Methods and apparatus for treating myopia

Abstract

The present invention relates to a method, apparatus and system for treating high myopia and pathological myopia, comprising: introducing a photoreactive drug into a sub-tenon's space of an eye, imaging at least a portion of the eye to configure a treatment plan, the treatment plan defining a region of the retina to be irradiated with photoactivating light to convert the photoreactive drug to an active substance; and irradiating the retina according to the treatment plan for a time sufficient to achieve scleral hardening.

Description

Technical Field

[0001] This disclosure pertains to the field of ophthalmic photodynamic therapy, and more specifically, relates to a method, apparatus, and system for the prevention and treatment of myopia and scleral thinning (including high myopia and pathological myopia). Background Technology

[0002] The following are references to the general background art that are considered to be related to this disclosure: US 5,865,832 US 6,099,522 US 7,947,672 US 9,452,172 US 11,058,772 US 2002 / 0133144 US 2011 / 0288466 US 2020 / 0129620 WO 2005 / 120573 EP 0584552 Wollensak, G. and Spoerl, E. in 2004 Cataract and Refractive Surgery Journal The article "Collagen crosslinking of human and porcine sclera" was published in Volume 30, Issue 3, pages 689-695. Myopia, also known as nearsightedness, is a refractive defect in the eye where parallel light, when accommodation is relaxed, causes an image to focus in front of the retina. The global prevalence of myopia is estimated to be between 800 million and 2.3 billion. In some countries such as China, India, and Malaysia, up to 41% of the adult population is myopic to -1 diopters, and approximately 80% is myopic to -0.5 diopters. Myopia is associated with the stretching of the collagenous sclera. This elongation of the eyeball leads to the progression of myopia in children and adolescents with a predisposition to myopia. In addition to elongation, other pathological changes can develop, including staphyloma and bulging of the eyeball. Changes in the size and shape of the sclera are thought to cause damage to the retina and subsequently lead to decreased and lost vision. This change typically slows and stops during the third decade, when body tissues mature and undergo natural hardening. This hardening is associated with glycation-mediated cross-linking.

[0003] Currently, there are no effective treatments to stop the progression of myopia and reduce vision loss caused by pathological or degenerative myopia. Surgical solutions have been reported that involve applying a reinforcing band around the eye and suturing it to the sclera to stop the progression of myopia. These surgical solutions are controversial, technically challenging, and not widely adopted. The critical age for intervention is childhood or early adolescence. Therefore, simpler methods for scleral sclerosis should be explored.

[0004] Since the progression of myopia is associated with the elongation of eye tissues (especially the posterior segment) and the resulting stretching of the sclera and choroidal retinal tissues, scleral sclerosis via collagen cross-linking holds promise for delaying / stopping disease progression and related conditions such as macular stretching and atrophy or hemorrhage and vision loss. Wollensak and Spoerl (2004) reported the use of RF / UVA therapy to treat... In vitro This cross-linking and reinforcement of the sclera in humans and pigs was achieved. In rabbits... in vivo The cross-linking sclerosis effect was confirmed in the experiment and showed that it lasted for several months. This treatment could be used to stop the progression of myopia.

[0005] Photodynamic therapy (PDT) is a form of phototherapy that involves a photosensitizing drug and light to elicit a desired therapeutic effect. In classic PDT, the photosensitizing drug administered to the subject can preferentially accumulate in the tissue to be treated. The photosensitizer can be activated by applying light of a specific wavelength limited to the treatment site.

[0006] Laser systems are widely used to assist in the characterization of the eye and as a treatment for eye diseases. When using these laser systems to treat eye diseases, it is crucial to operate with extreme caution, as damage to eye tissues caused by user error is often irreversible. Therefore, any optical treatment involving lasers must be meticulously planned.

[0007] The US 11,058,772 and US 9,452,172 assigned to the applicant disclose bacterial chlorophyll photosensitizers for the treatment of eye diseases (such as keratoconus or scleral weakness associated with degenerative myopia) via PDT.

[0008] US 2002 / 0133144 discloses an apparatus and method for mapping a target tissue region to be irradiated by a laser beam without irradiating the tissue surrounding the target region.

[0009] US 2011 / 0288466 discloses an apparatus and method for activating a crosslinking agent within at least one ocular component to stabilize and strengthen corneal tissue or other tissues of the eye. The crosslinking is activated within the ocular component by delivering the crosslinking agent to a treatment area of ​​the ocular component, delivering ultrasound waves to the ocular component, and then activating the crosslinking agent by delivering an initiating element (UV light) to at least one ocular component.

[0010] US 2020 / 0129620 relates to compositions based on a specific heptamethrin dye, which can be used to generate singlet oxygen using near-infrared irradiation. Methods using these compositions are used to treat myopia and other eye conditions. In some cases, the mechanical strength of the sclera can be improved. Summary of the Invention

[0011] This disclosure provides a method, apparatus, and system for treating myopia and preventing scleral thinning by generating treatment plans based on eye-based images.

[0012] According to one aspect, this disclosure provides a method for treating high myopia and pathological myopia in the eyes of a subject, the method comprising: A photoreactive drug is introduced into the subcapsular space of the eyeball fascia of the subject. The photoreactive drug can be converted into an active substance that can cause scleral sclerosis through photoactivation. Imaging at least a portion of the eye to configure a treatment plan, the treatment plan defining the area of ​​the retina to be irradiated with photoactivated light; and Photoactivated light is irradiated onto the area of ​​the retina for a duration sufficient to induce scleral sclerosis.

[0013] According to one embodiment, the irradiation includes: feeding a treatment plan to a beam shaping unit and passing photoactivated light through the unit to output a beam of light that is guided and shaped to irradiate the region. The irradiation may further include: tracking eye movements and changing the direction or shape of the beam to continuously irradiate the region even during eye movements. In one embodiment, at least one of the following is imaged: a portion of the retina, a portion of the choroid, or a portion of the sclera.

[0014] According to one embodiment, the photoactivated light is emitted at a visible or near-infrared (NIR) wavelength. The photoactivated light is emitted at a wavelength in the range of 750 nm to 756 nm. The photoactivated light is provided on the surface of the retina at a concentration of 1 mW / cm² to 1000 mW / cm². The photoreactive drug is palladium 3. 1 -Oxy-15-methoxycarbonylmethyl-Rhodophyll-13 1 -(2-sulfoethyl)amide or a pharmaceutically acceptable salt thereof.

[0015] The imaging is performed using at least one of the following: a fundus camera, optical coherence tomography (OCT), optical coherence elastography (OCE), ultrasound, Scheimpflug imaging, and nonlinear optical imaging. The imaging provides a scleral thickness map or a scleral hardness map. The beam shaping unit includes at least one of the following: a digital micromirror device, a liquid crystal panel, a liquid crystal on silicon (LCOS) panel, and a high-speed laser scanner.

[0016] According to one embodiment, the treatment plan also includes a specified irradiation dose within a given irradiation time period.

[0017] The step of introducing the photoreactive drug occurs at most about 15 minutes before the step of irradiating the photoactivated light. In another embodiment, the step of introducing the photoreactive drug occurs between about 15 minutes and about 4 hours before the step of irradiating the photoactivated light. In another embodiment, the step of introducing the photoreactive drug occurs more than about 4 hours before the step of irradiating the photoactivated light.

[0018] According to another aspect, this subject provides an apparatus for treating high myopia and pathological myopia in a subject's eye, comprising: a light source configured to emit photoactivated light that converts a photoreactive drug into an active substance capable of inducing scleral sclerosis; an imaging unit configured to image at least a portion of the retina of the eye and allow a user to configure a treatment plan including an area of ​​the retina to be irradiated by the photoactivated light; and a beam shaping unit configured to shape the beam emitted by the light source such that light irradiating the area irradiates only the area.

[0019] In one embodiment, the light source is configured to emit light of visible or near-infrared (NIR) wavelengths. The light source is configured to emit light with wavelengths in the range of 750 nm to 756 nm. The device is configured to provide 1 mW / cm² on the surface of the retina. 2 Up to 1000 mW / cm 2 The intensity. The photoreactive drug is palladium 3. 1 -Oxy-15-methoxycarbonylmethyl-Rhodophyll-13 1 -(2-sulfoethyl)amide or a pharmaceutically acceptable salt thereof.

[0020] In one embodiment, the retina is imaged using at least one of the following: a fundus camera, optical coherence tomography (OCT), optical coherence elastography (OCE), ultrasound, Scheimpflug imaging, and nonlinear optical imaging. The beam-shaping unit includes at least one of the following: a digital micromirror device, a liquid crystal panel, a liquid crystal on silicon (LCOS) panel, and a high-speed laser scanner. The device also includes a controller configured to: retrieve a treatment plan from the imaging unit; and control the beam-shaping unit.

[0021] The imaging unit provides a scleral thickness map or a scleral hardness map. The treatment plan also includes a specified irradiation dose over a given irradiation period. The device also includes an eye-tracking system for tracking eye movements and changing the direction or shape of the beam to continuously irradiate the area even during eye movements.

[0022] The device can be used for photodynamic therapy (PDT).

[0023] According to another aspect, this subject matter relates to a system for treating high myopia and pathological myopia in the eyes of a subject, comprising: a device as disclosed above; a source of a photoreactive drug; and an applicator configured to apply the drug into the subcapsular space of the eye. Attached Figure Description

[0024] To better understand the subject matter disclosed herein and to illustrate how it may be implemented in practice, embodiments will now be described by way of non-limiting example only with reference to the accompanying drawings, in which: Figure 1 This is a schematic diagram of PDT treatment of the sclera based on existing technology.

[0025] Figure 2A and Figure 2B This is a block diagram illustrating a device for treating myopia according to an embodiment of this subject matter.

[0026] Figure 3 This is a schematic diagram of a device for treating myopia according to an embodiment of this subject matter.

[0027] Figure 4A and Figure 4B This is an exemplary illustration of a retina including an excluded region, according to an embodiment of this subject matter.

[0028] Figure 5 This is an exemplary method of using the device of FIG2 according to an embodiment of this subject matter.

[0029] Figure 6 This is a schematic diagram illustrating a method for treating myopia in the eyes of a subject according to an embodiment of this subject matter. Detailed Implementation

[0030] Before elaborating on this topic in detail, it may be helpful to provide definitions for some of the terms used herein. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this topic pertains.

[0031] As used in this article, the term " PDT "This is intended to represent all these types of photodynamic therapy."

[0032] the term" PDT drugs "", PDT effective drugs "", Photosensitizers "", Photoreactive drugs "etc." is intended to indicate a drug or combination of drugs that is administered to a subject and can be activated by light to produce an active chemical substance, typically but not exclusively, a reactive oxygen species. Alternatively, light can be absorbed by the PDT drug to generate heat.

[0033] the term" PDT Effective Light "", Photosensitive effective light "", Photoactivated light "etc." is intended to indicate light that has the effect of activating effective drugs in PDT.

[0034] As used in this article, the term " Shortsighted Myopia (also known as nearsightedness) refers to the ability to see objects clearly at close range but not at a distance. As used herein, the term "myopia" refers to all forms and degrees of nearsightedness. In a specific embodiment, myopia is pathological and refers to elongation of the eyeball and is associated with thinning of the scleral tissue. High myopia can be defined as greater than 5 diopters. Pathological myopia and myopic macular degeneration can refer to various specific complications resulting from subsequent stretching of the posterior wall of the eyeball, including cataracts, choroidal retinal atrophy, macular holes with or without retinal detachment, myopic macular schisis, or optic nerve head changes. (Ikuno, Y., 2017 in...) retina The article "Overview of the complications of high myopia" is found in Volume 37, Issue 12 of the journal, pages 2347-2351. As used in this article, the term " sclera "" refers to the outer fibrous coating of the eye, which covers the entire eye except for the portion covered by the cornea.

[0035] the term" About"Approximately" indicates a quantity that can deviate from the stated numerical value by up to 10%, 15%, 20%, 25%, or even 30%. For example, approximately 10 should be understood as falling within the range of 9 to 11, 8.5 to 11.5, 8 to 12, 7.5 to 12.5, or even 7 to 13. Even if the numerical value is given without the "approximately" qualifier, these should be interpreted as indicating approximately a specified value, i.e., a value with the possible deviations described in this paragraph.

[0036] The terminology used in this document is for descriptive purposes and should not be considered restrictive. include "", Include "", have "", contain "", Involving The term "and its variations" is intended to cover the items listed thereafter, their equivalents, and additional items. Optional "or" Optional "This means that the component may or may not be present, or that the steps in the process may or may not occur, and the description includes cases where the component is present or the steps do occur, as well as cases where the component is absent or the steps do not occur."

[0037] As used herein, unless otherwise specified, the term " one "or" A sort of "Including both singular and plural forms. Therefore, in this application, the terms "an", "a", or "at least one" may be used interchangeably."

[0038] In some embodiments of the method, the photoreactive drug is a bacterial chlorophyll derivative that has major light absorption at about 750 nm to 756 nm (e.g., about 753 nm) and is capable of generating oxygen free radicals and / or having the ability to convert absorbed light into heat under illumination. The photoreactive drug is palladium 3... 1 -Oxo-15-methoxycarbonylmethyl-rhodobacteriochlorin-13 1 -(2-Sulfoethyl)amide (Padeliporfin; WST11) or a pharmaceutically acceptable salt thereof.

[0039] In some embodiments, the method utilizes the system provided in this disclosure.

[0040] Figure 1This illustrates a schematic PDT treatment protocol known in the prior art for scleral reinforcement. A photosensitizer (also known as a photoreactive drug) is injected into the posterior segment of the eye, where the drug diffuses into the tissue and is then irradiated with a harmless photosensitive light source configured to emit visible light (350 nm to 750 nm) or near-infrared (NIR) wavelengths (750 nm to 1400 nm). The light penetrates the biological tissue, allowing it to travel through the anterior segment to the sclera, where the photosensitizer is activated.

[0041] In one embodiment, PDT treatment can alter the sclera by, for example, increasing its tensile and / or compressive strength, increasing its flexibility, increasing its extensibility, or increasing its tissue toughness. Treatment can also result in scleral strengthening, scleral shape stabilization, scleral shape alteration, or a combination thereof.

[0042] Photosensitizers can be applied directly to the patient's tissues. The agent can be administered, for example, topically or via intraocular or intravenous injection. In one embodiment, the photosensitizer is applied to the sclera, for example, into the sub-Tenon's space of the eye. Alternatively, the agent can be applied to the suprachoroidal space.

[0043] The time between photosensitizer delivery and irradiation can vary and depends on several different factors. These may include, but are not limited to, the concentration of the photosensitizer, the rate of diffusion of the photosensitizer to the target area, or specific characteristics of the patient. For example, the photosensitizer may be administered to the patient, and after a period of time to ensure it has reached a specific location and / or a sufficient concentration, irradiation can then be applied to the target area. The photosensitizer can be monitored as it passes through the eye, and irradiation can be performed once the desired depth is reached. The photosensitizing drug may be administered to the subject for a period of time before or simultaneously with the start of light irradiation. In one embodiment, the photosensitizing drug is introduced up to about 15 minutes before the start of light irradiation. In some embodiments, the photosensitizing drug is administered between about 5 minutes and about 15 minutes (typically about 10 minutes) before the start of light irradiation. In another embodiment, the photosensitizing drug is introduced more than about 15 minutes but less than about 4 hours before the start of light irradiation. In yet another embodiment, the photosensitizing drug is administered more than 4 hours before the start of light irradiation.

[0044] Irradiating the eye with visible or near-infrared (NIR) wavelengths of light for a sufficient time and under specific conditions allows for targeted treatment of the sclera.

[0045] Such as about Figure 1As shown in the prior art, a photosensitizer (photoreactive drug) can be applied via a curved plastic or metal slide 12. The guide can be inserted through a conjunctival opening at the limbus. After the photoreactive drug is applied to the desired area at the desired concentration, the sclera can be irradiated by directly applying near-infrared light to the area to be treated.

[0046] Figure 2A and Figure 2B This is a block diagram illustrating a device 1 for treating myopia according to an embodiment of this subject matter.

[0047] According to one embodiment, a device 1 for treating myopia is configured to treat myopia in a subject's eye. The device 1 includes a light source 10, an imaging unit 20, and a beam shaping unit 30.

[0048] according to Figure 2B In one embodiment, the imaging unit 20 is collinear with the light source 10.

[0049] Light source 10 is configured to emit photoactivated light that converts a photoreactive drug into an active substance or heat capable of inducing scleral sclerosis. In one embodiment, the light source is configured to emit visible light or NIR wavelengths to allow light to travel through eye tissues to the retina. In a specific example, the light source is configured to emit light in the wavelength range of 750 nm to 756 nm. In some embodiments, the light source may be a laser that emits light at an intensity of 1 mW / cm² to 1000 mW / cm² on the retina.

[0050] In some embodiments, the photoreactive drug is a bacterial chlorophyll derivative that has major light absorption at about 750 nm to 756 nm and is capable of generating oxygen free radicals and / or heating the tissue to be treated under light irradiation.

[0051] In one embodiment, the photoreactive agent is a bacterial chlorophyll derivative. The bacterial chlorophyll derivative used in this invention can be prepared by the methods described in US 7,947,672 or WO 2005 / 120573. For the preparation of compounds in which R8 is an amino acid, peptide, or protein residue, the method described in EP 0584552 can be applied. For the preparation of negatively charged bacterial chlorophyll derivatives in which R8 is an amino acid residue, the method disclosed in EP 0584552 can be combined with the method described in scheme 1 of US 7,947,672. In a specific embodiment, the photoreactive agent is palladium 3. 1 -Oxy-15-methoxycarbonylmethyl-Rhodophyll-13 1 -(2-Sulfoethyl)amide or a pharmaceutically acceptable salt thereof (palipofen, WST-11). Palladium 3 1 -Oxy-15-methoxycarbonylmethyl-Rhodophyll-131 -(2-sulfoethyl)amide or a pharmaceutically acceptable salt thereof is specifically disclosed in US 11,058,772 as having specific efficacy against PDT for scleral weakness.

[0052] Imaging unit 20 is used to image at least a portion of the eye. The imaging unit can image at least a portion of the retina, or other eye tissues such as the choroid or sclera. Imaging unit 20 can also be used to allow a user to configure a treatment plan that includes an area of ​​the retina to be illuminated by photoactivated light. For example, imaging of the retina can provide a planar or 3D image of the inner surface of the eye. The eye can be imaged using any known eye imaging method and device, such as a fundus camera, optical coherence tomography (OCT), optical coherence elastography (OCE), ultrasound, Scheimpflug imaging, or nonlinear optical imaging, or combinations of these imaging types. Imaging unit 20 can be adapted to receive images of retinal regions. Images provided by imaging unit 20 can include imaging data, such as imaging data indicating tissue structures along the depth of the eye. The imaging unit can be used to image portions of the retina that require imaging data. By imaging the eye, the overall shape of the eye and the relative positions of different parts of the eye can be determined. Furthermore, imaging can provide an indication of the thickness or stiffness of the sclera. Specifically, imaging can determine the scleral thickness or hardness at different points around the eye, thus providing a scleral thickness map or a scleral hardness map. The generated images can be used to provide a treatment plan by allowing the user to determine which areas of the eye require PDT treatment and which areas should be excluded from irradiation. Excluded areas can be, for example, areas sensitive to NIR light or areas of the eye that do not require treatment. For example, excluded areas may include the optic nerve, macula, or fovea. Examples of excluded areas are as follows... Figure 4A and Figure 4B As shown. Figure 4A This is a diagram of the retina. Figure 4B This is an illustration of the retina, including the excluded region 51. Figure 4B In the example, region 51 is excluded, which includes the fovea and the optic nerve.

[0053] The beam shaping unit 30 is used to shape the light beam emitted by the light source so that the light illuminates only the area of ​​the retina that needs treatment. The light emitted from the light source 10 can be shaped, for example, by a combination of lenses and mirrors, to produce a therapeutic beam. In one embodiment, the beam shaping unit 30 can be at least one of a digital micromirror device, a liquid crystal panel, and a liquid crystal on silicon (LCOS) panel. Shaping the light beam emitted from the light source 10 allows the user to control the precise location of the light. For example, the light can be directed to illuminate only thinned segments of the sclera. Since photoreactive drugs only react in the presence of photoactivated light, it is expected that although the drug may be present in areas that do not need treatment, only the areas that need treatment (i.e., scleral reinforcement) will receive the photoactivated light. Furthermore, since certain areas of the eye (such as the fovea) can be light-sensitive, beam shaping allows these areas to be avoided.

[0054] The device 1 may also include a controller 40, which is configured to retrieve a treatment plan from the imaging unit and control the beam shaping unit.

[0055] The controller 40 may include a processor 41 and a memory device 42 communicating with the processor 41. The memory device 42 especially It may include a treatment planning module 43. The treatment planning module 43 can provide instructions for operating various aspects of the device 1, such as the light source 10, the imaging unit 20, or the beam shaping unit 30.

[0056] It should be understood that the aforementioned modules, processes, systems, and sections can be implemented in hardware, software-programmed hardware, software instructions stored on a non-transitory computer-readable medium, or a combination thereof. Methods for treating myopia can be implemented, for example, by using a processor configured to execute a sequence of programming instructions stored on a non-transitory computer-readable medium. The processor can be, but is not limited to, a personal computer or workstation or other such computing system (including processors, microprocessors, microcontroller devices), or comprised of control logic including integrated circuits (e.g., application-specific integrated circuits (ASICs)). Instructions can be compiled from source code instructions provided according to programming languages ​​such as Java, C++, C#.net, etc. Instructions can also include code and data objects provided according to languages ​​such as Visual Basic™ or other structured or object-oriented programming languages. The sequence of programming instructions and its associated data can be stored in a non-transitory computer-readable medium, such as computer memory or storage devices, which can be any suitable storage device, such as, but not limited to, read-only memory (ROM), programmable read-only memory (PROM), electrically erasable programmable read-only memory (EEPROM), random access memory (RAM), flash memory, disk drives, etc.

[0057] Furthermore, each individual component of the device described herein can be implemented as a single processor or a distributed processor. It should also be understood that the steps discussed herein can be executed on a single or distributed processor (single-core and / or multi-core). Furthermore, the distribution can be implemented on multiple computers or systems, or can coexist on a single processor or system.

[0058] Embodiments of the apparatus and methods may be implemented on general-purpose computers, special-purpose computers, programmable microprocessors or microcontrollers and peripheral integrated circuit elements, ASICs or other integrated circuits, digital signal processors, hardwired electronic or logic circuits (such as discrete component circuits), programmable logic circuits (such as programmable logic devices (PLDs), programmable logic arrays (PLAs), field-programmable gate arrays (FPGAs), programmable array logic (PAL) devices), etc. Generally, any process capable of implementing the functions or steps described herein can be used to implement the embodiments described herein.

[0059] Treatment planning module 43 may include a program or group of programs containing instructions configured to determine a result or output, i.e., a treatment plan, using received data (such as in one or more algorithms). Treatment planning module 43 may include instructions for controlling aspects of the treatment plan, such as the treatment area, and for providing a specified irradiation dose over a given irradiation period. Treatment planning module 34 may also include instructions for determining and controlling optical parameters, such as one or more algorithms. Control of emitted optical parameters may be based on information input by the user and / or (such as data received from one or more sensors) within the system. Input data may, for example, be imaging data received from imaging unit 20.

[0060] In some cases, the treatment planning module 43 can provide instructions to acquire one or more images of the retina for treatment, identify one or more areas of the eye where scleral thinning or weakening has occurred, generate a treatment plan, irradiate one or more areas of the retina with photoactivated light, and irradiate the light for a duration sufficient to achieve scleral sclerosis. The treatment planning module 43 may also include instructions for controlling one or more components of the device 1 and / or additional devices attached to the device 1. In some embodiments, the treatment planning module 43 can provide instructions for controlling aspects of the light source 10, the imaging unit 20, the beam shaping unit 30, and the display device 50.

[0061] Processor 41 can be configured to execute instructions and manipulate data to operate device 1. Although Figure 2A and Figure 2BA single processor 41 is shown, but multiple processors may be used depending on the needs and design of the device. In some embodiments, processor 41 may include one or more microprocessors. Processor 41 may be configured to receive and / or transmit data from various components of the device. Processor 41 may also be configured to process data.

[0062] Display device 50 can be used to display information to a user. Display 50 can be a monitor for displaying information. In one embodiment, display device 50 can operate as both a display and an input device. For example, display 50 can be a touch screen display, where a user's touch on the display generates input to device 1.

[0063] Figure 3 This is an example of a more detailed schematic diagram of the device of this subject. Imaging unit 20 may include multiple components that, when combined, provide an image of the retina. A user can use surgical microscope 71 to obtain a clear image of the retina. Fundus camera 72 can be used to obtain images of the eye. It should be understood that fundus camera 72 may be replaced by another imaging unit described above. Beam splitter 73 can be used to direct the transmitted retinal image to microscope 71 and to direct a portion of the reflected image to camera 72. The user uses microscope 71 to view the transmitted image and redirects the transmitted image to camera 72 via beam splitter. Fixation points for fixing the eye of the patient to be treated may be presented at a certain location. User interface 74 can be used by the user to manually input data into the device. Display 50 can be used to view the images provided by imaging unit 20. Display 50 can be used to display, for example, scleral thickness maps, scleral stiffness maps, or images of the retina.

[0064] As detailed above, the controller 40 is interconnected with the light source 10, the imaging unit 20, the beam shaping unit 30, and individual components of each unit. This allows for the configuration and implementation of treatment plans to treat myopia.

[0065] Light source 10 is configured to emit photoactivating light, which is guided to beam shaping unit 30. The light entering beam shaping unit 30 is first guided through fiber optic collimating lens 76. The light then passes through prism 77. Prism 77 may consist of two complementary prisms. Two or more prisms can be used to compensate for aberrations in the beam and allow the beam to be reflected to digital micromirror device 75, from which it is reflected and passes through prism 77. The final shape of the beam is configured as the light passes through DMD lens 78 and image size adjustment assembly (e.g., telecentric zoom lens) 79. In one embodiment, light combiner 80 is used to combine the optical path of the photoactivating light treatment beam with light from the imaging unit. In another embodiment, additional light combiner 83 is used to combine the optical path of the imaging unit with illumination source 70 to image the eye. Additional lens 81 may be used with or without contact lens 82 to complete the image of the treatment beam on the retina. The shaped beam illuminates the area of ​​the retina of eye 15 defined by the treatment plan. It should be understood that... Figure 3 This is exemplary, and the imaging unit 40 may include all or some of the components listed above. It should also be understood that a visible wavelength aiming beam, visible to the surgical microscope 71, may be emitted by the light source 10, and that the visible wavelength aiming beam is collinear with the treatment beam. The aiming beam allows the treatment beam to be aligned before the treatment beam is irradiated.

[0066] This subject matter also provides a method for treating myopia in a subject's eye and preventing scleral thinning. The method comprises performing the following steps in the stated order or any suitable order: (i) introducing a photoreactive drug into the subcapsular space of the subject's eye, the drug being converted into an active substance by photoactivated light, wherein the drug is active to induce scleral sclerosis; (ii) imaging the retina of the eye to configure a treatment plan defining an area of ​​the retina to be irradiated with photoactivated light; and (iii) irradiating said area of ​​the retina with photoactivated light for a duration sufficient to induce scleral sclerosis.

[0067] In some embodiments of the method, the irradiation includes feeding a treatment plan to a beam shaping unit and passing photoactivated light through the beam shaping unit to output a guided and shaped beam to irradiate the area of ​​the retina identified as requiring treatment.

[0068] In some embodiments of the method, the illumination includes tracking eye movements and changing the direction or shape of the beam to continuously illuminate the area even during eye movements. Tracking can be achieved by adjusting beam shaping elements to move the desired beam shape with eye movements.

[0069] Tracking eye movements can be used to track minute eye movements. By tracking eye movements, treatment can proceed continuously without interruption until the entire irradiation treatment is complete. In one embodiment, processor 41 can be programmed to track the movement of the treatment target area in real time and simultaneously and continuously send the target's current position to memory 42. Any of a variety of suitable automatic tracking techniques can be employed, including those similar to those described in US 5,865,832 and US 6,099,522.

[0070] An automatic shutdown module can also be incorporated into the device, in which the device automatically shuts down when the eye movement threshold is exceeded.

[0071] Figure 5 The relationship between treatment plan 100 and other components of the device is illustrated. Treatment plan 100 forms the focus of an exemplary method for treating myopia using device 1. In some embodiments, an eye-tracking system is configured to track eye movements for use by treatment plan 100. Eye-tracking system 110 can compute a three-dimensional image of the patient's eye via user input and data obtained from imaging unit 20, and may include real-time tracking of the subject's eye movements. Eye-tracking system can acquire data for determining and updating the PDT plan. For example, eye-tracking system 110 can use its acquired data to create an image of the posterior region of the patient's eye to update the treatment plan during treatment.

[0072] The treatment planning system 100 can be used with or connected to the imaging unit 20. In some embodiments, the imaging unit 20 is integrated with the light source 10 and the beam shaping unit 30 into a real-time feedback system, enabling the eye position to be updated in real time.

[0073] like Figure 5 As depicted, imaging unit data 120 and user inputs 170 (such as anatomical structures and irradiation parameters) can be input into the treatment planning system 100. Other inputs include information from the eye-tracking system 110. Outputs from the treatment planning system 100 include commands sent to the light source 10 and beam shaping unit 30 to characterize the size, shape, and power of the light source movement.

[0074] Figure 6An exemplary treatment method for treating myopia in a subject's eye using device 1 is demonstrated. Imaging unit 20 and physical examination 210 are used to create a map 220 of the eye. In some embodiments, a scleral thickness map is generated by imaging unit 20. Information from 210 is used to configure a treatment plan that identifies the area to be treated, light power and dose, and areas to be avoided. These variables may be determined by treatment software and user input. The patient is then positioned such that the eye to be treated and the emitted light are aligned (230). Treatment is applied (240) to illuminate the area of ​​the retina with photoactivated light. Treatment (240) is applied for a duration sufficient to achieve scleral sclerosis.

[0075] While this subject matter has been shown and described with reference to its preferred embodiments, those skilled in the art will understand that many substitutions, modifications, and variations can be made therein without departing from its spirit and scope. Therefore, it is intended to cover all such substitutions, modifications, and variations that fall within the spirit and broad scope of the claims.

[0076] All publications, patents and patent applications mentioned in this specification are incorporated herein by reference in their entirety, to the extent that each individual publication, patent or patent application is specifically and individually indicated as incorporated herein by reference.

Claims

1. A method for treating high myopia and pathological myopia in the eyes of a subject, comprising: A photoreactive drug is introduced into the subcapsular space of the eye of the subject, wherein the photoreactive drug is converted into an active substance that can cause scleral sclerosis by photoactivation. Imaging at least a portion of the eye to configure a treatment plan, the treatment plan defining an area of ​​the retina to be irradiated with the photoactivated light; as well as Photoactivated light is irradiated onto the area of ​​the retina for a duration sufficient to induce scleral sclerosis.

2. The method of claim 1, wherein the irradiation comprises: The treatment plan is fed to the beam shaping unit, and the photoactivated light is passed through the unit to output a beam that is guided and shaped to irradiate the region.

3. The method of claim 1 or 2, wherein the irradiation comprises: The beam tracks eye movements and changes its direction or shape to continuously illuminate the area even during eye movements.

4. The method of any one of claims 1 to 3, wherein at least one of the following is imaged: a portion of the retina, a portion of the choroid, and a portion of the sclera.

5. The method of any one of claims 1 to 4, wherein the photoactivated light is emitted at a visible or near-infrared (NIR) wavelength.

6. The method of claim 5, wherein the photoactivating light is emitted at a wavelength in the range of 750 nm to 756 nm.

7. The method according to any one of claims 1 to 6, wherein the photoreactive agent is palladium 3 1 -Oxy-15-methoxycarbonylmethyl-Rhodophyll-13 1 -(2-sulfoethyl)amide or a pharmaceutically acceptable salt thereof.

8. The method of any one of claims 1 to 7, wherein the imaging is performed by at least one of: fundus camera, optical coherence tomography (OCT), optical coherence elastography (OCE), ultrasound, Scheimpflug imaging, and nonlinear optical imaging.

9. The method of any one of claims 1 to 8, wherein the imaging provides a scleral thickness map or a scleral hardness map.

10. The method of any one of claims 2 to 9, wherein the beam shaping unit comprises at least one of: a digital micromirror device, a liquid crystal panel, a liquid crystal on silicon (LCOS) panel, and a high-speed laser scanner.

11. The method of any one of claims 1 to 10, wherein the treatment plan further includes a specified irradiation dose within a given irradiation time period.

12. The method of any one of claims 1 to 11, wherein the photoactivating light is provided on the surface of the retina at a rate of 1 mW / cm² to 1000 mW / cm².

13. The method of any one of claims 1 to 12, wherein the step of introducing the photoreactive drug occurs at most about 15 minutes before the step of irradiating the photoactivated light.

14. The method of any one of claims 1 to 12, wherein the step of introducing the photoreactive drug occurs between about 15 minutes and about 4 hours before the step of irradiating the photoactivated light.

15. The method of any one of claims 1 to 12, wherein the step of introducing the photoreactive drug occurs more than about 4 hours before the step of irradiating the photoactivated light.

16. A device for treating high myopia and pathological myopia in the eyes of a subject, comprising: A light source configured to emit photoactivated light, which converts a photoreactive drug into an active substance capable of inducing scleral sclerosis; An imaging unit for imaging at least a portion of the retina of the eye and allowing a user to configure a treatment plan, the treatment plan including an area of ​​the retina to be irradiated by the photoactivated light; as well as A beam shaping unit is used to shape the beam emitted by the light source so that the light illuminating the region only illuminates the region.

17. The device of claim 16, wherein the light source is configured to emit light of visible or near-infrared (NIR) wavelengths.

18. The device of claim 16 or 17, wherein the light source is configured to emit light in the wavelength range of 750 nm to 756 nm.

19. The device of claim 18, wherein the device is configured to provide 1 mW / cm² on the surface of the retina. 2 Up to 1000 mW / cm 2 The intensity.

20. The device according to any one of claims 16 to 19, wherein the photoreactive drug is palladium 3 1 -Oxy-15-methoxycarbonylmethyl-Rhodophyll-13 1 -(2-sulfoethyl)amide or a pharmaceutically acceptable salt thereof.

21. The device of any one of claims 16 to 20, wherein the retina is imaged by at least one of: fundus camera, optical coherence tomography (OCT), optical coherence elastography (OCE), ultrasound, Scheimpflug imaging, and nonlinear optical imaging.

22. The device of any one of claims 16 to 21, wherein the beam shaping unit comprises at least one of: a digital micromirror device, a liquid crystal panel, a liquid crystal on silicon (LCOS) panel, and a high-speed laser scanner.

23. The device of any one of claims 16 to 22, further comprising a controller configured to: retrieve the treatment plan from the imaging unit; and control the beam shaping unit.

24. The device of any one of claims 16 to 23, wherein the imaging unit provides a scleral thickness map or a scleral hardness map.

25. The device of any one of claims 16 to 24, wherein the treatment plan further includes a specified irradiation dose within a given irradiation time period.

26. The device as claimed in any one of claims 16 to 24, further comprising: An eye-tracking system for tracking eye movements and changing the direction or shape of the light beam to continuously illuminate the area even during eye movements.

27. The device of any one of claims 16 to 26, wherein the device is used for photodynamic therapy (PDT).

28. A system for treating high myopia and pathological myopia in the eyes of a subject, comprising: The device as described in any one of claims 16 to 27, The source of photoreactive drugs, and An applicator configured to apply the drug into the subcapsular space of the eye.

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