Laterally applying photobiomodulation therapy to an eye to treat a condition of an anterior segment
By laterally applying photobiomodulation therapy across the eye to avoid the retina, the treatment effectively addresses the limitations of traditional PBMT methods, ensuring safe and effective healing of corneal ulcers.
Patent Information
- Application Number
- PCT/US2024/056291
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-06-04
- Filing Date
- 2024-11-15
- Publication Date
- 2025-05-22
AI Technical Summary
Traditional photobiomodulation therapy (PBMT) applied directly to the eye for treating corneal ulcers can cause damage to the retina and other critical optical structures in the posterior segment, leading to discomfort and vision problems.
Applying PBMT laterally across and through a portion of the eye, avoiding direct exposure to the retina, using a system comprising a light delivery device and a controller to emit light signals at specific wavelengths, ensuring safe and effective treatment of the anterior segment.
The lateral application of PBMT effectively treats corneal ulcers without damaging the retina, offering a non-invasive, comfortable, and safe alternative to traditional therapies, promoting tissue regeneration and healing while minimizing side effects.
Smart Images

Figure US2024056291_22052025_PF_FP_ABST
Abstract
Description
LATERALLY APPLYING PHOTOBIOMODULATION THERAPY TO AN EYE TO TREAT A CONDITION OF AN ANTERIOR SEGMENTCross-Reference to Related Applications
[0001] This application claims the benefit of U.S. Provisional Application No, 63 / 600,408, filed November 17, 2023, entitled “MULTI- WAVELENGTH LASER AND LIGHT THERAPY FOR CORNEAL ULCER TREATMENT”, as well as U.S. Provisional Application No.63 / 655,777, filed June 4, 2024, entitled “PHOTOBIOMODULATION FOR TREATMENT OF CORNEAL ULCERS”. These provisional applications are hereby incorporated by reference in their entirety for all purposes.Technical Field
[0002] The present disclosure relates generally to treating a condition of an anterior segment of an eye and, more specifically, to systems and methods for treating the condition of the anterior segment of the eye by applying photobiomodulation therapy (PBMT) laterally to the eye.Background
[0003] Corneal ulcerations (also referred to as corneal ulcers) are open sores that form on and / or in the cornea. Corneal ulcers can be caused by infections (e.g., from bacteria, viruses, fungi, or parasites), dry eye, trauma, neurotrophy, autoimmune diseases, or the like. Ulcers can manifest at different depths within the cornea, from the superficial layers to the deep layers, and can vary in severity from mild to severe. Corneal ulcers can lead to significant visual impairment and, if left untreated, even blindness. Traditional treatment approaches vary depending on ulcer classification and can include topical application of medications for more mild cases or surgical interventions for more severe cases. Both topical application and surgical intervention methods have limitations in terms of effectiveness (e.g., was the ulcer correctly classified, was the surgical intervention and / or topical medication successful, or the like) and patient compliance (e.g., proper application of medications to the eye, proper post-surgical care, or the like).Photobiomodulation therapy (PBMT) is an alternative treatment that can eliminate some of these limitations, but PBMT is traditionally applied directly into the eye. Direct application of PBMT into the eye at dose profiles sufficient to treat corneal ulceration can cause damage to the retina and / or other critical optical structures in the posterior segment of the eye, causing at least discomfort and even insurmountable vision problems.Summary
[0004] The present disclosure relates to a photobiomodulation therapy (PBMT) based treatment a condition of an anterior segment of an eye (e.g., corneal ulceration). The PBMT of the present disclosure includes applying light signals laterally to the eye such that the light signals travel across and through a portion of the eye to treat the anterior segment. The PBMT of the present disclosure does not suffer from the limited effectiveness, compliance issues, and / or safety risks of traditional therapies.
[0005] In one aspect, the present disclosure can include a system for non-invasive treatment of ocular conditions, including corneal ulcerations. The system can include a light delivery device and a controller. The light delivery device can include one or more light sources, each configured to emit a light signal at a wavelength, and one or more other light sources, each configured to emit another light signal at another wavelength. The one or more light sources and the one or more other light sources can be configured in the light delivery device to deliver the light signal and the other light signal laterally across and through at least a portion of the patient’s eye to avoid at least a retina in the patient’s eye while treating the condition of the patient’s eye (e.g., corneal ulcer). The controller can include a power source, a non-transitory memory storing instructions, and a processor for executing the instructions. The controller can at least deliver power and parameter configurations to the light delivery device to treat the condition of the patient’s eye.
[0006] In another aspect, the present disclosure can include a method for treating a condition of a patient’s eye, such as a corneal ulcer. The method can include emitting a therapy comprising at least one light signal at a wavelength and at least one other light signal at another wavelength. The at least one light signal can be emitted by one or more light sources configured to emit the at least one light signal at the wavelength. The at least one other light signal can be emitted by one or more other light sources configured to emit the at least one other light signal atthe other wavelength. The method can further include delivering the therapy laterally across and through at least a portion of the patient’s eye to treat the condition of the patient’s eye (e.g., the corneal ulcer) and avoid at least a retina in the patient’s eye while treating the condition of the patient’s eye.Brief Description of the Drawings
[0007] The foregoing and other features of the present disclosure will become apparent to those skilled in the art to which the present disclosure relates upon reading the following description with reference to the accompanying drawings, in which:
[0008] FIG. l is a diagram showing an example of a treatment device for treating a condition of an anterior segment of an eye by delivering photobiomodulation therapy (PBMT) laterally to the eye;
[0009] FIG. 2 is a diagram showing the anterior segment of the eye that can be treated by the treatment device of FIG. 1;
[0010] FIG. 3 is a diagram showing an example of the treatment device of FIG. 1;
[0011] FIGS. 4-5 are diagrams showing example configurations of the light delivery device of FIG. 3;
[0012] FIG. 6 is a diagram showing an example configuration of the controller of FIG. 3; and
[0013] FIG. 7 is a process flow diagram of an example method for delivering PBMT laterally to the eye to treat the condition of the anterior segment of the eye.Detailed DescriptionI. Definitions
[0014] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure pertains.
[0015] In the context of the present disclosure, the singular forms “a,” “an”, and “the” can also include the plural forms, unless the context clearly indicates otherwise.
[0016] As used herein, the terms “comprises” and / or “comprising” can specify the presence of stated features, steps, operations, elements, and / or components, but do not precludethe presence or addition of one or more other features, steps, operations, elements, components, and / or groups.
[0017] As used herein, the term “and / or” can include any and all combinations of one or more of the associated listed items.
[0018] Additionally, although the terms “first,” “second,” etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. Thus, a “first” element discussed below could also be termed a “second” element without departing from the teachings of the present disclosure. The sequence of operations (or acts / steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.
[0019] As used herein, the term “photobiomodulation”, also referred to as “PBM”, refers to a method for treating a portion of a subject’s body to induce a phototherapeutic response in cells within the portion of the subject’s body. As an example, the portion of the subject’s body can be a portion of the anterior segment of a patient’s eye.
[0020] As used herein, the term “photobiomodulation therapy”, also referred to as “PBMT”, refers to a drug-free, non-invasive treatment procedure of a certain region of a subject’s body to treat a certain medical condition (e.g., a condition of the anterior segment of a patient’s eye) via a phototherapeutic response. It should be understood that PBM and PBMT may also be referred to as a “photoceutical therapy”, a “low level light therapy”, or the like.
[0021] As used herein, the term “anterior segment” of a patient’s eye refers to the front portion of the eye, parts of which can focus light onto the retina. The anterior segment can include at least one of the cornea, the iris, the lens, the aqueous humor, the anterior chamber, the posterior chamber, and the conjunctiva. The anterior segment may also include at least a portion of the lacrimal apparatus in some instances. Conditions that can affect the anterior segment can include but are not limited to corneal dystrophies (including ulcers), glaucoma, uncorrected refractive error, dry eye disease, cataracts, anterior uveitis, trachoma, or the like.
[0022] As used herein, the term “treatment device” refers to a handheld device that can deliver at least PBMT to a portion of a patient’s eye. The treatment device can deliver PBMT laterally through at least a portion of the anterior segment of the eye, without directing the PBMT towards the retina and / or other critical optical structures in the posterior portion of the eye. The treatment device can include at least a light delivery device and may include one ormore light sources, super pulsed lasers, and / or magnets. The treatment device can include and / or can be in electrical communication (wired and / or wireless) with a controller that can provide power and / or parameter configurations (e.g., power(s), wavelength(s), intensit(ies), timing(s), light source choice(s), etc.) to the light delivery device of the treatment device.
[0023] As used herein, the term “light source” refers to a component of a light delivery device that can deliver one or more light signals having one or more wavelengths. A light source can be, for instance, a low-level laser source such as a laser diode, a light emitting diode (LED), an eye-safe laser, or the like that can be a heat-free light source. For example, the light source can be a low-level laser source (e.g., a laser diode) that generates coherent light. The low-level laser source can operate in a super pulsed mode that generates ultrashort pulses with a high peak power and minimal heat. As another example, the light source can be an incoherent light source, such as a traditional LED or light bulb. The incoherent light source can operate in a pulsed mode and / or a continuous mode. As another example, the light source can be a super pulsed laser. As another example, the light source can be an eye-safe laser.
[0024] As used herein, the term “super pulsed laser” refers to a light source that produces a wavelength of light at a high peak power for a very brief duration. Even though the pulse peaks at a high power level, there are no thermal effects in the tissue due to the brevity of the pulse. The peak power is high compared to the average output power. By using a super pulsed laser, one is able to more effectively deliver higher densities of light energy into the tissue without associated deleterious thermal effects.
[0025] As used herein, the term “eye-safe laser” refers to a laser that emits light signals having wavelengths that are absorbed or mostly absorbed by the cornea and lens of the eye, preventing the light signals from reaching the retina and causing damage to the highly sensitive retina. An eye-safe laser can, for example, emit wavelengths longer than 1.4 pm. Examples of eye-safe lasers can include but are not limited to erbium lasers and erbium-doped fiber amplifiers emitting in the 1.5 pm spectral range, thulium lasers around the 2-pm range, semiconductor lasers, and lasers with optical parametric oscillator sources.
[0026] As used herein, the term “light signal” refers to light emitted in a direction from a light source and having at least one parameter (e.g., wavelength, intensity, power, timing, pulsation, and the like). One or more light signals having one or more wavelengths can be combined to create a synergistic effect that can improve the percentage of available light atgreater tissue depths. In some instances, the wavelengths can be within a wavelength range of 400-1100 nm. For example, the wavelengths can include at least one wavelength corresponding to the visible range of the electromagnetic spectrum (e.g., red light, 600-700 nm - reduces inflammation and triggers biochemical processes) and at least one wavelength corresponding to the near-infrared or infrared range (e.g., 700-1100 nm - deeper penetration, enhances circulation, reduces pain, affects cell membranes) of the electromagnetic spectrum.
[0027] As used herein, the term “treatment” refers to medical care given to a subject to heal or cure a medical condition, like a condition of the anterior segment of the eye, or a symptom of the condition. The terms “treatment” and “therapy” can be used interchangeably herein.
[0028] As used herein, the term “lateral” refers to something (e.g., light signals) being directed toward a target (e.g., a portion of the eye) from the side. Lateral can be exactly a 90° angle from a direct application (with direct being along an X axis, representing the anterior- posterior axis on the transverse plane) and / or can include one or more buffers (e.g., can be ±20° or less, ±15° or less, ±10° or less, ±5° or less, or the like from 90° from the X-axis). It should also be understood that a lateral application can include a tilt up or down along the y-axis and / or the z-axis (e.g., the one or more light signals can be applied at a laterally tilted direction).
[0029] As used herein, the term “direct” refers to something (e.g., light signals) being directed toward a target (e.g., a center of the eye) from a central direction (e.g., along an x-axis). Direct can be exactly a 0° angle (along an X axis, representing the anterior-posterior axis on the transverse plane) and / or can include one or more buffers (e.g., can be ±20° or less, ±15° or less, ±10° or less, ±5° or less, or the like from 90°). It should also be understood that a direct application can include a tilt up or down along the y-axis and / or the z-axis.
[0030] As used herein, the terms “patient” and “subject” can be used interchangeably and refer to any warm-blooded organism that can suffer from a condition of an anterior segment of the eye including, but not limited to, a human being, a pig, a rat, a mouse, a dog, a cat, a goat, a sheep, a horse, a monkey, an ape, a rabbit, a cow, etc.II. Overview
[0031] Portions of an anterior segment of an eye can allow light to enter the eye, help the eye focus, and serve as a crucial barrier against microorganisms entering the eyes and thebloodstream. The anterior segment can be affected by conditions that can cause damage (mild to severe) such as, but not limited to, corneal dystrophies (including ulcers), glaucoma, uncorrected refractive error, dry eye disease, cataracts, anterior uveitis, trachoma, or the like. Such conditions can be caused by infection (e.g., bacterial, viral, fungal, or the like), trauma (e.g., blunt force or lacerations), chemical bums, underlying systemic conditions (e.g., epithelial dystrophy), keratoconjunctivitis sicca (dry eye), endocrine diseases (e.g., diabetes, Cushing's disease, hypothyroidism, etc.), or the like. Diagnosis of conditions of the anterior segment can be based on clinical signs (e.g., for comeal ulcers: excessive tearing, eyelid spasms, light sensitivity, conjunctival redness, swelling, pupil constriction, and the like) and testing (e.g., for comeal ulcers: the retention of topically applied fluorescein dye by the comeal stroma). Treatment strategies vary, but generally range from topical treatments to surgical interventions. For example, for comeal ulcers, topical treatments can include the application of eye drops (e.g., including antibiotics, non-steroidal anti-inflammatories, collagen precursors, mydriatics, and metalloproteinase inhibitors) and surgical interventions can include the formation of conjunctival flaps, comeal transplantation, or amniotic membrane transplantation, which may be necessary for deep ulcers at high risk of perforation. The objective in all cases is to stimulate the growth of blood vessels reaching the injury site to promote corneal healing, as these vessels bring new comeal cells, fibrovascular tissue, and natural anti -collagenases to facilitate tissue repair. However, these methods are often associated with drawbacks such as limited penetration of medications (e.g., improper patient administration) and potential complications (such as secondary infections, surgical damage, or the like) arising from invasive procedures. Photobiomodulation therapy (PBMT) has emerged as an alternative treatment that can eliminate these drawbacks, but PBM can cause damage to the retina of the eye since PBM is traditionally applied directly into the eye. Direct application of PBM at power / wavelength profiles sufficient to treat conditions of the anterior segment (like comeal ulceration) can cause side effects that can range from discomfort to insurmountable vision problems.
[0032] Described herein is an alternate application of PBMT laterally through only a portion of the eye. The lateral delivery provides PBMT to at least a portion of the anterior segment of the eye without delivering light directly to at least the patient’s retina and / or other structures in the posterior portion of the eye. Thus, the retina and / or other portions of the posterior portion of the eye are not directly exposed to the PBMT and the risk of damage (e.g.,from the PBMT dose profile sufficient to treat the condition(s)) is reduced and / or removed . This approach of applying PBMT laterally provides a comprehensive non-invasive treatment to promote tissue regeneration, stimulate cellular activity, modulate / reduce inflammation, and expedite the healing process to enhance tissue repair, while addressing the shortcomings of traditional treatments. The overall goal of the PBMT application is to target one or more specific areas of concern while sparing healthy parts of the eye from unnecessary exposure, reducing the likelihood of side effects. Additionally, patents experience greater comfort during treatment because the approach is less intrusive and more tolerable compared to directing light into the eye.III. Photobiomodulation Therapy (PBMT)
[0033] Photobiomodulation therapy (PBMT) (also referred to as a photoceutical therapy, low level light therapy, and the like) can be applied laterally through a portion of a patient’s eye (e.g., across at least a portion of the eye’s surface) to treat a condition of a least a portion of an anterior segment of the eye (e.g., at least one of a cornea, a portion of conjunctiva, an iris, a pupil, a ciliary body and processes, a lens, at least a portion of a lacrimal apparatus, or the like) without damaging the retina of the eye (or other components of the eye in the posterior segment). For ocular PBMT, safety considerations are paramount to avoid thermal damage, preserve ocular tissue, and preserve sight. Patient comfort is also an important consideration as the eye is an extremely sensitive organ. PBMT can provide a low-cost, effective alternative or adjunctive treatment for many conditions of the anterior segment of the eye. As described herein, PBMT can be safely and effectively applied to treat conditions of the eye (e.g., mitigating inflammation while supporting tissue repair and alleviating discomfort and / or pain). For example, conditions of the anterior segment, including corneal dystrophies (including ulcers), glaucoma, uncorrected refractive error, dry eye disease, cataracts, anterior uveitis, trachoma, or the like, can be treated in this manner.
[0034] PBMT may include application of one or more light signals from one or more light sources, at least a portion of which can be eye-safe light sources. The one or more light sources may provide one or more light signals with different properties to create a synergistic therapeutic effect. The different properties can be wavelengths, treatment frequencies, powers, power densities, energies, energy densities, application times, exposure times, and / or other one or more properties. For example, wavelengths and other properties of the one or more light signals can beoptimized for ocular tissue penetration and therapeutic impact. Specific one or more wavelengths and other properties can be chosen based on their ability to address one or more conditions of at least a portion of the anterior segment effectively. Therapeutic doses for laser therapy typically range from 0.001 to 10,000 joules (J), with energy comprising single or multiple wavelengths between 400 and 1100 nanometers (nm). Various light sources, including lasers and LEDs, can be used in continuous, pulsed, and / or super-pulsed modes. The effectiveness of laser therapy depends on the chosen type of light source, wavelength, and dose (e.g., number of applications, application times, exposure times, powers, power densities, etc.), as well as the condition to be treated. Dose requirements fluctuate based on factors like wavelength composition, pulsing, light source selection, and total energy delivered. In some instances, the PBMT may also include application of a magnetic signal (e.g., a magnetic field) in combination with the light signal. It should be understood that PBMT can be used as a standalone treatment and / or as a complementary therapy in conjunction with one or more other medical interventions.
[0035] The light of PBMT has been shown to have a modulatory effect promoting healing based on the principle that certain molecules in living systems (cellular chromophores, chiefly mitochondria) absorb photons (in other words, harness light energy) and trigger signaling pathways in response to light initiating a cascade of photochemical reactions that bestow a multitude of benefits crucial for efficient tissue repair and regeneration. While not wishing to be bound by theory, there is strong evidence to suggest that one of the basic cellular tasks mechanisms of PBMT is the acceleration of electron transfer by electromagnetic radiation in the visible and near infrared region of the spectrum, via the modulation of cytochrome c-oxidase (“CCO”) activity in cells. CCO is the primary photo acceptor of visible to near infrared light energy and is the enzyme responsible for catalyzing oxygen consumption in cellular respiration and for the production of nitric oxide under hypoxic conditions. High-energy electrons are passed from electron carriers through a series of trans-membrane complexes (including CCO) to the final electron acceptor, generating a proton gradient that is used to produce adenosine triphosphate (ATP), the body’s energy currency (fueling a wide array of cellular functions essential for tissue repair). The application of light directly results in ATP production and electron transport. In short, the application of PBMT can increase ATP production, down- regulate cellular respiration modulated by NO, and promotes the metabolism of oxygen, while increasing the production of reactive oxygen species (ROS). The heightened ATO availabilityempowers cells involved in healing of conditions of the anterior segment of the eye with the necessary energy reservoirs to drive the reparative process.
[0036] The improved ATP production is intimately linked to elevated cellular respiration. Enhanced cellular respiration not only augments the efficiency of energy conversion but also fuels a more robust metabolic environment. This accelerated metabolism accelerates the synthesis of essential molecules, such as proteins and enzymes, pivotal for cell growth and tissue repair. Consequently, the overall healing process is expedited. The cascade of photochemical reactions initiated by PBMT extends beyond energy metabolism. These reactions can stimulate cellular signaling pathways that govern various aspects of cellular behavior. For instance, the activation of signaling molecules like reactive oxygen species (ROS) can trigger beneficial responses, including cellular proliferation and the modulation of inflammatory processes. This plays a pivotal role in creating an environment conducive to healing while simultaneously reducing the risk of chronic inflammation that could impede recovery. The comprehensive enhancement of tissue repair orchestrated by PBMT is underpinned by its multi-faceted approach. Not only does it increase ATP production and cellular respiration, but it also bolsters the production of essential molecules, influences cellular signaling, and maintains a balanced inflammatory response.
[0037] Moreover, PBMT exhibits also a remarkable capacity to finely modulate immune responses, including the intricate control of interferon gamma (IFN-y) levels. Through the precise application of specific wavelengths, laser light can penetrate tissue and interact with immune cells, triggering a cascade of responses. Notably, laser therapy demonstrates the unique ability to both up-regulate and down-regulate IFN-y production. In situations requiring an immune boost, such as combating infections, laser therapy enhances IFN-y synthesis, empowering immune cells for more effective pathogen defense. Conversely, in scenarios marked by IFN-y overexpression, like autoimmune diseases, laser therapy curtails excessive production, thereby mitigating immune hyperactivity and dampening harmful inflammatory processes. This dual modulatory effect highlights laser therapy's potential as a versatile tool for immune regulation, offering a tailored approach to address diverse immune-related conditions.
[0038] Healing is intricate and heavily reliant on a well-coordinated interplay of various biological factors. Among these factors, the stimulation of angiogenesis through the application of specific wavelengths of light stands out as a pivotal mechanism that significantly influencesthe healing process. Angiogenesis, the growth of new blood vessels from existing ones, is a fundamental process in tissue repair and regeneration. Certain wavelengths of light have been scientifically demonstrated to induce and accelerate angiogenesis in the affected area. This phenomenon is of paramount significance due to its multifaceted impact on the healing environment. The formation of new blood vessels brings about a host of benefits that collectively create an optimal milieu for tissue repair. One of the most immediate advantages is the enhanced delivery of oxygen and nutrients to the ulcerated site. Oxygen is a critical component for cellular metabolism and energy production, both of which are essential for the cells involved in the regenerative process. Furthermore, the increased supply of nutrients facilitates the rebuilding of damaged tissue components, aiding in the restoration of the corneal structure. Additionally, the new blood vessels act as conduits for immune cells, which play an indispensable role in combatting infections and orchestrating the intricate processes of tissue repair. By fostering an increased presence of immune cells at the ulcerated site, the immune response becomes more efficient and effective, thereby accelerating the clearance of pathogens and debris. Furthermore, the enhanced blood circulation resulting from angiogenesis promotes the removal of waste products and toxins from the site of injury. This detoxification process further contributes to the establishment of a healthier environment for cellular regeneration and healing. By promoting the growth of new blood vessels, the therapy sets in motion a cascade of positive effects — improved oxygenation, enhanced nutrient supply, increased immune cell presence, and efficient waste elimination.IV. Systems
[0039] As shown in FIG. 1, a handheld treatment device 100 can treat at least one condition of at least an anterior segment of the eye. The handheld treatment device 100 can be configured and positioned to deliver photobiomodulation therapy (PBMT) (which can also be referred to as a photoceutical therapy, low level light therapy, and the like) to at least a portion of the patient’s eye that includes the anterior segment. The handheld treatment device 100 can be configured and positioned to deliver the PBMT laterally to at least a portion of a patient’s eye (e.g., across at least a portion of the eye’s surface) to treat the condition of the anterior segment of the eye without damaging (or with reduced damage to) the retina of the eye and / or other components of the posterior segment of the eye . The treatment device 100 is shown as a-l ihandheld device embodied within a single housing, but it should be understood that this is only one example for simplicity of illustration and description, and the treatment device need not be a handheld device in a single housing. The treatment device 100 can be embodied in one or more portions having different housings and / or configurations (e.g., wearable, removably adhered, standalone device that the patient stands or sits by, or the like) as long as the PBMT can be delivered laterally to at least the anterior segment of the eye .
[0040] The anterior segment of the eye is shown in FIG. 2 in the box with the dotted line and can include at least one of a cornea, a portion of conjunctiva, an iris, a pupil, a ciliary body and processes, a lens, at least a portion of a lacrimal apparatus, or the like. Conditions of the anterior segment that can be treated by the PBMT can include corneal dystrophies (including ulcers), glaucoma, uncorrected refractive error, dry eye disease, cataracts, anterior uveitis, trachoma, or the like. The treatment can be targeted to the area of the anterior segment with the condition such as an epithelium of the cornea, an endothelium of the cornea, a stroma of the cornea, an adjacent structure, nerve endings, or any other part of the anterior segment that satisfies the goal of promoting healing while preserving vision and minimizing discomfort (e.g., by not directly applying PBMT to at least a portion of the posterior segment of the eye including at least the retina). While not clearly demarcated in FIG. 2 it should be understood that the posterior segment of the eye can include the back two-thirds of the eye, including, but not limited to, the retina, the choroid, the vitreous humor, and the optic nerve.
[0041] Referring again to FIG. 1, the treatment device 100 can include one or more light sources (and may include one or more magnetic field sources) to provide the PBMT. Characteristics / parameters of the PBMT can be determined and / or configured to provide the greatest ability to interact with cellular components and influence cellular behavior for healing. The one or more light sources can each be configured to deliver individual portions of the PBMT according to one or more parameters (e.g., wavelength, intensity, power, timing, pulsation, and the like). The parameter(s) can be chosen based on the specific condition of the anterior segment, the location in the anterior segment of the condition, condition severity, patient characteristics, etc. For example, the parameter can be wavelength, which can correspond to light of different colors, with colors chosen from green, amber, blue, red, infrared, etc. and the combination of colors (such that the treatment is optimized for effect on the condition being treated). The lateral delivery of PBMT can lead to a distribution of energy (e.g., light energy) more evenly across theeye’s surface while sparing the retina (and other areas of the posterior segment) from direct exposure to concentrated light.
[0042] As an example, the treatment device 100 can include two or more light sources with different parameters (e.g., wavelength, therapy dose (including power, energy, exposure time, and the like), treatment frequency, etc.). Each of the light sources can be configured to deliver continuous light, pulsed light, and / or “super-pulsed” light. As an example, wavelength can be the parameter varied between the two or more light sources in this example (such that the wavelengths correspond to a single wavelength or multiple different wavelengths) and each wavelength can have different therapeutic effects (however, the dose is also very important). The different wavelengths can cause different reactions at least because light at different wavelengths can be absorbed by specific chromophores within cells, initiating various photochemical reactions with outcomes ranging from enhanced cellular metabolism to modulation of signaling pathways, ultimately leading to therapeutic effects. The wavelengths can be selected independently and may be between 400 nm and 1100 nm. As an example, the wavelengths can be varied, and the wavelengths used can stimulate cellular activity, enhance tissue repair, modulate the inflammatory response, or the like. Longer wavelengths (e.g., red and infrared) can penetrate more deeply into tissues, stimulating mitochondrial activity and enhancing adenosine triphosphate (ATP) production, providing a source of energy crucial for cellular function and tissue repair. Additionally or alternatively, specific wavelengths and combinations can modulate immune responses and mitigate inflammation with multi -wavelength PBMT addressing different aspects of the inflammatory cascade. Additionally or alternatively, light in various wavelengths can influence intercellular signaling and gene expression with multi-wavelength approaches having the potential to target multiple signaling pathways leading to more nuanced and effective cellular communication. It should be noted that the optimal dose varies based on the specific condition, tissue depth, and individual patient.
[0043] Utilizing multiple wavelengths concurrently enables comprehensive and potent therapeutic effects by effectively targeting various cellular processes. Additionally, each wavelength possesses a unique tissue penetration depth and absorption profile, enhancing treatment across different tissue layers. This multi-wavelength approach also prevents the development of tolerance, avoiding reduced therapeutic effectiveness over time. Employing a variety of wavelengths ensures broader coverage of absorption spectra, eliminating "dead zones"where a single wavelength may be poorly absorbed. This adaptability allows for tailored treatment protocols, customized to specific conditions or desired therapeutic outcomes. Lastly, certain combinations of wavelengths have demonstrated synergistic effects, enhancing overall therapeutic benefits beyond what individual wavelengths can achieve. By leveraging the diversity of wavelengths, this approach optimizes cytochrome c oxidase activity, benefiting from spectral overlap and synergistic interactions. Simultaneously targeting multiple absorption peaks of cytochrome c oxidase enhances its activation and photochemical reactions, resulting in a more robust modulation of cellular metabolism and tissue repair processes through cumulative energy delivery from various wavelengths.
[0044] The treatment device 100 can have one or more sized and shaped openings that can be used to deliver the PBMT to the patient (e.g., for the light sources to emit through / from). Although the treatment device 100 is shown as being a handheld device, it should be understood that a handheld device is just one way the PBMT can be delivered laterally through the patient’s eye. Other devices that can deliver PBMT laterally through the patient’s eye are contemplated - including a solo device with many light sources, multiple devices each with one or more light sources, etc. - but the handheld device is shown and described for ease of illustration and description. The PBMT can include one or more light signals (with the same or different parameters chosen based on the condition the PBMT is treating) that are heat-free and / or eyesafe (that can emit in an eye-safe spectral region).
[0045] The treatment device 100 can be configured to deliver one or more wavelengths of light (e.g., from lasers, such as eye-safe lasers, LEDs, or the like) to offer a non-invasive, patientfriendly solution that provides a more effective and comfortable alternative for managing disorders of the anterior segment of the eye without damaging the retina and other parts of the peripheral segment of the eye. The lateral delivery can also reduce complications, patient discomfort, and anxiety, in turn providing increased compliance, enhanced safety / comfort, and precise treatment. In some instances, the lateral delivery of PBMT can accelerate the recovery process from one or more conditions of the anterior segment. For instance, more light can reach the anterior segment in a given application (e.g. greater amount of the anterior segment can be reached, greater dose profiles can be utilized, or the like), the patient can better tolerate the application (e.g., less blinking or moving away compared to direct light application), or the like. Additionally, while not shown it should be understood that the treatment device 100 can includeor be in communication with a user interface (e.g., buttons, keys, touch screen, or the like) for inputting manual information and / or instructions and can include other components for basic functions such as circuitry and / or wireless transducers,
[0046] The components of the treatment device 100 are shown in greater detail in FIG. 3. As shown in FIG. 3, the treatment device 100 can include a light delivery device 202 coupled to (e.g., in wired and / or wireless electrical communication with) a controller 208. While the light delivery device 202 must be within the treatment device 100, the controller 208 can be located within the treatment device 100 (e.g., within the handle) and / or can be located outside the treatment device 100 (e.g., the controller can be coupled and uncoupled from the light delivery device 202). The controller 208 can include a memory 210 (e.g., a non-transitory memory) storing instructions and / or a processor 212 (e.g., one or more processors) that can access the instructions in the memory 210 and execute the instructions to at least deliver the PBMT to treat the condition of the eye. For instance, the instructions, upon execution, can facilitate the configuration and generation of the light signal for PBMT (e.g., controlling the dose delivered by the light delivery device 202 based on a prescription, the condition in the patient’s eye, a depth of the condition in the patient’s eye, a characteristic of the patient / patient’s biology, or the like). The controller 208 can also include a power source 214 (e.g., an internal power source configured to provide power to the light delivery device 202). In some instances, the internal power source 214 can be an internal battery (e.g. rechargeable and / or replaceable). In other instances, the internal power source 214 can interface with an external power source and the internal power source can receive and / or store power from the external source (e.g., line power). In each instance, the power source 214 can generate / store power used by the light delivery device 202.
[0047] The light delivery device 202 can include at least one light source 1-N (where N is greater than or equal to 1) 204(l-N) and at least one other light source 1-M (where M is greater than or equal to 1) 206(1 -M). It should be understood that N and M may be equal to one another, but need not be, and can be selected and / or controlled independently. In some instances, the light delivery device can include one or more additional light sources 1-P (where P is greater than or equal to 1) 218(1-P). It should be understood that P may be equal to N and / or M but P, M, and N are selected independently. The light source(s) 1-N 204(l-N), the other light source(s) 1-M 206(l-M), and the additional light source(s) 1-P 218(1 -P) can emit light having the samewavelengths and / or different wavelengths from each other. In other instances, the light delivery device 202 can include at least one magnetic field source 1-Q (where Q is greater than or equal to 1) 206(l-Q) such as permanent magnets, temporary magnets, and / or electromagnets. It should be understood that Q may be equal to or different from N, M, and / or P and can be selected and / or controlled independently.
[0048] For example, the light delivery device 202 can include at least one light source 1-N (where N is greater than or equal to 1) 204(1 -N) that can each emit a light signal at a wavelength and at least one other light source 1-M (where M is greater than or equal to 1) 206(l-M) that can each emit another light signal at another wavelength. The one or more light sources 1-N 204(1- N) and the one or more other light sources 1-M 206(l-M) can be configured (e.g., shaped, directed, positioned, focused, etc.) in the light delivery device 202 to deliver the light signal(s) and the other light signal(s) laterally across and through at least a portion of the patient’s eye (e.g., at least a portion of the anterior segment) to treat the condition of the patient’s eye and avoid at least the retina (e.g., to limit and / or prevent damage to the retina). The light delivery device 202 may include one or more additional light sources 1-P (where P is greater than or equal to 1) 218(1-P), which can emit one or more additional light signals each at one or more additional wavelengths (e.g., the same and / or different from each other, the wavelength, and / or the other wavelength). The one or more additional light signals can also be delivered laterally across and / or through at least a portion of the patient’s eye to treat the condition, while avoiding at least the retina. The light delivery device 202 may also and / or alternatively include at least one magnetic field source 1-Q (where Q is greater than or equal to 1) 216(1-Q) that can form at least one magnetic field having flux and / or a force. The at least one magnetic field source 1-Q (where Q is greater than or equal to 1) 216(1-Q) can provide one or more static magnetic fields that can influence cellular behavior and enhance blood flow, which can be important for nutrient delivery to the tissue being treated. In some instances, the at least one magnetic field source 1-Q (where Q is greater than or equal to 1) 216(1-Q) can provide one or more static magnetic fields that can enhance the effectiveness of the light sources 204, 206, and / or 218.
[0049] The at least one light source 1-N (where N is greater than or equal to 1) 204(l-N), the at least one other light source 1-M (where M is greater than or equal to 1) 206(l-M), and, optionally, the at least one additional light source 1-P (where is greater than or equal to 1) 218(1- P) can each operate in a same and / or a different operational mode. The operational modes caninclude a pulsed operational mode, a continuous operational mode, and a super-pulsed operational mode. In one instance, the at least one light source 1-N 204(1 -N) can emit at least one light signal having at least one red light wavelength in a pulsed operational mode or a continuous operational mode. The at least one other light source 1-M 206(1 -M) can emit at least one light signal having at least one infrared wavelength in a pulsed operational mode or a continuous operational mode. And the at least one additional light source 1-P 218(1-P) can emit at least one light signal having at least one red light wavelength in a super pulsed operational mode and / or at least one infrared light wavelength in a super pulsed operational mode.
[0050] Example configurations of the treatment face side (e.g., the light-emitting surface side) of the light delivery device 202 are shown in in FIGS. 4-5. The light sources and / or magnetic field sources can be positioned in one or more zones, groupings, and / or other configurations as shown. These examples show example configurations of the treatment side of the light deliver device 202 for descriptive purposes but are not intended to be limiting. It should be understood that other configurations, including groupings, zones, clusters, or the like are considered. In all situations, the light delivery device 202 can provide PBMT -based treatments of one or more ocular conditions to an anterior segment of the eye. Moreover, the example configurations can be adapted for in clinic and / or at home use.
[0051] For instance, FIG. 4, element A shows the light-emitting surface of the light delivery device 202 can be divided into a plurality of zones. Four zones, labeled as cluster 1 402, cluster 2 404, cluster 3 406, and cluster 4 408, in a quadrant configuration are shown and discussed herein, but it should be understood this is simply an example for illustrative purpose and is not meant to be limiting. The plurality of zones can have any configuration, such as but not limited to the quadrant / radial configuration, concentric circles, or separate groupings of the same and / or different shapes, size, or numbers. Each of the zones can be individually homogenous (e.g., within one zone there can be one type of light source or magnetic source) and / or heterogenous (e.g., within one zone there can be multiple types of light source and / or magnetic sources). Each of the zones can be the same and / or different from the others. For instance, each of the zones can have two or more different light sources emitting different wavelength configurations (e.g., one or more of the at least one light sources 204 and one or more of the at least one other light sources 206, and optionally one or more of the at least one additional light source 218) and / or magnetic field sources (e.g., magnetic field sources 216). Theplurality of zones on the light emitting surface can create a non-uniform distribution of light, with areas of varying light intensity that can be delivered to at least the anterior segment of the eye to treat the condition. As an example, one of the zones can include a first one or more light sources and a second one of the zones can include a second one or more light sources (e.g., configured to provide a different wavelength).
[0052] FIG. 4, element B shows example configurations of the zones of FIG. 4, element A where each zone is heterogenous and where each zone is different from the others. It should be understood that each zone is meant to illustrate one example configuration and any combinations can be used. Cluster 1 402 shows a zone including a light source (emitting a wavelength and / or intensity), another light source (emitting another wavelength and / or intensity), and additional light source (emitting an additional wavelength and / or intensity), and a magnet (causing a magnetic field to be formed). Cluster 2 404 shows a zone including two light sources and two other light sources (e.g., the two light sources can emit a wavelength and the two other light sources can emit another wavelength). It should be understood that two is used as an example and any numbers of light source and other light source, the same or different, can be included. Cluster 3 406 shows a zone including a light source, another light source, and an additional light source, with no magnet. Cluster 4 408 shows a zone including two light sources (can be two or more and could be two or more other light sources or two or more additional light sources) and a magnet (could be one or more). FIG. 4, element C shows an example of zones that are internally homogenous. Cluster 1 402 is shown with three light source (can be any number one or more) (e.g., all emitting a same wavelength but may vary in intensity, timing, and / or operational mode). Cluster 2404 is shown with two other light source (can be any number one or more) (e.g., all emitting a same wavelength but may vary in intensity, timing, and / or operational mode). Cluster3 406 is shown with three additional light source (can be any number one or more) (e.g., all emitting a same wavelength but may vary in intensity, timing, and / or operational mode). Cluster4 408 is shown with two magnets (can be any number one or more)(e.g., can have same and / or different strengths to cause different forces and / or fluxes) It should be understood that the zones can be mixed and / or matched and internal configurations of each zone and / or each zone itself can have any shapes, sizes, and / or positioning in the treatment head. Each component and / or zone may be physically present and can be controlled to change (e.g., one / off / different parameters) according to a prescription (e.g. by controller 208).
[0053] FIG. 5 shows a detailed example of one configuration of the light-emitting surface of the light delivery device 202 that includes two types of zones (examples encircled in dashed and dotted lines, respectively). There can be four of each type of zone in an alternating pattern and in a radial configuration. The first zone type includes one light source (having a wavelength, intensity, and operational mode), two other light sources (each having another wavelength, intensity, and operational mode), one additional light source (having an additional wavelength, intensity, and operational mode), and a magnet (having at least a magnetic strength). The second zone type includes one light source (having a wavelength, intensity, and operational mode), two other light sources (each having another wavelength, intensity, and operational mode), and a magnet (having at least a magnetic strength). The parameters of each light source and / or magnet can be the same across zones and / or different. This light delivery device can emit a non-uniform distribution of light towards the patient’s eye with areas of varying light intensity. For example, the light source can emit red light in a continuous or pulsed operational mode, the two other light sources can emit infrared light in a continuous and / or pulsed operational mode and the additional light source can emit red light or infrared light in a super pulsed operational mode. The magnet can emit a magnetic field, and the magnetic fields of each magnet may interact with one another.
[0054] In some instances, the light delivery device 202 can include at least one pulsed light source or continuous light source and a super pulsed laser. For example, the light sources can include one or more groups of a super pulsed laser (emitting red and / or infrared light), a red diode (or multiple red diodes), and an infrared diode (or multiple infrared diodes), where at least a portion of the diodes can deliver pulsed light. The at least one pulsed light source and the super pulsed laser can each provide versatility in treatment. While not wishing to be bound by theory, it is believed that pulsing light is ideal for superficial treatment of the anterior segment as it minimizes tissue damage and promotes cell proliferation, collagen synthesis, and circulation to expedite healing. Light from super pulsed lasers can penetrate more deeply, stimulating cellular metabolism, reducing inflammation, and triggering repair mechanisms, while minimizing tissue risk. In fact, a combination of one or more super pulsed lasers, LED therapy, and magnetic fields can accelerate healing, inflammation control, and nutrient delivery, creating an optimal environment for tissue repair potentially by enhancing ATP production, metabolism, and cellular signaling. Indeed, immune modulation with PBM can help regulate IFN-y levels, while allowing angiogenesis to promote tissue repair, addressing various aspects of the healing process.
[0055] Pulsing LEDs and lasers can emit light in a series of intermittent bursts. This approach minimizes the risk of thermal damage to surrounding tissues while allowing for precise control over the therapeutic dose. For example, it is believed that pulsing mode is particularly suitable for treating superficial corneal ulcerations by promoting cellular proliferation, collagen synthesis, and enhanced circulation. These ultimately accelerate the wound healing process.
[0056] Super pulsed lasers can emit high-energy bursts of light for ultra-short durations. This technology penetrates deeper into the tissues, making it ideal for treating deeper corneal ulcerations. The super pulse mode can stimulate cellular metabolism, reduce inflammation, and trigger a cascade of cellular repair mechanisms. By delivering energy in brief yet intense bursts, super pulsed lasers can maximize the therapeutic effects while minimizing the risk of tissue damage.
[0057] Static magnetic fields have been studied for their potential to influence cellular behavior and modulate various physiological processes. Without wishing to be bound by theory, it is believed that magnetic fields can affect ion movement, membrane potential, and cellular signaling. Additionally, static magnetic fields have shown the ability to enhance blood flow, which can be particularly beneficial in improving nutrient and oxygen delivery to ulcerated corneal tissues.
[0058] Super pulsed lasers and LED therapy, established for tissue regeneration and inflammation control, bring distinct advantages. Concurrently, static magnetic fields, known for their influence on cellular dynamics and vascular circulation, introduce an intriguing dimension to this therapeutic approach. This combined application of PBMT with super pulsed lasers and LEDs and static magnetic fields can expedite ulcer closure, regulate inflammation, and enhance nutrient delivery to the affected area. By synergizing these modalities, a conducive environment for tissue repair is envisioned, offering potential for more comprehensive and accelerated healing outcomes.
[0059] Referring now to FIG. 6, illustrated is an example controller 208. The controller 208 can be in wired and / or wireless communication with the light delivery device 202. In some instances, the controller 208 can be in a same device as the light delivery device 202 (e.g., in a same housing of treatment device 100 - in the handle, for example). In other instances, the controller 208 can be at least partially in a separate device (at least a portion can be within a same treatment device 100 as the light delivery device 202 (e g., memory 210 and power source214 can be in a separate device and processor 212 can be in the same device, or the like). In still other instances, the controller 208 can be entirely separate (in different devices) than the light delivery device 202. In any case, the controller can have a power source 214 (that can be at least partially internal), a memory 210 (e.g., non-transitory), and at least one processor 212. As noted, the at least one processor 212 can access the memory 210 and execute instructions stored thereon to at least deliver power and / or parameter configurations to the light delivery device to treat the condition (e.g., comeal ulcer). For instance, the controller 208 can deliver the PBMT based on one or more prescriptions 502 stored in memory 210. The one or more prescriptions 502 can in some instances be configured for the specific patient (e.g., condition, depth of condition in the eye, biology, etc.). The processor 212 can execute instructions 504 to set up at least one therapy dose of the PBMT based on the prescription. The at least one therapy dose can be set for the condition of the patient’s eye based on the condition, a depth of the condition, and / or the patient’s biology. Setting the dose can include determining which light sources (e.g. the at least one light source 204, the at least one light source 206, and / or the at least one additional light source 218) and / or magnets (e.g., magnet 216) should be used for a given therapy dose and the parameters for each light source and / or magnet. Parameters can include, but are not limited to, power, energy, intensity, application time, exposure time, operational mode, or the like.V. Methods
[0060] Another aspect of the present disclosure can include a method 700, as shown in FIG. 7, for delivering photobiomodulation therapy (PBMT) (also referred to as a photoceutical therapy, low level light therapy, and the like) laterally to an eye to treat a condition of an anterior segment of the eye. It should be understood that PBMT can be used as a standalone treatment and / or as a complementary therapy in conjunction with one or more other medical interventions (e.g., surgical intervention and / or topical medication application). For ocular PBMT, safety considerations are paramount to avoid thermal damage, preserve ocular tissue, and preserve sight. Patient comfort is also an important consideration as the eye is an extremely sensitive organ. The method 700 can reduce the risk of harm to the eye’s delicate tissues (e.g., the retina and / or other optical structures in the posterior segment of the eye). For example, conditions of the anterior segment that can be treated can include corneal dystrophies (including ulcers), glaucoma, uncorrected refractive error, dry eye disease, cataracts, anterior uveitis, trachoma, orthe like. Using lateral delivery instead of traditional direct delivery, the PBMT applied with the method 700 can be safely and effectively applied to treat conditions of the anterior segment of the eye (e.g., mitigating inflammation while supporting tissue repair and alleviating discomfort and / or pain) without directly stimulating the retina and other elements of the posterior segment.
[0061] The method 700 is illustrated as process flow diagrams with flowchart illustrations. For purposes of simplicity, the method 700 is shown and described as being executed serially; however, it is to be understood and appreciated that the present disclosure is not limited by the illustrated order as some steps could occur in different orders and / or concurrently with other steps shown and described herein. Moreover, not all illustrated aspects may be required to implement the method 700. The method 700 can be executed by hardware - for example, at least a portion of the therapy delivery device 100 shown in FIGS. 1 and 3 and described above Additionally, one or more elements that implement the method 700, such as the controller 208 of FIG. 3, may include a non-transitory memory and one or more processors that can facilitate the configuration and generation of the light of the PBMT and / or provide power to the light delivery device 202 of FIG. 3.
[0062] PBMT may include application of one or more light signals from one or more light sources and one or more other light signals from one or more other light sources (where the light sources and the other light sources emit light having different wavelengths and / or intensities). The light sources can be LEDs, laser diodes, and / or eye-safe lasers. The combination of light sources can provide one or more light signals with different properties to create a synergistic therapeutic effect. For example, at 702 a therapy comprising at least one light signal at one wavelength and at least one other light signal at another wavelength can be emitted (e.g., from light sources 204 and 206 of a therapy device 100). However, the properties of the one or more light signals that are different are not limited to wavelengths, but could be treatment frequencies, powers, power densities, energies, energy densities, application times, exposure times, and / or other one or more properties. In some instances, the therapy can also include the emission of one or more additional light signals from one or more additional light sources that can have at least a different wavelength than the light signals from the light sources and the other light sources.
[0063] In some instances, the one or more light sources and / or the one or more other light sources (and optionally the one or more additional light sources) can be one or more eye-safe lasers and / or the light can be heat-free. For example, wavelengths and other properties of the oneor more light signals can be optimized for ocular tissue penetration and therapeutic impact. Specific one or more wavelengths and other properties can be chosen based on their ability to address one or more conditions of at least a portion of the anterior segment effectively.Therapeutic doses for laser therapy typically range from 0.001 to 10,000 joules (J), with energy comprising single or multiple wavelengths between 400 and 1100 nanometers (nm). Various light sources, including lasers and LEDs, can be used in continuous, pulsed, and / or super-pulsed modes. The effectiveness of laser therapy depends on the chosen type of light source, wavelength, and dose (e.g., number of applications, application times, exposure times, powers, power densities, etc.), as well as the condition to be treated. Dose requirements fluctuate based on factors like wavelength composition, pulsing, light source selection, and total energy delivered. In some instances, the PBMT may also include application of a magnetic signal (or magnetic field) in combination with the light signal. The dose of the therapy (e.g., at least a power, an energy, an exposure time, or the like, for the at least one light signal and the at least the other light signal) can be determined before delivery in some instances.
[0064] At 704, the therapy can be delivered laterally across and through at least a portion of the patient’s eye to treat a condition of the patient’s eye and avoid at least a retina of the patient’s eye. The treatment can be applied from a lateral side of the patient(e.g., left side of a left eye, right side of a right eye) in the medial direction. The lateral delivery of the treatment can be across at least a portion of the anterior segment of the eye and through at least a portion of the anterior segment of the eye. The therapy device can be tilted left, right, up, down, on a diagonal, or the like to improve focus of the PBMT on the condition (e.g., the ulcer) in the anterior segment of the eye. Lateral delivery of PBMT prevents the light from being delivered directly to the retina and / or other portions of the posterior segment of the eye that are more easily damaged at the dose profiles required to treat ocular conditions. Accordingly, this therapy enables precise targeting of specific areas of the anterior segment, while sparing healthy parts of the retina and other parts of the posterior segment from unnecessary exposure (reducing the risk of vision- related complications). This therapy is not only non-invasive (e.g., to reduce complications, patient discomfort, anxiety, and the like), but also offers precise, patient-friendly treatment of one or more conditions of the anterior segment while enhancing safety and compliance.Advantageously, the lateral delivery distributes the light energy more evenly across the eye’s surface (than traditional delivery directly into the eye), leading to concentrated light exposurewhile reducing / minimizing the risk of damage to the retina and other portions of the posterior segment.VI. Experimental
[0065] The following experiment evaluates the effectiveness and safety of Super Pulsed Laser Therapy (SPLT) in promoting the healing of corneal ulcers in canine patients. The study was designed to assess both therapeutic outcomes and the safety profile of SPLT on ocular structures, including the retina, through daily non-invasive thermography and optical coherence tomography (OCT) monitoring. It was thought that SPLT, administered at 50 Hz for 1 minute (33 J) with daily thermography monitoring, should effectively promote corneal ulcer healing without adverse effects to the retina or other ocular structures.
[0066] A prospective observational design was employed, incorporating a comprehensive checklist to standardize procedures and ensure consistent data collection. The study included three canine patients, each meeting specific inclusion criteria, such as a confirmed unilateral corneal ulcer diagnosis via OCT scan, veterinarian approval, and absence of contraindicating conditions. Exclusion criteria were applied to eliminate cases with bilateral ulcers, hypersensitivity to light-based treatments, or prior interventions that could interfere with study outcomes.
[0067] Pre-treatment data included demographic information (age, breed, sex, weight, and medical history) and a detailed ophthalmic examination, confirmed via OCT and ultrasound bio microscopy (UBM) to evaluate the cornea and retina. SPLT was applied tangentially to the eye surface for 1 minute at 50 Hz, ensuring coverage across the corneal surface while minimizing direct penetration into deep ocular structures.
[0068] Outcome measures included ulcer size, corneal appearance (opacity, scarring, and neovascularization), and discomfort levels (monitored via blepharospasm and pain-related behaviors). Daily thermographic scans provided real-time monitoring of ocular temperature changes, allowing for continuous assessment of the treatment’s efficacy and safety.
[0069] Results indicated that SPLT facilitated corneal re-epithelialization in 66.7% of cases, with significant symptom relief in two patients who achieved healing. These patients experienced substantial discomfort reduction, achieving response rates of 75% and 80%, respectively. However, one patient with a larger, more complex ulcer exhibited limitedimprovement, achieving only a 20% reduction in discomfort and incomplete re-epithelialization, suggesting that SPLT alone may be less effective for chronic or severe ulcers.
[0070] Post-treatment follow-up with OCT scans confirmed healing in successfully treated cases, with no adverse effects detected on the retina or other ocular structures. This study suggests that SPLT can be an effective treatment for canine corneal ulcers, particularly for small to moderate lesions, while larger or chronic ulcers may require adjunctive therapies for optimal outcomes.
[0071] From the above description, those skilled in the art will perceive improvements, changes and modifications. Such improvements, changes and modifications are within the skill of one in the art and are intended to be covered by the appended claims. All patents, patent applications, and publications cited herein are incorporated by reference in their entirety.
Claims
The following is claimed:
1. A system comprising: a light delivery device comprising: one or more light sources, each configured to emit a light signal at a wavelength; one or more other light sources, each configured to emit another light signal at another wavelength, wherein the one or more light sources and the one or more other light sources are configured in the light delivery device to deliver the light signal and the other light signal laterally across and through at least a portion of a patient’s eye to avoid at least a retina in the patient’s eye while treating the condition of the patient’s eye; and a controller comprising a power source, a non-transitory memory storing instructions, and a processor for executing the instructions to at least deliver power to the light delivery device.
2. The system of claim 1, wherein the controller is further configured to control delivery of the signal by the light delivery device according to a prescription.
3. The system of claim 1, wherein at least the light delivery device is handheld and embodied in a single housing.
4. The system of claim 1, wherein the one or more light sources and / or the other one or more light sources are eye-safe lasers or light emitting diodes that emit in eye-safe spectral regions and do not generate heat.
5. The system of claim 1, wherein the light delivery device further comprises one or more additional light sources, each configured to emit one or more additional light signals each at one or more additional wavelengths, wherein each of the one or more additional wavelengths are different from each other and the wavelength and the other wavelength.
6. The system of claim 4, wherein the one or more light sources emit a red light signal in a pulsed operational mode or a continuous operational mode, the one or more other light sourcesemit an infrared light signal in the pulsed operational mode or the continuous operational mode, and the one or more additional light sources emit a super pulsed red light signal and / or a super pulsed infrared light signal in a super pulsed operational mode.
7. The system of claim 1, wherein the light delivery device further comprises one or more magnetic field sources configured to produce a magnetic field, wherein the magnetic field is applied to treat the condition of the patient’s eye in combination with the light signal and the other light signal.
8. The system of claim 1, wherein the light delivery device comprises one or more groups of light sources comprising at least one of the one or more light sources and at least one of the other one or more light sources.
9. The system of claim 1, wherein the light delivery device comprises a light-emitting surface, wherein the light-emitting surface is divided into a plurality of zones that each provide different light signals, wherein each of the plurality of zones comprises at least one of the one or more light sources or the one or more other light sources.
10. The system of claim 9, wherein the plurality of zones emit a non-uniform distribution of light toward the patient’s eye with areas of varying light intensity.
11. The system of claim 1, wherein the processor of the controller is further configured to at least set a therapy dose for the condition of the patient’s eye based on the condition of the patient’s eye, a depth of the condition in the patient’s eye, and / or the patient’s biology.
12. The system of claim 11, wherein the therapy dose comprises parameters, wherein the parameters comprise power, energy, and / or exposure time.
13. A method comprising: emitting a therapy comprising at least one light signal at a wavelength and at least one other light signal at another wavelength, wherein:the at least one light signal is emitted by one or more light sources configured to emit the at least one light signal at the wavelength, and the at least one other light signal is emitted by one or more other light sources configured to emit the at least one other light signal at the other wavelength; and delivering the therapy laterally across and through at least a portion of a patient’s eye to treat a condition of the patient’s eye and avoid at least a retina in the patient’s eye while treating the condition of the patient’s eye.
14. The method of claim 13, further comprising treating a cornea of the patient’s eye, structures adjacent to the cornea of the patient’s eye, and / or nerve endings in the cornea of the patient’s eye.
15. The method of claim 13, wherein the condition of the patient’s eye is a condition of the anterior segment of the patient’s eye.
16. The method of claim 15, wherein the condition of the anterior segment is an ocular surface disease of a portion of the anterior segment.
17. The method of claim 15, wherein the condition of the patient’s eye is a corneal ulcer.
18. The method of claim 15, wherein the condition of the patient’s eye is a condition of at least a portion of a lacrimal apparatus of the patient’s eye.
19. The method of claim 15, further comprising determining a dose of the therapy for the patient, wherein the dose of the therapy comprises at least a power, an energy, and / or an exposure time for the at least one light signal and the at least the other light signal.
20. The method of claim 19, wherein the dose of the therapy is determined by a controller, the controller comprising at least a processor setting the power, the energy, and / or the exposure time for the at least one light signal and the at least the other light signal based on the condition of the patient’s eye, a depth of the condition in the patient’s eye, and / or the patient’s biology.
Citation Information
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