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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.
Trial registration number NCT02873026.
- Retina
- Trauma
- Vitreous
Data availability statement
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.
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Footnotes
Twitter @edwardcasswell, @Suzie_cro
Collaborators See Contributor Statement regarding ASCOT Investigator Study Group.
Contributors Design of work: SC, VRC, PJB, RTE, VE, CB, JK, CM, ER, DC; acquisition, analysis or interpretation of data for the work: EJC, SC, VRC, PJB, TMZ, RTE, VE, BA, SMS, CB, JK, CM, ER, DC. All authors were involved in the drafting and review of the manuscript as well as final approval. DC is the guarantor of the study and responsible for the overall content. The ASCOT Investigator Study Group served as non-author contributors/collaborators, who collected data and cared for study patients, namely: Mr Arijit Mitra (Birmingham and Midland Eye Centre (BMEC)), Prof Tim Jackson (Kings College Hospital London), Mr Luke Membrey (Maidstone and Tunbridge Wells NHS Trust), Mr Jonathan Smith (Sunderland Eye Infirmary), Ms Arabella Poulson (Addenbrookes Hospital, Cambridge), Prof Ian Pearce (St Pauls Eye Unit, Liverpool), Mr Felipe Dhawahir-Scala (Manchester Royal Eye Hospital), Mr Yash Ramkissoon (Royal Hallamshire Hospital, Sheffield), Mr Alistair Laidlaw (St Thomas’ Hospital London), Ms Daniela Vaideanu-Collins (South Tees Hospital NHS Trust), Mr Mark Costen (Hull University Teaching Hospitals), Ms Cordelia McKechnie (Whipps Cross Hospital London), Mr Richard Haynes (University Hospitals Bristol), Dr Jas Singh (Princess Alexandra Eye Pavilion, Edinburgh), Dr David Yorston (Tennent Institute of Ophthalmology, Glasgow), Ms Rahila Zakir (Western Eye Hospital London), Mr Fung Yang (Queen Alexandra Hospital Portsmouth), Prof Robert MacLaren (Oxford Eye Hospital), Mr Fred Frimpong-Ansah (Royal Eye Infirmary Plymouth), Mr Ravikiran Gandhewa (University Hospital, Derby), Mr Aman Chandra (Mid and South Essex NHS Foundation Trust), Mr Kam Balaggan (Royal Wolverhampton NHS Trust), Ms Roxane Hillier (Newcastle Upon Tyne NHS Foundation Trust), Mr David Schultz (East Kent Hospital NHS Foundation Trust), Mr Mandeep Bindra (Stoke Mandeville Hospital).
Funding This study was supported by the United Kingdom Clinical Research Collaboration-registered King's Clinical Trials Unit at King's Health Partners, which is in part funded by the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King's College London and the NIHR Evaluation, Trials and Studies Coordinating Centre. EJC was supported by the Royal College of Surgeons in Edinburgh and the Special Trustees of Moorfields Eye Hospital. CB is in part funded/supported by the National Institute for Health Research (NIHR) Biomedical Research Centre based at the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London. DC is supported by the National Institute for Health Research (NIHR) Biomedical Research Centre based at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology. These funding organisations had no role in the design or conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication.
Disclaimer The views expressed in this publication are those of the author(s) and not necessarily those of the RCSEd, Special Trustees, NHS, NIHR or Department of Health.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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