NCT03383731

A Study of a New Surgical Treatment of Macular Hole Retinal Detachment in High Myopia

A Single Center, Randomized and Controlled Clinical Study of Inverted Internal Limiting Membrane Insertion Combined With Air Tamponade in the Treatment of Macular Hole Retinal Detachment in High Myopia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the surgical outcomes of inverted internal limiting membrane insertion combined with air tamponade in the treatment of macular hole retinal detachment (MHRD) in high myopia, and also to compare the treatment efficacy and safety between different surgical approaches of MHRD

Detailed description

This study uses a new surgical method (vitrectomy combined with inverted internal limiting membrane insertion and intraocular sterilized air tamponade) to assess its effectiveness and safety on the prognosis of macular hole retinal detachment secondary to high myopia, and also compares this new type of surgery with the current commonly used surgery (vitrectomy combined with internal limiting membrane peeling + silicone oil infusion).

Conditions

• Macular Holes
• Retinal Detachment
• High Myopia

Interventions

Type	Name	Description
PROCEDURE	Group 1	the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + air-fluid exchange + silicone oil infusion
PROCEDURE	Group 2	the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + inverted internal limiting membrane insertion + air-fluid exchange

Timeline

• Start date: 2017-04-07
• Primary completion: 2020-04-06
• Completion: 2020-04-06
• First posted: 2017-12-26
• Last updated: 2017-12-26

Locations

1 site across 1 country: China