Study of the efficacy of intravenous tissue plasminogen activator in central retinal artery occlusion.

RATIONALE: Central retinal artery occlusion is a stroke of the eye caused by a blockage of its main blood supply by platelet-fibrin clot. Systemic thrombolysis has been successful in restoring perfusion to ischaemic tissue by fibrin-platelet clot lysis in ischaemic stroke and myocardial infarction. Several open-label studies have demonstrated efficacy of thrombolysis in the treatment of central retinal artery occlusion, with up to 60-70% of treated subjects experiencing an improvement in visual acuity. Most of these are given intraarterially, which is an invasive procedure and not widely applicable to all treatment centres. An alternative is the intravenous infusion of tissue plasminogen activator using existing stroke thrombolysis protocols. A systematic review of all observational studies of intravenous tissue plasminogen activator in acute central retinal artery occlusion showed that 48·5% of subjects had a four line or more visual acuity improvement with an acceptable rate of haemorrhagic complications, creating the equipoise necessary to conduct a randomised controlled trial. AIM: To determine the efficacy of intravenous thrombolysis in acute treatment of central retinal artery occlusion.
DESIGN: A phase II, placebo-controlled, double-blind, randomised controlled trial comparing intravenous tissue plasminogen activator at 0·9 mg/kg to placebo (normal saline) 100 ml in a 1:1 block randomisation. STUDY OUTCOME: The primary outcome measure is an improvement of three lines or more on the Snellen visual acuity chart, which signifies a doubling of the visual angle.

RCT Entities:   Population Interventions Outcomes