Abstract
BackgroundEyes 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/designPatients 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.DiscussionThis 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 No2007/005138/35
Highlights
Eyes sustaining open globe trauma (OGT) is a group at high risk of severe visual impairment
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
Projected Trial End - November 2013 Trial Duration - 24 months Duration of patient’s participation - 6 months. This pilot randomized controlled trial investigating the use of intensive antiinflammatory agents will be the first to evaluate their role as an adjunctive agent in patients undergoing vitrectomy surgery following open globe trauma
Summary
Eyes sustaining open globe trauma (OGT) is a group at high risk of severe visual impairment. Ocular trauma is the commonest cause of unilateral blindness in the world today and in developing countries the high incidence of ocular trauma has extensive socioeconomic costs [4]. It is clear from recent published data that vitreoretinal surgical techniques have improved, outcomes remain unsatisfactory and that the development of proliferative vitreoretinopathy (PVR) is the leading cause of this [6,7,8,9]. Proliferative vitreoretinopathy Eyes sustaining penetrating or open globe trauma (OGT) are a group at high risk of severe visual impairment. It is estimated to occur in 10-45% of all OGTs [5,6,7,8,9,10,11,12,13]
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