Evidence map›Paper›PMID 37840322›Full record

Trial reportHealth technology assessment (Winchester, England)2023

A randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery for open globe trauma - the ASCOT study.

David G Charteris, Suzie Cro, Edward Casswell, Rhiannon Tudor Edwards, Victory Ezeofor, Bethany Anthony, Catey Bunce, Elizabeth Robertson, Joanna Kelly, Caroline Murphy and 2 more

Open access · diamondAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Health technology assessment (Winchester, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.0field-weighted citation impact, top 14% 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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
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

12 authors at 6 institutions in 1 country.

David G CharterisMoorfields Eye Hospital NHS Foundation Trust, London, UK.ORCID 0000-0001-6267-4180
Suzie CroImperial College Clinical Trials Unit, Imperial College London, London, UK.ORCID 0000-0002-6113-1173
Edward CasswellMoorfields Eye Hospital NHS Foundation Trust, London, UK.ORCID 0000-0002-8837-9910
Rhiannon Tudor EdwardsCentre for Health Economics and Medicines Evaluation, School of Medical and Health Sciences, Bangor University, Gwynedd, UK.ORCID 0000-0003-4748-5730
Victory EzeoforCentre for Health Economics and Medicines Evaluation, School of Medical and Health Sciences, Bangor University, Gwynedd, UK.ORCID 0000-0002-4211-8942
Bethany AnthonyCentre for Health Economics and Medicines Evaluation, School of Medical and Health Sciences, Bangor University, Gwynedd, UK.ORCID 0000-0002-2593-1069
Catey BunceResearch Data and Statistics Unit (RDSU), Royal Marsden NHS Foundation Trust, London, UK.ORCID 0000-0002-0935-3713
Elizabeth RobertsonMoorfields Eye Hospital NHS Foundation Trust, London, UK.ORCID 0000-0002-2880-2086
Joanna KellyKing's Clinical Trial Unit, Research Management and Innovation Directorate, Institute of Psychiatry, Kings College, London, UK.ORCID 0000-0002-4389-5284
Caroline MurphyKing's Clinical Trial Unit, Research Management and Innovation Directorate, Institute of Psychiatry, Kings College, London, UK.ORCID 0000-0001-7547-8998
Philip BanerjeeFrimley Park Hospital, Camberley, UK.ORCID 0000-0001-6687-426X
Victoria R CorneliusImperial College Clinical Trials Unit, Imperial College London, London, UK.ORCID 0000-0002-0080-1065
Bangor University · GBMoorfields Eye Hospital NHS Foundation Trust · GBImperial College London · GBKing's College London · GBFrimley Park Hospital · GBRoyal Marsden NHS Foundation Trust · GB

Funding

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

Abstract

Background: Eyes sustaining open globe trauma are at high risk of severe visual impairment. Proliferative vitreoretinopathy is the most common cause of retinal detachment and visual loss in eyes with open globe trauma. There is evidence from experimental studies and pilot clinical trials that the use of adjunctive steroid medication triamcinolone acetonide can reduce the incidence of proliferative vitreoretinopathy and improve outcomes of surgery for open globe trauma. Objective: The Adjunctive Steroid Combination in Ocular Trauma or ASCOT study aimed to investigate the clinical effectiveness of adjunctive triamcinolone acetonide given at the time of vitreoretinal surgery for open globe trauma. Design: A phase 3 multicentre double-masked randomised controlled trial randomising patients undergoing vitrectomy following open globe trauma to either adjunctive triamcinolone acetonide or standard care. Setting: Hospital vitreoretinal surgical services dealing with open globe trauma. Participants: Patients undergoing vitrectomy surgery who had sustained open globe trauma. Interventions: Triamcinolone acetonide 4 mg/0.1 ml into the vitreous cavity and 40 mg/1 ml sub-Tenon's or standard vitreoretinal surgery and postoperative care. Main outcome measures: The primary outcome was the proportion of patients with at least 10 letters of improvement in corrected visual acuity at six months. Secondary outcomes included retinal detachment secondary to proliferative vitreoretinopathy, retinal reattachment, macula reattachment, tractional retinal detachment, number of operations, hypotony, elevated intraocular pressure and quality of life. Health-related quality of life was assessed using the EuroQol Five Domain and Visual Function Questionnaire 25 questionnaires. Results: A total of 280 patients were randomised; 129 were analysed from the control group and 130 from the treatment group. The treatment group appeared, by chance, to have more severe pathology on presentation. The primary outcome (improvement in visual acuity) and principal secondary outcome (change in visual acuity) did not demonstrate any treatment benefit for triamcinolone acetonide. The proportion of patients with improvement in visual acuity was 47% for triamcinolone acetonide and 43% for standard care (odds ratio 1.03, 95% confidence interval 0.61 to 1.75, Conclusions: The use of combined intraocular and sub-Tenon's capsule triamcinolone acetonide is not recommended as an adjunct to vitrectomy surgery for intraocular trauma. Secondary outcome measures are suggestive of a negative effect of the adjunct, although the treatment group appeared to have more severe pathology on presentation. Future work: The use of alternative adjunctive medications in cases undergoing surgery for open globe trauma should be investigated. Refinement of clinical grading and case selection will enable better trail design for future studies. Trial registration: This trial is registered as ISRCTN 30012492, EudraCT number 2014-002193-37, REC 14/LNO/1428, IRAS 156358, Local R&D registration CHAD 1031. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (12/35/64) and will be published in full in

Indexed as

Retinal DetachmentVitreoretinal SurgeryVitreoretinopathy, ProliferativeGlucocorticoidsHumansQuality of LifeTriamcinolone AcetonideGlucocorticoidsTriamcinolone AcetonideOCULAR TRAUMAPROLIFERATIVE VITREORETINOPATHYTRIAMCINOLONE ACETONIDEVITRECTOMY

Identifiers

PMID37840322
PMCPMC10591211
OpenAlexW4387662036

What OpenQuestion holds

Textmetadata
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.