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. 2018 Aug 30;19(1):469.
doi: 10.1186/s13063-018-2833-y.

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

Ying Zheng  1 , Mei Kang  2 , Hong Wang  1 , Haiyun Liu  1 , Tao Sun  1 , Xiaodong Sun  1 , Fenghua Wang  3
Affiliations

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

Ying Zheng et al. Trials. .

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.

Keywords: Air tamponade; High myopia; Inverted internal limiting membrane insertion; Macular hole retinal detachment.

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Conflict of interest statement

Ethics approval and consent to participate

The ethics committee of the Shanghai General Hospital Institutional Review Board has granted ethics approval for this study (6 April 2017, Approval Number: 2017 [16]). Written informed consent will be obtained from all participants or their authorized representatives.

Consent for publication

Not applicable. Results will be presented at relevant national and international conferences as well as being published in peer-reviewed journals.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study design
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References

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