Actively Recruiting
Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma
Led by Okuvision GmbH · Updated on 2026-03-12
50
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
Sponsors
O
Okuvision GmbH
Lead Sponsor
I
Interdisciplinary Center for Clinical Trials, University Medical Center Mainz
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to participate with signed informed consent before screening
- Age 40 years or older
- Diagnosed with primary open-angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma, or normal tension glaucoma in the study eye
- Current visual field progression of at least 1.5 dB per year in the study eye and mean defect between 6 and 12 dB (Octopus) or between -6 and -12 dB (Humphrey) in screening
- Visual acuity of at least 0.2 decimal (0.7 logMAR) in the study eye
- Ability to master home stimulation after thorough training
- Ability to understand the study and give informed consent
- If both eyes qualify, the eye with higher mean defect or worse visual acuity is selected; if equal, the right eye is chosen
- Negative pregnancy test for women of childbearing potential at screening
- Women of childbearing potential must agree to abstinence or use highly effective contraception throughout the study
You will not qualify if you...
- Neovascularization in the study eye
- History of arterial or venous occlusions in the study eye
- Intraocular surgery in the study eye within 3 months before screening
- Active intraocular inflammation in any eye
- Diabetic retinopathy (non-proliferative or proliferative) in the study eye
- Retinal detachment history in the study eye
- Dry or exudative age-related macular degeneration affecting the study eye
- Macular edema in the study eye
- Other significant retinal diseases in the study eye
- Corneal degenerations limiting vision in the study eye
- Any disease other than glaucoma affecting the central 30° visual field in the study eye
- Planned cataract or other eye surgery during the study period (except laser trabeculoplasty)
- Presence of active implants
- Difficult-to-control general illnesses that could interfere with study routines
- Poor general health according to investigator
- Mental illness or dementia impairing understanding of study procedures and use of OkuStim 2 System
- Participation in another interventional study or recent interventions within 30 days
- Breastfeeding women
- Inability to give consent
- Previous participation in the TES-GPS study
- Allergies or hypersensitivity to silver or contraindications to OkuStim 2 use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Actively Recruiting
Research Team
K
Katrin Lorenz, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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