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

High Myopia Clinical Trial

Official title:

High Myopic Posterior Scleral Fixation System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05034016
• Other study ID #: TREC2019-30.A2
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• High Myopia
• Macular Schisis
• Myopia

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