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

NCT ID: NCT05034016

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2022-04-24

Brief 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

High Myopia; Macular Schisis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HM experimental group

Intraocular implant test product

Group Type: EXPERIMENTAL

High Myopic Posterior Scleral Fixation System

Intervention Type: DEVICE

Implant HM into the eye through posterior scleral reinforcement

Natural observation control group

Natural observation of the disease changes, no surgical intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

High Myopic Posterior Scleral Fixation System

Implant HM into the eye through posterior scleral reinforcement

Intervention Type: DEVICE

Other Intervention Names

HM

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GuangZhou WeiShiBo Biotechnology Co., ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenbing Wei, MD,Ph.D

Role: STUDY_CHAIR

Beijing Tongren Hospital

Locations

The First Affiliated Hospital of Guangzhou University of traditional Chinese Medicine

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qianying Gao, MD,Ph.D

Role: CONTACT

kevin.gao@vesber.com

020-28687088

Other Identifiers

TREC2019-30.A2

Identifier Type: -

Identifier Source: org_study_id