TY - JOUR
T1 - Randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery following open globe trauma
T2 - The ASCOT study
AU - The ASCOT Investigator Study Group
AU - Casswell, Edward J.
AU - Cro, Suzie
AU - Cornelius, Victoria R.
AU - Banerjee, Philip J.
AU - Zvobgo, Tapiwa M.
AU - Edwards, Rhiannon Tudor
AU - Ezeofor, Victory
AU - Anthony, Bethany
AU - Shahid, Syed Mohammed
AU - Bunce, Catey
AU - Kelly, Joanna
AU - Murphy, Caroline
AU - Robertson, Elizabeth
AU - Charteris, David
AU - Mitra, Arijit
AU - Jackson, Tim
AU - Membrey, Luke
AU - Smith, Jonathan
AU - Poulson, Arabella
AU - Pearce, Ian
AU - Dhawahir-Scala, Felipe
AU - Ramkissoon, Yash
AU - Laidlaw, Alistair
AU - Vaideanu-Collins, Daniela
AU - Costen, Mark
AU - McKechnie, Cordelia
AU - Haynes, Richard
AU - Singh, Jas
AU - Yorston, David
AU - Zakir, Rahila
AU - Yang, Fung
AU - MacLaren, Robert
AU - Frimpong-Ansah, Fred
AU - Gandhewa, Ravikiran
AU - Chandra, Aman
AU - Balaggan, Kam
AU - Hillier, Roxane
AU - Schultz, David
AU - Bindra, Mandeep
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2024.
PY - 2023/2/27
Y1 - 2023/2/27
N2 - 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.
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.
UR - http://www.scopus.com/inward/record.url?scp=85152202357&partnerID=8YFLogxK
U2 - 10.1136/bjo-2022-322787
DO - 10.1136/bjo-2022-322787
M3 - Article
C2 - 36849205
AN - SCOPUS:85152202357
SN - 0007-1161
VL - 108
SP - 440
EP - 448
JO - British Journal of Ophthalmology
JF - British Journal of Ophthalmology
IS - 3
ER -