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Adjunctive Steroid Combination in Ocular Trauma (ASCOT) Study: A phase 3 multi-centre double-masked randomised controlled trial of adjunctive intraocular and periocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma

Funder

NIHR – Health Technology Assessment (HTA)

Webpage

UKCRN page http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=17226

Registration number

ISRCTN: 30012492;
EudraCT: 2014-002193-37

Collaborating Investigators/Institutions:

Mr. David G Charteris, Moorfields Eye Hospital

Project Summary

The ASCOT study is a phase 3, double-masked, randomised, multi-site trial in patients undergoing pars plana vitrectomy following open globe trauma with an internal pilot. This study aims to test the hypothesis that adjunctive triamcinolone acetonide, given at the time of surgery, can improve the outcome of vitreoretinal surgery for open-globe ocular trauma.  The study will specifically analyse the influence of the study intervention on visual acuity, the incidence of retinal detachment and the development of scarring (proliferative vitreoretinopathy) in patients with open globe trauma. Quality of life assessment will be undertaken on the study patients and a cost-effectiveness analysis carried out. In total 300 patients will be recruited and randomly allocated to two treatment arms from 20 sites throughout the U.K. The primary outcome will be best corrected visual acuity measured at 6 months. 

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