Abstract
BackgroundOpen globe ocular trauma complicated by intraocular scarring (proliferative vitreoretinopathy) is a relatively rare, blinding, but potentially treatable condition for which, at present, surgery is often unsatisfactory and visual results frequently poor. To date, no pharmacological adjuncts to surgery have been proven to be effective. The aim of the Adjunctive Steroid Combination in Ocular Trauma (ASCOT) randomised controlled trial is to determine whether adjunctive steroid (triamcinolone acetonide), given at the time of surgery, can improve the outcome of vitreoretinal surgery in patients with open globe ocular trauma. This article presents the statistical analysis plan for the main publication as approved and signed off by the Trial Steering Committee prior to the first data extraction for the Data Monitoring Committee meeting report.Methods/designASCOT is a pragmatic, multi-centre, parallel-group, double-masked randomised controlled trial. The aim of the study is to recruit from 20–25 centres in the United Kingdom and randomise 300 eyes (from 300 patients) into two treatment arms. Both groups will receive standard surgical treatment and care; the intervention arm will additionally receive a pre-operative steroid combination (triamcinolone acetonide) into the vitreous cavity consisting of 4 mg/0.1 ml and 40 mg/1 ml sub-Tenon’s. Participants will be followed for 6 months post-surgery. The primary outcome is the proportion of patients achieving a clinically meaning improvement in visual acuity in the study eye at 6 months after initial surgery, defined as a 10 letter score improvement in the ETDRS (the standard scale to test visual acuity).Trial registrationISRCTN30012492. Registered on 5 September 2014.EudraCT2014-002193-37. Registered on 5 September 2014.
Highlights
Open globe ocular trauma complicated by intraocular scarring is a relatively rare, blinding, but potentially treatable condition for which, at present, surgery is often unsatisfactory and visual results frequently poor
proliferative vitreoretinopathy (PVR) is the main cause of recurrent retinal detachment and visual loss in eyes with open globe trauma (OGT)
Experimental work has suggested that steroid treatment can reduce the severity of PVR [9] and that it appears to have no significant retinal toxicity [10]
Summary
Trauma is a major cause of visual impairment and blindness worldwide; in particular, it is the most common cause of unilateral blindness [1, 2]. 1.6 million people across the globe became blind as a result of ocular trauma, with up to 19 million living with unilateral blindness or low vision [2]. Ocular injuries invariably affect the posterior segment of the eye, and vitreoretinal surgery is required to prevent visual loss. Recent published results have shown that, vitreoretinal surgical techniques have improved, outcomes remain unsatisfactory, mainly due to the development of the intraocular scarring response proliferative vitreoretinopathy (PVR) [3,4,5,6]. PVR is the main cause of recurrent retinal detachment and visual loss in eyes with open globe trauma (OGT). Final retinal attachment may be achieved, multiple surgeries are often needed, and visual results remain very poor [7, 8]. Experimental work has suggested that steroid (triamcinolone acetonide) treatment can reduce the severity of PVR [9] and that it appears to have no significant retinal toxicity [10]
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