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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05034016
Other study ID # TREC2019-30.A2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date April 24, 2022

Study information

Verified date August 2021
Source GuangZhou WeiShiBo Biotechnology Co., ltd
Contact Qianying Gao, MD,Ph.D
Phone 020-28687088
Email kevin.gao@vesber.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date April 24, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Age 18~65, male or female; 2. Refractive ranges from -6.00d to -25.00d; 3. The axial length of the operative eye was 26-32mm; 4. Macular cleavage 200-1000µm; 5. Corrected visual acuity of the operative eye < 0.3; 6. Able to understand the purpose of the test, voluntarily participate and sign the informed consent form. Exclusion Criteria: 1. Known allergy to silica gel and patients with scar constitution; 2. Ocular inflammation; 3. Fundus hemorrhage; 4. Macular hole; 5. Macular cleavage of the contralateral eye greater than 200µm; 6. Corrected visual acuity of contralateral eye < 0.4; 7. Opacity of the refractive medium; 8. Eye tumor; 9. History of hyperthyroidism; 10. Other ophthalmic concomitant diseases that cannot be controlled, such as diabetic retinopathy, hypertensive fundus lesions, optic nerve atrophy, etc.; 11. 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); 12. 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; 13. a history of drug abuse or alcohol abuse; 14. participate in other drug or medical device clinical trials within 30 days prior to the screening of this clinical trial; 15. 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.); 16. Poor compliance of the subject, unable to complete the test process as required.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
High Myopic Posterior Scleral Fixation System
Implant HM into the eye through posterior scleral reinforcement

Locations

Country Name City State
China The First Affiliated Hospital of Guangzhou University of traditional Chinese Medicine Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
GuangZhou WeiShiBo Biotechnology Co., ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Macular reduction rate 24 weeks after implantation of the High Myopic Posterior Scleral Fixation System 24 weeks
Secondary Best corrected visual acuity ETDRS table Baseline (Before surgery), 1 day, 1 week, 4 weeks, 12 weeks, 24 weeks,
Secondary Axial length A-scan Baseline (Before surgery), 24 weeks after surgery
Secondary Diopter Refractometer Baseline (Before surgery), 24 weeks after surgery
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