Evidence map›Paper›PMID 27484082›Full record

Trial reportTrials2016

A phase III, multi-centre, double-masked randomised controlled trial of adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): statistical analysis plan.

Jessica W Lo, Catey Bunce, David Charteris, Philip Banerjee, Rachel Phillips, Victoria R Cornelius

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.6field-weighted citation impact, top 28% 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

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Prophylactic chorioretinectomy in deadly weapon-related open globe injuries.Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES · 2026
    Article
  4. Review
  5. Article
  6. 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

6 authors at 5 institutions in 1 country.

Jessica W LoDepartment of Primary Care and Public Health Sciences, King's College London, 4th Floor Addison House, Guy's Campus, London, SE1 1UL, UK.
Catey BunceMoorfields Eye Hospital NHS Foundation Trust, City Road, London, EC1V 2PD, UK.
David CharterisMoorfields Eye Hospital NHS Foundation Trust, City Road, London, EC1V 2PD, UK.
Philip BanerjeeMoorfields Eye Hospital NHS Foundation Trust, City Road, London, EC1V 2PD, UK.
Rachel PhillipsDepartment of Primary Care and Public Health Sciences, King's College London, 4th Floor Addison House, Guy's Campus, London, SE1 1UL, UK.
Victoria R CorneliusImperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK. v.cornelius@imperial.ac.uk.
University College London · GBGuy's and St Thomas' NHS Foundation Trust · GBImperial College London · GBKing's College London · GBMoorfields Eye Hospital NHS Foundation Trust · GB

Funding

Department of Health 12/35/64
6 · The paper itself

Abstract

backgroundOpen globe ocular trauma complicated by intraocular scarring (proliferative vitreoretinopathy) is a relatively rare, blinding, but potentially treatable condition for which, at present, surgery is often unsatisfactory and visual results frequently poor. To date, no pharmacological adjuncts to surgery have been proven to be effective. The aim of the Adjunctive Steroid Combination in Ocular Trauma (ASCOT) randomised controlled trial is to determine whether adjunctive steroid (triamcinolone acetonide), given at the time of surgery, can improve the outcome of vitreoretinal surgery in patients with open globe ocular trauma. This article presents the statistical analysis plan for the main publication as approved and signed off by the Trial Steering Committee prior to the first data extraction for the Data Monitoring Committee meeting report. METHODS/

designASCOT is a pragmatic, multi-centre, parallel-group, double-masked randomised controlled trial. The aim of the study is to recruit from 20-25 centres in the United Kingdom and randomise 300 eyes (from 300 patients) into two treatment arms. Both groups will receive standard surgical treatment and care; the intervention arm will additionally receive a pre-operative steroid combination (triamcinolone acetonide) into the vitreous cavity consisting of 4 mg/0.1 ml and 40 mg/1 ml sub-Tenon's. Participants will be followed for 6 months post-surgery. The primary outcome is the proportion of patients achieving a clinically meaning improvement in visual acuity in the study eye at 6 months after initial surgery, defined as a 10 letter score improvement in the ETDRS (the standard scale to test visual acuity).

trial registrationISRCTN30012492 . Registered on 5 September 2014. EudraCT2014-002193-37 . Registered on 5 September 2014.

Indexed as

Models, StatisticalVitrectomyVitreoretinal SurgeryAdministration, OphthalmicChemotherapy, AdjuvantClinical ProtocolsData Interpretation, StatisticalDouble-Blind MethodEye InjuriesGlucocorticoidsHumansRecovery of FunctionResearch DesignTime FactorsTreatment OutcomeTriamcinolone AcetonideGlucocorticoidsTriamcinolone AcetonideOpen globe traumaRandomised controlled trialRetinaStatistical analysis planTriamcinolone acetonide

Identifiers

PMID27484082
PMCPMC4970240
OpenAlexW2486122905

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.