Abstract
IMPORTANCE: Effective treatments for restoring visual field defects (VFDs) in patients with stroke necessitate validation through randomized clinical trials. OBJECTIVE: To evaluate the efficacy and safety of a personalized digital therapeutic based on visual perceptual learning for treating poststroke VFDs. DESIGN, SETTING, AND PARTICIPANTS: A multicenter randomized clinical trial was conducted from October 19, 2022, to November 8, 2023, at 12 hospitals in South Korea. The study included poststroke outpatients 19 years or older with persistent VFDs (>3 months after stroke) and neuroimaging-confirmed stroke lesions in the visual pathway. INTERVENTION: The training group underwent personalized visual discrimination tasks (orientation and rotation) using a mobile virtual reality headset 5 days a week for 12 weeks, with 360 trials per day. The control group received no intervention. MAIN OUTCOME AND MEASURES: The primary outcome was improved visual areas (defined as sensitivity increased by ≥6 decibels [dB] during 12 weeks) assessed using Humphrey visual field tests at baseline and 12 weeks. RESULTS: Of 93 enrolled stroke outpatients with VFDs, 82 were included in the final analysis (41 in the intervention group and 41 in the control group; median [IQR] age, 52 [42-65] years; 57 male [69.5%]). As primary measures, the training group, with a high adherence rate, showed significantly greater improvement (sensitivity increased by ≥6 dB) in the whole field (median difference, 72 [95% CI, 36-108] degrees squared; P = .003; mean [SD], 194.1 [197.3] vs 82.5 [95.0] degrees squared) and defective hemifield (median difference, 72 [95% CI, 36-108] degrees squared; P = .002; mean [SD], 158.9 [159.0] vs 72.0 [91.4] degrees squared) compared with the control group. As secondary measures, mean (SD) Humphrey visual field test scores improved after 12 weeks in the training group (whole field: 0.72 [1.55] dB; P = .005; defective hemifield: 1.20 [2.08] dB; P < .001) but not in the control group (whole field: 0.03 [1.30] dB; P = .88; defective hemifield: 0.06 [1.85] dB; P = .84). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of a digital therapeutic for chronic poststroke VFDs, the visual perceptual learning-based training demonstrated significant improvements in the whole field and defective hemifield. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05525949.