PURPOSE: To investigate the feasibility of conducting a randomised controlled trial in patients undergoing parsplana vitrectomy surgery following open globe trauma (OGT). Additionally, to investigate the treatment effect and toxicity of intensive anti-inflammatory agents. METHODS: A 2-year, pilot, single-centre prospective, participant and surgeon-masked randomised controlled trial (RCT). Forty patients requiring vitrectomy surgery following OGT were randomised to either standard (control) or study treatment (adjuncts) in a 1:1 allocation ratio. Perioperatively, the adjunct group received intravitreal and subtenons triamcinolone acetonide, oral flurbiprofen and guttae prednisolone acetate 1%. The control group received standard care. Primary outcome was anatomical success at 6 months. Secondary outcomes included final visual acuity, occurrence of proliferative vitreoretinopathy, intraocular pressure rise, number of operations and recruitment rate. RESULTS:40 patients were recruited within 21 months. Primary outcome assessment showed similar results in anatomical success with 50% (10/20) in the adjunct group compared with 47% (9/19) in the standard group (OR 1.11, 95% CI 0.316 to 3.904). Visual outcomes were better in the adjunct group with a final median visual acuity of 31 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with 25 ETDRS letters in the standard group. A higher proportion of patients gained 10, 20 and 30 ETDRS letters in the adjunct group (80%, 65% and 50%, respectively) compared with the standard group (52.6%, 52.6% and 42.1%). Fewer adjunct patients (15%, n=3) had poor visual outcomes (Zero ETDRS letters) compared with 42.1%, (n=8). CONCLUSIONS: An RCT in this population is deliverable and estimated recruitment rates are realistic. Results and patient discussions determined that the definitive study should have vision as a primary outcome. This pilot study is supportive of there being a positive treatment effect of intensive anti-inflammatory agents in OGT. TRIAL REGISTRATION NUMBER: European Clinical Trials Database 2007-005138-35; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
RCT Entities:
PURPOSE: To investigate the feasibility of conducting a randomised controlled trial in patients undergoing pars plana vitrectomy surgery following open globe trauma (OGT). Additionally, to investigate the treatment effect and toxicity of intensive anti-inflammatory agents. METHODS: A 2-year, pilot, single-centre prospective, participant and surgeon-masked randomised controlled trial (RCT). Forty patients requiring vitrectomy surgery following OGT were randomised to either standard (control) or study treatment (adjuncts) in a 1:1 allocation ratio. Perioperatively, the adjunct group received intravitreal and subtenons triamcinolone acetonide, oral flurbiprofen and guttae prednisolone acetate 1%. The control group received standard care. Primary outcome was anatomical success at 6 months. Secondary outcomes included final visual acuity, occurrence of proliferative vitreoretinopathy, intraocular pressure rise, number of operations and recruitment rate. RESULTS: 40 patients were recruited within 21 months. Primary outcome assessment showed similar results in anatomical success with 50% (10/20) in the adjunct group compared with 47% (9/19) in the standard group (OR 1.11, 95% CI 0.316 to 3.904). Visual outcomes were better in the adjunct group with a final median visual acuity of 31 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with 25 ETDRS letters in the standard group. A higher proportion of patients gained 10, 20 and 30 ETDRS letters in the adjunct group (80%, 65% and 50%, respectively) compared with the standard group (52.6%, 52.6% and 42.1%). Fewer adjunct patients (15%, n=3) had poor visual outcomes (Zero ETDRS letters) compared with 42.1%, (n=8). CONCLUSIONS: An RCT in this population is deliverable and estimated recruitment rates are realistic. Results and patient discussions determined that the definitive study should have vision as a primary outcome. This pilot study is supportive of there being a positive treatment effect of intensive anti-inflammatory agents in OGT. TRIAL REGISTRATION NUMBER: European Clinical Trials Database 2007-005138-35; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Entities:
Keywords:
Eye (Globe); Inflammation; Trauma; Treatment Surgery
Authors: Philip J Banerjee; Victoria R Cornelius; Rachel Phillips; Jessica W Lo; Catey Bunce; Joanna Kelly; Caroline Murphy; Rhiannon Tudor Edwards; Elizabeth L Robertson; David G Charteris Journal: Trials Date: 2016-07-22 Impact factor: 2.279