Myopia reversal treatment method and device based on synergistic effect of composite optical adjustment and biological stimulation

Abstract

The invention relates to the technical field of myopia treatment, in particular to a myopia reversal treatment method and device based on the synergistic effect of composite optical adjustment and biological stimulation. The device comprises an adjustable optical training module, a micro-current stimulation module and an intelligent control system which are cooperatively operated, and the adjustable optical training module is designed by dynamic defocusing of an area corresponding to double lenses so as to synchronously drive and adjust a corresponding diopter difference range. The ciliary muscle is guided to carry out focusing-relaxing alternate training; the micro-current stimulation module can output adjustable pulse current and is synchronously integrated with the PID temperature control system to maintain the hot compress temperature; the intelligent control system analyzes the length of the ocular axis and the curvature of the cornea in real time and adjusts the lag amount, parameters corresponding to the adjustable optical training module and the micro-current stimulation module are dynamically optimized, and therefore precise regulation and control of a personalized myopia reversal treatment scheme are achieved. According to the invention, effective reversion, prevention and control of myopia can be realized.

Description

Technical Field

[0001] The present invention relates to the technical field of myopia treatment, and in particular to a myopia reversal treatment method and device based on the synergistic effect of composite optical adjustment and biological stimulation. Background Art

[0002] Myopia is a common refractive error worldwide, with a particularly high incidence among adolescents. With the prevalence of prolonged close-up eye use in modern society, the incidence and progression of myopia are increasing year by year. Myopia not only affects vision, but severe myopia can also lead to ocular complications such as retinal detachment, cataracts, and glaucoma, posing long-term health risks to patients. Therefore, the prevention and treatment of myopia have long been a focus of ophthalmic research. In recent years, synergistic treatments based on optical accommodation and biostimulation have gradually attracted academic attention. Combined optical accommodation modulates the focal length of the eye's optics to alter axial length growth, thereby effectively controlling the progression of myopia. Optical treatments such as bifocal lenses and orthokeratology (Ortho-K) have been used clinically and can, to a certain extent, slow the progression of myopia. However, these optical accommodation methods cannot completely reverse established myopia. On the other hand, biostimulation technologies (such as low-intensity laser and bioelectrical stimulation) have also shown some effectiveness in clinical treatment. However, current biostimulation technologies are primarily used as adjunctive therapies, and their effectiveness as standalone treatments remains limited. Summary of the Invention

[0003] Based on this, it is necessary for the present invention to provide a method and device for reversing myopia based on the synergistic effect of composite optical adjustment and biological stimulation to solve at least one of the above technical problems.

[0004] To achieve the above-mentioned purpose, a myopia reversal treatment device based on the synergistic effect of composite optical adjustment and biological stimulation is proposed, which comprises an adjustable optical training module, a microcurrent stimulation module and an intelligent control system, wherein:

[0005] The adjustable optical training module is designed with dynamic defocusing of the corresponding areas of the dual lenses, including a central correction area and a peripheral defocus area. The central correction area uses a spherical lens, and the peripheral defocus area uses an aspherical annular zone design to synchronously drive and adjust the diopter difference between the central correction area and the peripheral defocus area within a range of +1.50D to -4.00D. At the same time, a stepper motor drives the dual lenses to move back and forth within a range of 28-35cm at a frequency of 0.5-3Hz with a movement accuracy of ±0.1mm, and guides the ciliary muscle to perform alternating focus-relaxation training to simulate the dynamic adjustment load of 5-20D during natural vision, so as to reduce the corresponding elastic modulus of the ciliary muscle by ≥25%;

[0006] The microcurrent stimulation module includes a 16-point flexible electrode array, each with a diameter of 3mm and a spacing of 5mm. It precisely covers eight pairs of orbital acupoints, namely Qingming, Zanzhu, Yuyao, Sizhukong, Taiyang, Chengqi, Sibai and Qiuhou. It can output a pulse current of 0.5-2mA with an adjustable frequency of 1-100Hz, and a synchronous integrated PID temperature control system to maintain a hot compress temperature of 38-42°C.

[0007] The intelligent control system has a built-in OCT axial length monitoring unit and a machine learning processor to analyze the axial length, corneal curvature and adjustment lag in real time, and dynamically optimize the frequency, distance and refractive power difference corresponding to the dual lenses in the adjustable optical training module and the pulse current and hot compress temperature corresponding to the microcurrent stimulation module, thereby achieving precise control of personalized myopia reversal treatment plans.

[0008] Furthermore, the adjustable optical training module further includes:

[0009] The dual-zone linkage mechanism is used to achieve synchronous translation of the diopter difference between the central correction zone and the peripheral defocus zone corresponding lenses through magnetic coupling, where the diopter difference is specifically Where K represents the adjustment coefficient, specifically 0.8-1.2, L represents the real-time distance the lens moves, and L0 represents the initial distance of the lens;

[0010] Dynamic blur control automatically increases the diopter difference to ΔD+0.75D when it detects a lens adjustment lag greater than 0.5D between the central correction area and the peripheral defocus area.

[0011] Anti-dizziness design, the double lenses are coated with a 420-450nm blue light cut-off film layer and an anti-fog coating with a contact angle of >110° to reduce visual fatigue during high-frequency movement.

[0012] Furthermore, the stepper motor drive includes a flexible coupling, wherein the torsional stiffness is 20N·mm / rad and the grating scale has closed-loop feedback, wherein the resolution is 0.5μm. When the lens movement speed deviation is greater than 5% or the position error is greater than 0.2mm, the PID controller is triggered for automatic correction, wherein the PID controller corresponds to a proportional coefficient of 1.2, an integral time of 0.3s, an integral coefficient of 0.5, and a differential coefficient of 0.05 to ensure that the diopter switching delay during the dynamic adjustment process corresponding to the reciprocating movement is ≤30ms.

[0013] Furthermore, the implementation of the microcurrent stimulation module further includes:

[0014] Acupoint positioning: real-time calibration of the position of each flexible electrode through infrared imaging to ensure the adaptive fit of the 16-point flexible electrode array;

[0015] Temperature-current coupling: When the hot compress temperature adjusted by the PID temperature control system reaches 40°C, the current intensity corresponding to the pulse current is automatically reduced by 20% to avoid burns;

[0016] Biostimulation feedback unit: used to monitor eyelid electromyographic signals and suspend stimulation when the eyelid electromyographic signals corresponding to muscle spasm are greater than 200μV.

[0017] Furthermore, the PID temperature control system has an adjustment fluctuation range of ±0.5°C.

[0018] Furthermore, the present invention also provides a method for treating myopia reversal based on the synergistic effect of composite optical adjustment and biostimulation. The method is implemented based on the above-mentioned device for treating myopia reversal based on the synergistic effect of composite optical adjustment and biostimulation. The method for treating myopia reversal based on the synergistic effect of composite optical adjustment and biostimulation comprises the following steps:

[0019] Initial parameter generation: The patient's axial length AL0 is collected through OCT, and the initial refractive power D0 is obtained through computer optometry. The corresponding initial refractive power difference is calculated based on the formula: initial refractive power difference = -0.5 × (AL0 - 23.5) + 0.3 × D0 × age coefficient. The age coefficient is 1.2 for 5-10 years old and 1.0 for 11-18 years old. Based on the human ciliary muscle during natural vision and the corresponding eye microcurrent safety threshold, the initial value of the lens movement frequency is determined to be 1.5Hz and the initial value of the current intensity is 1.0mA;

[0020] Photomodulation-biostimulation synergistic intervention:

[0021] 1) Optical accommodation phase: The lenses were moved back and forth within a range of 28-35 cm at an initial lens movement frequency of 1.5 Hz. The patient focused on the central correction area visual target. The spatial frequency of the visual target was switched every 5 minutes, specifically from 1° / deg to 3° / deg to 2° / deg. The ciliary muscle was guided to produce an accommodation amplitude change of 2-6 degrees. A single training session triggered ≥1800 focus-relaxation alternating accommodation movements.

[0022] 2) Biostimulation Stage: A pulsed current with an initial current intensity of 1.0 mA was applied simultaneously with a hot compress temperature of 38-42°C. This pulsed current stimulation used three independent channels with a 120° phase difference between the currents in each channel, creating a rotating electric field effect and enhancing the stimulation depth corresponding to eight pairs of orbital acupoints with a penetration depth of ≥3mm.

[0023] Closed-loop feedback control: Axial length ΔAL, adjustment hysteresis AMP, and choroidal thickness CT are collected every 10 minutes. If ΔAL is greater than 0.02mm / 2 weeks or AMP is greater than 1.50D, the refractive error is automatically increased by 0.25D and the lens movement frequency is reduced by 0.1Hz. If CT increases by ≥15μm, the current intensity is reduced by 0.1mA and the hot compress temperature is increased by 0.5℃.

[0024] Efficacy evaluation and treatment management: Scleral thickness (ST) and retinal choroidal complex thickness (RCT) were measured by OCT every 2 weeks. If the ST growth rate was ≤-0.5 μm / month and the RCT growth rate was ≥2 μm / month, it was considered an effective response and the current reversal treatment course was maintained. Otherwise, cross-modal feature fusion analysis was initiated to incorporate tear osmolarity and intraocular pressure parameters to complete the reversal treatment course iteration within 72 hours.

[0025] Furthermore, the visual target adopts a moving checkerboard pattern, wherein the spatial frequency is 1-3c / deg, the contrast modulation frequency is 0.5-3Hz, and the frequency is the same as the lens movement frequency and the phase is opposite, thereby enhancing the adjustment load of the ciliary muscle, and the adjustment amplitude is improved by ≥1.50D after training.

[0026] Furthermore, the pulse current waveform corresponding to the ciliary muscle regulation adopts adaptive modulation technology, and the electrical activity of the extraocular muscles is monitored in real time based on the electrooculogram signal. When the discharge frequency of the medial rectus muscle is detected to be greater than 50Hz, the current frequency is automatically increased to 5Hz and the current intensity is increased by 0.3mA to form a control loop corresponding to the nerve-muscle-sclera. Electromyography recording has verified that the contraction force of the extraocular muscles can be increased by ≥18%.

[0027] Furthermore, the three channels are independently controlled to correspond to the innervation areas of the supraorbital nerve, trochlear nerve, and lacrimal nerve, respectively; the current waveform is a sine wave superimposed on a Gaussian envelope with an envelope width of 50-100ms; the stimulation phase is synchronized with the optical training cycle and the delay is ≤50ms.

[0028] Furthermore, the current corresponding reversal treatment course is divided into three stages:

[0029] 1) Intensive phase, from week 1 to week 4: 25 minutes twice a day, gradually increasing the refractive error from +1.50 D to the target refractive error at a rate of 0.1 D per week;

[0030] 2) Consolidation period, from week 5 to week 12: once a day for 30 minutes, and maintain the target refractive error;

[0031] 3) Maintenance phase, starting from the 13th week: once every other day for 20 minutes, gradually reducing the intensity of stimulation. The transition conditions for each stage are based on the dynamic determination of the axial growth rate. The intensive phase requires ≤0.01mm / week, and the consolidation phase requires ≤0.005mm / week.

[0032] Beneficial effects of the present invention:

[0033] 1. The myopia reversal treatment device proposed by the present invention, which is based on the synergistic effect of composite optical adjustment and biological stimulation, is composed of an adjustable optical training module, a microcurrent stimulation module and an intelligent control system. Compared with the prior art, the beneficial effect of the present application lies in the dynamic defocus design of the dual lens areas through the adjustable optical training module, in which the central correction area adopts a spherical lens, which can accurately correct vision and ensure basic visual clarity; the aspheric ring design of the peripheral defocus area can effectively control the growth of the eye axis and reduce the factors of myopia development from the peripheral visual area. The refractive power difference is flexibly adjusted between +1.50D and -4.00D, and is adaptable to different To meet the needs of patients with the same degree of myopia, the stepper motor drives the dual lenses to move back and forth within the range of 28-35cm at a frequency of 0.5-3Hz and a high precision of ±0.1mm, simulating the dynamic adjustment load of 5-20D during natural vision, prompting the ciliary muscle to perform alternating focus-relaxation training. This high-frequency, high-precision training mode can effectively exercise the contraction and relaxation ability of the ciliary muscle. Long-term use can reduce the corresponding elastic modulus of the ciliary muscle by ≥25%, significantly improving the elasticity and adjustment ability of the ciliary muscle, improving the eye's adjustment function, delaying the progression of myopia, and even helping some patients achieve a certain degree of vision recovery, providing a new and effective way for the prevention, control and treatment of myopia. Then, the microcurrent stimulation module demonstrates excellent precision treatment characteristics with its 16-point flexible electrode array. The fine layout of each flexible electrode with a diameter of 3mm and a spacing of 5mm can accurately cover 8 pairs of key orbital acupoints such as Qingming and Zanzhu. These acupoints are closely connected with the eye meridians and are crucial for regulating eye qi and blood and improving visual function. It can output a pulse current of 0.5-2mA and an adjustable frequency of 1-100Hz. It can flexibly adjust the stimulation intensity and frequency according to individual differences of patients and treatment stages to achieve personalized treatment. The synchronously integrated PID temperature control system maintains a hot compress temperature of 38-42℃. Warm stimulation can effectively promote blood circulation in the eyes, relieve eye fatigue, and enhance eye tissue metabolism. At the same time, combined with microcurrent stimulation, it has a synergistic effect. By stimulating acupoints and the warm effect, the module can dredge the eye meridians, regulate nerve function, promote the nutrient supply of intraocular tissues, and improve the function of eye muscles and retina, thereby playing a significant role in relieving visual fatigue, controlling the deepening of myopia, and improving eye discomfort symptoms, which can gradually reverse the already formed myopia.Finally, the intelligent control system, as the "brain" of the entire myopia treatment plan, has core value. The built-in OCT axial length monitoring unit and machine learning processor, like a sophisticated monitoring and decision-making center, can accurately analyze key eye parameters such as axial length, corneal curvature and accommodation lag in real time. These parameters are important indicators for evaluating the development of myopia and the effectiveness of treatment. Through dynamic monitoring and analysis of them, the system can promptly understand changes in the patient's eye condition. Based on this, the intelligent control system can dynamically optimize the frequency, distance and refractive power difference of the dual lenses in the adjustable optical training module, as well as the pulse current and hot compress temperature corresponding to the microcurrent stimulation module, to achieve precise control of the treatment plan. According to the individual differences and disease progression of different patients, personalized myopia reversal treatment plans are formulated to avoid "one-size-fits-all" treatment methods and improve the targetedness and effectiveness of treatment. This intelligent and personalized treatment model can not only improve the effect of myopia treatment, but also reduce ineffective treatment and overtreatment, providing patients with a more scientific, efficient and safe myopia treatment experience.

[0034] 2. The myopia reversal treatment method proposed by the present invention based on the synergistic effect of composite optical adjustment and biological stimulation has the following beneficial effects compared with the existing technology:

[0035] (1) The axial length of the eye is collected by OCT, and the initial refractive power is obtained by computer optometry. The initial refractive power difference is accurately calculated in combination with the age coefficient. Taking into account the differences in eye development and accommodation ability between people aged 5-10 and 11-18, the treatment parameters are more in line with the actual needs of patients of different age groups. According to the microcurrent safety threshold of the human ciliary muscle during natural vision, the initial value of the lens movement frequency is determined to be 1.5Hz and the initial value of the current intensity is 1.0mA. This not only ensures the safety of the treatment, but also lays a scientific foundation for subsequent treatment. This method of generating initial parameters based on precise measurement and scientific calculation avoids the blindness of the treatment parameter setting, provides a reliable starting point for the implementation of subsequent personalized myopia treatment plans, helps to improve the targetedness and effectiveness of the treatment, and improves the myopia treatment effect from the source.

[0036] (2) The optical accommodation-biostimulation synergistic intervention model has significant advantages. In the optical accommodation stage, the dual lenses move back and forth within the range of 28-35 cm at a frequency of 1.5 Hz, and the cyclic switching of the visual target spatial frequency guides the ciliary muscle to produce an accommodation amplitude change of 2-6 D. A single training session triggers more than 1800 focus-relaxation alternating accommodation movements. High-intensity and diversified training can fully exercise the ciliary muscle and enhance its accommodation ability and elasticity. In the biostimulation stage, 1.0 mA pulse current and 38-42 ° C hot compress temperature are applied simultaneously. The rotating electric field effect formed by the independent control of three channels and the current phase difference of 120 ° increases the stimulation depth to ≥3 mm, deeply stimulates 8 pairs of orbital acupoints, promotes blood circulation in the eyes, regulates nerve function, and the synergistic effect of optical and biostimulation improves the physiological function of the eye in multiple dimensions, effectively relieves visual fatigue, controls the progression of myopia, and improves the comprehensive effect of myopia treatment.

[0037] (3) The closed-loop feedback control mechanism can provide dynamic optimization guarantee for myopia treatment. It collects key data such as axial length, adjustment lag, choroidal thickness, etc. every 10 minutes, and adjusts treatment parameters in time according to data changes. When the axial length increases by more than 0.02mm / 2 weeks or the refractive power increases by more than 1.50D, the refractive power difference is automatically increased and the lens movement frequency is reduced to strengthen the control of myopia development; when the choroidal thickness increases by ≥15μm, the current intensity is reduced and the hot compress temperature is increased to avoid excessive stimulation, making the treatment safer and more reasonable. This dynamic adjustment based on real-time data can adapt to changes in the patient's eye condition in time, avoid ineffective treatment or excessive treatment, ensure that the treatment plan is always in the optimal state, continuously improve the effectiveness and safety of myopia treatment, and ensure that patients obtain better treatment results.

[0038] (4) The efficacy evaluation and treatment course management system can achieve precise control of treatment. The scleral thickness and retinal choroidal complex thickness are measured by OCT every 2 weeks, and a clear growth rate standard is used to determine whether the treatment is effectively responded. If the standard is met, the current course of treatment is maintained to ensure the continuity of treatment; if not, cross-modal feature fusion analysis is initiated, tear osmolarity and intraocular pressure parameters are incorporated, and the course of treatment iteration is completed within 72 hours. This comprehensive and flexible evaluation and management method avoids the limitations of single indicator evaluation, can more accurately judge the treatment effect, and timely discover potential problems. By introducing more eye health indicators for comprehensive analysis, the treatment plan can be quickly optimized and adjusted to ensure that patients receive personalized treatment that best suits their conditions, improve the success rate of myopia reversal treatment, and help patients better restore their vision health. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Other features, objects and advantages of the present invention will become more apparent upon reading the detailed description of non-limiting embodiments thereof made with reference to the following drawings:

[0040] Figure 1 This is a module schematic diagram of the myopia reversal treatment device based on the synergistic effect of composite optical adjustment and biological stimulation of the present invention. DETAILED DESCRIPTION

[0041] The following is a clear and complete description of the technical device of the present invention in conjunction with the accompanying drawings. It is obvious that the embodiments described are part of the embodiments of the present invention, but not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making any creative efforts are within the scope of protection of the present invention.

[0042] In addition, the accompanying drawings are merely schematic illustrations of the present invention and are not necessarily drawn to scale. Identical reference numerals in the figures denote identical or similar parts, and thus repetitive descriptions thereof will be omitted. Some of the block diagrams shown in the accompanying drawings are functional entities that do not necessarily correspond to physically or logically separate entities. These functional entities may be implemented in software, in one or more hardware modules or integrated circuits, or in different networks and / or processor devices and / or microcontroller devices.

[0043] It should be understood that although the terms "first," "second," and the like may be used herein to describe various elements, these elements should not be limited by these terms. These terms are used solely to distinguish one element from another. For example, a first element may be referred to as a second element, and similarly, a second element may be referred to as a first element, without departing from the scope of the exemplary embodiments. The term "and / or" as used herein includes any and all combinations of one or more of the listed associated items.

[0044] To achieve this, please refer to Figure 1 The present invention provides a myopia reversal treatment device based on the synergistic effect of composite optical adjustment and biological stimulation, the device comprises an adjustable optical training module, a microcurrent stimulation module and an intelligent control system, wherein,

[0045] The adjustable optical training module is designed by dynamically defocusing the corresponding regions of the double lenses, including a central correction region and a peripheral defocusing region, wherein the central correction region adopts a spherical lens, and the peripheral defocusing region adopts an aspherical ring design to synchronously drive and adjust the refractive power difference between the central correction region and the peripheral defocusing region in the range of +1.50D to -4.00D, while the double lenses are driven by a stepping motor to reciprocally move in the range of 28-35 cm at a frequency of 0.5-3 Hz and a moving accuracy of ±0.1 mm, and the ciliary muscles are guided to perform focus-relaxation alternating training, so as to simulate the dynamic adjustment load of 5-20D in natural viewing, so that the corresponding elastic modulus of the ciliary muscles is reduced by ≥25%.

[0046] In the embodiment of the present application, the adjustable optical training module is designed by dynamically defocusing the corresponding regions of the double lenses in the myopia reversal treatment device, and a 14-year-old myopia patient is taken as an example, wherein the central correction region is equipped with a spherical lens, and the peripheral defocusing region adopts an aspherical ring design, and through a precise gear transmission system and a stepping motor, the refractive power difference between the central correction region and the peripheral defocusing region can be synchronously driven and adjusted, the initial refractive power difference is -0.5×(AL0-23.5)+0.3×D0×age coefficient, and with the progress of treatment, it is gradually adjusted, and the refractive power difference is in the range of +1.50D to -4.00D, the driving accuracy of the stepping motor is ±0.1 mm, the double lenses are driven to reciprocally move linearly in the range of 28-35 cm at a frequency of 1.5 Hz, in a 30-minute training, the moving distance of the lenses is monitored in real time by a laser range finder to ensure the moving accuracy, through this reciprocating movement, the ciliary muscles are guided to perform focus-relaxation alternating training, to simulate the dynamic adjustment load of 5-20D in natural viewing, before the training, the elastic modulus of the ciliary muscles is detected by ultrasonic elastography to be 40 kPa, after 8 weeks of continuous training, 5 days a week, 2 times a day, the elastic modulus of the ciliary muscles is detected again to be 28 kPa, the elastic modulus is reduced by 40-28 / 40×100%=30%≥25%, and the elasticity of the ciliary muscles is effectively improved, which lays a physiological foundation for myopia reversal.

[0047] Preferably, the micro-current stimulation module comprises a 16-point flexible electrode array, wherein each flexible electrode has a diameter of 3 mm and a spacing of 5 mm, so as to accurately cover 8 pairs of orbital acupoints corresponding to qingming, zuanzhu, yuyao, zhitu kong, taiyang, chengqi, sibai and houqian, can output a pulse current with a frequency of 1-100 Hz and a current of 0.5-2 mA, and is synchronously integrated with a PID temperature control system to maintain a hot compress temperature of 38-42℃.

[0048] In an embodiment of the present invention, the microcurrent stimulation module utilizes a 16-point flexible electrode array, each with a diameter of 3mm and a spacing of 5mm. The electrodes are precisely fixed to a medical silicone substrate using high-precision 3D printing technology. During treatment, an infrared positioning system precisely positions the electrode array to cover eight pairs of acupuncture points around the patient's eye sockets, including Qingming and Zanzhu. The electrodes are connected to a high-precision constant current source that can output a pulsed current of 0.5-2mA with an adjustable frequency of 1-100Hz. For this 14-year-old patient, the initial current intensity is set to 1.0mA and the frequency is 5Hz. Simultaneously, an integrated PID temperature control system monitors the hot compress temperature in real time using a micro-thermistor with a temperature control accuracy of ±0.5°C, maintaining the hot compress temperature between 38-42°C. During a 20-minute treatment, the current intensity and frequency are precisely controlled by a programmable logic controller (PLC), and the temperature data is transmitted to the control system in real time via a data acquisition card. After treatment, a skin temperature tester confirms that the temperature of the electrode-covered area is uniformly distributed between 38-42°C, ensuring the safety and effectiveness of the treatment.

[0049] Preferably, the intelligent control system has a built-in OCT axial length monitoring unit and a machine learning processor to analyze the axial length, corneal curvature and adjustment lag in real time, and dynamically optimize the frequency, distance and refractive power difference corresponding to the dual lenses in the adjustable optical training module and the pulse current and hot compress temperature corresponding to the microcurrent stimulation module, thereby achieving precise control of personalized myopia reversal treatment plans.

[0050] In an embodiment of the present invention, an OCT axial length monitoring unit and a machine learning processor are built into an intelligent control system to achieve precise control of personalized myopia reversal treatment plans. The axial resolution of the OCT axial length monitoring unit is 5μm, and the axial length can be measured in real time; the corneal curvature measurement accuracy is ±0.05D; the accommodation lag is measured by an infrared ophthalmometer with an accuracy of ±0.25D. During the treatment process, the machine learning processor collects axial length, corneal curvature and accommodation lag data every 10 minutes. Taking the 14-year-old patient as an example, in the second week of treatment, OCT monitoring showed that the axial length increased by 0.03mm and the accommodation lag increased by 0.03mm. The amount is 1.75D. The machine learning processor calculates the parameters that need to be adjusted based on the preset algorithm model (set as ΔP=k1ΔL+k2ΔA, where ΔP is the parameter adjustment amount, ΔL is the eye axis change amount, ΔA is the adjustment hysteresis amount, k1=10, k2=5). The system automatically reduces the dual-lens frequency of the adjustable optical training module to 1.3Hz and increases the refractive power difference to +1.75D; at the same time, the pulse current intensity of the microcurrent stimulation module is increased to 1.2mA, and the hot compress temperature is maintained at 39.5℃. Through this real-time dynamic optimization, it ensures that the treatment plan matches the patient's ocular physiological state and realizes personalized and precise regulation.

[0051] Furthermore, the adjustable optical training module further includes:

[0052] The dual-zone linkage mechanism is used to achieve synchronous translation of the diopter difference between the central correction zone and the peripheral defocus zone corresponding lenses through magnetic coupling, where the diopter difference is specifically Where K represents the adjustment coefficient, specifically 0.8-1.2, L represents the real-time distance the lens moves, and L0 represents the initial distance of the lens;

[0053] In an embodiment of the present invention, a dual-zone linkage mechanism is used to achieve synchronous translation of the refractive power difference between the central correction zone and the peripheral defocus zone corresponding lenses during the actual myopia reversal treatment process. Taking a myopic patient as an example, the refractive power of the central correction zone of the lens initially worn is -3.00D, the refractive power of the peripheral defocus zone is -2.00D, and the initial distance of the lens is 10mm. When the patient adjusts the eye, the lens will move accordingly according to the eye movement. Assuming that the adjustment coefficient K is 1.0 (within the range of 0.8-1.2), the real-time distance L of the lens movement is 2mm, according to the refractive power difference formula (where ΔD is the refractive power difference and L0 is the initial distance of the lens), it can be calculated that the refractive power difference at this time is ΔD = 0.16D. Through magnetic coupling technology, it is ensured that the lenses in the central correction area and the peripheral defocus area can be translated synchronously, so that the refractive power difference is always kept within the appropriate range to provide a stable myopia correction effect. For example, when the patient looks at distant objects, the lens will automatically adjust to make the refractive power of the central correction area more suitable for long-distance vision, and the refractive power of the peripheral defocus area will be adjusted accordingly to reduce the hyperopic defocus of the peripheral retina, thereby helping to control the development of myopia.

[0054] Preferably, the dynamic blur control automatically increases the diopter difference to ΔD+0.75D when it is detected that the lens adjustment lag between the central correction area and the peripheral defocus area is greater than 0.5D;

[0055] In an embodiment of the present invention, dynamic blur control plays a key role in the myopia reversal treatment process. When it is detected that the lens adjustment lag between the central correction area and the peripheral defocus area is greater than 0.5D, the refractive power difference needs to be automatically increased. Taking a patient undergoing treatment as an example, at a certain moment, through professional eye detection equipment, it is found that the lens adjustment lag between the central correction area and the peripheral defocus area is 0.6D, which exceeds the threshold of 0.5D. At this time, according to the preset rules, the refractive power difference is automatically increased to ΔD+0.75D (where ΔD is the current refractive power difference). Assuming that the current refractive power difference ΔD is 0.16D, the increased refractive power difference is 0.16D+0.75D=0.91D. By dynamically adjusting the refractive power difference in this way, the lag of lens adjustment can be compensated in time to ensure that patients can obtain clear vision under different visual needs, and it also helps to improve the effect of myopia reversal treatment.

[0056] Preferably, an anti-dizziness design is adopted, and the double lenses are coated with a 420-450nm blue light cut-off film layer and an anti-fog coating with a contact angle greater than 110° to reduce visual fatigue during high-frequency movement.

[0057] In an embodiment of the present invention, an anti-dizziness design is adopted to reduce visual fatigue caused by high-frequency movement when patients wear dual lenses. The dual lenses are coated with a 420-450nm blue light cut-off film layer and an anti-fog coating with a contact angle greater than 110°. Taking a specific dual-lens product as an example, its blue light cut-off film layer can effectively cut off blue light with a wavelength in the range of 420-450nm, reducing the irritation of blue light to the eyes. At the same time, the contact angle of the anti-fog coating is greater than 110°, which makes the lens surface hydrophobic and can effectively prevent the formation of fog and maintain a clear field of vision of the lens. When the patient is engaged in daily activities, such as exercising or turning the head quickly, the double lenses will move at high frequency with the movement of the head. Due to the effects of the blue light cut-off film layer and the anti-fog coating, patients can reduce visual fatigue caused by blue light stimulation and lens fogging, and improve wearing comfort and visual quality. For example, when exercising outdoors, even if the lens surface encounters water vapor, the anti-fog coating can make the water vapor slide off quickly, keeping the lens clear, allowing patients to clearly see the surrounding environment, while reducing the damage to the eyes caused by blue light, which helps the smooth progress of myopia reversal treatment.

[0058] Furthermore, the stepper motor drive includes a flexible coupling, wherein the torsional stiffness is 20N·mm / rad and the grating scale has closed-loop feedback, wherein the resolution is 0.5μm. When the lens movement speed deviation is greater than 5% or the position error is greater than 0.2mm, the PID controller is triggered for automatic correction, wherein the PID controller corresponds to a proportional coefficient of 1.2, an integral time of 0.3s, an integral coefficient of 0.5, and a differential coefficient of 0.05 to ensure that the diopter switching delay during the dynamic adjustment process corresponding to the reciprocating movement is ≤30ms.

[0059] In an embodiment of the present invention, in a myopia reversal treatment device based on the synergistic effect of composite optical adjustment and biostimulation, a stepper motor drive system is a key component for achieving precise movement of the lens. Taking a certain treatment device as an example, the stepper motor is connected to the lens transmission mechanism through a flexible coupling with a torsional stiffness of 20N·mm / rad. The coupling can effectively buffer the torque fluctuation during motor operation to ensure smooth movement of the lens. At the same time, the system is equipped with a grating ruler with a resolution of 0.5μm for closed-loop feedback to monitor the position information of the lens in real time. During the treatment process, when the lens movement speed is set to 10mm / s and the movement distance is 5mm, if the actual lens movement speed is detected to be 9.4mm / s, the speed deviation is (10-9.4) / 10×100%=6%>5%; or the actual movement position is 4.7mm, the position error is 5-4.7=0.3mm>0.2mm, then the system immediately triggers the PID controller for automatic correction. The proportional coefficient of the PID controller is 1.2, the integral time is 0.3s, the integral coefficient is 0.5, and the differential coefficient is 0.05. Through the formula (where u(t) is the controller output, K p is the proportionality coefficient, K i is the integral coefficient, K d is the differential coefficient, e(t) is the error) and the adjustment amount is calculated to adjust the driving parameters of the stepper motor. After actual testing, the refractive power switching delay is always controlled within 30ms during this dynamic adjustment process, ensuring the timeliness and accuracy of optical adjustment and providing stable optical conditions for myopia reversal treatment.

[0060] Furthermore, the implementation of the microcurrent stimulation module further includes:

[0061] Acupoint positioning: real-time calibration of the position of each flexible electrode through infrared imaging to ensure the adaptive fit of the 16-point flexible electrode array;

[0062] In the embodiment of the present invention, the accuracy of acupoint positioning is crucial during biostimulation treatment. The treatment device uses infrared imaging technology to calibrate the position of the 16-point flexible electrode array in real time. Taking the acupoint treatment around the eye as an example, after the patient wears the treatment device, the infrared imaging system scans the eye area at a speed of 20 frames per second, capturing the temperature distribution difference on the surface of the eye skin, thereby identifying the acupoint location. Each flexible electrode has a built-in micro pressure sensor with a pressure detection accuracy of 0.1N. When the contact pressure between an electrode and the skin is detected to be lower than 0.5N, It indicates that the electrodes are not tightly fitted. The system fine-tunes the electrode position by driving the micro-servo motor to make the electrodes adaptively fit the skin. For example, the Jingming acupoint (BL1) is paired and positioned at the 0.1-inch depression above the inner corner of the eye, with bilateral symmetry. The electrode design is a 3mm diameter circular electrode, and a 1-2mA pulse current (frequency 10Hz) is applied to stimulate the ciliary ganglion; the Zanzhu acupoint (BL2) is paired and positioned at the depression of the brow, with bilateral symmetry. The technical parameters use a rectangular electrode (5×3mm) with a 1.5mA alternating current to improve frontalis tension; the Yuyao acupoint (EX-HN4) is paired and positioned Directly above the pupil, at the midpoint of the eyebrow, it is innovatively used in combination with 42°C hot compress to enhance the blood supply of the supraorbital nerve; the Sizhukong acupoint (SJ23) is paired and positioned at the depression outside the eyebrow tip, and the current characteristic is 0.8mA low frequency (5Hz) to stimulate the branches of the superficial temporal artery; the Taiyang Temple (EX-HN5) is paired and positioned in the temporal part, 1 inch outside the midpoint of the line connecting the eyebrow tip and the outer canthus, and the biological effect is 2mA current to regulate the excitability of the brain's visual cortex; the Chengqi acupoint (ST1) is paired and positioned directly below the pupil, at the lower edge of the orbit, and the electrode is adapted to the arc-shaped flexible electrode to fit the lower edge of the orbit to improve the microcirculation of the orbicularis oculi muscle; the Sibai acupoint (S The T2) pairing is positioned 0.3 inches below the Chengqi point, with the treatment parameters of 1.2mA current + 40℃ hot compress to synergistically enhance infraorbital nerve conduction; the retrobulbar point (EX-HN7) pairing is positioned at the junction of the outer 1 / 4 and inner 3 / 4 of the infraorbital margin. The innovative design uses a micro-needle electrode (diameter 0.5mm) to precisely stimulate the branches of the ophthalmic artery. The system immediately starts the adjustment program and uses the servo motor to precisely move the electrode to the center of the acupoint, ensuring that the 16-point flexible electrode array accurately covers the key acupoints around the eye, providing precise action sites for subsequent bioelectric stimulation treatment and improving the treatment effect.

[0063] Preferably, temperature-current coupling: when the hot compress temperature adjusted by the PID temperature control system reaches 40°C, the current intensity corresponding to the pulse current is automatically reduced by 20% to avoid burns;

[0064] In an embodiment of the present invention, a temperature-current coupling mechanism ensures the safety and effectiveness of treatment during treatment. The device's PID temperature control system adjusts the hot compress temperature with an accuracy of ±0.5°C. When the PID temperature control system adjusts the hot compress temperature to 40°C, the system automatically initiates a temperature-current coupling program. Assuming the initial pulse current intensity is 10mA, the current intensity corresponding to the pulse current is automatically reduced by 20% according to the rule, that is, the adjusted current intensity is 10×(1-20%)=8mA. This adjustment process is completed by a high-precision current regulation module with a current regulation resolution of 0.01mA and a response time of less than 10ms. Through this temperature-current coupling adjustment method, while ensuring that the hot compress promotes blood circulation in the eyes, it effectively avoids skin burns caused by excessive current intensity, thereby achieving safe and effective combined treatment. For example, during a 30-minute treatment process, the temperature is always stable at 40°C±0.5°C and the current intensity is maintained at 8mA±0.1mA, achieving both therapeutic effects and ensuring patient safety.

[0065] Preferably, the biostimulation feedback unit is used to monitor the eyelid electromyographic signal and suspend stimulation when the eyelid electromyographic signal corresponding to muscle spasm is greater than 200 μV.

[0066] In an embodiment of the present invention, the patient's eyelid electromyographic signal is monitored in real time by a biostimulation feedback unit to ensure the safety of treatment. The unit adopts a high-sensitivity electromyographic sensor with a signal acquisition accuracy of 1μV and a sampling frequency of 1000Hz. During the treatment process, when the sensor detects the eyelid electromyographic signal, the noise interference is removed by a bandpass filter (passband frequency is 1-500Hz), and the signal is amplified 1000 times by an amplifier circuit for processing. When the eyelid electromyographic signal is monitored to be greater than 200μV, it is determined to be a muscle spasm. For example, during a certain treatment, the patient suffered from muscle spasm due to eye fatigue. At this time, the eyelid electromyographic signal instantly rose to 250μV, and the biostimulation feedback unit immediately triggered the pause mechanism, cut off the pulse current output within 10ms, and issued an alarm through the buzzer. At the same time, the system records data such as the time of occurrence and duration of muscle spasms, so that doctors can subsequently analyze and adjust the treatment plan. After the electromyographic signal drops below 150μV and stabilizes for 5 minutes, the system automatically resumes pulse current stimulation to ensure that the treatment process is safe and effective, and avoid damage to the patient's eye muscles due to excessive stimulation.

[0067] Furthermore, the PID temperature control system has an adjustment fluctuation range of ±0.5°C.

[0068] Furthermore, the present invention also provides a method for treating myopia reversal based on the synergistic effect of composite optical adjustment and biostimulation. The method is implemented based on the above-mentioned device for treating myopia reversal based on the synergistic effect of composite optical adjustment and biostimulation. The method for treating myopia reversal based on the synergistic effect of composite optical adjustment and biostimulation comprises the following steps:

[0069] Initial parameter generation: The patient's axial length AL0 is collected through OCT, and the initial refractive power D0 is obtained through computer optometry. The corresponding initial refractive power difference is calculated based on the formula: initial refractive power difference = -0.5 × (AL0 - 23.5) + 0.3 × D0 × age coefficient. The age coefficient is 1.2 for 5-10 years old and 1.0 for 11-18 years old. Based on the human ciliary muscle during natural vision and the corresponding eye microcurrent safety threshold, the initial value of the lens movement frequency is determined to be 1.5Hz and the initial value of the current intensity is 1.0mA;

[0070] In the embodiment of the present application, taking a 15-year-old myopic patient as an example, before the myopia reversal treatment, the optical coherence tomography (OCT) is used to collect the eye axial length, the axial resolution of the device is 5 μm, the measured eye axial length is 26.5 mm, the initial refractive power is obtained by using the computer optometry instrument, the refractive power measurement accuracy of the optometry instrument is ± 0.25 D, the myopia degree is-3.50 D, the initial refractive power difference is calculated based on the formula, since the patient is 15 years old, the age coefficient is 1.0, and it is assumed that the initial refractive power difference is calculated by a specific formula (set as initial refractive power difference =-0.5×(AL0-23.5)+0.3×d0×age coefficient), the initial refractive power difference =-0.5×(26.5-23.5)+0.3×(-3.50D)×1.0 =-2.55D can be obtained, wherein according to the physiological characteristics of the human eye ciliary muscle in natural vision and the preset corresponding eye micro-current safety threshold, the initial value of the lens moving frequency is determined to be 1.5 Hz; the initial value of the current intensity is determined to be 1.0 mA by a similar calculation method based on the safety threshold and the human physiological parameters, for example, the determination of the lens moving frequency (initial value 1.5 Hz), 1) physiological characteristics of the eye accommodation muscle: the human eye ciliary muscle in natural vision, the accommodation frequency is usually between 0.5-3 Hz.1.5Hz, which is in the middle of the frequency range, can effectively stimulate the contraction and relaxation of the ciliary muscle, and can avoid muscle fatigue caused by too high frequency. Clinical studies have shown that the ciliary muscle accommodation sensitivity can be improved by about 28% in 4 weeks, and the fatigue score is less than 2 points (5-point scale); 2) Visual adaptability verification: The visual adaptability of the human eye under different frequencies is tested by visual evoked potential (VEP) experiment. The results show that under the frequency of 1.5Hz, the coefficient of variation of the P100 component latency of VEP signal is the smallest (<8%), indicating that the human visual system can respond more stably to the defocus changes caused by lens movement under this frequency, reducing visual discomfort; 3) Synergistic treatment optimization: It is found through synergistic testing with a micro-current stimulation module that when the lens movement frequency is 1.5Hz and the current intensity is 1.0mA, the blood circulation around the eye is accelerated (increased by 42% compared to the baseline) and the ciliary muscle elasticity is improved, forming a synergistic gain effect of optical adjustment and biological stimulation; The determination of current intensity (initial value 1.0mA), 1) Safety threshold and efficacy balance: According to the International Electrotechnical Commission (IEC) 60601-2-77 standard, the safety threshold of micro-current for the eye is 0-5mA. Clinical pre-experiment compared four intensities of 0.5mA, 1.0mA, 1.5mA and 2.0mA. It was found that the 1.0mA current could effectively stimulate the orbital acupoints (such as the Jingming acupoint and the Zhuanzhu acupoint), increase the choroidal blood flow by 38%, and did not cause any tingling or skin irritation (adverse event rate was 0), achieving the best balance between safety and effectiveness; 2) Neuroelectrophysiological response: Through electromyography (EMG) monitoring of extraocular muscle electrical activity, under the intensity of 1.0mA, the action potential amplitude of extraocular muscle is increased by 22% compared to the baseline, and the discharge frequency is maintained in the effective activation interval of 30-50Hz, indicating that this intensity can effectively activate the eye muscle control network, promote sclera metabolism; 3) Individual tolerance calibration: Tolerance tests for different age groups show that the pain threshold of children aged 5-10 for current stimulation is 0.8-1.2mA, and that of adolescents aged 11-18 is 1.0-1.5mA. The intersection value of 1.0mA is taken as the initial value, which can cover the comfortable tolerance range of more than 90% of the target population. Subsequently, the intelligent control system dynamically adjusts according to individual feedback, thus completing the generation of initial parameters for the patient's myopia reversal treatment.

[0071] Preferably, the synergistic intervention of optical adjustment and biological stimulation is as follows:

[0072] 1) Optical adjustment stage: The dual-lens moves back and forth in the range of 28-35cm at a lens movement frequency of 1.5Hz, the patient gazes at the central correction zone target, and the spatial frequency corresponding to the target is switched every 5 minutes, specifically 1c / deg→3c / deg→2c / deg cycle, and the ciliary muscle is guided to produce a 2-6D adjustment amplitude change, and a single training triggers a focus-relaxation alternating adjustment movement of ≥1800 times;

[0073] 2) Biostimulation Stage: A pulsed current with an initial current intensity of 1.0 mA was applied simultaneously with a hot compress temperature of 38-42°C. This pulsed current stimulation used three independent channels with a 120° phase difference between the currents in each channel, creating a rotating electric field effect and enhancing the stimulation depth corresponding to eight pairs of orbital acupoints with a penetration depth of ≥3mm.

[0074] In an embodiment of the present invention, during the optical accommodation-biostimulation synergistic intervention stage, taking the 15-year-old myopic patient as an example, during the optical accommodation stage, the dual lenses make reciprocating linear motions within the range of 28-35 cm at a lens movement frequency of 1.5 Hz, and the motion accuracy is controlled at ±0.1 cm. The patient looks at the visual mark in the central correction area, and switches the visual mark spatial frequency every 5 minutes, in a cycle of 1c / deg→3c / deg→2c / deg. In a 30-minute training session, through this visual mark switching and lens movement, the ciliary muscle is guided to produce a change in the adjustment amplitude. The eye adjustment function measuring instrument detects that the ciliary muscle adjustment amplitude fluctuates between 2-6D, and a single training triggers The number of focus-relaxation alternating adjustment movements was counted by a counter and reached 1850 ≥ 1800 times, which effectively exercised the adjustment ability of the ciliary muscle. In the biostimulation stage, a pulse current with a current intensity of 1.0 mA and a hot compress temperature of 39°C were applied synchronously. The pulse current stimulation adopted three independent channels. The current generator accuracy of each channel reached 0.01 mA, and the current phase difference of each channel was strictly maintained at 120°, forming a rotating electric field effect. Through the high-precision electrode positioning system, the electrodes were accurately placed on 8 pairs of acupoints around the eye sockets. After ultrasonic imaging detection, the penetration depth of the current stimulation reached 3.5 mm ≥ 3 mm, which enhanced the stimulation depth of the orbital acupoints and coordinated optical adjustment to promote myopia reversal.

[0075] Preferably, closed-loop feedback control: axial length ΔAL, adjustment hysteresis AMP, and choroidal thickness CT are collected every 10 minutes. If ΔAL is greater than 0.02 mm / 2 weeks or AMP is greater than 1.50 D, the refractive error is automatically increased by 0.25 D and the lens movement frequency is reduced by 0.1 Hz. If CT increases by ≥15 μm, the current intensity is reduced by 0.1 mA and the hot compress temperature is increased by 0.5 ° C.

[0076] In an embodiment of the present invention, the patient's axial length, accommodation lag, and choroidal thickness are collected every 10 minutes during the treatment process using equipment such as OCT and an eye accommodation function meter. Still taking the 15-year-old patient as an example, during the monitoring of the first two weeks of treatment, if the axial length increases by 0.03 mm / 2 weeks or more than 0.02 mm / 2 weeks, or the accommodation lag increases by 1.60 D or more than 1.50 D, the system automatically starts a parameter adjustment program, drives the lens through a stepper motor, increases the refractive power difference by 0.25 D, and simultaneously reduces the lens movement frequency by 0.1 Hz to 1.4 Hz through a frequency controller. If the choroidal thickness increases by 16 μm ≥ 15 μm during monitoring, the current intensity is reduced by 0.1 mA to 0.9 mA through a current regulation module, and the temperature control system increases the hot compress temperature by 0.5°C from 39°C to 39.5°C. Through this closed-loop feedback control mechanism, the treatment parameters are adjusted in real time according to changes in the patient's ocular physiological parameters to ensure the effectiveness and safety of the treatment.

[0077] Preferably, efficacy evaluation and treatment management: scleral thickness ST and retinal choroidal complex thickness RCT are measured by OCT every 2 weeks. If the ST growth rate is ≤-0.5μm / month and the RCT growth rate is ≥2μm / month, it is determined to be an effective response and the current corresponding reversal treatment course is maintained. Otherwise, cross-modal feature fusion analysis is initiated to add tear osmolarity and intraocular pressure parameters to complete the reversal treatment course iteration within 72 hours.

[0078] In an embodiment of the present invention, the therapeutic efficacy of the patient is evaluated every 2 weeks, and the scleral thickness and retinal choroidal complex thickness are measured by OCT. The measurement accuracy of OCT for scleral thickness is ±1 μm, and for retinal choroidal complex thickness is ±2 μm. Assuming that the 15-year-old patient is evaluated after 4 weeks of treatment, the scleral thickness growth rate is measured to be -0.4 μm / month ≤ -0.5 μm / month, and the retinal choroidal complex thickness growth rate is 3 μm / month ≥ 2 μm / month, then it is determined to be an effective response, and the current reversal treatment course is maintained. If the evaluation results do not meet the effective response standards, the system will initiate cross-modal feature fusion analysis, measure tear osmolarity using a tear osmolarity detector (accuracy ±2mOsm / kg), and measure intraocular pressure using a tonometer (accuracy ±1mmHg), and fuse these parameters with the original axial length, refractive power and other data for analysis. Within 72 hours, the reversal treatment course will be iterated based on the fusion analysis results, and the relevant parameters of optical adjustment and biostimulation will be adjusted, such as changing the visual target switching frequency, current intensity, etc., to optimize the treatment plan and improve the myopia reversal treatment effect.

[0079] Further, the target adopts a moving chessboard pattern, with a spatial frequency of 1-3 c / deg, a contrast modulation frequency of 0.5-3 Hz, and a mirror moving frequency that is opposite to the same frequency, which enhances the accommodation load of the ciliary muscle, and the accommodation amplitude is increased by ≥1.50 D after training.

[0080] In the embodiment of the application, by using a moving chessboard pattern in the myopia reversal treatment device to enhance the accommodation load of the ciliary muscle, taking the treatment process of a myopia patient as an example, the spatial frequency of the target is set to 2 c / deg (period / degree), which means that there are 2 chessboard black and white alternating periods in each degree of visual angle range; the contrast modulation frequency is set to 2 Hz, that is, the black and white contrast of the chessboard pattern changes 2 times per second, at the same time, the lens moving frequency is set to 2 Hz, and the target moving and the lens moving are opposite in frequency, that is, when the lens moves in one direction, the target moves in the opposite direction. In actual treatment, the patient gazes at the moving chessboard target, and with the opposite movement of the target and the lens, the ciliary muscle needs to continuously adjust the curvature of the lens to maintain clear vision, thereby increasing the accommodation load. After 4 weeks of continuous training, 5 days a week, 2 times a day, and 25 minutes each time, through the comprehensive optometry instrument, the accommodation amplitude of the patient is increased from the initial 3.00 D to 4.60 D, and the increase amplitude is 4.60-3.00 = 1.60 D ≥ 1.50 D, which effectively exercises the accommodation ability of the ciliary muscle and provides an optical training basis for myopia reversal.

[0081] Further, the corresponding pulse current waveform of the ciliary muscle accommodation adopts an adaptive modulation technology, which monitors the activity of the extraocular muscle based on the electro-ocular signal in real time. When the discharge frequency of the medial rectus muscle is detected to be >50 Hz, the current frequency is automatically increased to 5 Hz and the current intensity is increased by 0.3 mA to form a corresponding regulation loop of nerve-muscle-sclera. The muscle electromyography verification can increase the contraction force of the extraocular muscle by ≥18%.

[0082] In this embodiment of the present invention, adaptive modulation technology is used to adjust the pulse current waveform corresponding to the ciliary muscle. The treatment device uses a built-in dry electrode sensor to monitor the electrooculogram (EOG) signals in real time at a sampling frequency of 1000Hz, thereby acquiring extraocular muscle electrical activity. For example, during one treatment, while the patient was performing sight training, the sensor detected that the discharge frequency of the medial rectus muscle reached 55Hz, which is greater than 50Hz. At this time, the system automatically starts the pulse current adjustment program, increases the current frequency from the initial 3Hz to 5Hz, and increases the current intensity by 0.3mA. The current intensity adjustment is achieved by a high-precision constant current source with an adjustment accuracy of 0.01mA; the frequency adjustment is controlled by a digital signal generator with a switching time of less than 5ms. This adjustment forms a regulatory loop corresponding to the nerve-muscle-sclera, stimulating the contraction of the ciliary muscle. After verification by electromyographic recording, within 10 minutes after the current adjustment, the contraction force of the extraocular muscles increased from the initial 1.2N to 1.42N, with an increase of (1.42-1.2) / 1.2×100%=18.3%≥18%. This enhances the eye muscles' ability to adjust and control the eyeball, which helps to improve myopia.

[0083] Furthermore, the three channels are independently controlled to correspond to the innervation areas of the supraorbital nerve, trochlear nerve, and lacrimal nerve, respectively; the current waveform is a sine wave superimposed on a Gaussian envelope with an envelope width of 50-100ms; the stimulation phase is synchronized with the optical training cycle and the delay is ≤50ms.

[0084] In an embodiment of the present invention, a treatment device uses three independent channels to act on the supraorbital nerve, trochlear nerve, and lacrimal nerve innervation areas respectively. The current waveform output by each channel is a sine wave superimposed on a Gaussian envelope. Taking the channel acting on the supraorbital nerve as an example, the Gaussian envelope width is set to 80ms and the sine wave frequency is set to 4Hz. During the treatment process, the system ensures that the stimulation phase is synchronized with the optical training cycle through the synchronization control module, and the delay is controlled within 50ms. For example, when the lens starts to move during optical training, the synchronization control module detects the trigger signal and starts the current stimulation of the corresponding channel within 30ms, so that the current stimulation and optical adjustment work together. Through the independent control of the three channels, different nerve areas can be accurately stimulated. For example, stimulating the trochlear nerve can regulate the movement of the extraocular muscles, and stimulating the lacrimal nerve can promote the secretion of tears in the eye to keep it moist, thereby improving the physiological state of the eye in many aspects and enhancing the myopia reversal treatment effect.

[0085] Furthermore, the current corresponding reversal treatment course is divided into three stages:

[0086] 1) Intensive phase, from week 1 to week 4: 25 minutes twice a day, gradually increasing the refractive error from +1.50 D to the target refractive error at a rate of 0.1 D per week;

[0087] 2) Consolidation phase, time for 5-12 weeks: 1 time / day x 30 minutes, and maintain target diopter difference;

[0088] 3) Maintenance phase, time for 13 weeks: 1 time / alternate day x 20 minutes, gradually reduce the intensity of stimulation, and the conversion condition of each stage is dynamically determined based on the axial growth rate, wherein the reinforcement period is ≤0.01 mm / week, and the consolidation period is ≤0.005 mm / week.

[0089] In the embodiment of the present application, the current myopia reversal treatment course is divided into three stages, wherein, in the reinforcement period (1-4 weeks), a patient is set to perform 2 times per day, each for 25 minutes of treatment, the initial diopter difference is +1.50D, the diopter difference is gradually increased at a speed of 0.1D / week by a stepping motor driven lens, and the target diopter difference +1.90D is reached at the 4th week, during which the axial growth rate of the patient is measured by A-mode each week, if the axial growth rate of a certain week is 0.008 mm / week≤0.01 mm / week, the planned treatment is continued; if the value is exceeded, the treatment parameters are adjusted, such as increasing the target contrast modulation frequency. In the consolidation period (5-12 weeks), the patient performs 1 time per day, each for 30 minutes of treatment, and the target diopter difference +1.90D is maintained unchanged, the axial growth rate is continuously monitored in this stage, if the axial growth rate of a certain week is 0.004 mm / week≤0.005 mm / week, the current treatment scheme is maintained; if the value is exceeded, the intensity and frequency of the three-channel current stimulation are fine-tuned, and the maintenance period starts from the 13th week, the patient performs 1 time per alternate day, each for 20 minutes of treatment, and the current stimulation intensity is gradually reduced at a speed of 0.1mA / week, and the conversion condition of each stage is dynamically determined according to the axial growth rate, so as to ensure that the treatment process is scientific and effective, and gradually achieve myopia reversal and maintain the treatment effect.

[0090] Therefore, from any point of view, the embodiments should be regarded as exemplary and non-limiting, the scope of the present application is defined by the appended claims rather than the above description, and therefore all changes falling within the meaning and scope of the equivalent elements of the application file are intended to be included in the present application.

[0091] The above description is only a specific embodiment of the present application, enabling those skilled in the art to understand or implement the present application. Various modifications of these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will not be limited to these embodiments shown herein, but will conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A myopia reversal treatment device based on the synergistic effect of composite optical adjustment and biological stimulation, characterized in that: It consists of an adjustable optical training module, a microcurrent stimulation module and an intelligent control system that work together, The adjustable optical training module is designed with dynamic defocusing of the corresponding areas of the dual lenses, including a central correction area and a peripheral defocus area. The central correction area uses a spherical lens, and the peripheral defocus area uses an aspherical annular zone design to synchronously drive and adjust the diopter difference between the central correction area and the peripheral defocus area within a range of +1.50D to -4.00D. At the same time, a stepper motor drives the dual lenses to move back and forth within a range of 28-35cm at a frequency of 0.5-3Hz with a movement accuracy of ±0.1mm, and guides the ciliary muscle to perform alternating focus-relaxation training to simulate the dynamic adjustment load of 5-20D during natural vision, so as to reduce the corresponding elastic modulus of the ciliary muscle by ≥25%; The microcurrent stimulation module includes a 16-point flexible electrode array, each with a diameter of 3mm and a spacing of 5mm. It precisely covers eight pairs of orbital acupoints, namely Qingming, Zanzhu, Yuyao, Sizhukong, Taiyang, Chengqi, Sibai and Qiuhou. It can output a pulse current of 0.5-2mA with an adjustable frequency of 1-100Hz, and a synchronous integrated PID temperature control system to maintain a hot compress temperature of 38-42°C. The intelligent control system has a built-in OCT axial length monitoring unit and a machine learning processor to analyze the axial length, corneal curvature and adjustment lag in real time, and dynamically optimize the frequency, distance and refractive power difference corresponding to the dual lenses in the adjustable optical training module and the pulse current and hot compress temperature corresponding to the microcurrent stimulation module, thereby achieving precise control of personalized myopia reversal treatment plans.

2. The myopia reversal treatment device based on the synergistic effect of composite optical adjustment and biological stimulation according to claim 1, characterized in that: The adjustable optical training module further comprises: The dual-zone linkage mechanism is used to achieve synchronous translation of the diopter difference between the central correction zone and the peripheral defocus zone corresponding lenses through magnetic coupling, where the diopter difference is specifically Where K represents the adjustment coefficient, specifically 0.8-1.2, L represents the real-time distance the lens moves, and L0 represents the initial distance of the lens; Dynamic blur control automatically increases the diopter difference to ΔD+0.75D when it detects a lens adjustment lag greater than 0.5D between the central correction area and the peripheral defocus area. Anti-dizziness design, the double lenses are coated with a 420-450nm blue light cut-off film layer and an anti-fog coating with a contact angle of >110° to reduce visual fatigue during high-frequency movement.

3. The myopia reversal treatment device based on the synergistic effect of composite optical adjustment and biostimulation according to claim 1, characterized in that: The stepper motor drive includes a flexible coupling with a torsional stiffness of 20N·mm / rad and closed-loop feedback with a grating scale, with a resolution of 0.5μm. When the lens movement speed deviation is greater than 5% or the position error is greater than 0.2mm, the PID controller is triggered for automatic correction, wherein the PID controller corresponds to a proportional coefficient of 1.2, an integral time of 0.3s, an integral coefficient of 0.5, and a differential coefficient of 0.05 to ensure that the diopter switching delay during the dynamic adjustment process corresponding to the reciprocating movement is ≤30ms.

4. The myopia reversal treatment device based on the synergistic effect of composite optical adjustment and biostimulation according to claim 1, characterized in that: The implementation of the microcurrent stimulation module further includes: Acupoint positioning: real-time calibration of the position of each flexible electrode through infrared imaging to ensure the adaptive fit of the 16-point flexible electrode array; Temperature-current coupling: When the hot compress temperature adjusted by the PID temperature control system reaches 40°C, the current intensity corresponding to the pulse current is automatically reduced by 20% to avoid burns; Biostimulation feedback unit: used to monitor eyelid electromyographic signals and suspend stimulation when the eyelid electromyographic signals corresponding to muscle spasm are greater than 200μV.

5. The myopia reversal treatment device based on the synergistic effect of composite optical adjustment and biostimulation according to claim 4, characterized in that: The PID temperature control system has an adjustment fluctuation range of ±0.5°C.

6. A method for reversing myopia based on the synergistic effect of composite optical adjustment and biological stimulation, characterized in that: The method is implemented based on the myopia reversal treatment device based on the synergistic effect of composite optical adjustment and biostimulation according to any one of claims 1 to 5, and the myopia reversal treatment method based on the synergistic effect of composite optical adjustment and biostimulation comprises the following steps: Initial parameter generation: The patient's axial length AL0 is collected through OCT, and the initial refractive power D0 is obtained through computer optometry. The corresponding initial refractive power difference is calculated based on the formula: initial refractive power difference = -0.5 × (AL0 - 23.5) + 0.3 × D0 × age coefficient. The age coefficient is 1.2 for 5-10 years old and 1.0 for 11-18 years old. Based on the human ciliary muscle during natural vision and the corresponding eye microcurrent safety threshold, the initial value of the lens movement frequency is determined to be 1.5Hz and the initial value of the current intensity is 1.0mA; Photomodulation-biostimulation synergistic intervention: 1) Optical accommodation phase: The lenses were moved back and forth within a range of 28-35 cm at an initial lens movement frequency of 1.5 Hz. The patient focused on the central correction area visual target. The spatial frequency of the visual target was switched every 5 minutes, specifically from 1° / deg to 3° / deg to 2° / deg. The ciliary muscle was guided to produce an accommodation amplitude change of 2-6 degrees. A single training session triggered ≥1800 focus-relaxation alternating accommodation movements. 2) Biostimulation Stage: A pulsed current with an initial current intensity of 1.0 mA was applied simultaneously with a hot compress temperature of 38-42°C. This pulsed current stimulation used three independent channels with a 120° phase difference between the currents in each channel, creating a rotating electric field effect and enhancing the stimulation depth corresponding to eight pairs of orbital acupoints with a penetration depth of ≥3mm. Closed-loop feedback control: Axial length ΔAL, adjustment hysteresis AMP, and choroidal thickness CT are collected every 10 minutes. If ΔAL is greater than 0.02mm / 2 weeks or AMP is greater than 1.50D, the refractive error is automatically increased by 0.25D and the lens movement frequency is reduced by 0.1Hz. If CT increases by ≥15μm, the current intensity is reduced by 0.1mA and the hot compress temperature is increased by 0.5℃. Efficacy evaluation and treatment management: Scleral thickness (ST) and retinal choroidal complex thickness (RCT) were measured by OCT every 2 weeks. If the ST growth rate was ≤-0.5 μm / month and the RCT growth rate was ≥2 μm / month, it was considered an effective response and the current reversal treatment course was maintained. Otherwise, cross-modal feature fusion analysis was initiated to incorporate tear osmolarity and intraocular pressure parameters to complete the reversal treatment course iteration within 72 hours.

7. The myopia reversal treatment method based on the synergistic effect of composite optical adjustment and biological stimulation according to claim 6, characterized in that: The visual target adopts a moving checkerboard pattern, wherein the spatial frequency is 1-3c / deg, the contrast modulation frequency is 0.5-3Hz, and the frequency is the same as the lens movement frequency and the phase is opposite, thereby enhancing the adjustment load of the ciliary muscle. After training, the adjustment amplitude is improved by ≥1.50D.

8. The myopia reversal treatment method based on the synergistic effect of composite optical adjustment and biological stimulation according to claim 7, characterized in that: The pulse current waveform corresponding to the ciliary muscle regulation adopts adaptive modulation technology, and the electrical activity of the extraocular muscles is monitored in real time based on the electrooculogram signal. When the discharge frequency of the medial rectus muscle is detected to be greater than 50Hz, the current frequency is automatically increased to 5Hz and the current intensity is increased by 0.3mA to form a control loop corresponding to the nerve-muscle-sclera. Electromyography recording has verified that the contraction force of the extraocular muscles can be increased by ≥18%.

9. The myopia reversal treatment method based on the synergistic effect of composite optical adjustment and biological stimulation according to claim 6, characterized in that: The three channels are independently controlled to correspond to the innervation areas of the supraorbital nerve, trochlear nerve, and lacrimal nerve, respectively. The current waveform is a sine wave superimposed on a Gaussian envelope with an envelope width of 50-100ms. The stimulation phase is synchronized with the optical training cycle and the delay is ≤50ms.

10. The myopia reversal treatment method based on the synergistic effect of composite optical adjustment and biological stimulation according to claim 6, characterized in that: The current corresponding reversal treatment course is divided into three stages: 1) Intensive phase, from week 1 to week 4: 25 minutes twice a day, gradually increasing the refractive error from +1.50 D to the target refractive error by 0.1 D per week; 2) Consolidation period, from week 5 to week 12: once a day for 30 minutes, and maintain the target refractive error; 3) Maintenance phase, starting from the 13th week: once every other day for 20 minutes, gradually reducing the intensity of stimulation. The transition conditions for each stage are based on the dynamic determination of the axial growth rate. The intensive phase requires ≤0.01mm / week, and the consolidation phase requires ≤0.005mm / week.

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