A pilot study of intraocular use of intensive anti-inflammatory; triamcinolone acetonide to prevent proliferative vitreoretinopathy in eyes undergoing vitreoretinal surgery for open globe trauma; the Adjuncts in Ocular Trauma (AOT) Trial: study protocol for a randomised controlled trial.

BACKGROUND: Eyes sustaining open globe trauma (OGT) is a group at high risk of severe visual impairment. Proliferative vitreoretinopathy (PVR) is the commonest cause of retinal redetachment in these eyes and is reported to occur in up to 45% of cases. Intensive anti-inflammatory agents have been shown to be effective at modifying experimental PVR and to be well tolerated clinically.The Adjuncts in Ocular Trauma (AOT) Trial was designed to investigate the benefits of using intensive anti-inflammatory agents (intravitreal and sub-Tenon's triamcinolone, oral flurbiprofen and guttae prednisolone 1.0%) perioperatively in patients undergoing vitrectomy surgery following open globe trauma.

METHODS/DESIGN: Patients requiring posterior vitrectomy surgery following open globe trauma will be randomised to receive either standard treatment or study treatment. Both groups will receive the standard surgical treatment appropriate for their eye condition and routine perioperative treatment and care, differing only in the addition of supplementary adjunctive agents in the treatment group. The investigated primary outcome measure is anatomical success at 6 months in the absence of internal tamponade.

DISCUSSION: This is the first randomised controlled clinical trial to investigate the use of adjunctive intensive antiinflammatory agents in patients undergoing vitrectomy following open globe trauma. It will provide evidence for the role of these adjuncts in this group of patients, as well as provide data to power a definitive study. EUDRACT NO: 2007/005138/35.