Adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): study protocol for a phase III, multi-centre, double-masked randomised controlled trial.

BACKGROUND: Eyes sustaining open globe trauma are at high risk of severe visual impairment. Ocular injuries which result in visual loss invariably affect the posterior segment of the eye, and prevention of visual loss involves posterior segment (vitreoretinal) surgery. Despite improvements in vitreoretinal surgical techniques, outcomes in these patients remain unsatisfactory, and development of the intraocular scarring response proliferative vitreoretinopathy is the leading cause. Proliferative vitreoretinopathy is the most common cause of recurrent retinal detachment in these eyes; it is reported to occur in up to 45 % of cases. METHODS/DESIGN: The Adjunctive Steroid Combination in Ocular Trauma (ASCOT) trial is a multi-centre, double-masked, parallel-arm randomised controlled trial with an internal pilot designed to investigate the effectiveness and cost-effectiveness of using intravitreal and sub-Tenon's triamcinolone acetonide peri-operatively in patients undergoing vitrectomy following open globe trauma. In total, 300 eyes of 300 patients will be recruited and randomly allocated to one of two treatment groups. Both groups will receive standard surgical treatment and routine pre-operative and post-operative treatment and care. The treatment group will receive an adjunctive peri-operative steroid combination (triamcinolone acetonide) consisting of 4 mg/0.1 ml into the vitreous cavity and 40 mg/1 ml into the sub-Tenon's space. The trial incorporates a two-stage internal pilot to examine projected recruitment and retention rates. Progression criteria from the internal pilot study will enable us to determine whether to undertake the main trial. Patients and primary outcome assessors will be masked to treatment allocation. The primary outcome will be an improvement from baseline to 6 months of at least 10 on the corrected visual acuity as measured by ETDRS letter score. Secondary outcomes will be development of scarring, retinal detachment, intraocular pressure abnormalities, quality of life and public sector service use. DISCUSSION: This is the first powered, controlled clinical trial to investigate the use of adjunctive triamcinolone in patients undergoing vitrectomy following open globe trauma. TRIAL REGISTRATION: EudraCT2014-002193-37 . Registered on 5 September 2014. ISRCTN30012492 . Registered on 5 September 2014.

Resources involved in managing retinal detachment complicated by proliferative vitreoretinopathy.

PURPOSE: To report the differences in cost of treatment and outcome in retinal detachment (RD) cases with and without proliferative vitreoretinopathy (PVR). METHODS: Analysis of clinical trial databases of RD observed in 190 eyes of 190 patients. Eyes were classified as no PVR, developing PVR, or established PVR. For each eye, total cost of treatment undertaken on Moorfields Eye Hospital vitreoretinal unit, final retinal status, and best-corrected visual acuity were recorded. RESULTS: Management of patients who developed PVR involved approximately double the resources of RD without PVR. Eyes with pre-exiting PVR had similar resource input to those with RD without PVR. Patients who developed PVR had a mean of 3.7 operations (including subsequent cataract surgery) compared to 1.8 and 2.1 respectively for noncomplicated RD and pre-existing PVR. Anatomic success and visual outcome was significantly worse in eyes with PVR. CONCLUSIONS: Treatment of eyes that developed PVR after initial surgery cost significantly more than eyes with no PVR or established PVR (P < 0.01). Improvements in the management of RD aimed at preventing PVR and advances in PVR treatment may have significant financial as well as clinical benefits.

A cost-utility analysis of interventions for severe proliferative vitreoretinopathy.

PURPOSE: The purpose of this study was to report a reference case, patient preference-based, incremental, cost-utility analysis for treatments of retinal detachment associated with severe proliferative vitreoretinopathy (PVR). DESIGN: Computer-based economic model utilizing data from the Medicare health insurance system in the United States. METHODS: A cost-utility analysis compared vitreoretinal surgery using expanding gases and silicone oil therapy to the natural course of retinal detachment associated with severe PVR. The model applies long-term published visual data from the Silicone Study Group, time tradeoff utility analysis, decision analysis with Markov modeling, and discounting of costs and health benefits as per the Panel on Cost-Effectiveness in Health and Medicine. The major outcome measure was in year 2000 United States dollars per quality-adjusted life-year (dollars/QALY) gained. RESULTS: Vitreoretinal surgery for retinal detachment complicated by severe PVR, as compared with no treatment, resulted in a mean gain of 0.128-0.200 discounted (3% annual rate) quality-adjusted life-years per treated patient. Silicone oil (dollars/QALY gained of 40,252 dollars) was slightly more cost-effective than perfluoropropane (C(3)F(8)) gas (dollars/QALY gained of 46,926 dollars) in eyes with PVR without previous vitrectomy, whereas C(3)F(8) gas (dollars/QALY gained of 46,162 dollars) was more cost-effective than silicone oil (dollars/QALY gained of 62,383 dollars) with previous vitrectomy and PVR. Sensitivity analysis resulted in a dollars/QALY gained of 13,347 dollars when 10% of opposite eyes had a severe visual loss to 202,128 dollars when a discount rate of 10% was utilized and opposite eyes initially had good vision. CONCLUSIONS: The incremental expense of interventions for retinal detachment associated with PVR is cost-effective when compared with other widely accepted interventional therapies across diverse medical specialties.