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

High Myopic Posterior Scleral Fixation System

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.

Study Overview

• Status: Recruiting
• Conditions: High Myopia; Macular Schisis
• Intervention / Treatment: Device: High Myopic Posterior Scleral Fixation System

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qianying Gao, MD,Ph.D; Phone Number: 020-28687088; Email: kevin.gao@vesber.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510030
      • Recruiting
      • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HM experimental group; Intraocular implant test product	Device: High Myopic Posterior Scleral Fixation System; Implant HM into the eye through posterior scleral reinforcement; Other Names: HM
No Intervention: Natural observation control group; Natural observation of the disease changes, no surgical intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular reduction rate	24 weeks after implantation of the High Myopic Posterior Scleral Fixation System	24 weeks

Secondary Outcome Measures

Outcome Measure	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	Baseline (Before surgery), 24 weeks after surgery
Diopter	Refractometer	Baseline (Before surgery), 24 weeks after surgery

Collaborators and Investigators

• Sponsor: GuangZhou WeiShiBo Biotechnology Co., ltd
• Investigators: Study Chair: Wenbing Wei, MD,Ph.D, Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): April 24, 2022

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Posterior scleral reinforcement; Macular ischemia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: TREC2019-30.A2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No