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

Abstract

BackgroundEyes 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/designThe 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.DiscussionThis is the first powered, controlled clinical trial to investigate the use of adjunctive triamcinolone in patients undergoing vitrectomy following open globe trauma.Trial registrationEudraCT2014-002193-37. Registered on 5 September 2014.ISRCTN30012492. Registered on 5 September 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1445-7) contains supplementary material, which is available to authorized users.

Slow-Release Dexamethasone in Proliferative Vitreoretinopathy

“…Furthermore, replacing anatomic primary outcomes with a visual outcome seems to be a plausible design for future vitreoretinal clinical trials and is strongly advocated by patient groups involved in protocol development. 12,47,48 Overall, we observed a higher number of AEs in the control group. There were fewer cases of postoperative uveitis in the adjunct group, perhaps indicative of the additional anti-inflammatory activity of the dexamethasone.…”

Surgical rehabilitation of terror-related open globe injuries in the Turkish Military: long-term results

“…Though there is one study designed to compare periocular steroid injections undergoing PPV in OGI 12. The mentioned study has not reported a conclusion about this issue yet 12. Even though high-dose therapy was not administered to the present subjects, this treatment approach in severely injured eyes is not supported by the reliable evidence and additional randomised clinical trials are needed.…”

“…Some authors recommend high-dose systemic steroids (eg, acute spinal cord injury)9 10 but some authors do not (eg, traumatic optic neuropathy)11 in a patient with trauma. Though there is one study designed to compare periocular steroid injections undergoing PPV in OGI 12. The mentioned study has not reported a conclusion about this issue yet 12.…”

A four-step strategy for handling missing outcome data in randomised trials affected by a pandemic

“…As an example, we consider the Adjunctive Steroid Combination in Ocular Trauma (ASCOT) trial, a pragmatic, double-blind, multi-centre randomised controlled trial testing whether adjunctive steroid (triamcinolone acetonide), given at the time of surgery for open globe trauma can improve the outcome of surgery [13]. Adults undergoing vitrectomy for open globe trauma were randomised to receive adjunctive intraocular and periocular steroid or standard treatment (no steroid) during surgery in a 1:1 ratio.…”