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Randomized Controlled Trial
. 2023 Jun 1;43(2):237-242.
doi: 10.1097/WNO.0000000000001654. Epub 2022 Jul 8.

FLUORESCE: A Pilot Randomized Clinical Trial of Fluoxetine for Vision Recovery After Acute Ischemic Stroke

Colleen L Schneider  1 , Emily K Prentiss, Ania Busza, Zoë R Williams, Bradford Z Mahon, Bogachan Sahin
Affiliations
Randomized Controlled Trial

FLUORESCE: A Pilot Randomized Clinical Trial of Fluoxetine for Vision Recovery After Acute Ischemic Stroke

Colleen L Schneider et al. J Neuroophthalmol. .

Abstract

Background: Poststroke homonymous hemianopia is disabling, and complete spontaneous recovery is rare. In this randomized, placebo-controlled, double-blind, pilot clinical trial, we tested whether fluoxetine enhances vision recovery after stroke.

Methods: We randomized 17 consecutive adults 1:1 to 90 days of fluoxetine 20 mg daily vs placebo within 10 days of an ischemic stroke causing isolated homonymous hemianopia. The primary end point was percent improvement in 24-2 automated perimetry at 6 months. Twelve participants completed the study. Clinical trial registration NCT02737930.

Results: Intention-to-treat analysis of the primary end point, percent improvement in perimetric mean deviation, showed a nonsignificant benefit of fluoxetine (64.4%, n = 5) compared with placebo (26.0%, n = 7, one-tailed 95% confidence interval (CI) = (-2.13, ∞), P = 0.06). The original blind field completely recovered in 60% receiving fluoxetine and 14% receiving placebo (odds ratio = 7.22, one-tailed 95% CI = (0.50, ∞)).

Conclusion: These results suggest a trend in favor of fluoxetine for vision recovery after stroke and have the potential to inform the design of a larger multicenter trial.

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Conflict of interest statement

B.Z. Mahon is CSO and cofounder of MindTrace Technologies Inc, which licenses software from Carnegie Mellon University to predict neurologic recovery from brain mapping (PCT/US2019/064015). The remaining authors report no conflicts of interest.

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