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Graefe's Archive for Clinical and Experimental Ophthalmology

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Open Access 13-12-2022 | Peeling | Retinal Disorders

A randomised controlled trial evaluating internal limiting membrane peeling forceps in macular hole surgery

Authors: Mariantonia Ferrara, Antonio Rivera-Real, Roxane J. Hillier, Maged Habib, Mustafa R. Kadhim, Maria T. Sandinha, Katie Curran, Alyson Muldrew, David H. W. Steel

Published in: Graefe's Archive for Clinical and Experimental Ophthalmology | Issue 6/2023

Abstract

Purpose

To assess study design and a range of anatomical and functional changes after internal limiting membrane (ILM) peeling using forceps developed for atraumatic ILM pick-up compared to standard forceps.

Methods

We conducted a masked proof-of concept randomised controlled trial (RCT) on 65 patients who underwent ILM peeling for idiopathic full-thickness macular hole (FTMH) using etched-tip forceps (etched-tip group, 33 eyes) compared to standard ILM forceps (smooth-tip group, 32 eyes). Patients were assessed preoperatively, 3 weeks, 3 and 6 months postoperatively.

Results

The primary closure rate was 95.4%. There was no statistically significant difference between the groups in terms of final visual acuity (66.9 vs 70.9 ETDRS letters, p = 0.13), difference of visual field mean deviation (1.32 vs 1.14 decibels), and number of eyes with pick-up-related retinal haemorrhages (16% vs 16%, p = 0.96), swelling of arcuate nerve fibre layer lesions (63% vs 55%, p = 0.54), number of dissociated optic nerve fibre layer lesions (31.4 vs 41.0, p = 0.16), nor inner retina defects (37% vs 22%, p = 0.17). Similar changes in inner retinal volumes were detected in all 9 sectors of an ETDRS grid except for a trend (p = 0.06) towards a lower reduction in the inferior inner sector in the etched-tip group.

Conclusions

The study was successfully completed with masking maintained and a low risk of bias. Multiple endpoints relating to ILM peeling were assessed, and estimates were provided that can be used for future studies. Although the study was not powered to assess any specific endpoint, the anatomical and functional outcomes assessed did not significantly differ.

Available only for authorised users

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Title: A randomised controlled trial evaluating internal limiting membrane peeling forceps in macular hole surgery
Authors: Mariantonia Ferrara
Antonio Rivera-Real
Roxane J. Hillier
Maged Habib
Mustafa R. Kadhim
Maria T. Sandinha
Katie Curran
Alyson Muldrew
David H. W. Steel
Publication date: 13-12-2022
Publisher: Springer Berlin Heidelberg
Keyword: Peeling
Published in: Graefe's Archive for Clinical and Experimental Ophthalmology / Issue 6/2023
Print ISSN: 0721-832X
Electronic ISSN: 1435-702X
DOI: https://doi.org/10.1007/s00417-022-05932-y

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Springer Medicine

A randomised controlled trial evaluating internal limiting membrane peeling forceps in macular hole surgery

Abstract

Purpose

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

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