Journal Article

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

Schultz, David, Casswell, Edward J, Tudor Edwards, Rhiannon, Smith, Jonathan, Zvobgo, Tapiwa M, Gandhewa, Ravikiran, MacLaren, Robert, Frimpong-Ansah, Fred, Murphy, Caroline, Poulson, Arabella, Charteris, David, Pearce, Ian, Zakir, Rahila, Vaideanu-Collins, Daniela, Laidlaw, Alistair, Banerjee, Philip J, Mitra, Arijit, Jackson, Tim, Costen, Mark, Bunce, Catey, Ramkissoon, Yash, Dhawahir-Scala, Felipe, Hillier, Roxane, Cro, Suzie, Membrey, Luke, Kelly, Joanna, Yang, Fung, Chandra, Aman, Cornelius, Victoria R, Shahid, Syed Mohammed, Haynes, Richard, Yorston, David, Anthony, Bethany, Robertson, Elizabeth, Singh, Jas, Balaggan, Kam, Bindra, Mandeep, Ezeofor, Victory, McKechnie, Cordelia

2024

Overview

Background/aimsTo investigate the clinical effectiveness of adjunctive triamcinolone acetonide (TA) given at the time of vitreoretinal surgery following open globe trauma (OGT).MethodsA 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.Results280 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.ConclusionThe use of combined intraocular and sub-Tenons capsule TA is not recommended as an adjunct to vitrectomy surgery following OGT.Trial registration number NCT02873026.

• Publisher: BMJ Publishing Group Ltd,BMJ Publishing Group LTD
• Subject: Consent / Diabetic retinopathy / Diabetic Retinopathy - complications / Drug therapy / Eye Injuries - complications / Eye surgery / Glucocorticoids - therapeutic use / Humans / Quality of Life / Retina / Retinal detachment / Retinal Detachment - complications / Retinal Detachment - drug therapy / Retinal Detachment - surgery / Statistical analysis / Steroids / Surgeons / Trauma / Treatment Outcome / Triamcinolone Acetonide - therapeutic use / Vitrectomy / Vitreoretinal Surgery - adverse effects / Vitreous