The Exploratory Clinical Trials on the Primary Safety and Effectiveness of High Myopic Posterior Scleral Fixation System

Study Overview
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Brief Summary
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The purpose of this study is to assess the primary safety and efficacy of High Myopic Posterior Scleral Fixation System in the treatment of macular schisis caused by high myopia.

Detailed Description
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Posterior Scleral Reinforcement（PSR） is the only surgical method that can delay the the development of high myopia. However, The surgical method is restricted by the material source limitation and macular ischemia in the eye after reinforcement. The investigators have designed a new posterior scleral fixation system，Its basic material is medical silicone，The product is designed to solve the problem of material source limitation and macular ischemia in the eye after reinforcement.

Official Title
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High Myopic Posterior Scleral Fixation System

Conditions
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High Myopia, Macular Schisis

Intervention / Treatment
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* Device: High Myopic Posterior Scleral Fixation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 65, male or female; Refractive ranges from -6.00d to -25.00d; The axial length of the operative eye was 26-32mm; Macular cleavage 200-1000μm; Corrected visual acuity of the operative eye < 0.3; Able to understand the purpose of the test, voluntarily participate and sign the informed consent form. Exclusion Criteria: Known allergy to silica gel and patients with scar constitution; Ocular inflammation; Fundus hemorrhage; Macular hole; Macular cleavage of the contralateral eye greater than 200μm; Corrected visual acuity of contralateral eye < 0.4; Opacity of the refractive medium; Eye tumor; History of hyperthyroidism; Other ophthalmic concomitant diseases that cannot be controlled, such as diabetic retinopathy, hypertensive fundus lesions, optic nerve atrophy, etc.; Severe impairment of liver and kidney function and/or severe systemic diseases (such as cardiovascular, respiratory, digestive, nervous, endocrine, genitourinary, etc., depending on the tolerance of surgery); Women who are pregnant (determined by a blood pregnancy test at the first visit), who are preparing for pregnancy during the test, and who are breastfeeding; a history of drug abuse or alcohol abuse; participate in other drug or medical device clinical trials within 30 days prior to the screening of this clinical trial; Any condition of the subject that the study physician considers to be an impediment to the clinical trial (e.g. subject's susceptibility to mental stress, uncontrollable mood, depression, etc.); Poor compliance of the subject, unable to complete the test process as required.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HM experimental group<br>Intraocular implant test product | Device: High Myopic Posterior Scleral Fixation System<br>* Implant HM into the eye through posterior scleral reinforcement<br>* Other names: HM;|
| No Intervention: Natural observation control group<br>Natural observation of the disease changes, no surgical intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular reduction rate | 24 weeks after implantation of the High Myopic Posterior Scleral Fixation System | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | ETDRS table | Baseline (Before surgery), 1 day, 1 week, 4 weeks, 12 weeks, 24 weeks, | 
| Axial length | A-scan | Baseline (Before surgery), 24 weeks after surgery | 
| Diopter | Refractometer | Baseline (Before surgery), 24 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posterior scleral reinforcement, Macular ischemia