BACKGROUND: Uveal melanoma is the most common primary intraocular malignancy. Plaque radiation (brachytherapy) has emerged as the most common treatment in the current management of uveal melanoma, but is complicated by visual loss in close to 70% of patients at 10 years follow-up. Strategies for the prevention and early treatment of radiation retinopathy (and radiation maculopathy in particular) need to be developed to improve visual outcome following eye-conserving treatment of uveal melanoma. Triamcinolone, a long acting locally-administered corticosteroid, is of established benefit in macular oedema from other causes.
PURPOSE: This study will evaluate the efficacy of sub-Tenon triamcinolone in the prevention of radiation maculopathy in patients undergoing plaque radiotherapy for uveal melanoma.
DESIGN: A prospective randomised control study.
STUDY POPULATION: 170 patients undergoing plaque radiation treatment for uveal melanoma.
SETTING: Ocular Oncology Service, Wills Eye Hospital, Philadelphia, USA.
INTERVENTION: Triamcinolone acetonide (40 mg in 1 cc) injected into the sub-Tenon space using sterile technique at the time of plaque radiotherapy and 4 and 8 months later.
OUTCOME MEASURES: Visual acuity, optical coherence tomographic (OCT) analysis of macular architecture and foveal thickness, at 4, 8, and 12 months following brachytherapy.
EXCLUSION CRITERIA: Pre-existing macular disease (e.g. age-related macular degeneration, diabetic maculopathy, vascular occlusion, macular hole); prior retinal detachment; media opacities precluding accurate OCT imaging; history of intraocular pressure elevation related to corticosteroid treatment -'steroid responder'; history of glaucoma.
