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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM experimental group | Experimental | Intraocular implant test product |
|
| Natural observation control group | No Intervention | Natural observation of the disease changes, no surgical intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Myopic Posterior Scleral Fixation System | Device | Implant HM into the eye through posterior scleral reinforcement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Macular reduction rate | 24 weeks after implantation of the High Myopic Posterior Scleral Fixation System | 24 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qianying Gao, MD,Ph.D | Contact | 020-28687088 | kevin.gao@vesber.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenbing Wei, MD,Ph.D | Beijing Tongren Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou University of traditional Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510030 | China |
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| Baseline (Before surgery), 24 weeks after surgery |
| Diopter | Refractometer | Baseline (Before surgery), 24 weeks after surgery |