Randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery following open globe trauma: The ASCOT study.

Autor:	Casswell EJ; Sussex Eye Hospital, Brighton, UK edcasswell@hotmail.com.; Ophthalmology, University Hospitals Sussex NHS Foundation Trust, Worthing, UK.; Vitreoretinal Department, Moorfields Eye Hospital, London, UK., Cro S; Imperial Clinical Trials Unit, Imperial College London, London, UK., Cornelius VR; Imperial Clinical Trials Unit, Imperial College London, London, UK., Banerjee PJ; Vitreoretinal Department, Moorfields Eye Hospital, London, UK.; Ophthalmology, Frimley Health NHS Foundation Trust, Frimley, UK., Zvobgo TM; Vitreoretinal Department, Moorfields Eye Hospital, London, UK.; NIHR Moorfields Biomedical Research Centre, London, UK., Tudor Edwards R; Centre for Health Economics & Medicines Evaluation, Bangor University, Bangor, UK., Ezeofor V; Centre for Health Economics & Medicines Evaluation, Bangor University, Bangor, UK., Anthony B; Centre for Health Economics & Medicines Evaluation, Bangor University, Bangor, UK., Shahid SM; Vitreoretinal Department, Moorfields Eye Hospital, London, UK.; Ophthalmology, William Harvey Hospital, East Kent University Hospitals NHS Trust, UK., Bunce C; RM CTU, Royal Marsden Hospital NHS Trust, London, UK., Kelly J; King's Clinical Trials Unit, King's College London, London, UK., Murphy C; King's Clinical Trials Unit, King's College London, London, UK., Robertson E; Vitreoretinal Department, Moorfields Eye Hospital, London, UK., Charteris D; Vitreoretinal Department, Moorfields Eye Hospital, London, UK.; NIHR Moorfields Biomedical Research Centre, London, UK.
Jazyk:	angličtina
Zdroj:	The British journal of ophthalmology [Br J Ophthalmol] 2024 Feb 21; Vol. 108 (3), pp. 440-448. Date of Electronic Publication: 2024 Feb 21.
DOI:	10.1136/bjo-2022-322787
Abstrakt:	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. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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