PT  - JOURNAL ARTICLE
AU  - Edward J Casswell
AU  - Suzie Cro
AU  - Victoria R Cornelius
AU  - Philip J Banerjee
AU  - Tapiwa M Zvobgo
AU  - Rhiannon Tudor Edwards
AU  - Victory Ezeofor
AU  - Bethany Anthony
AU  - Syed Mohammed Shahid
AU  - Catey Bunce
AU  - Joanna Kelly
AU  - Caroline Murphy
AU  - Elizabeth Robertson
AU  - David Charteris
ED  - ,
TI  - Randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery following open globe trauma: The ASCOT study
AID  - 10.1136/bjo-2022-322787
DP  - 2024 Mar 01
TA  - British Journal of Ophthalmology
PG  - 440--448
VI  - 108
IP  - 3
4099  - http://bjo.bmj.com/content/108/3/440.short
4100  - http://bjo.bmj.com/content/108/3/440.full
SO  - Br J Ophthalmol2024 Mar 01; 108
AB  - 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.Data are available upon reasonable request. Data requests would need to be assessed by the Moorfields Eye Hospital Research Managers to ensure any data shared complies with Data Protection laws.