Background: Proliferative vitreoretinopathy (PVR) is the commonest cause of late anatomical failure in rhegmatogenous\r\nretinal detachment. Visual and anatomical outcomes remain poor despite advances in vitreoretinal surgical techniques\r\nwith reported primary failure rates of up to nearly 50%. Numerous adjunctive medications have been evaluated in\r\nclinical trials with no agent gaining widespread acceptance and use.\r\nThis study was designed to investigate the benefits of using a slow-release dexamethasone implant delivered\r\nintra-operatively in patients undergoing vitrectomy surgery for retinal detachment with established PVR.\r\nMethods/design: For the study, 140 patients requiring vitrectomy surgery with silicone oil for retinal detachment\r\nwith established PVR will be randomised to receive either standard treatment or study treatment in a 1:1 treatment\r\nallocation ratio. Both groups will receive the standard surgical treatment appropriate for their eye condition and routine\r\nperi-operative treatment and care, differing only in the addition of the supplementary adjunctive agent in the\r\ntreatment group. The investigated primary outcome measure is stable retinal reattachment with removal of silicone\r\noil without additional vitreoretinal surgical intervention at 6 months.\r\nDiscussion: This is the first randomised controlled clinical trial to investigate the use of an adjunctive slow-release\r\ndexamethasone implant in patients undergoing vitrectomy surgery for retinal detachments with proliferative\r\nvitreoretinopathy.
Loading....