A randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery for open globe trauma - the ASCOT study

D. G  Charteris; Suzie Cro; Edward J. Casswell; Rhiannon Tudor Edwards; Victory Ezeofor; Bethany Anthony; Catey Bunce; Robertson Elizabeth; Joanna Kelly; Caroline Murphy; Philip J. Banerjee; V. R  Cornelius

doi:10.3310/GNBJ1387

A randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery for open globe trauma - the ASCOT study

D. G Charteris
, Suzie Cro
, Edward J. Casswell
, Rhiannon Tudor Edwards
, Victory Ezeofor
, Bethany Anthony
, Catey Bunce
, Robertson Elizabeth
, Joanna Kelly
, Caroline Murphy
, Philip J. Banerjee
, V. R Cornelius

Ysgol Gwyddorau Iechyd

Moorfields Eye Hospital
Grand Challenges in Ecosystem and the Environment Initiative, Imperial College London, Silwood Park Campus, Ascot, Berkshire SL5 7PY, UK [email protected].
Research Data and Statistics Unit (RDSU), Royal Marsden NHS Foundation Trust, London, UK
Kings College London
Frimley Park Hospital, Camberley, UK

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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.

Iaith wreiddiol	Saesneg
Tudalennau (o-i)	1-50
Cyfnodolyn	Health Technology Assessment
Cyfrol	27
Rhif cyhoeddi	12
Dynodwyr Gwrthrych Digidol (DOIs)	https://doi.org/10.3310/GNBJ1387
Statws	Cyhoeddwyd - 1 Gorff 2023

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Charteris, D. G., Cro, S., Casswell, E. J., Edwards, R. T., Ezeofor, V., Anthony, B., Bunce, C., Elizabeth, R., Kelly, J., Murphy, C., Banerjee, P. J., & Cornelius, V. R. (2023). A randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery for open globe trauma - the ASCOT study. Health Technology Assessment, 27(12), 1-50. https://doi.org/10.3310/GNBJ1387

@article{bd1ce899f89a4196a8c8984e7026143f,

title = "A randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery for open globe trauma - the ASCOT study",

abstract = "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{\textendash}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.",

author = "Charteris, \{D. G\} and Suzie Cro and Casswell, \{Edward J.\} and Edwards, \{Rhiannon Tudor\} and Victory Ezeofor and Bethany Anthony and Catey Bunce and Robertson Elizabeth and Joanna Kelly and Caroline Murphy and Banerjee, \{Philip J.\} and Cornelius, \{V. R\}",

year = "2023",

month = jul,

day = "1",

doi = "10.3310/GNBJ1387",

language = "English",

volume = "27",

pages = "1--50",

journal = "Health Technology Assessment",

issn = "1366-5278",

publisher = "NIHR Journals Library",

number = "12",

}

Charteris, DG, Cro, S, Casswell, EJ, Edwards, RT , Ezeofor, V , Anthony, B, Bunce, C, Elizabeth, R, Kelly, J, Murphy, C, Banerjee, PJ & Cornelius, VR 2023, 'A randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery for open globe trauma - the ASCOT study', Health Technology Assessment, cyfrol. 27, rhif 12, tt. 1-50. https://doi.org/10.3310/GNBJ1387

TY - JOUR

T1 - A randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery for open globe trauma - the ASCOT study

AU - Charteris, D. G

AU - Cro, Suzie

AU - Casswell, Edward J.

AU - Edwards, Rhiannon Tudor

AU - Ezeofor, Victory

AU - Anthony, Bethany

AU - Bunce, Catey

AU - Elizabeth, Robertson

AU - Kelly, Joanna

AU - Murphy, Caroline

AU - Banerjee, Philip J.

AU - Cornelius, V. R

PY - 2023/7/1

Y1 - 2023/7/1

N2 - 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.

AB - 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.

U2 - 10.3310/GNBJ1387

DO - 10.3310/GNBJ1387

M3 - Article

SN - 1366-5278

VL - 27

SP - 1

EP - 50

JO - Health Technology Assessment

JF - Health Technology Assessment

IS - 12

ER -

A randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery for open globe trauma - the ASCOT study

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