Evidence map›Paper›PMID 36512088›Full record

Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2023

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

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

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Mariantonia Ferrara *Sunderland Eye Infirmary, Queen Alexandra Road, Sunderland, SR2 9HP, UK.
Antonio Rivera-Real *Bioscience Institute, Newcastle University, Newcastle Upon Tyne, UK.
Roxane J HillierNewcastle Eye Centre, Royal Victoria Infirmary, Queen Victoria Road, Newcastle Upon Tyne, UK.
Maged HabibSunderland Eye Infirmary, Queen Alexandra Road, Sunderland, SR2 9HP, UK.
Mustafa R KadhimNewcastle Eye Centre, Royal Victoria Infirmary, Queen Victoria Road, Newcastle Upon Tyne, UK.
Maria T SandinhaSt. Paul's Eye Unit, The Royal Liverpool University Hospital, Liverpool, UK.
Katie CurranCentre for Public Health, Queen's University of Belfast, Belfast, UK.
Alyson MuldrewCentre for Public Health, Queen's University of Belfast, Belfast, UK.
David H W SteelSunderland Eye Infirmary, Queen Alexandra Road, Sunderland, SR2 9HP, UK. David.steel@ncl.ac.uk.
Newcastle University · GBQueen's University Belfast · GBRoyal Victoria Infirmary · GBSunderland Eye Infirmary · GBRoyal Liverpool University Hospital · GB

Funding

Alcon IIS (IIT#38075469)
6 · The paper itself

Abstract

purposeTo 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.

methodsWe 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.

resultsThe 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.

conclusionsThe 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.

Indexed as

Epiretinal MembraneRetinal PerforationsBasement MembraneHumansRetinaRetrospective StudiesTomography, Optical CoherenceVitrectomyDissociated optic nerve fibre layer lesionsFull-thickness macular holeInner retina defectsInternal limiting membraneInternal limiting membrane forcepsProof of concept randomised controlled trialSwelling of arcuate nerve fibre layer lesion

Identifiers

PMID36512088
PMCPMC10198899
OpenAlexW4311230341

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.