Trials / Unknown
UnknownNCT05034016
The Exploratory Clinical Trials on the Primary Safety and Effectiveness of High Myopic Posterior Scleral Fixation System
High Myopic Posterior Scleral Fixation System
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- GuangZhou WeiShiBo Biotechnology Co., ltd · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | High Myopic Posterior Scleral Fixation System | Implant HM into the eye through posterior scleral reinforcement |
Timeline
- Start date
- 2020-06-01
- Primary completion
- 2021-12-31
- Completion
- 2022-04-24
- First posted
- 2021-09-05
- Last updated
- 2021-09-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05034016. Inclusion in this directory is not an endorsement.