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

NCT05034016 | Unknown

• 1 other identifier: TREC2019-30.A2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

High Myopia; Macular Schisis

Keywords

Posterior scleral reinforcement; Macular ischemia

Outcome Measures

Primary Outcomes (1)

• Macular reduction rate

  24 weeks after implantation of the High Myopic Posterior Scleral Fixation System

  24 weeks

Secondary Outcomes (3)

• Best corrected visual acuity

  Baseline (Before surgery), 1 day, 1 week, 4 weeks, 12 weeks, 24 weeks,

• Axial length

  Baseline (Before surgery), 24 weeks after surgery

• Diopter

  Baseline (Before surgery), 24 weeks after surgery

Study Arms (2)

HM experimental group

EXPERIMENTAL

Intraocular implant test product

Device: High Myopic Posterior Scleral Fixation System

Natural observation control group

NO INTERVENTION

Natural observation of the disease changes, no surgical intervention

Interventions

High Myopic Posterior Scleral Fixation System DEVICE

Implant HM into the eye through posterior scleral reinforcement

Also known as: HM

HM experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18\~65, male or female;
• Refractive ranges from -6.00d to -25.00d;
• The axial length of the operative eye was 26-32mm;
• Macular cleavage 200-1000μm;
• Corrected visual acuity of the operative eye \< 0.3;
• Able to understand the purpose of the test, voluntarily participate and sign the informed consent form.

You may not qualify if:

• Known allergy to silica gel and patients with scar constitution;
• Ocular inflammation;
• Fundus hemorrhage;
• Macular hole;
• Macular cleavage of the contralateral eye greater than 200μm;
• Corrected visual acuity of contralateral eye \< 0.4;
• Opacity of the refractive medium;
• Eye tumor;
• History of hyperthyroidism;
• Other ophthalmic concomitant diseases that cannot be controlled, such as diabetic retinopathy, hypertensive fundus lesions, optic nerve atrophy, etc.;
• 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);
• 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;
• a history of drug abuse or alcohol abuse;
• participate in other drug or medical device clinical trials within 30 days prior to the screening of this clinical trial;
• 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.);

Sponsors & Collaborators

• GuangZhou WeiShiBo Biotechnology Co., ltd: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou University of traditional Chinese Medicine

Guangzhou, Guangdong, 510030, China

RECRUITING

Study Officials

• Wenbing Wei, MD,Ph.D

  Beijing Tongren Hospital

  STUDY CHAIR

Central Study Contacts

Qianying Gao, MD,Ph.D

CONTACT

020-28687088; kevin.gao@vesber.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 5, 2021
• Study Start: June 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: April 24, 2022
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

CN (1)