of oxidative stress, progression of inflammation, accumulation of extracellular debris, and as a result, significant loss of cells (it is estimated that approximately 30% of the central rod and cone cells are lost by the age of 70).

[0006]

[0007] ​There are two types of macular degeneration. In particular, there is a more widespread type called "dry," which is not exudative (about 85% of cases), which causes changes in the retinal pigment epithelium that appear as punctate scotomas and can lead to drusen, which are accumulations of extracellular debris that appear as yellow spots.

[0008] Furthermore, there is also a "wet" type of exudative retina, which occurs when the retina undergoes an abnormal process of blood vessel formation, known as choroidal neovascularization, which can lead to localized macular edema and hemorrhage, resulting in localized detachment of the retinal epithelium and rapid loss of visual function.

[0009] Treatment options for these disorders include nutritional supplements primarily composed of zinc oxide, copper, vitamin C, vitamin E, and lutein; insulin administration for diabetic retinopathy; and administration of vitreous vascular endothelial growth factor antagonists for moist macular degeneration. Retinal laser treatment is also widely used; light generated using the noble gas argon (argon laser) heats the irradiated area through thermal action, enabling treatment.

[0010] The problem with treatment using nutritional supplements is that it is only effective in reducing the risk of progression of retinal damage and cannot effectively treat retinal cells. However, intravitreal drug administration is not effective for all types of retinal degeneration. On the other hand, insulin administration can treat diabetes at a systemic level and slow the progression of diabetic retinopathy, but it cannot cure retinal cells.

[0011] On the other hand, a problem with retinal laser (argon laser) treatment, which is used to treat diabetic retinopathy and macular degeneration, is that its main purpose is to destroy the retinal areas affected and damaged by these disorders, and it cannot repair retinal cells. Furthermore, because argon laser treatment directly intervenes in the patient's eye, it is considered an invasive treatment, and if not performed correctly, it can lead to severe visual impairment or permanent damage to the patient's eye tissue.

[0012] Therefore, currently available treatments are not effective in treating damage to the internal tissues of the eye. The damage remains in a state of disrepair or its progression is slowed, making it difficult to treat, and severely impacting the quality of life for patients suffering from the condition.

[0013] Different types of devices for treating retinal tissue are shown in patent US2021 / 315736. This patent describes a wearable device comprising a first light source adapted to emit a light beam having wavelengths in the near-infrared region and a second light source adapted to emit light having wavelengths in the range of 600–700 nm or 550–650 nm. The device also comprises a diffuser adapted to diffuse the light of the first light beam and / or the light of the second light beam so that at least a portion of the first light beam and at least a portion of the second light beam are directed through the patient's retinal tissue when the patient is wearing the device.

[0014] Japanese Patent US2016 / 067087 also describes a wearable device for directing light-based therapy to a patient's eye tissue. The device comprises a first light source adapted to produce a light beam having a first wavelength between 800 nm and 900 nm, and at least one second light source adapted to produce a light beam having a second wavelength between 600 nm and 700 nm or between 550 nm and 650 nm. The device further comprises a spatial light modulator adapted to receive light from the first and second light sources and to modulate the light beam directed to the patient's eye, such that when the patient is wearing the device, at least a portion of the first light beam and a portion of the second light beam are directed to the patient's eye.

[0015] Further examples of devices that use light to treat ocular lesions such as diabetic retinopathy and wet and dry age-correlated macular degeneration (AMD) are shown in patent US2016 / 008625.

[0016] US Patent No. 2021 / 060354 describes a method for preventing and treating diabetic retinopathy and diabetic macular edema, which involves administering a photobiomodulatory amount of light having wavelengths in the infrared region to the patient's eyes. In particular, the wavelengths envisioned for the treatment method are in the range of approximately 670 ± 50 nm, and more specifically, 670 ± 30 nm.

[0017] Patent US2014 / 005757 describes a removable spare part adapted to connect to a support device, the support device comprising a radiation source adapted to emit radiation in the direction of the area to be treated, particularly toward the user's eyes, and a structure for positioning the radiation source in a predetermined position relative to the area to be treated. Wavelengths between 450 and 580 nm are mentioned for the treatment of diabetic retinopathy and macular degeneration.

[0018] Patent application WO2023 / 283699 also describes a therapeutic device using photobiomodulation.

[0019] Several devices have been developed for treating eye disorders using light of specific wavelengths, but there is a need to identify a solution that offers improved therapeutic efficacy.

[0020] (Disclosure of Information) The object of the present invention is to solve the aforementioned problems by devising an eye disorder treatment device that can effectively treat damage to the internal tissues of the eye.

[0021] Within the scope of this problem, a further object of the present invention is to provide an eye disorder treatment device that can perform non-invasive treatment of disorders of the internal tissues of the eye.

[0022] A further object of the present invention is to provide a device that automatically treats damage to the internal tissues of the eye.

[0023] A further object of the present invention is to provide a treatment device for eye disorders having a simple structure and functional design, reliable operation, multi-purpose use, and a relatively low cost.

[0024] The recited object is achieved according to the present invention by the eye disorder treatment device according to claim 1, the computer program according to claim 10, and the readable memory according to claim 18.

[0025] In particular, this device is suitable for treating structures located behind the eyeball.

[0026] The eye disorder treatment device includes a mask, preferably having the shape of an anthropomorphic mask.

[0027] A plurality of light sources are arranged on the inner surface of the mask.

[0028] The light source is a type of light-emitting diode and is usually called an LED for simplicity by taking the initial letter.

[0029] Advantageously, the light-emitting diode is configured to emit electromagnetic radiation adapted to stimulate the cell function of retinal cells.

[0030] The LED is arranged on the inner surface of the mask in a state facing the user's face during use. In particular, the LED is distributed on the inner surface of the mask in a region facing the user's eyeball region during use so as to form at least one matrix.

[0031] Preferably, the LED is connected to a suitable electrical circuit capable of managing the power supply and the correct operation of the diode.

[0032] Preferably, the LED is electrically connected to the control unit and / or the power supply unit of the device.

[0033] Preferably, the control unit and / or power supply unit are located outside the mask and connected to the mask, for example, by appropriate connecting cables.

[0034] The control and / or power supply unit includes a control interface.

[0035] Preferably, the control interface is adapted to allow the user to easily set commands relating to the treatment protocol for the internal tissues of the eye, particularly the retina. For example, the interface may allow the user to start or stop the treatment protocol, or to set parameters that characterize such treatment, such as the duration of the treatment or the selection of the wavelength emitted by the activated diode.

[0036] Preferably, the interface includes a screen.

[0037] More preferably, the interface may consist of a touchscreen or a screen associated with appropriate command buttons.

[0038] Alternatively, the control interface can be associated with the mask.

[0039] Preferably, the external control and / or power supply unit comprises an electronic computer and a memory readable by the electronic computer.

[0040] The memory readable by the electronic computer includes, when executed by the electronic computer, a command that causes the electronic computer to perform the following steps: receiving a command from an operator via the control interface regarding a protocol for treating the internal tissue of the user's eye; automatically selecting a plurality of the light-emitting diodes and automatically setting their wavelengths and emission times; commanding the user to close their eyes with a warning signal; operating the plurality of light-emitting diodes in a first time interval, continuous mode, at wavelengths in the range of ±40 nm centered on 590 nm, and emitting electromagnetic radiation in the direction of the user's closed eye; commanding the user to open their eyes with a warning signal; and operating the plurality of light-emitting diodes in a second time interval, continuous mode, at wavelengths in the range of ±40 nm centered on 590 nm The steps include: operating at a wavelength and emitting electromagnetic radiation in the direction of the user's closed eye; instructing the user to open their eye with a warning signal; operating the plurality of light-emitting diodes in a second time period in pulse mode at a wavelength in the ±40nm range around 590nm and emitting electromagnetic radiation in the direction of the user's open eye; commanding the user to close their eye with a warning signal; operating the plurality of light-emitting diodes in a first time period in continuous mode at a wavelength in the ±40nm range around 630nm and emitting electromagnetic radiation in the direction of the user's closed eye; commanding the user to open their eye with a warning signal; and operating the plurality of light-emitting diodes in a second time period in pulse mode at a wavelength in the ±40nm range around 630nm and emitting electromagnetic radiation in the direction of the user's open eye.

[0041] Advantageously, the warning signal is an acoustic signal and / or a vibration signal and / or a signal displayed on the control interface.

[0042] Preferably, the signals displayed on the control interface are images and / or text messages.

[0043] A device equipped with a control unit having a memory containing commands that enable the execution of the steps described above has the effect of effectively treating eye disorders, particularly those affecting structures located at the back of the eyeball. Based on experimental data, particularly medical evidence obtained from clinical trials, it has been found that remarkable results in terms of therapeutic effect can be obtained by alternately using pulsed light and continuous-mode light of a specific wavelength, and by having the user alternately open and close their eyes. In particular, the aforementioned steps performed by this device are effective in treating retinal disorders such as retinal macular degeneration.

[0044] Furthermore, it has been observed that using a device that includes a mask placed on the user's face provides greater comfort to the user during the treatment protocol. The mask increases the freedom of posture the user can adopt, for example, allowing the user to lie down.

[0045] The LEDs in at least one of the macular are configured to emit a beam of electromagnetic radiation of a predetermined wavelength in order to inhibit cellular mechanisms involved in retinal macular degeneration and to increase mitochondrial metabolic activity of retinal cells through photobiomodulation.

[0046] Advantageously, the LED is configured to emit electromagnetic radiation at a wavelength of around 590 nm or equal to 590 nm (yellow light). The technical effect of these features is to suppress the expression of vascular endothelial growth factor (VEGF) and increase the expression of nitric oxide in retinal cells. Vascular endothelial growth factor (VEGF) is a signaling protein that stimulates the formation of blood vessels, which contribute to the development of the wet form of retinal macular degeneration, while nitric oxide reduces intracellular oxidative stress-mediated lesions and increases oxygen distribution.

[0047] Advantageously, the LED is configured to emit electromagnetic radiation with a wavelength of around 630 nm or equal to 630 nm (red light). It has been experimentally observed that radiation having this wavelength is adapted to suppress inflammatory events by increasing mitochondrial metabolic activity, understood as the production of ATP (adenosine triphosphate) molecules and oxygen in retinal cells, thereby promoting electron transport and oxygen binding by cytochrome C oxidase (CCO), and reducing cell death.

[0048] The aforementioned interval is preferably 40 nm wide around the indicated value for both yellow light and red light.

[0049] In particular, the LED is a high-power type.

[0050] Preferably, the mask is formed by thin plate-shaped bodies that constitute the plurality of light sources.

[0051] The mask is preferably associated with appropriate support means adapted to hold the mask in a predetermined position in front of the user's face when in use. In particular, the device is held at an optimal distance from the user's face by the support means.

[0052] The LEDs are positioned on the mask at substantially the same distance from the user's eyes. This distance is suitably calculated based on the wavelength characteristics of the light beam emitted from the LEDs.

[0053] Preferably, the LED is positioned at a distance of 1 cm to 4 cm from the area being processed during use.

[0054] This distance is determined based on the focus and absorption of electromagnetic radiation, and it is found that this interval is optimal.

[0055] Preferably, the memory includes a command, when executed by the electronic computer, to cause the electronic computer to automatically select a plurality of light-emitting diodes, automatically set their wavelengths and emission times, and perform treatment of the internal tissues of the user's eye, particularly the user's retinal cells.

[0056] In particular, the memory may, when executed by the electronic computer, include commands that cause the electronic computer to automatically select a plurality of the light-emitting diodes and automatically set their wavelengths and emission times, as a function of commands set by an operator via the control interface relating to a protocol for treating the internal tissues of the user's eye.

[0057] According to one aspect of the present invention, it is possible to provide that the LED circuit is connected to a controller associated with the mask, which is adapted to manage the operation of the LED, and that the external unit is used solely for the function of electrically supplying power to the LED. In this case, the control interface can be associated with the mask or the external power supply unit.

[0058] The thin plate-like body of the mask is preferably made of a polymer material. Alternatively, the mask may be made of other suitable materials such as skin, leather, cloth and / or paper derivatives.

[0059] Preferably, the mask is filled with eye areas to accommodate the LED matrix. More specifically, for each eye, the mask has an area suitable for accommodating its respective LED matrix. In this way, the LED matrix can be used to treat conditions affecting the internal tissues of the user's eye.

[0060] Preferably, the matrix is ​​sized to illuminate the user's eyeball, including the area around the eye, for diffuse irradiation.

[0061] Preferably, the LEDs are regularly arranged in the eye area on the mask. In particular, in each column of the matrix, the LEDs are arranged at the same distance from each other.

[0062] Preferably, the LEDs arranged on the mask in the eye region are inclined at a predetermined angle with respect to the surface of the mask.

[0063] More preferably, the LED is tilted at a 45° angle.

[0064] Preferably, each LED matrix in one eye includes a substantial central region in which the LEDs are of a predetermined size, and at least one pair of LEDs positioned on the opposing sides of the central region and having a larger size than the LEDs in the central region. The aforementioned inclination of the LEDs, along with the described distribution, was considered, based on experimental evidence, to be advantageous for treating the internal tissues of the eye.

[0065] Preferably, the mask may also have additional LED matrices adapted for use in performing appropriate therapeutic treatments on other areas, such as different parts of the face, like the forehead and / or cheeks.

[0066] Preferably, the matrix arranged in the eye region includes a number of LEDs per surface unit greater than the number of LEDs per surface unit of the further matrix.

[0067] Preferably, the LEDs in the matrix arranged in the eye region have a size smaller than the size of the LEDs that constitute the further matrix.

[0068] Preferably, the thin plate-shaped body of the mask has a thickness suitable for inserting the LED and the relative circuit.

[0069] According to one aspect of the present invention, the thin plate-shaped body of the mask includes a first outer layer and a second inner layer that are integrated with each other.

[0070] Preferably, the LED and the relative circuit are housed between the first outer layer and the second inner layer.

[0071] Preferably, the second inner layer has a pair of openings in the eye region so as to expose the matrix of the LED toward the eyelid and periocular region.

[0072] Preferably, the opening has an elliptical shape so as to define each entire region having a shape suitable for illuminating the entire surface of the eyeball together with the surrounding region through the matrix LED.

[0073] A series of further openings, preferably in the form of strips, adapted to accommodate the further LED matrix, can also be formed in the second inner layer.

[0074] Preferably, the strips have different lengths depending on the area of ​​the mask on which they are made, and are arranged sequentially to one another along the longitudinal direction of the mask.

[0075] Advantageously, the LEDs positioned in different areas of the face other than the eye area may have different properties. For example, they may be suitable for emitting red light to stimulate collagen production, blue light to combat bacterial acne, yellow light to stimulate the lymphatic and nervous systems, or infrared light. Preferably, LEDs with different properties are combined in the same mask to perform a mixed treatment.

[0076] It is possible to provide that the surface of the LED directed towards the skin being treated is covered with a suitable filter adapted to remove potentially dangerous frequencies present in the emission spectrum of the LED.

[0077] Preferably, the apparatus comprises an image acquisition device adapted to acquire an image of the user's eyes, and / or motion sensor means adapted to detect whether the user's eyes are open or closed. In particular, the image acquisition device is used to check whether the user's eyes are open or closed.

[0078] Preferably, the device includes an acoustic signal transmitter adapted to transmit an acoustic signal to the user to open or close their eyes.

[0079] Advantageously, the acoustic signal transmitter is adapted to transmit a first acoustic signal and a second acoustic signal, wherein the first acoustic signal differs from the second acoustic signal. For example, the first acoustic signal has a different emission time than the second acoustic signal.

[0080] Preferably, the first acoustic signal instructs the user to close their eyes, and the second acoustic signal instructs the user to open their eyes.

[0081] The present invention also relates to a computer program to be executed by an apparatus for the treatment of internal ocular tissues, particularly retinal tissue.

[0082] The computer program includes instructions that cause the device to perform the step of receiving commands from an operator via the control interface regarding a protocol for treating the internal tissue of the user's eye.

[0083] Preferably, the step of receiving commands from an operator via the control interface regarding a protocol for treating the internal tissues of the user's eye provides receiving an initiation command to start the treatment protocol. In particular, the operator may press an initiation button or select an appropriate icon on the interface to start this protocol.

[0084] Furthermore, the program provides a function to automatically select a plurality of LEDs and automatically set their wavelength and emission time.

[0085] This program can instruct the user to close their eyes using a warning signal.

[0086] This program provides a mechanism to operate the plurality of LEDs in continuous mode over a first time interval so that they emit electromagnetic radiation in the direction of the user's closed eyes at wavelengths in the ±40nm range centered around 590nm.

[0087] The program then instructs the user to open their eyes via a warning signal.

[0088] Next, this program provides that the plurality of LEDs be operated in pulse mode at wavelengths in the ±40nm range centered around 590nm over a second time interval, emitting electromagnetic radiation in the direction of the user's open eye.

[0089] The next step is to provide a warning signal that instructs the user to close their eyes, and then to operate the plurality of LEDs in continuous mode for the first time interval at wavelengths in the ±40 nm range centered on 630 nm, emitting electromagnetic radiation in the direction of the user's closed eyes.

[0090] Finally, this program can instruct the user to open their eyes via a warning signal.

[0091] Next, the program provides that the plurality of LEDs operate in pulse mode for the second time interval at wavelengths in the ±40 nm range centered on 630 nm, emitting electromagnetic radiation in the direction of the user's open eye.

[0092] The aforementioned steps performed by this device have been experimentally observed to be effective in treating retinal disorders such as macular degeneration. More specifically, these steps result in a reduction of oxidative stress in retinal cells and suppression of inflammatory mediators, leading to a decrease in progressive inflammatory episodes that cause the accumulation of extracellular debris and loss of retinal cells. This can improve visual acuity and contrast sensitivity and reduce the volume of drusen and macula in patients with progressive diseases such as senile macular degeneration. These effects depend on the combination of treatment time, treatment method (i.e., whether the patient's eyes are open or closed), and the wavelength used.

[0093] As already mentioned, radiation with wavelengths in the 590 nm range or substantially equal to it is adapted to inhibit the expression of vascular endothelial growth factor (VEGF) and increase the expression of nitric oxide in retinal cells, while radiation with a wavelength of 630 nm is adapted to promote electron transport and oxygen binding of cytochrome C oxidase (CCO) by increasing mitochondrial metabolic activity, understood as the production of ATP (adenosine triphosphate) molecules and oxygen in retinal cells, thereby suppressing inflammatory phenomena by reducing cell death.

[0094] Experimental results show that this program can be effectively used to treat amblyopia, retinitis pigmentosa, and corneal inflammation, with experimental confirmation of reduced inflammatory cytokine levels and restoration of irregularities caused by corneal and retinal cell damage. Furthermore, by increasing tear production, it also improves the condition of patients suffering from dry eye disease (DED).

[0095] This program is also effective for treating eye injuries and wound healing after surgery.

[0096] Furthermore, it can be observed that when a treatment protocol command is received from the operator, the program automatically and easily administers the treatment to the patient.

[0097] Preferably, the warning signal is an acoustic signal and / or a vibration signal and / or a signal displayed on the control interface.

[0098] Preferably, the signals displayed on the control interface are images and / or text messages.

[0099] According to one aspect of the present invention, the program includes a step of checking whether the user's eyes are closed or open before the step of operating the predetermined wavelength LED.

[0100] Preferably, the step of checking whether the user's eyes are closed or open is performed by the operator. Alternatively, the step of checking whether the user's eyes are closed or open is performed by an image acquisition device adapted to acquire at least one image of the user's eyes, and / or by motion sensor means.

[0101] Advantageously, the first time interval is longer than the second time interval.

[0102] Preferably, the first time interval is 5 minutes or more, and the second time interval is less than 2 minutes.

[0103] More preferably, the first time interval is equal to 6 minutes, or a duration of 6 minutes with a difference of approximately ±1 minute.

[0104] More preferably, the second time interval is equal to 1 minute, or approximately ±15 seconds for a duration of 1 minute.

[0105] Advantageously, both of the patient's eyes receive treatment with electromagnetic radiation simultaneously through the device.

[0106] Preferably, the steps performed by the apparatus constitute a treatment session.

[0107] Advantageously, the program includes further instructions that define a treatment cycle by repeating the steps that constitute a treatment session for at least one further treatment session, preferably six to seven more such sessions.

[0108] Preferably, the program includes further instructions for setting time intervals between sessions consisting of three to four days and subsequent sessions.

[0109] Preferably, the program includes a command to activate the LED after a period of six to nine months from the first execution, thereby setting the repetition of the treatment cycle for a predetermined number of sessions, preferably between four and seven sessions, and preferably equal to six sessions.

[0110] When mixed therapy is performed, for example, when treatment of the eye area is performed together with treatment of other areas of the face, the additional LED matrix placed on the affected area is also activated.

[0111] In the case of mixed processing, the operator selects the additional LEDs of interest via the interface of the control and / or power supply unit and proceeds with the processing by inputting parameters appropriate to the type of processing, such as duration and power output values.

[0112] (Brief explanation of the drawing) Further details of the present invention will become clearer from a detailed description of preferred embodiments of the eye disorder treatment device according to the present invention, which are illustrated in the accompanying drawings: Figure 1 is a front perspective view of the components of this device; Figure 2 is a front view showing one embodiment of the components of this device; Figure 3 is a front view showing one embodiment of the components of this device; Figure 4 is a rear front view of the components of this device; Figure 5 is a front view of a different embodiment of the components of the apparatus shown in Figure 2; Figure 6 is a front view of a different embodiment of the components of the apparatus shown in Figure 4; Figure 7 is a front view of a different embodiment of the components of the apparatus shown in Figure 3; Figure 8 is a front perspective view of the control device of this apparatus; Figure 9 shows an image of a user wearing the components of the device according to the present invention; Figures 10a, 10b, 10c, and 10d show the sequential steps of the treatment protocol executed by the electronic computer of this device; Figures 11-13 show images of the retina of the same eye of a subject before and after treatment using the device according to the present invention; Figure 14a shows images of the subject's retina acquired using SD-OCT (Spectral-Domain Optical Coherence Tomography) technology under reference conditions; Figure 14b shows a retinal image of the same subject as in Figure 14a, acquired by SD-OCT technology one month after treatment performed with the device according to the present invention; Figure 14c shows retinal images of the same subjects as in Figures 14a and 14b, acquired by SD-OCT technology three months after treatment performed with the apparatus according to the present invention; Figures 15a and 15b show fundus images of the same subjects as in Figures 14a-14c, obtained by FAF Fundus Autofluorescence in a reference state, and fundus images of the same subjects three months after treatment performed with this device, respectively. Figures 16a and 16b show the retinal sensitivity maps of the same subjects obtained by microperimetry in Figures 15a and 15b, respectively, under baseline conditions, and the retinal sensitivity maps of the same subjects 3 months after treatment with the device.

[0113] (Description of Embodiments of the Invention) Referring in particular to these figures, the apparatus for treating eye disorders, especially disorders of the internal tissues of the eye, according to the present invention is shown in whole as 1.

[0114] Apparatus 1 includes a mask 2, which preferably has the form of a mask that mimics a human. The mask 2 is formed by a thin plate-like body containing a plurality of light-emitting diode (usually abbreviated as LED for simplicity) type light sources 3 arranged on the inner surface of the mask 2.

[0115] In particular, LED3 is a high-power type.

[0116] Mask 2 is preferably associated with appropriate support means (see Figure 9) adapted to hold the mask in a predetermined position in front of the user's face when in use.

[0117] In particular, device 1 is held by support means at an optimal distance from the user's face so that the distance between LED 3 and the user's eyes is maintained in a range between 1 cm and 4 cm. This distance is determined based on the focus and absorption of electromagnetic radiation and is optimal within this range.

[0118] LED3 is connected to the appropriate electrical circuit (which is known and therefore not illustrated), which allows for power management and the correct operation of the diode.

[0119] The LED circuit 3 is electrically connected to the control and / or power supply unit 4 of this device. The control and / or power supply unit 4 is located outside of the mask 2 and is connected to the mask 2 by, for example, an appropriate connecting cable (not shown).

[0120] The control unit 4 includes a control interface 6 adapted to allow for the simple selection of commands related to treatment protocols for the internal tissues of the eye, particularly the retina, or the simple setting of parameters that characterize such treatments, such as the duration of treatment or the selection of wavelengths emitted by diodes that are alternately activated according to the steps of the current treatment protocol. The control interface 6 also allows for the display of appropriate signals to assist in the execution of the treatment protocol, as will be better described below.

[0121] The control interface 6 is equipped with a screen. In particular, the interface 6 may consist of a touchscreen or a screen associated with an appropriate control button.

[0122] Alternatively, a control interface can be provided to set treatment parameters related to Mask 2.

[0123] The external control and / or power supply unit 4 comprises an electronic computer 41 and a memory 42 readable by the electronic computer.

[0124] Memory 42, when executed by the electronic computer 41, includes a command to cause the electronic computer 41 to automatically select a plurality of light-emitting diodes 3, automatically set their wavelength and emission time, and perform treatment of the user's retinal cells.

[0125] In particular, the memory 42 may include a command, when executed by the electronic computer 41, that causes the electronic computer 41 to automatically select a plurality of the light-emitting diodes 3 and to automatically set their wavelength and emission time, as a function of a command set by the operator via a control interface 6 relating to a protocol for treating the internal tissue of the user's eye.

[0126] Memory 42 also contains commands, when executed by the electronic computer 41, that cause the electronic computer 41 to instruct the user to open and close their eyes. This signal is given by transmitting vibration signals and / or acoustic signals and / or by warning signals displayed on interface 6.

[0127] The warning signal may be an image displayed on interface 6, particularly on the screen, indicating whether to open or close one's eyes. The warning signal may also be a text message displayed on interface 6 at all times, either in place of or in conjunction with an image, which serves the same function of informing the user that they need to open or close their eyes.

[0128] In another embodiment, the circuit for LED3 may be connected to a controller connected to mask 2 to manage the operation of LED3, and the external unit 4 may be used solely for the function of supplying power to LED3. In this case, the control interface 6 may be associated with mask 2 or the external power supply unit 4.

[0129] The thin plate-like body of the mask 2 has a thickness suitable for inserting the LED 3 and related circuits. The LED is positioned on the inner surface of the mask 2, which is oriented towards the user's face when in use. In particular, the LED 3 is positioned on the inner surface of the mask 2 such that it forms at least one matrix 30 in the area of ​​the user's eyelids and around the eyes when in use.

[0130] The matrix 30 preferably includes LEDs 3 that emit light in the range around 590 nm or at a wavelength equal to 590 nm (yellow light) and LEDs 3 that emit light in the range around 630 nm or at a wavelength equal to 630 nm (red light). Advantageously, the yellow-emitting LEDs 3 and the red-emitting LEDs 3 can be operated alternately during use, depending on the steps of the treatment protocol being performed.

[0131] The aforementioned interval preferably has a width of 40 nm around the indicated value for both yellow light and red light.

[0132] The thin, plate-like body of mask 2 is preferably made of a polymer material. Alternatively, it may be made of other suitable materials such as leather, hide, cloth and / or paper derivatives.

[0133] Mask 2 has an area covering the entire eye to accommodate the aforementioned matrix 30 of LED 3. More specifically, for each eye, a suitable area is obtained in Mask 2 to accommodate each matrix 30 of LED 3. In this way, the matrix 30 of LED 3 can be used to treat pathological conditions affecting the internal tissues of the user's eye. More specifically, the matrix 30 is sized to irradiate the user's eyeball, including the area around the eye, for diffuse irradiation.

[0134] Preferably, the LEDs 3 are regularly arranged in the eye area of ​​the mask 2. In particular, in each column of the matrix 30, the LEDs 3 are arranged at the same distance from each other.

[0135] According to the embodiment of mask 2 shown in Figures 5-7, each matrix 30 positioned in the eye area includes a plurality of LEDs 3 tilted at a predetermined angle with respect to the surface of the mask. Preferably, the LEDs 3 are tilted at an angle of 45°.

[0136] Each matrix 30 arranged in the eye includes a substantial central region having an LED 3 of a predetermined size, and at least one pair of LEDs 3 arranged on the opposite sides of the central region, having a larger size than the central LED 3.

[0137] Based on clinical evidence, the mask configurations shown in Figures 5-7 have been evaluated as particularly advantageous for treatment procedures on the internal tissues of the eye.

[0138] Mask 2 may also have a further matrix 31 of LEDs 3 adapted for use in performing appropriate therapeutic treatments on the skin in other areas, such as different parts of the face, like the forehead and / or cheeks (see Figures 1-4).

[0139] The number of LED3s per surface unit in matrix 30, which is positioned in the eye region, is greater than the number of LED3s per surface unit in a further matrix 31.

[0140] Preferably, the size of the LED3 in matrix 30 is smaller than the size of the LED3 that make up a further matrix 31.

[0141] According to a preferred embodiment, the thin plate-like body of the mask 2 is composed of a first outer layer 8 and a second inner layer 9 that are integrated with each other.

[0142] The LED3 and associated circuitry are housed between a first outer layer 8 and a second inner layer 9. The second inner layer 9 has a pair of openings 10 in the eye area so as to expose the matrix 30 of the LED3 toward the eyelid and the area around the eye.

[0143] Preferably, the opening 10 has an elliptical shape so as to define each entire region having a shape suitable for illuminating the entire surface of the eyeball together with the surrounding region through the LED 3 of the matrix 30.

[0144] A series of further openings 10, preferably formed in strips, adapted to accommodate a further matrix 31 of LEDs 3, can also be formed on the second inner layer 9. The strips have different lengths depending on the area of ​​the mask to be made and are arranged sequentially to one another along the longitudinal direction of the mask.

[0145] LED3 is positioned on mask 2 at substantially the same distance from the user's eyelids. This distance is appropriately calculated based on the wavelength characteristics of the light beam emitted from LED3.

[0146] Preferably, the LED3 is positioned at a distance of 1 cm to 4 cm from the area being processed during use.

[0147] LEDs 3 positioned in different areas of the face other than the eye area, i.e., LEDs 3 constituting the matrix 31, may exhibit different characteristics. For example, they may be suitable for emitting red light to stimulate collagen production, blue light to combat bacterial acne, yellow light to stimulate the lymphatic and nervous systems, or even infrared light. Preferably, LEDs 3 with different characteristics are combined in the same mask 2 to perform mixed therapy.

[0148] LED3 of Matrix 30 in the eye region is configured to emit a beam of electromagnetic radiation having a predetermined wavelength in order to suppress the cellular mechanisms involved in retinal macular degeneration and to increase the mitochondrial metabolic activity of retinal cells through photobiomodulation.

[0149] The surface of the LED3 directed towards the skin being treated can be covered with a suitable filter adapted to remove potentially dangerous frequencies present in the LED3's emission spectrum.

[0150] The present invention also relates to a computer program executed by a device for treating internal eye tissue, particularly retinal tissue, the program which provides commands set by an operator via a control interface 6 to expose retinal cells to a predetermined amount of electromagnetic radiation to induce molecular-level changes in the retinal cells, and is useful for treating retinal disorders such as macular degeneration.

[0151] In fact, it has been experimentally observed that radiation with a wavelength corresponding to 590 nm is suitable for suppressing the expression of vascular endothelial growth factor (VEGF) and increasing the expression of nitric oxide in retinal cells.

[0152] Vascular endothelial growth factor (VEGF) is a signaling protein that stimulates the formation of blood vessels, which contribute to the development of the wet form of retinal macular degeneration, while nitric oxide reduces intracellular oxidative stress-mediated lesions and increases oxygen distribution.

[0153] Furthermore, it has been experimentally observed that radiation with a wavelength of 630 nm is adapted to suppress inflammatory phenomena by increasing mitochondrial metabolic activity, which is understood as the production of ATP (adenosine triphosphate) molecules and oxygen in retinal cells, thereby promoting electron transport and oxygen binding by cytochrome C oxidase (CCO), and reducing cell death.

[0154] Therefore, such programs performed by this device can lead to a reduction in oxidative stress in retinal cells and a suppression of inflammatory mediators, resulting in a decrease in progressive inflammatory episodes that cause the accumulation of extracellular debris and loss of retinal cells, thereby improving visual acuity and contrast sensitivity, and reducing the volume of drusen and macula in patients with degenerative diseases such as senile macular degeneration.

[0155] Such programs can also be effectively used to treat amblyopia, retinitis pigmentosa, and corneal inflammation, with experimental evidence showing a reduction in inflammatory cytokine levels and recovery from damage caused by corneal and retinal cell damage. Furthermore, by increasing tear production, they improve the condition of patients suffering from dry eye disease (DED).

[0156] It is also effective for treating eye injuries and wound healing after surgery.

[0157] Preferably, the device 1 is associated with an image acquisition device (not shown). The image acquisition device may be, for example, a camera or video camera, and is used to acquire images of the user's eyes to check whether they are open or closed during treatment. Instead of, or together with, the device 1 includes motion sensor means adapted to detect whether the user's eyes are closed or open.

[0158] Finally, device 1 may also include an acoustic signal transmitter, also not shown in the figure, adapted to transmit an acoustic signal to indicate the need to open or close the eyes during treatment.

[0159] The operation of the device used to treat the internal tissues of the eye can be easily understood from the explanation above.

[0160] First, place mask 2 in front of the user's face using appropriate support means (see Figure 9).

[0161] The operator sets activation commands for a protocol to treat the internal tissues of the user's eye via the interface 6 of the control and / or power supply unit 4. Essentially, the operator can start the treatment protocol by pressing a start button or selecting the appropriate icon on the interface.

[0162] The program executed by the electronic computer 41 selects the LED3s placed in the eye area and automatically sets the wavelength and illumination time of the LED3s to be suitable for the treatment to be performed.

[0163] Subsequently, the user receives treatment during a predetermined time interval corresponding to the luminescence time Δt.

[0164] In particular, the user is instructed to close their eyes, and LED3 is then operated in continuous mode for a first time interval Δt1 to emit electromagnetic radiation in the direction of the user's closed eyes in the range of ±40 nm around 590 nm, preferably substantially equal to 590 nm (see Figure 10a).

[0165] Next, the user is instructed to open their eyes, and LED3 is activated for a second set time interval Δt2 to emit electromagnetic radiation in pulse mode in the direction of the user's open eyes at a wavelength of ±40 nm around 590 nm, preferably substantially equal to 590 nm (see Figure 10b).

[0166] Furthermore, the user is instructed to close their eyes, and LED3 is activated for a first set time interval Δt1 in continuous mode to emit electromagnetic radiation in the direction of the user's closed eyes in the range of ±40 nm around 630 nm, preferably substantially equal to 630 nm (see Figure 10c).

[0167] Next, the user is instructed to open their eyes, and LED3 is activated for a second set time interval Δt2 to emit electromagnetic radiation in pulse mode in the direction of the user's open eyes at a wavelength of ±40 nm around 630 nm, preferably substantially equal to 630 nm (see Figure 10d).

[0168] The user is instructed to open and close the eyes by transmitting an acoustic signal and / or a vibration signal and / or a warning signal displayed on the control interface.

[0169] Preferably, the program provides a further step of checking whether the user's eyes are closed or open by an image acquisition device adapted to acquire at least one image of the user's eyes, and / or by motion sensor means. Alternatively, this check can be performed by an operator responsible for treatment control.

[0170] Advantageously, the first time interval Δt1 is greater than the second time interval Δt2.

[0171] Preferably, the first time interval Δt1 is greater than 5 minutes, and the second time interval Δt2 is less than 2 minutes.

[0172] For example, the first time interval Δt1 is 6 minutes, or approximately 6 minutes plus or minus 1 minute.

[0173] For example, the second time interval Δt2 is equal to 1 minute, or approximately ±15 seconds of the duration of 1 minute.

[0174] Advantageously, both of the patient's eyes receive treatment with electromagnetic radiation simultaneously from device 1.

[0175] The above treatment steps are performed by a computer program using LED3 in the user's eye during a treatment session. It is preferable to constitute a session cycle by repeating up to 7 to 8 sessions at intervals of time, preferably every 3 to 4 days.

[0176] Preferably, the treatment session cycle is performed again by a computer program via LED3 in the user's eye after a period of 6 to 9 months following the first execution. The number of sessions in this next treatment cycle preferably consists of 4 to 7 sessions, preferably equal to 6.

[0177] It is preferable to check the health of the cells in the internal tissues of the eye at predetermined time intervals, for example, one month, two months, and four months after the end of the last treatment cycle.

[0178] A randomized, controlled, multicenter clinical trial was conducted in patients presenting with AMD (age-related macular degeneration) grades 2 and 3 according to the AREDS classification. The apparatus according to the present invention was used in the clinical trial, and the memory of each apparatus, when executed by the electronic computer 41, contains instructions that cause the electronic computer 41 to perform the steps described above. The aforementioned steps include administering electromagnetic radiation of a specific wavelength to each patient's closed or open eye for a predetermined time interval.

[0179] The objective of the clinical trial was to check whether the device performing the aforementioned steps had the effect of slowing the progression of advanced disease. The results of the clinical trial demonstrated the effectiveness of treatment with this device.

[0180] As an example, we will present two case studies from clinical trials that were conducted.

[0181] (Case 1) The patient for treatment is a 68-year-old woman with age-related macular degeneration (ADM) classified as Grade 3 according to the AREDS classification.

[0182] The best corrected visual acuity of women before treatment was quantified using a 50-character table in the ETDRS (Early Treatment Diabetic Retinopathy Study) format.

[0183] The woman underwent treatment involving two sessions per week for four weeks, using a device that ran the program as described.

[0184] After one month of treatment, the woman's health status was evaluated, and in particular, her best corrected visual acuity using ETDRS 55 letters was measured. Furthermore, as shown in Figure 11-13, a reduction in the amount of drusen in the macular region was observed by acquiring a series of images of the woman's retina.

[0185] (Case 2) The patient was a 55-year-old male with nonvascular age-related macular degeneration. His best corrected visual acuity measured before treatment was 25 letters on the ETDRS chart. SD-OCT (spectral-area optical coherence tomography) technology highlighted substantial detachment of the pigment epithelium, along with subretinal fluid at its apex.

[0186] The man received treatment using a device that performed the steps described. The treatment consisted of one session per week for four weeks. Following the first month of treatment, the man received sessions every two weeks for two months.

[0187] One month after the completion of treatment, complete absorption of subretinal fluid and a reduction in pigment epithelial detachment were observed without any residual retinal atrophy. The best corrected visual acuity was measured using the ETDRS 60 character scale.

[0188] The improvement in the man's health was also documented by images acquired at different time intervals (see Figures 14a to 16b). In particular, Figure 14a shows an image of the man's retina, representing the man's reference state before treatment, acquired using SD-OCT technology. The reference state image shows significant pigment epithelial detachment (PED) with subretinal fluid.

[0189] Figure 14b shows a retinal image taken with SD-OCT one month after treatment. This image highlights the flattening of the pigment epithelium detachment, along with the presence of high / low reflectivity material.

[0190] The image in Figure 14c was taken using SD-OCT three months after treatment, and it can be seen that the detachment of the pigment epithelium has become even flatter.

[0191] Furthermore, Figures 15a and 15b show images of the subject's fundus obtained by autofluorescence (FAF) in the baseline state and images of the subject's fundus three months after the aforementioned treatment, respectively. In Figure 15a, a hyperautofluorescence ring is observed in the peripheral area of ​​the pigment epithelial detachment, while in Figure 15b, isoautofluorescence is observed in the macula, and no atrophy of the retinal pigment epithelium is observed.

[0192] Finally, Figure 16a shows a decrease in retinal sensitivity in the macular region, with an average value of 7.4 dB. Microperimetry performed three months after treatment (see Figure 16b) showed an average improvement of 26.5 dB in macular sensitivity.

[0193] The reported cases support the effectiveness of treatment using this device.

[0194] According to one aspect of the present invention, in the case of preventive treatment, particularly for the preventive treatment of age-related macular degeneration of dry type (dAMD), the aforementioned treatment steps constituting a treatment session are performed by a computer program for at least one further treatment session one week after the first session. It is preferable to repeat the treatment up to four times at regular time intervals, preferably every week, to constitute a session cycle.

[0195] This program also includes instructions for setting up a cycle of preventative maintenance therapy following the initial cycle of sessions. This cycle consists of two treatment sessions over a week, with 3-4 day intervals, once a quarter. The preventative maintenance therapy cycle should be implemented throughout the patient's life.

[0196] It is preferable to perform health checks of the cells in the internal tissues of the eye at predetermined time intervals, for example, every 6 to 12 months after the end of the last treatment cycle.

[0197] According to a further aspect of the present invention, in the case of treating severe dry age-related macular degeneration (dAMD), a program executed by an electronic computer 41 selects LEDs 3 located in the eye area and sets up an initial treatment cycle. Each session of the initial treatment cycle includes the treatment steps described above, but with different time intervals, as shown below.

[0198] Preferably, the first time interval Δt1 is 10 minutes or more, and the second time interval Δt2 is less than 4 minutes. More preferably, the first time interval is equal to 12 minutes, or approximately ±2 minutes for a duration of 12 minutes.

[0199] More preferably, the second time interval is equal to 2 minutes, or approximately ±30 seconds for a duration of 2 minutes.

[0200] After the initial four-week treatment cycle is completed, it is desirable to repeat the treatment sessions twice a week for up to four consecutive weeks.

[0201] Following the initial cycle of sessions, the program also includes instructions to set up a maintenance treatment cycle involving activating LED3, with two sessions per week for three months starting from the end of the first month of the initial cycle. Each maintenance cycle session consists of the aforementioned treatment steps, but the time intervals are shortened compared to each treatment session in the initial cycle.

[0202] In particular, the first time interval Δt1 is 5 minutes or more, and the second time interval Δt2 is less than 1 minute. More preferably, the first time interval is equal to 5 minutes, or approximately ±100 seconds with a duration of 5 minutes. Even more preferably, the second time interval is 1 minute, or approximately ±50 seconds with a duration of 1 minute.

[0203] Preferably, the program includes a command to set up a repeat of the maintenance cycle by activating an LED after a period consisting of 6 to 9 months from the first cycle. The number of sessions in this second maintenance cycle is preferably 4 to 7 sessions, more preferably 6 sessions.

[0204] It is preferable to check the health status of the cells in the internal tissues of the eyeball at predetermined time intervals, for example, one month, four months, and twelve months after the end of the last treatment cycle.

[0205] According to a further aspect of the present invention, in the case of treating non-neovascular age-related macular degeneration (nnAMD) and chronic central serous chorioretinopathy (cCSC), a program executed by an electronic computer 41 selects LEDs 3 positioned in the eye region and sets an initial treatment cycle.

[0206] Central serous chorioretinopathy (CSC) is the fourth most common retinopathy, generally occurring in young and middle-aged adults, and is more prevalent in men. It is characterized by choroidal vascular abnormalities associated with retinal pigment epithelium (RPE) dysfunction, leading to detachment of the pigment epithelium (PED) and serous neuroretinal detachment of the posterior pole. While generally a self-limiting disease, subretinal fluid (SRF) can persist for more than six months in 5-10% of cases, resulting in a chronic disease with RPE and / or photoreceptor cell damage.

[0207] The initial treatment cycle consists of one treatment session per week for four weeks. Each session in the initial treatment cycle consists of the treatment steps described above. Following the initial cycle of sessions, the program also includes instructions to set up a maintenance treatment cycle, consisting of two sessions per week for three months, after the initial one-month treatment, by operating the LED3.

[0208] Preferably, the program includes a command to activate the LED so that the repetition of the maintenance cycle from the 5th to the 12th month from the first session consists of a predetermined number of sessions, preferably one to two times every four weeks.

[0209] It is preferable to check the health status of the cells in the internal tissues of the eyeball at predetermined time intervals, for example, one month, four months, and twelve months after the end of the last treatment cycle.

[0210] When mixed therapy is performed, for example, when treatment of the eye area and treatment of other areas of the face are performed together, additional matrix 31 of LED3 placed in the affected area is also activated.

[0211] In the case of mixed processing, the operator selects any additional LEDs 3 of interest through the interface 6 of the control and / or power supply unit 4 and inputs parameter values ​​appropriate to the type of processing, such as duration and discharge power.

[0212] The device described as an example can be modified and transformed in numerous ways to meet various needs.

[0213] In practical implementation of the present invention, the materials used, as well as the shape and size, are arbitrary and subject to requirements.

[0214] Where reference numerals are used to accompany the technical features described in each claim, such reference numerals are provided solely for the purpose of enhancing the understanding of the claims and, as a result, do not have any limiting value to the scope of each element exemplified by such reference numerals. [Brief explanation of the drawing]

[0215] [Figure 1] This is a front perspective view of the components of this device. [Figure 2] This is a front view showing one embodiment of the components of this device. [Figure 3] A front view showing one embodiment of the components of this device. [Figure 4] This is a rear view of the components of this device. [Figure 5] Figure 2 is a front view of a different embodiment of the components of the device shown. [Figure 6] Figure 4 is a front view of a different embodiment of the components of the device shown. [Figure 7] Figure 3 is a front view of a different embodiment of the components of the device shown. [Figure 8] This is a front perspective view of the control unit of this device. [Figure 9] The image shows a user wearing components of the device according to the present invention. [Figure 10a]This shows the sequence of steps in the treatment protocol executed by the electronic computer of this device. [Figure 10b] This shows the sequence of steps in the treatment protocol executed by the electronic computer of this device. [Figure 10c] This shows the sequence of steps in the treatment protocol executed by the electronic computer of this device. [Figure 10d] This shows the sequence of steps in the treatment protocol executed by the electronic computer of this device. [Figure 11] The images show the retina of the same eye of a subject before and after treatment using the device according to the present invention. [Figure 12] The images show the retina of the same eye of a subject before and after treatment using the device according to the present invention. [Figure 13] The images show the retina of the same eye of a subject before and after treatment using the device according to the present invention. [Figure 14a] Images of the subject's retina obtained using SD-OCT (Spectral-Domain Optical Coherence Tomography) technology are shown under reference conditions. [Figure 14b] Figure 14a shows a retinal image of the same subject, obtained by SD-OCT technology one month after treatment performed with the device according to the present invention. [Figure 14c] Figures 14a and 14b show retinal images of the same subjects, acquired by SD-OCT technology three months after treatment performed with the device according to the present invention. [Figure 15a] Figures 14a-14c show fundus images of the same subjects obtained by FAF Fundus Autofluorescence in a reference state, as well as fundus images of the same subjects 3 months after treatment performed with this device. [Figure 15b] Figures 14a-14c show fundus images of the same subjects obtained by FAF Fundus Autofluorescence in a reference state, as well as fundus images of the same subjects 3 months after treatment performed with this device. [Figure 16a] Figures 15a-15b show the retinal sensitivity maps of the same subjects obtained by microperimetry under baseline conditions, and the retinal sensitivity maps of the same subjects 3 months after treatment with the device. [Figure 16b] Figures 15a-15b show the retinal sensitivity maps of the same subjects obtained by microperimetry under baseline conditions, and the retinal sensitivity maps of the same subjects 3 months after treatment with the device.

Claims

1. A device for treating eye disorders, particularly for treating the internal tissues of the user's eye, Mask (2); A plurality of light-emitting diodes (3) arranged on the inner surface of the mask (2), the plurality of light-emitting diodes (3) comprising at least one matrix (30) of light-emitting diodes (3) arranged in a region of the inner surface of the mask (2) that is adapted to face the user's eye area when in use, the plurality of light-emitting diodes (3) being arranged at substantially the same distance from the user's eye and configured to emit electromagnetic radiation adapted to stimulate the cellular function of retinal cells; Support means adapted to hold the mask (2) in a predetermined position in front of the user's face when in use; and An external control and / or power supply unit (4) electrically connected to the light-emitting diode (3) and equipped with a control interface (6); Equipped with, The control and / or power supply unit (4) is connected to an electronic computer (41); The memory (42) is readable by the aforementioned electronic computer and includes, when executed by the aforementioned electronic computer (41), a command that causes the aforementioned electronic computer (41) to perform the following steps; The following steps are performed: (a) The step of receiving a command from the operator via the control interface (6) relating to a protocol for treating the internal tissue of the user's eye, (b) A step of automatically selecting a plurality of the light-emitting diodes (3) and automatically setting their wavelength and emission time (Δt), (c) A step of instructing the user to close their eyes by a warning signal, (d) The plurality of light-emitting diodes (3) emit electromagnetic radiation in the direction of the user's closed eye in a first time interval Δt in continuous mode at wavelengths in the ±40 nm range centered on 590 nm. １ During the operation, the steps are as follows: (e) A step of instructing the user to open their eyes by a warning signal, (f) The plurality of light-emitting diodes (3) emit electromagnetic radiation in pulse mode in the direction of the user's open eye at a wavelength in the ±40 nm range centered on 590 nm for a second time interval Δt ２ During the operation, the steps are as follows: (g) A step of instructing the user to close their eyes by a warning signal, (h) The plurality of light-emitting diodes (3) emit electromagnetic radiation in the direction of the user's closed eye in a continuous mode at a wavelength in the ±40 nm range centered on 630 nm, in the first time interval Δt １ During the operation, the steps are as follows: (i) A step of instructing the user to open their eyes by a warning signal, (j) The plurality of light-emitting diodes (3) emit electromagnetic radiation in pulse mode in the direction of the user's open eye at a wavelength in the range of ±40 nm centered on 630 nm, in the second time interval Δt ２ During the operation, the steps are as follows: An apparatus characterized by including

2. The apparatus according to claim 1, wherein the warning signal is an acoustic signal and / or a vibration signal and / or a signal displayed on the control interface (6).

3. The apparatus according to claim 2, wherein the signal displayed on the control interface (6) is an image and / or a text message.

4. The apparatus according to claim 1, 2, or 3, wherein the light-emitting diode (3) is configured to emit a beam of electromagnetic radiation at a wavelength in the range of ±40 nm centered on 590 nm in order to inhibit the expression of vascular endothelial growth factor (VEGF) and increase the expression of nitric oxide.

5. The apparatus according to any one of claims 1 to 4, wherein the light-emitting diode (3) is configured to emit a beam of electromagnetic radiation at a wavelength in the range of ±40 nm centered on 630 nm in order to promote electron transport and oxygen binding of cytochrome C oxidase (CCO) by increasing the metabolic activity of mitochondria.

6. The apparatus according to any one of claims 1 to 5, wherein the memory (42) readable by the electronic computer includes a command, when executed by the electronic computer (41), to cause the electronic computer (41) to automatically select a plurality of light-emitting diodes (3), automatically set their wavelengths and emission times, and perform treatment of the internal tissues of the user's eye.

7. The apparatus according to claim 6, wherein the memory (42), when executed by the electronic computer (41), includes a command to cause the electronic computer (41) to automatically select a plurality of light-emitting diodes (3) and to automatically set their wavelengths and emission times as a function of commands set by an operator via the control interface (6) relating to a protocol for treating the internal tissue of a user's eye.

8. The apparatus according to any one of claims 1 to 7, comprising an image acquisition device and / or motion sensor means adapted to acquire an image of the user's eyes, wherein the image acquisition device and / or motion sensor means are adapted to detect whether the user's eyes are open or closed.

9. The apparatus according to any one of claims 1 to 8, comprising an acoustic signal transmitter.

10. A computer program including a command to cause the apparatus described in any one of claims 1 to 9 to perform the following steps, The following steps are performed: a) The step of receiving commands from the operator via the control interface (6) regarding a protocol for treating the internal tissue of the user's eye, b) A step of automatically selecting a plurality of the light-emitting diodes (3) and automatically setting their wavelength and emission time (Δt), c) A step of instructing the user to close their eyes by a warning signal, d) The plurality of light-emitting diodes (3) emit electromagnetic radiation in the direction of the user's closed eye in a first time interval Δt in continuous mode at wavelengths in the ±40 nm range centered on 590 nm. １ During the operation, the steps are as follows: e) A step of instructing the user to open their eyes by a warning signal, f) The plurality of light-emitting diodes (3) emit electromagnetic radiation in pulse mode at wavelengths in the ±40 nm range centered on 590 nm, in the direction of the user's open eye, for a second time interval Δt ２ During the operation, the steps are as follows: g) A step of instructing the user to close their eyes by a warning signal, h) The plurality of light-emitting diodes (3) are made to emit electromagnetic radiation in the direction of the user's closed eye in a continuous mode at a wavelength in the ±40 nm range centered on 630 nm, in the first time interval Δt １ During the operation, the steps are as follows: i) A step of instructing the user to open their eyes by a warning signal, j) The plurality of light-emitting diodes (3) emit electromagnetic radiation in pulse mode at wavelengths in the ±40 nm range centered on 630 nm, in the direction of the user's open eye, in the second time interval Δt ２ During the operation, the steps are as follows: A computer program that includes [this].

11. The computer program according to claim 10, wherein the warning signal is an acoustic signal and / or a vibration signal and / or a signal displayed on the control interface (6).

12. The computer program according to claim 11, wherein the signal displayed on the control interface (6) is an image and / or a text message.

13. The computer program according to claim 10, 11, or 12, further comprising the step of checking whether the user's eyes are closed or open before steps d, f, and h.

14. The computer program according to claim 13, wherein the step of checking whether the user's eyes are closed or open is performed by an image acquisition device adapted to acquire an image of at least one of the user's eyes, and / or by motion sensor means.

15. the first time interval Δt １ is approximately equal to 6 minutes, or a duration of 6 minutes plus or minus about 1 minute, and the second time interval Δt2 is approximately equal to 1 minute, or a duration of 1 minute plus or minus about 15 seconds, according to any one of claims 10 to 14. The computer program according to any one of claims 10 to 14.

16. The computer program according to claim 15, further comprising instructions to set the repetition of steps a to j constituting a treatment session for at least one further treatment session, preferably six to seven further sessions, thereby defining a treatment cycle, and setting a time interval between a session consisting of three to four days and the further sessions.

17. The computer program according to claim 16, further comprising: a command to set a repetition of the treatment cycle by operating the light-emitting diode (3) after a period consisting of six to nine months from the first treatment session; and a command to set a total number of treatment sessions consisting of four to seven, or equal to six.

18. A computer-readable memory on which the computer program described in claim 10 is loaded.

Images