Thrombolytic therapy for central retinal vein occlusion: results of a pilot study.
OBJECTIVE
To evaluate the feasibility of conducting a randomized, controlled trial of thrombolytic therapy for central retinal vein occlusion (CRVO) using tissue plasminogen activator (TPA); to establish relative efficacy and safety of various dosing regimens.


METHODS
Ninety-six patients with CRVO were treated with TPA between May 1986 and December 1992. Prior to patient enrollment, a standardized, detailed protocol was developed for evaluation and treatment of all patients. This included standard protocols for determining eligibility, reporting complications, performing photography and electroretinography, and measuring visual acuity.


METHODS
Best corrected visual acuity at 6 months, systemic and ophthalmic treatment complications.


RESULTS
At 6 months' follow-up, 42% (n = 89) of eyes gained three or more lines of vision from pretreatment levels (average gain, 5.1 lines), 37% remained stable, and 21% lost three or more lines. Of eyes with 20/100 or worse pretreatment vision (n = 32), 59% gained three or more lines vision (average gain, 6.4 lines), 31% remained stable, and 9% lost three or more lines. One patient suffered a fatal stroke. Three patients developed intraocular bleeding during TPA administration.


CONCLUSIONS
Thromobolytic therapy with TPA appears to be a promising, albeit risky, new treatment; conclusive evaluation of safety and efficacy awaits a multicenter, randomized, clinical trial; feasibility of such a trial has been established by this study.
Elman
M J
MJ
D000328:Adult; D000368:Aged; D005240:Feasibility Studies; D005260:Female; D005451:Fluorescein Angiography; D005654:Fundus Oculi; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010960:Plasminogen Activators / Q000009:adverse effects / Q000627:therapeutic use*; D012169:Retinal Vein / Q000473:pathology / Q000503:physiopathology; D012170:Retinal Vein Occlusion / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D015912:Thrombolytic Therapy; D010959:Tissue Plasminogen Activator / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
D010960:Plasminogen Activators; D010959:Tissue Plasminogen Activator