Clinical trial NCT05034016: The Exploratory Clinical Trials on the Primary Safety and Effectiveness of High Myopic Posterior Scleral Fixation System
Official title: High Myopic Posterior Scleral Fixation System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High Myopia
Macular Schisis
Keywords: Posterior scleral reinforcement
Macular ischemia
Lead sponsor: GuangZhou WeiShiBo Biotechnology Co., ltd
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Macular reduction rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: Baseline (Before surgery), 1 day, 1 week, 4 weeks, 12 weeks, 24 weeks,
measure: Axial length
timeFrame: Baseline (Before surgery), 24 weeks after surgery
measure: Diopter
timeFrame: Baseline (Before surgery), 24 weeks after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of traditional Chinese Medicine
state: Guangdong
Study officials:
affiliation: Beijing Tongren Hospital
name: Wenbing Wei, MD,Ph.D
role: STUDY_CHAIR
References: