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Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Inverted internal limiting membrane insertion combined with air tamponade in the treatment of macular hole retinal detachment in high myopia: study protocol for a randomized controlled clinical trial

Authors: Ying Zheng, Mei Kang, Hong Wang, Haiyun Liu, Tao Sun, Xiaodong Sun, Fenghua Wang

Published in: Trials | Issue 1/2018

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Abstract

Background

Macular hole retinal detachment (MHRD) occurs most commonly in high myopia and causes severe visual impairment and greatly reduces the quality of life. The aim of this study is to evaluate the efficacy and safety of inverted internal limiting membrane insertion combined with air tamponade in the treatment of MHRD in high myopia, and also to compare the treatment efficacy with that of the conventional “vitrectomy plus internal limiting membrane peeling plus silicone oil tamponade” method for high myopia-associated MHRD.

Methods/design

In this clinical trial, 38 patients with MHRD in high myopia will be randomly assigned to two groups (Group 1: standard 3-port 23-gauge pars plana vitrectomy plus internal limiting membrane peeling plus air-fluid exchange plus silicone oil infusion; Group 2: standard 3-port 23-gauge pars plana vitrectomy plus internal limiting membrane peeling plus inverted internal limiting membrane insertion plus air-fluid exchange). The primary outcome is macular hole closure rate in 3 months after the initial surgery. The secondary outcomes are best corrected visual acuity (BCVA), reattachment rate of retinal detachment, and postoperative complication rate.

Discussion

The study results may help to evaluate the efficacy and safety of inverted internal limiting membrane insertion combined with air tamponade in the treatment of MHRD in high myopia, and also compare the efficacy of the new treatment with the conventional “vitrectomy plus internal limiting membrane peeling plus silicone oil tamponade” method. This trial may provide a novel surgical treatment for MHRD in high myopia with more effectiveness and less pain.

Trial registration

ClinicalTrials.gov, NCT03383731. Registered on 19 December 2017. Retrospectively registered.
Appendix
Available only for authorised users
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Metadata
Title
Inverted internal limiting membrane insertion combined with air tamponade in the treatment of macular hole retinal detachment in high myopia: study protocol for a randomized controlled clinical trial
Authors
Ying Zheng
Mei Kang
Hong Wang
Haiyun Liu
Tao Sun
Xiaodong Sun
Fenghua Wang
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2833-y

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