Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma
NCT06682962 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-03-12
Summary
Glaucoma is a progressive optic neuropathy with retinal ganglion cell loss which leads to visual field loss. Open-angle glaucoma is the most common form of glaucoma.
The aim of this pilot study is to evaluate the safety and effectiveness of the treatment of visual field defects using transcorneal electrical stimulation (TES) with the OkuStim 2 System in patients with primary open-angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or normal tension glaucoma.
Conditions
- Glaucoma
- Primary Open Angle Glaucoma
- Pseudoexfoliation Glaucoma
- Pigment Dispersion Glaucoma
- Normal Tension Glaucoma
Interventions
- DEVICE
-
Transcorneal electrical stimulation (TES) with the OkuStim 2 System
Retinal stimulation is achieved through transcorneal current application: using a thread electrode, a weak current (≤ 1mA) is introduced onto the surface of the eye, which spreads through the eye towards the retina.
Sponsors & Collaborators
-
Interdisciplinary Center for Clinical Trials, University Medical Center Mainz
collaborator UNKNOWN -
University Medical Center of the Johannes Gutenberg University Mainz, Department of Ophthalmology
collaborator UNKNOWN -
Sponsored by the German Federal Ministry of Education and Research (FKZ 13GW0732A)
collaborator UNKNOWN -
Okuvision GmbH
lead INDUSTRY
Principal Investigators
-
Katrin Lorenz, Prof. · Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-02
- Primary Completion
- 2028-06-30
- Completion
- 2028-06-30
Countries
- Germany
Study Locations
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