Pilot Study of Transcorneal Electrical Stimulation Using OkuStim 2 System for Treating Visual Field Loss in Open-Angle Glaucoma Patients

What this Trial Is About

Glaucoma is a progressive eye disease causing loss of retinal cells and visual field defects, with open-angle glaucoma being the most common type. This study aims to evaluate the safety and effectiveness of transcorneal electrical stimulation TES using the OkuStim 2 System for treating visual field loss in patients with primary open-angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma, or normal tension glaucoma. The research is a randomized, double-masked, sham-controlled pilot study conducted at a single center. Participants are randomly assigned to one of two groups a sham group receiving no actual electrical stimulation and a TES group receiving stimulation at a maximum tolerated current below the pain threshold. TES is applied to one eye once a week for 30 minutes over an 18-month period. All patients continue their usual pressure-lowering eye drops to ensure safety during the treatment. Throughout the study, participants undergo regular visual field tests, eye pressure measurements, imaging scans, and questionnaires to monitor changes in vision and eye health. Researchers compare the effects of TES with the sham treatment by examining differences in visual field outcomes after 18 months. Safety and adherence to the therapy are closely monitored, with the total participation lasting 18 months for each patient.

Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma