Device for treating ocular conditions

Abstract

A device for treating ocular conditions, in particular internal tissue conditions of the eye, comprises a mask and a plurality of light emitting diodes distributed over an inner surface of the mask. The plurality of light-emitting diodes comprises at least one matrix of light-emitting diodes arranged in a region of an inner surface of the mask adapted to face in use an eye region of a user, and is configured to emit electromagnetic radiation adapted to stimulate cellular function of retinal cells.

Description

Technical Field

[0001] The present invention relates to a device for treating eye diseases, in particular to a device for treating diseases of the inner tissues of the eye. Background Art

[0002] The need to treat eye disorders, particularly disorders of the inner eye tissues such as the retina, a neurally derived membrane covering the inner surface of the eye and extending from the optic nerve to the pupil, has long been recognized.

[0003] Numerous retinal disorders include diabetic retinopathy, which causes damage to the retinal blood vessels, and macular degeneration, a degenerative disease that affects retinal cells, leading to profound vision loss.

[0004] If not properly treated, both conditions can cause permanent damage to retinal tissue, leading to degeneration of vision and contrast sensitivity, and in the most severe cases, even loss of visual function.

[0005] In particular, macular degeneration is caused by age-dependent degeneration of retinal cells and, in fact, tends to affect people over the age of 60 years and is estimated to affect approximately 50 million people worldwide, making it one of the leading causes of visual impairment in developed countries.

[0006] Age-dependent macular degeneration is caused by the gradual accumulation of mitochondrial DNA (mtDNA) mutations, which leads to a decrease in the formation of ATP (adenosine triphosphate), the energy source of cellular metabolism, and an increase in the production of reactive oxygen species, thereby inducing oxidative stress, progressive inflammation, and accumulation of extracellular debris, leading to significant cell loss (it is estimated that by around 70 years of age, approximately 30% of central rod photoreceptor cells will be lost).

[0007] Macular degeneration occurs in two forms. In particular, there is the "dry", ie non-exudative, more widespread form (approximately 85% of cases), which causes changes in the retinal pigment epithelium, visible as dark spots, and can lead to retinal drusen, ie accumulations of extracellular debris, visible as yellow spots.

[0008] There is also a "wet," exudative form, which occurs when the retina undergoes choroidal neovascularization, a process in which abnormal blood vessels form, which may cause localized macular edema or hemorrhage, leading to localized detachment of the retinal epithelium and rapid loss of visual function.

[0009] For these types of conditions, treatments envisaged include dietary supplementation therapy based on zinc oxide, copper, vitamin C, vitamin E and lutein, as well as the administration of drugs, in particular insulin for forms of diabetic retinopathy and intravitreal vascular endothelial growth factor antagonists for wet forms of macular degeneration. Retinal treatment by retinal laser therapy is also popular, using a beam generated by the inert gas argon (argon laser) that has a thermal effect, heating the targeted area, allowing it to be treated.

[0010] One problem in the case of treatments administered via dietary supplements is that they only provide benefits in terms of reducing the risk of developing advanced retinal disease, but they are not effective in treating retinal cells, and treatments administered via intravitreal medications are not effective in treating all types of retinal degeneration. On the other hand, insulin administration, while treating diabetes at a systemic level and slowing diabetic retinopathy, does not cure retinal cells.

[0011] On the other hand, the problem with retinal laser (argon laser) treatments, which are used to treat both diabetic retinopathy and macular degeneration, is that their main purpose is to destroy the retinal area affected and damaged by these diseases, but they cannot heal the retinal cells. Treatments with argon lasers are also considered invasive treatments because they involve direct intervention in the patient's eyes, which, if not performed properly, can cause severe visual impairment and permanent damage to the patient's eye tissue.

[0012] As a result, currently available treatments are not effective in treating disorders of the inner tissues of the eye, which remain difficult to treat or slow in progression and still severely impact the quality of life of patients suffering from such disorders.

[0013] Patent US2021 / 315736 shows a different type of device for treating retinal tissue. The patent describes a wearable device comprising: a first light source adapted to emit a light beam having a wavelength included in the near infrared; a second light source adapted to emit light at a wavelength included in an interval between 600 and 700 nm or between 550 and 650 nm. The device also includes a diffuser adapted to diffuse the light of the first light beam and / or the light of the second light beam so that when the patient wears the device, at least a portion of the first light beam and the second light beam is directed through the patient's retinal tissue.

[0014] Patent US2016 / 067087 also shows a wearable device for directing light-based therapy to the patient's ocular tissue. The device includes: a first light source, suitable for generating a light beam having a first wavelength in the interval between 800 and 900 nm; and at least a second light source, suitable for generating a light beam having a second wavelength in the interval between 600 and 700 nm or between 550 and 650 nm. The device also includes a spatial light modulator, which is suitable for receiving light from the first light source and the second light source and modulating the light beam directed to the patient's eye, so that when the patient wears the device, a portion of the first light beam and at least a portion of the second light beam are directed to the patient's eye.

[0015] Patent US2016 / 008625 shows another example of a device that uses light to treat eye diseases such as diabetic retinopathy, wet and dry forms of age-related macular degeneration (AMD).

[0016] Patent US2021 / 060354 describes a method for preventing and treating diabetic retinopathy and diabetic macular edema, which administers a certain amount of light with a wavelength in the infrared range having a photobiomodulatory effect to the patient's eyes. In particular, the wavelength envisioned for the treatment method is included in about 670±50nm, or more particularly 670±30nm.

[0017] Patent US2014 / 005757 describes a detachable spare part suitable for connection to a support device, the detachable spare part comprising a radiation source suitable for emitting radiation in the direction of an area to be treated, in particular towards the eyes of a user, and a structure for positioning the radiation source in a predetermined position relative to the area to be treated. Wavelengths included in the interval between 450 and 580 nm are mentioned for the treatment of diabetic retinopathy and macular degeneration.

[0018] Patent application WO 2023 / 283699 likewise describes a device for therapy by photobiomodulation.

[0019] Although a variety of devices have been developed to treat eye conditions using light of predetermined wavelengths, there remains a need to find improved solutions in terms of treatment efficacy. Summary of the invention

[0020] The task of the present invention is to solve the above problems by designing a device for treating eye diseases, which can effectively treat diseases of the inner tissues of the eye.

[0021] Within the scope of this task, a further object of the invention is to provide a device for treating eye diseases which enables non-invasive treatment of diseases of the inner tissues of the eye.

[0022] Another object of the present invention is to provide a device for automatically treating diseases of the internal tissues of the eye.

[0023] Another object of the present invention is to provide a device for treating eye diseases, which has a simple structural and functional design, reliable operation, diverse uses, and relatively low cost.

[0024] According to the invention, this object is achieved by a device for treating eye disorders according to claim 1 , a computer program according to claim 10 and a readable memory according to claim 18 .

[0025] In particular, the device is suitable for treating structures located at the back of the eye.

[0026] The apparatus for treating an eye condition comprises a mask, preferably in the form of an anthropomorphic mask.

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

[0028] The light source is of the light emitting diode type, usually abbreviated to LED for simplicity.

[0029] Advantageously, the light emitting diodes are configured to emit electromagnetic radiation suitable for stimulating cellular function of retinal cells.

[0030] The LEDs are distributed on the inner surface of the mask, facing the user's face when in use. In particular, the LEDs are distributed to form at least one matrix in the area of ​​the inner surface of the mask facing the user's eye area when in use.

[0031] Preferably, said LED is connected to an appropriate circuit allowing management of the power supply and the correct operation of said diode.

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

[0033] Preferably, the control and / or power supply unit is arranged externally relative to the mask and is connected thereto, for example via a suitable connecting cable.

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

[0035] Preferably, the control interface is adapted to allow easy setting of commands related to a treatment regimen of the internal tissue of the user's eye, in particular the retina. For example, the interface may allow starting or stopping a treatment regimen or setting parameters characterizing such a treatment, such as, for example, the duration of the treatment or the choice of the wavelength emitted by the diode to be activated.

[0036] Preferably, the interface is provided with a screen.

[0037] Even more preferably, the interface may consist of a touch screen or a screen associated with suitable command buttons.

[0038] Alternatively, the control interface may be provided in association 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 instructions, and when the electronic computer executes the instructions, the electronic computer performs the following steps: receiving a command related to a plan for treating the internal tissue of the user's eye from the operator through the control interface; automatically selecting a plurality of the light-emitting diodes and automatically setting their wavelengths and emission durations; instructing the user to close their eyes through a warning signal; operating the plurality of light-emitting diodes in a continuous mode within a first time interval to emit electromagnetic radiation in the direction of the user's closed eyes at a wavelength within a range of about 590nm±40nm; instructing the user to open his eyes through a warning signal; and in a second time interval The method comprises operating the plurality of light emitting diodes in a pulse mode within the first time interval to emit electromagnetic radiation in the direction of the user's open eyes at a wavelength within the range of about 590nm±40nm; instructing the user to close his eyes through a warning signal; operating the plurality of light emitting diodes in a continuous mode within the first time interval to emit electromagnetic radiation in the direction of the user's closed eyes at a wavelength within the range of about 630nm±40nm; instructing the user to open his eyes through a warning signal; operating the plurality of light emitting diodes in a pulse mode within the second time interval to emit electromagnetic radiation in the direction of the user's open eyes at a wavelength within the range of about 630nm±40nm.

[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 signal displayed on the control interface is an image and / or text information.

[0043] The device is effective for treating eye diseases, in particular diseases affecting structures located at the back of the eyeball, wherein the device comprises a control unit provided with a memory including instructions allowing the execution of the above steps. According to experimental data, in particular medical evidence from clinical trials, it has been found that alternating the use of pulsed light at a specific wavelength and light in a continuous mode, and having the user alternately open and close their eyes, produces surprising results in terms of therapeutic efficacy. In particular, the above steps performed by the device are effective for treating retinal diseases, such as, for example, macular degeneration.

[0044] It can also be observed that using a device comprising a mask positioned on the user's face gives the user greater comfort during the treatment regimen. The mask provides more freedom in the positions the user can take, for example, the user can lie down.

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

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

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

[0048] For yellow light and red light, the interval is preferably 40 nm wide around the indicated value, respectively.

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

[0050] Preferably, the mask is formed by a laminar body comprising the plurality of light sources.

[0051] The mask is preferably associated with a suitable support device, the support device being 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 device.

[0052] The LEDs are distributed on the mask at substantially the same distance from the user's eyes, which distance is appropriately calculated based on the wavelength characteristics of the light beams emitted by the LEDs.

[0053] Preferably, the LED is arranged, in use, at a distance comprised between 1 cm and 4 cm from the area to be treated.

[0054] It can be observed that this distance is determined based on the focus and absorption of electromagnetic radiation being optimal within this interval.

[0055] Preferably, the memory includes instructions, which, when executed by the electronic computer, cause the electronic computer to automatically select multiple light-emitting diodes and automatically set their wavelengths and emission durations to treat the internal tissues of the user's eyes, particularly the user's retinal cells.

[0056] In particular, the memory may include instructions which, when executed by the electronic computer, enable the electronic computer to automatically select a plurality of the light-emitting diodes and automatically set their wavelengths and emission durations according to commands related to a plan for treating the internal tissue of the user's eye set by the operator through the control interface.

[0057] According to one aspect of the invention, it may be provided that the LED circuit is connected to a controller associated with the mask, the controller being adapted to manage the operation of the LEDs, and wherein the external unit is only used for the function of powering the LEDs. In this case, the control interface may be associated with the mask or the external power supply unit.

[0058] The laminar body of the mask is preferably made of a polymer material. Alternatively, it may be provided that the mask is made of other suitable materials, such as skin, leather, fabric and / or paper derivatives.

[0059] Preferably, the mask has a complete eye area in order to accommodate the LED matrix. More specifically, for each eye, an area suitable for accommodating a corresponding LED matrix is ​​obtained in the mask. In this way, the LED matrix can be used to treat lesions affecting the internal tissues of the user's eyes.

[0060] Preferably, the matrix is ​​sized to illuminate an eye of a user and includes a periocular area for diffuse illumination.

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

[0062] Preferably, the LEDs distributed at the eye area on the mask are inclined at a predetermined angle relative to the mask surface.

[0063] Even more preferably, the LEDs are tilted at an angle of 45°.

[0064] Preferably, each LED matrix at one eye comprises a substantially central zone, wherein the LEDs have a predefined size, and at least one pair of LEDs arranged on opposite sides of the central zone, the at least one pair of LEDs having a size larger than the LEDs of the central zone. Based on experimental evidence, the above LED tilt together with the described distribution is believed to be beneficial for treating tissue inside the eye.

[0065] Preferably, the mask may also have further LED matrices in other areas, for example in different parts of the face, such as the forehead and / or cheeks, which are suitable for providing an appropriate therapeutic treatment to the skin.

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

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

[0068] Preferably, the laminar body of the mask has a thickness suitable for the insertion of the LEDs and associated circuitry.

[0069] According to one aspect of the invention, the laminar body of the mask comprises a first outer layer and a second inner layer which are integrally formed with each other.

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

[0071] Preferably, said second inner layer has a pair of openings at the eye region to expose said matrix of LEDs towards the eyelids and periocular area.

[0072] Preferably, the opening is elliptical in shape so as to define a corresponding complete area having a shape suitable for illuminating the eyeball and the periocular area by the LEDs of the matrix.

[0073] A series of further openings may also be made in the second inner layer, preferably in the form of strips, for accommodating the further LED matrices.

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

[0075] Advantageously, the LEDs distributed at different areas of the face other than the eye area may have different characteristics, for example they may be adapted to emit red beams to stimulate collagen production, or blue beams to counteract bacterial acne, or yellow beams to stimulate the lymphatic and nervous systems, or even infrared beams. Preferably, LEDs with different characteristics are combined in the same mask for a mixed treatment.

[0076] It may be provided that the surface of the LED facing the skin to be treated is covered with a suitable filter adapted to eliminate any potentially hazardous frequencies present in the emission spectrum of the LED.

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

[0078] Preferably, the device comprises an acoustic signal transmitter adapted to send an acoustic signal to the user to instruct 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 is different from the second acoustic signal. For example, the first acoustic signal may be different from the second acoustic signal in terms of transmission duration.

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

[0081] The invention also relates to a computer program executed by the device for treating internal tissue of the eye, in particular 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 related to a regimen for treating tissue inside an eye of a user.

[0083] Preferably, the step of receiving commands related to the scheme for treating the inner tissue of the user's eye from the operator through the control interface is arranged to receive an activation command to start the treatment scheme. In particular, the operator can press a start button or select an appropriate icon on the interface to start the scheme.

[0084] The program is then arranged to automatically select a plurality of said LEDs and automatically set their wavelengths and emission durations.

[0085] The program is arranged to instruct the user to close his eyes by means of a warning signal.

[0086] The program is configured to operate the plurality of LEDs in a continuous mode during a first time interval to emit electromagnetic radiation at a wavelength within a range of about 590 nm ±40 nm in the direction of the user's closed eyes.

[0087] The program is then arranged to instruct the user to open his eyes by means of a warning signal.

[0088] The program is then configured to operate the plurality of LEDs in a pulsed mode during a second time interval to emit electromagnetic radiation at a wavelength within a range of about 590 nm ±40 nm in the direction of the user's open eyes.

[0089] The next step is configured to instruct the user to close his eyes through a warning signal, and then operate the plurality of LEDs in a continuous mode during the first time interval to emit electromagnetic radiation in the direction of the user's closed eyes at a wavelength within the range of about ±40nm around 630nm.

[0090] Finally, the program is arranged to instruct the user to open his eyes by means of a warning signal.

[0091] The program is then configured to operate the plurality of LEDs in a pulsed mode during the second time interval to emit electromagnetic radiation at a wavelength within the interval of about 630 nm ±40 nm in the direction of the user's open eyes.

[0092] It has been experimentally observed that the above steps performed by the device are effective for treating retinal disorders such as, for example, macular degeneration. More specifically, the above steps can reduce oxidative stress in retinal cells and inhibit inflammatory mediators, thereby reducing progressive inflammatory episodes that produce extracellular debris accumulation and retinal cell loss, improving vision and contrast sensitivity, and reducing macular sclerosis and macula volume in patients with degenerative diseases such as age-related macular degeneration. These effects are due to a combination of treatment time and treatment mode, i.e., whether the patient has their eyes open or closed, and the wavelength used.

[0093] As previously stated, radiation having a wavelength within the indicated interval or substantially equal to 590 nm is suitable for inhibiting the expression of vascular endothelial growth factor (VEGF) and increasing the expression of nitric oxide in retinal cells, while radiation having a wavelength of 630 nm is suitable for promoting electron transfer and oxygen binding of cytochrome C oxidase (CCO) by increasing mitochondrial metabolic activity in retinal cells (understood as the production of ATP (adenosine triphosphate) molecules and oxygen), and inhibiting inflammatory events by reducing cell death.

[0094] Experimental results show that the procedure can also be effectively used to treat amblyopia, retinitis pigmentosa and corneal inflammation, where the reduction of inflammatory cytokine levels and the restoration of irregularities caused by corneal and retinal cell damage have been experimentally verified. It also improves the condition of patients with dry eye disease (DED) by increasing tear volume.

[0095] The procedure also helps wounds heal after eye trauma or surgery.

[0096] It can also be observed that once the command for a treatment regimen is received from the operator, the program allows the treatment to be automatically and easily administered 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 signal displayed on the control interface is an image and / or text information.

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

[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 a motion sensor device.

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

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

[0103] Even more preferably, said first time interval is equal to 6 minutes, or ±1 minute around a duration of 6 minutes.

[0104] Even more preferably, said second time interval is equal to 1 minute, or ±15 seconds around the duration of 1 minute.

[0105] Advantageously, both eyes of the patient are treated with electromagnetic radiation simultaneously by the device.

[0106] Preferably, the above steps performed by the device constitute a therapeutic session.

[0107] Advantageously, the program comprises further instructions for repeating said steps constituting a course of treatment for at least one further course of treatment, preferably a further 6-7 said courses, thereby defining a treatment cycle.

[0108] Preferably, the program comprises further instructions for setting a time interval between one course of treatment and a further course of treatment comprised between 3 and 4 days.

[0109] Preferably, the program comprises instructions for setting a repetition of the treatment cycle performed by operating the LED, the repetition of the treatment cycle being performed after a period of 6 to 9 months from the first performance, for a total of a predetermined number of treatments, preferably between 4 and 7 treatments, preferably equal to 6 treatments.

[0110] If a mixed treatment is carried out, for example a treatment of the eye area combined with a treatment of other areas of the face, the further LED matrix arranged in the affected area will also be activated.

[0111] In the case of mixed therapy, the operator selects the further LEDs of interest via the interface of the control and / or power supply unit and enters parameter values ​​suitable for the type of therapy, such as duration and emission power. BRIEF DESCRIPTION OF THE DRAWINGS

[0112] Details of the invention will become more apparent from the detailed description of a preferred embodiment of the device for treating eye disorders according to the invention, which is illustrated by way of example in the accompanying drawings, in which:

[0113] Figure 1 A front perspective view showing components of the device;

[0114] Figure 2 A front elevational view showing an embodiment of components of the device;

[0115] Figure 3 A front view of an embodiment of components of the device is shown;

[0116] Figure 4 A rear front view showing components of the device;

[0117] Figure 5 Shows Figure 2 front views of various embodiments of components of the illustrated apparatus;

[0118] Figure 6 Shows Figure 4 front views of various embodiments of components of the illustrated apparatus;

[0119] Figure 7 Shows Figure 3 front views of various embodiments of components of the illustrated apparatus;

[0120] Figure 8 A front perspective view of a control unit of the device is shown;

[0121] Fig. 9 An image showing a user wearing components of a device according to the invention;

[0122] Fig.10a , 10b , 10c, 10d show the successive steps of the treatment plan implemented by the electronic computer of the device;

[0123] Figure 11-13 showing images of the retina of the same eye of a subject before and after treatment with a device according to the invention;

[0124] Fig.14a shows the subject's retinal images acquired by SD-OCT (spectral domain optical coherence tomography) technology under reference conditions;

[0125] Fig.14b Shown with Fig.14a Retinal images of the same subject acquired by SD-OCT technique one month after treatment with the device according to the present invention;

[0126] Fig.14c Shows Fig.14a and Fig.14b Retinal images of the same subject obtained by SD-OCT technology three months after treatment with the device according to the present invention;

[0127] Fig.15a and 15b They are shown respectively Figures 14a-14c Fundus images of the same subject obtained under reference conditions by autofluorescence examination (FAF Fundus Autofluorence) and fundus images of the same subject obtained three months after treatment with the device;

[0128] Fig.16a and 16b They are shown respectively Figure 15a to Figure 15bRetinal sensitivity map obtained using microperimetry for the same subject in reference conditions and retinal sensitivity map of the same subject three months after treatment with the device. DETAILED DESCRIPTION

[0129] With particular reference to these drawings, an apparatus for treating eye disorders, and in particular for treating disorders of the inner tissues of the eye, according to the present invention is indicated generally at 1.

[0130] The device 1 comprises a mask 2 preferably in the form of an anthropomorphic mask. The mask 2 is formed by a laminar body comprising a plurality of light sources 3 of the light emitting diode (generally indicated by the acronym LED for simplicity) type arranged on the inner surface of the mask 2.

[0131] In particular, the LED 3 is of a high-power type.

[0132] The mask 2 is preferably associated with suitable supporting means, such as Fig. 9 As seen in FIG. 1 , the support device is adapted to hold the same mask in a predetermined position in front of the user's face during use.

[0133] In particular, the device 1 is held by the support means at an optimal distance from the user's face so that the distance between the LED 3 and the user's eyes is maintained within an interval comprised between 1 cm and 4 cm. This distance is determined based on the focusing and absorption of electromagnetic radiation being optimal within this interval.

[0134] The LED 3 is connected to an appropriate circuit, known per se and therefore not shown, which allows managing the power supply and the correct operation of the diode.

[0135] The LED circuit 3 is electrically connected to a control and / or power supply unit 4 of the device. The control and / or power supply unit 4 is arranged externally with respect to the mask 2 and is connected thereto, for example, via a suitable connection cable (not visible in the figure).

[0136] The control unit 4 comprises a control interface 6 adapted to allow easy setting of commands relating to a treatment regimen of the internal tissues of the eye, in particular the retina, or setting of parameters characterizing such a treatment, such as, for example, the duration of the treatment or the selection of the wavelengths emitted by the diodes to be activated alternately according to the steps of the current treatment regimen, as will be better explained below. The control interface 6 also allows the display of appropriate signals facilitating the execution of the treatment regimen, as will be better explained below.

[0137] The control interface 6 is provided with a screen. In particular, the interface 6 may consist of a touch screen or a screen associated with appropriate control buttons.

[0138] Alternatively, a control interface associated with the mask 2 for setting therapy parameters may be provided.

[0139] The external control and / or power supply unit 4 comprises an electronic computer 41 and a memory 42 which is readable by the electronic computer.

[0140] The memory 42 includes instructions, which, when executed by the electronic computer 41, cause the electronic computer 41 to automatically select a plurality of light emitting diodes 3 and automatically set their wavelengths and emission durations to treat the user's retinal cells.

[0141] In particular, the memory 42 may include instructions, which, when executed by the electronic computer 41, enable the electronic computer 41 to automatically select multiple light-emitting diodes 3 and automatically set their wavelengths and emission durations according to commands related to a plan for treating the internal tissue of the user's eye set by the operator through the control interface 6.

[0142] The memory 42 also includes instructions, which, when executed by the electronic computer 41, cause the electronic computer 41 to instruct the user to open or close his eyes. The signal is sent by sending a vibration signal and / or an acoustic signal and / or by a warning signal displayed on the interface 6.

[0143] The warning signal can be an image that appears on the interface 6, in particular on the screen, indicating to open or close the eyes. The warning signal can be a text message, alternatively or together with the image, always displayed on the interface 6, which performs the same function, namely to inform the need to open or close the eyes.

[0144] In a different embodiment, it may be provided that the circuit of the LED 3 is connected to a controller associated with the mask 2, which controller is suitable for managing the operation of the LED 3, and that the external unit 4 is used only for the function of powering the LED 3. In this case, the control interface 6 may be associated with the mask 2 or with the external power supply unit 4.

[0145] The laminar body of the mask 2 has a thickness suitable for the insertion of the LEDs 3 and the associated circuitry. The LEDs are distributed on the inner surface of the mask 2, facing the face of the user when in use. In particular, the LEDs 3 are distributed so as to form at least one matrix 30 in the area of ​​the inner surface of the mask 2 facing the eyelids and periocular area of ​​the user when in use.

[0146] The matrix 30 preferably comprises LEDs 3 emitting light at a wavelength in the interval around 590 nm or equal to 590 nm (yellow light) and LEDs 3 emitting light at a wavelength in the interval around 630 nm or equal to 630 nm (red light). Advantageously, in use, the LEDs 3 emitting yellow light and the LEDs 3 emitting red light can be activated alternately according to the steps of the treatment regimen being performed.

[0147] For yellow light and red light, the above intervals are preferably 40 nm wider to the left and right of the indicated values, respectively.

[0148] The laminar body of the mask 2 is preferably made of a polymer material. Alternatively, it may be provided that the mask 2 is made of other suitable materials, such as leather, leather, fabric and / or paper derivatives.

[0149] The mask 2 has a complete eye area in order to accommodate the aforementioned matrix 30 of LEDs 3. More specifically, for each eye, an area suitable for accommodating a respective matrix 30 of LEDs 3 is obtained in the mask 2. In this way, the matrix 30 of LEDs 3 can be used to treat pathologies affecting the internal tissues of the user's eyes. More specifically, the matrix 30 is sized to illuminate the user's eyeball and includes a periocular area for diffuse illumination.

[0150] Preferably, the LEDs 3 are regularly distributed at the eye region on the mask 2. In particular, in each row of the matrix 30, the LEDs 3 are arranged at the same distance from each other.

[0151] according to Figures 5 to 7 In the embodiment of the mask 2 shown, the matrix 30 arranged at the eye region comprises a plurality of LEDs 3, each of which is inclined at a predetermined angle relative to the surface of the mask. Preferably, the LEDs 3 are inclined at an angle of 45°.

[0152] Each matrix 30 arranged at the eye comprises a substantially central area, wherein the LEDs 3 have a predefined size, and at least one pair of LEDs 3 arranged on opposite sides of the central area, the at least one pair of LEDs 3 having a size larger than the central LED 3 .

[0153] Based on clinical evidence, Figures 5 to 7 The configuration of the mask shown is assessed to be particularly advantageous for administering treatments to tissues inside the eye.

[0154] The mask 2 may also have further matrices 31 of LEDs 3 in other areas, for example, in different parts of the face, such as the forehead and / or the cheeks, which are suitable for providing a suitable therapeutic treatment for the skin (see Figures 1 to 4 ).

[0155] The matrix 30 arranged at the eye region comprises a greater number of LEDs 3 per surface unit than the further matrix 31 .

[0156] Preferably, the size of the LEDs 3 of the matrix 30 is smaller than the size of the LEDs 3 making up the further matrix 31 .

[0157] According to a preferred embodiment, the laminar body of the mask 2 is composed of a first outer layer 8 and a second inner layer 9 made integrally with each other.

[0158] The LEDs 3 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 at the eye region to expose the matrix 30 of LEDs 3 towards the eyelids and periocular region.

[0159] Preferably, the opening 10 is elliptical in shape so as to define a corresponding complete area having a shape suitable for illuminating the eyeball and the periocular area by the LEDs 3 of the matrix 30 .

[0160] A series of further openings 10 may also be made in the second inner layer 9, preferably in the form of strips, suitable for accommodating a matrix 31 of further LEDs 3. The strips have different lengths depending on the area of ​​the mask in which they are made and are arranged sequentially one after the other in the longitudinal direction of the mask.

[0161] The LEDs 3 are distributed on the mask 2 at substantially the same distance from the eyelids of the user. The distance is appropriately calculated based on the wavelength characteristics of the light beams emitted by the LEDs 3.

[0162] Preferably, in use, the LED 3 is arranged at a distance of 1 cm to 4 cm comprised from the area to be treated.

[0163] The LEDs 3 distributed in different areas of the face other than the eye area, i.e. the LEDs 3 forming the matrix 31, may exhibit different characteristics, for example they may be suitable for emitting red light beams to stimulate collagen production, or blue light beams to counteract bacterial acne, or yellow light beams to stimulate the lymphatic and nervous systems, or even infrared light beams. Preferably, LEDs 3 with different characteristics are combined in the same mask 2 for a mixed treatment.

[0164] The LEDs 3 of the matrix 30 at the eye region are configured to emit a beam of electromagnetic radiation having a predetermined wavelength to inhibit cellular mechanisms involved in macular degeneration and increase mitochondrial metabolic activity of retinal cells through photobiomodulation.

[0165] It may be provided that the surface of the LED 3 facing the skin to be treated is covered with a suitable filter adapted to eliminate any potentially dangerous frequencies present in the LED 3 emission spectrum.

[0166] The present invention also relates to a computer program implemented by the device for treating internal tissues of the eye, especially retinal tissue, wherein an operator sets a command through the control interface 6, which exposes retinal cells to a predetermined amount of electromagnetic radiation, thereby causing changes in the retinal cells at the molecular level, for treating retinal diseases, such as macular degeneration.

[0167] In fact, it has been experimentally observed that radiation having a wavelength in the indicated interval or substantially equal to 590 nm is suitable for inhibiting the expression of vascular endothelial growth factor (VEGF) and increasing the expression of nitric oxide in retinal cells.

[0168] Vascular endothelial growth factor (VEGF) is a signaling protein that stimulates the formation of blood vessels, which contributes to the wet form of macular degeneration, while nitric oxide can reduce oxidative stress-mediated changes in cells and increase oxygen distribution.

[0169] Furthermore, it was experimentally observed that radiation with a wavelength of 630 nm is suitable for promoting electron transfer and oxygen binding of cytochrome C oxidase (CCO) by increasing mitochondrial metabolic activity in retinal cells (understood as the production of ATP (adenosine triphosphate) molecules and oxygen), and inhibiting inflammatory events by reducing cell death.

[0170] Thus, the procedure performed by the device can reduce oxidative stress in retinal cells and inhibit inflammatory mediators, thereby reducing progressive inflammatory episodes that generate extracellular debris accumulation and retinal cell loss, improving visual acuity and contrast sensitivity, and reducing macular sclerosis and macula volume in patients with degenerative diseases such as age-related macular degeneration.

[0171] The procedure can also be effectively used to treat amblyopia, retinitis pigmentosa and corneal inflammation, where the reduction of inflammatory cytokine levels and the restoration of irregularities caused by corneal and retinal cell damage have been experimentally verified. It also improves the condition of patients with dry eye disease (DED) by increasing tear volume.

[0172] It also helps wound healing after eye trauma or surgery.

[0173] Preferably, the device 1 is associated with an image acquisition device (not shown in the figure). The image acquisition device may be, for example, a camera or a video camera and is used to acquire images of the user's eyes in order to check whether the eyes are open or closed during treatment. As an alternative to the image acquisition device or in combination with the image acquisition device, the device 1 comprises a motion sensor device adapted to detect whether the user's eyes are closed or open.

[0174] Finally, the device 1 may also comprise an acoustic signal transmitter (also not shown in the figures) adapted to send an acoustic signal during treatment to signal the need to open or close the eyes.

[0175] The operation of the apparatus for treating internal tissue of the eye can be readily understood from the foregoing description.

[0176] First, place the mask 2 in front of the user's face using a suitable support device (see Fig. 9 ).

[0177] The operator sets activation commands associated with a protocol for treating tissue inside 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 an appropriate icon on the interface.

[0178] The program executed by the electronic computer 41 selects the LEDs 3 arranged at the eye region and automatically sets the wavelength and emission duration of the LEDs 3 suitable for the treatment to be performed.

[0179] The user will then receive treatment for a predetermined time interval corresponding to the emission duration Δt.

[0180] In particular, the user is instructed to close his eyes, and then the LED 3 is operated in a continuous mode for a first time interval Δt1 to emit electromagnetic radiation in the direction of the user's closed eyes at a wavelength in the interval of ±40 nm around 590 nm, preferably substantially equal to 590 nm (see Fig.10a ).

[0181] Subsequently, the user is instructed to open his eyes, and the LED 3 is operated in a pulse mode for a second set time interval Δt2 to emit electromagnetic radiation in the direction of the user's open eyes at a wavelength in the range of ±40 nm around 590 nm, preferably substantially equal to 590 nm (see Fig.10b ).

[0182] Furthermore, the user is instructed to close his eyes and the LED 3 is operated in a continuous mode for a first set time interval Δt1 to emit electromagnetic radiation in the direction of the user's closed eyes at a wavelength in the range of ±40 nm around 630 nm, preferably substantially equal to 630 nm (see Fig.10c ).

[0183] Subsequently, the user is instructed to open his eyes, and the LED 3 is operated in a pulse mode for a second set time interval Δt2 to emit electromagnetic radiation in the direction of the user's open eyes at a wavelength in the range of ±40 nm around 630 nm, preferably substantially equal to 630 nm (see Fig.10d ).

[0184] The user is instructed to open or close his eyes by sending an acoustic signal and / or a vibration signal and / or a warning signal displayed on a control interface.

[0185] Preferably, the program also provides the further step of checking whether the user's eyes are closed or open by means of an image acquisition device adapted to acquire at least one image of the user's eyes and / or by means of a motion sensor device. Alternatively, the check may be performed by an operator responsible for therapy control.

[0186] Advantageously, the first time interval Δt1 is greater than the second time interval Δt2.

[0187] Preferably, the first time interval Δt1 is greater than 5 minutes, and the second time interval Δt2 is less than 2 minutes.

[0188] For example, the first time interval Δt1 is 6 minutes, or a duration of 6 minutes plus or minus 1 minute.

[0189] For example, the second time interval Δt2 is equal to 1 minute, or the duration of 1 minute is around ±15 seconds.

[0190] Advantageously, both eyes of the patient are treated with electromagnetic radiation simultaneously by means of the device 1 .

[0191] The above treatment steps are performed by a computer program in a treatment session on the user's eyes using LEDs 3. It is preferred to repeat the treatment at certain time intervals, preferably every 3 or 4 days, for up to 7 or 8 sessions to constitute a treatment cycle.

[0192] Preferably, after a period comprised between 6 and 9 months from the first execution, the computer program executes again a cycle of treatment sessions by means of the LEDs 3 on the user's eyes. The number of sessions of the next treatment cycle is preferably comprised between 4 and 7, preferably equal to 6 sessions.

[0193] Preferably, the health status of the tissue cells inside the eye is checked at predetermined time intervals, for example, 1 month, 2 months and 4 months after the end of the last treatment cycle.

[0194] A randomized controlled multicenter clinical trial was conducted on patients with AMD stage 2 and 3 according to the AREDS classification. Devices according to the present invention have been used in clinical testing, wherein the memory of each device includes instructions that, when executed by the electronic computer 41, cause the electronic computer 41 to perform the above steps. The above steps involve applying electromagnetic radiation at a specific wavelength towards the closed or open eye of each patient at predetermined time intervals.

[0195] The purpose of the clinical trial established was to examine whether the device implementing the above steps had the effect of slowing down the progression of advanced disease. The results of the clinical trial conducted demonstrated the efficacy of the treatment administered by the device.

[0196] For example, here are two cases selected from ongoing clinical trials.

[0197] Case 1

[0198] The treated subject was a 68-year-old female with grade 3 age-related macular degeneration (ADM) according to the AREDS classification.

[0199] The woman's best-corrected visual acuity before treatment was quantified using 50 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) table.

[0200] The woman was treated using a device that performed the described procedure, which involved twice-weekly sessions for four weeks.

[0201] The woman's health status was evaluated one month after treatment, and in particular, her best corrected visual acuity was measured, which was 55 ETDRS letters. In addition, by taking a series of images of the woman's retina, it was observed that the volume of retinal drusen in the macular area decreased, such as Figures 11 to 13 shown.

[0202] Case 2

[0203] The subject treated was a 55-year-old male with nonvascular age-related macular degeneration. The best corrected visual acuity measured before treatment was 25 letters on the ETDRS chart. SD-OCT (spectral domain optical coherence tomography) technology highlighted a large detachment of the pigment epithelium with subretinal fluid on top of it.

[0204] The man received treatment with a device that performed the steps. The treatment consisted of one course of treatment per week for four weeks. After the first month of treatment, the man received one course of treatment every two weeks for two months.

[0205] One month after the end of treatment, complete absorption of subretinal fluid, reduction of pigment epithelial detachment, and no residual retinal atrophy were observed. Best corrected visual acuity was measured at 60 ETDRS letters.

[0206] Images taken at different time intervals also documented the man's improved health (see Figures 14a to 16b ). In particular, Fig.14a An image of the male's retina acquired using SD-OCT technology is shown, representing the male's reference condition before treatment. The image under the reference condition shows obvious pigment epithelial detachment (PED) and subretinal fluid.

[0207] on the other hand, Fig.14b An image of the man's retina acquired using SD-OCT technology one month after treatment is shown. The image highlights the flattening of the pigment epithelial detachment and the hyper / hypo-reflective material.

[0208] Fig.14c The image was acquired using SD-OCT technology three months after treatment and shows further resolution of the pigment epithelial detachment.

[0209] also, Fig.15a and Fig.15b The fundus images of the subject obtained by autofluorescence examination (FAF fundus autofluorescence) under reference conditions and the fundus images of the subject three months after the above treatment are shown respectively. It can be observed that Fig.15a shows a high autofluorescence ring around the periphery of the pigment epithelium detachment, while Fig.15b Isoautofluorescence of the macular area is shown without any remnant of retinal pigment epithelial atrophy.

[0210] at last, Fig.16a The results showed that the retinal sensitivity in the macular area decreased, with an average value of 7.4 dB. Microperimetry was performed three months after treatment (see Fig.16b ) shows an improvement in sensitivity in the macular area, with an average of 26.5dB.

[0211] Reported cases demonstrate the efficacy of treatments delivered by the device.

[0212] According to one aspect of the invention, in the case of preventive treatment, in particular for the prevention of dry age-related macular degeneration (dAMD), one week after the first course, the above treatment steps constituting a course of treatment are performed by a computer program for at least one additional course of treatment. It is preferred that the treatment is repeated at certain time intervals, preferably weekly, for up to 4 courses of treatment to constitute a course of treatment cycle.

[0213] After the first treatment cycle, the program also includes instructions for setting a preventive maintenance treatment cycle by operating LED 3, which is applied once a quarter and includes two treatment courses performed within a one-week period, 3 to 4 days apart. The preventive maintenance treatment cycle should be performed throughout the patient's life.

[0214] Preferably, the health of the tissue cells inside the eye is checked at predetermined time intervals, for example every 6 to 12 months from the end of the last treatment cycle.

[0215] According to another aspect of the invention, in the case of treating a severe form of dry age-related macular degeneration (dAMD), the program executed by the electronic computer 41 selects the LEDs 3 arranged at the eye area and sets an initial treatment cycle. Each course of the initial treatment cycle includes the above treatment steps, but at different time intervals, as shown below.

[0216] Preferably, the first time interval Δt1 is greater than or equal to 10 minutes, and the second time interval Δt2 is less than 4 minutes. Even more preferably, the first time interval is equal to 12 minutes, or ±2 minutes around a duration of 12 minutes.

[0217] Even more preferably, the second time interval is equal to 2 minutes, or ±30 seconds around the duration of 2 minutes.

[0218] Preferably, at the end of the initial 4-week treatment period, the weekly treatment regimen is repeated twice for up to 4 consecutive weeks.

[0219] After the initial treatment cycle, the program also includes instructions for setting a maintenance treatment cycle by operating the LED 3, which maintenance treatment cycle includes two treatment courses per week for a period of three months starting from the first month of the initial cycle and ending at the end of the first month of the initial cycle. Each maintenance cycle includes the above treatment steps, but the time interval is reduced relative to each treatment course of the initial cycle.

[0220] In particular, the first time interval Δt1 is greater than 5 minutes, and the second time interval Δt2 is less than 1 minute. Even more preferably, the first time interval is equal to 5 minutes, or ±100 seconds around the duration of 5 minutes. Even more preferably, the second time interval is equal to 1 minute, or ±50 seconds around the duration of 1 minute.

[0221] Preferably, the program comprises instructions for setting a repetition of a maintenance cycle by operating the LED after a period comprised between 6 and 9 months from the initial cycle. The number of sessions of this second maintenance cycle is preferably comprised between 4 and 7 sessions, preferably equal to 6 sessions.

[0222] Preferably, the health of the tissue cells inside the eye is checked at predetermined time intervals, for example, 1 month, 4 months and 12 months after the end of the last treatment cycle.

[0223] According to a further aspect of the invention, in the case of treatment of non-neovascular age-related macular degeneration (nnAMD) and chronic central serous chorioretinopathy (cCSC), a program executed by the electronic computer 41 selects the LEDs 3 arranged at the eye area and sets an initial treatment cycle.

[0224] Central serous chorioretinopathy (CSC) is said to be the fourth most common retinal disease, usually affecting young and middle-aged adults, with a higher incidence in males. It is characterized by choroidal vascular abnormalities associated with retinal pigment epithelium (RPE) dysfunction, leading to pigment epithelial detachment (PED) and serous neurosensory retinal detachment of the posterior pole. It is usually a self-limited disease, although in 5-10% of cases, subretinal fluid (SRF) may persist for more than 6 months. It is usually a self-limited disease, but in 5-10% of cases, subretinal fluid (SRF) may persist for more than 6 months, resulting in a chronic disease associated with RPE and / or photoreceptor damage.

[0225] The initial cycle includes one treatment session per week for 4 weeks. Each treatment session of the initial treatment cycle includes the above treatment steps. After the first treatment session cycle, the program also includes instructions for setting a maintenance treatment cycle by operating the LED 3, the maintenance treatment cycle including two treatment sessions per week for a period of three months after the first initial month of treatment.

[0226] Preferably, the program includes instructions for setting a maintenance cycle repetition by operating the LED, which maintenance cycle is repeated from the fifth month to the twelfth month from the first course of treatment, for a total of a predetermined number of courses, preferably including between 1 and 2 courses every 4 weeks.

[0227] Preferably, the health of the tissue cells inside the eye is checked at predetermined time intervals, for example, 1 month, 4 months and 12 months after the end of the last treatment cycle.

[0228] If a mixed treatment is to be carried out, for example a treatment of the eye area combined with a treatment of other areas of the face, further matrices 31 of LEDs 3 arranged in the affected area will also be activated.

[0229] In the case of mixed therapy, the operator selects the further LEDs 3 of interest via the interface 6 of the control and / or power supply unit 4 and enters parameter values ​​suitable for the type of therapy, such as duration and emission power.

[0230] The devices described above by way of example can be modified and varied in many ways according to different requirements.

[0231] In the actual implementation of the present invention, the materials, shapes and sizes used can be arbitrarily selected as needed.

[0232] When the technical features mentioned in each claim are followed by reference numerals, these reference numerals are merely for increasing the understanding of the claims and therefore, they do not have any limiting effect on the scope of each element identified by these reference numerals in an exemplary manner.

Claims

1. A device for treating eye diseases, in particular for treating the internal tissue of a user's eye, comprising: Mask (2); a plurality of light emitting diodes (3) distributed 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 an area of ​​the inner surface of the mask (2) adapted to face the eye area of ​​the user when in use, the light emitting diodes (3) being arranged at substantially the same distance from the eyes of the user and being configured to emit electromagnetic radiation adapted to stimulate the cellular function of retinal cells; A support device, adapted to maintain the mask (2) in a predetermined position in front of the user's face when in use; an external control and / or power supply unit (4), electrically connected to the light emitting diode (3) and provided with a control interface (6); The control and / or power supply unit (4) comprises an electronic computer (41); a memory (42) readable by the electronic computer, wherein the memory (42) comprises instructions, and when the electronic computer (41) executes the instructions, the electronic computer (41) performs the following steps: a) receiving commands from an operator via the control interface (6) relating to a protocol for treating tissue inside the user's eye; b) automatically selecting a plurality of said light emitting diodes (3) and automatically setting their wavelengths and emission durations (Δt); c) instructing the user to close his eyes through a warning signal; d) operating the plurality of light emitting diodes (3) in a continuous mode within a first time interval Δt1 to emit electromagnetic radiation at a wavelength within a range of about 590 nm ±40 nm in the direction of the closed eyes of the user; e) instructing the user to open his eyes by means of a warning signal; f) operating the plurality of light emitting diodes (3) in a pulsed mode within a second time interval Δt2 to emit electromagnetic radiation at a wavelength within a range of about 590 nm ±40 nm in the direction of the user's open eyes; g) instructing the user to close his eyes through a warning signal; h) operating the plurality of light emitting diodes (3) in a continuous mode during the first time interval Δt1 to emit electromagnetic radiation at a wavelength within the range of about 630 nm ±40 nm in the direction of the user's closed eyes; i) instructing the user to open his eyes through a warning signal; j) operating the plurality of light emitting diodes (3) in a pulsed mode within the second time interval Δt2 to emit electromagnetic radiation at a wavelength within the range of about 630 nm ±40 nm in the direction of the open eyes of the user.

2. The device 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 device 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 an electromagnetic radiation beam with a wavelength within the range of about 590nm±40nm to inhibit the expression of vascular endothelial growth factor (VEGF) and increase the expression of nitric oxide.

5. Apparatus according to any one of the preceding claims, wherein: The light emitting diode (3) is configured to emit an electromagnetic radiation beam with a wavelength within the range of about 630nm±40nm to promote electron transfer and oxygen binding of cytochrome C oxidase (CCO) by increasing mitochondrial metabolic activity.

6. Apparatus according to any one of the preceding claims, wherein: The memory (42) readable by the electronic computer includes instructions, and when the electronic computer (41) executes the instructions, the electronic computer (41) automatically selects a plurality of the light-emitting diodes (3) and automatically sets their wavelengths and emission durations to treat the internal tissues of the user's eyes.

7. The device according to claim 6, wherein: The memory (42) includes instructions, and when the electronic computer (41) executes the instructions, the electronic computer (41) automatically selects a plurality of the light-emitting diodes (3) and automatically sets their wavelengths and emission durations according to commands related to a treatment plan for the internal tissue of the user's eye set by an operator through the control interface (6).

8. Apparatus according to any one of the preceding claims, wherein: The device comprises an image acquisition device adapted to acquire an image of a user's eyes and / or a motion sensor arrangement adapted to detect whether the user's eyes are open or closed.

9. Apparatus according to any one of the preceding claims, wherein: The device includes an acoustic signal transmitter.

10. A computer program comprising instructions for causing an apparatus according to any one of the preceding claims to perform the following steps: a) receiving commands from an operator via the control interface (6) relating to a protocol for treating tissue inside the user's eye; b) automatically selecting a plurality of said light emitting diodes (3) and automatically setting their wavelengths and emission durations (Δt); c) instructing the user to close his eyes through a warning signal; d) operating the plurality of light emitting diodes (3) in a continuous mode within a first time interval Δt1 to emit electromagnetic radiation at a wavelength within a range of about 590 nm ±40 nm in the direction of the closed eyes of the user; e) instructing the user to open his eyes by means of a warning signal; f) operating the plurality of light emitting diodes (3) in a pulsed mode within a second time interval Δt2 to emit electromagnetic radiation at a wavelength within a range of about 590 nm ±40 nm in the direction of the user's open eyes; g) instructing the user to close his eyes through a warning signal; h) operating the plurality of light emitting diodes (3) in a continuous mode during the first time interval Δt1 to emit electromagnetic radiation at a wavelength within the range of about 630 nm ±40 nm in the direction of the user's closed eyes; i) instructing the user to open his eyes through a warning signal; j) operating the plurality of light emitting diodes (3) in a pulsed mode within the second time interval Δt2 to emit electromagnetic radiation at a wavelength within the range of about 630 nm ±40 nm in the direction of the open eyes of the user.

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. A computer program according to claim 10, 11 or 12, wherein: Before steps d, f and h, a step of checking whether the user's eyes are closed or open is provided.

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

15. A computer program according to any one of claims 10 to 14, wherein: The first time interval Δt1 is equal to 6 minutes, or to a duration of 6 minutes or thereabouts ±1 minute, and the second time interval Δt2 is equal to 1 minute, or to a duration of 1 minute or thereabouts ±15 seconds.

16. Computer program according to claim 15, wherein the computer program comprises further instructions for setting the repetition of said steps a to j constituting a course of treatment performed by said device for at least one further course of treatment, preferably for a further 6-7 said courses, thereby defining a treatment cycle, and setting the time intervals between a course of treatment and said further courses comprised between 3 and 4 days.

17. The computer program according to claim 16, wherein: The computer program comprises further instructions for setting a repetition of the treatment cycle by operating the light-emitting diode (3) after a period of time comprised between 6 and 9 months from the first treatment course and a total number of treatment courses comprised between 4 and 7 courses or equal to 6 courses.

18. A computer readable memory, into which the computer program according to claim 10 is loaded.

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