Randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery following open globe trauma: the ASCOT study
File(s)ASCOT BJO Revision Clean 5 1 23.docx (92.67 KB)
Accepted version
Author(s)
Type
Journal Article
Abstract
BACKGROUND/AIMS: To investigate the clinical effectiveness of adjunctive triamcinolone acetonide (TA) given at the time of vitreoretinal surgery following open globe trauma (OGT). METHODS: A phase 3, multicentre, double-masked randomised controlled trial of patients undergoing vitrectomy following OGT comparing adjunctive TA (intravitreal and subtenons) against standard care (2014-2020). The primary outcome was the proportion of patients with at least 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letter improvement in corrected visual acuity (VA) at 6 months. Secondary outcomes included: change in ETDRS, retinal detachment (RD) secondary to PVR, retinal reattachment, macular reattachment, tractional RD, number of operations, hypotony, elevated intraocular pressure and quality of life. RESULTS: 280 patients were randomised over 75 months, of which 259 completed the study. 46.9% (n=61/130) of patients in the treatment group had a 10-letter improvement in VA compared with 43.4% (n=56/129) of the control group (difference 3.5% (95% CI -8.6% to 15.6%), OR=1.03 (95% CI 0.61 to 1.75), p=0.908)). Secondary outcome measures also failed to show any treatment benefit. For two of the secondary outcome measures, stable complete retinal and macular reattachment, outcomes were worse in the treatment group compared with controls, respectively, 51.6% (n=65/126) vs 64.2% (n=79/123), OR=0.59 (95% CI 0.36 to 0.99), and 54.0% (n=68/126) vs 66.7% (n=82/123), OR=0.59 (95% CI 0.35 to 0.98), for TA vs control. CONCLUSION: The use of combined intraocular and sub-Tenons capsule TA is not recommended as an adjunct to vitrectomy surgery following OGT. TRIAL REGISTRATION NUMBER: NCT02873026.
Date Issued
2024-02-21
Date Acceptance
2023-02-15
Citation
British Journal of Ophthalmology, 2024, 108 (3), pp.440-448
ISSN
0007-1161
Publisher
BMJ Publishing Group
Start Page
440
End Page
448
Journal / Book Title
British Journal of Ophthalmology
Volume
108
Issue
3
Copyright Statement
Copyright © 2023 The Author(s). This article has been accepted for publication in British Journal of Ophthalmology following peer review, and the Version of Record can be accessed online at http://dx.doi.org/10.1136/bjo-2022-322787
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/36849205
PII: bjo-2022-322787
Subjects
Retina
Trauma
Vitreous
Publication Status
Published
Coverage Spatial
England
Date Publish Online
2023-02-27