RecruitingNot ApplicableNCT06682962

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

Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma - a Monocentric, Randomized, Double-Masked, Sham-Controlled Pilot Study


Sponsor

Okuvision GmbH

Enrollment

50 participants

Start Date

Apr 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether transcorneal electrical stimulation (TES) — a gentle electrical stimulation applied to the eye through a contact lens-like device — can slow vision loss in people with open-angle glaucoma whose sight is still declining despite treatment. **You may be eligible if...** - You are 40 or older - You have open-angle glaucoma (including normal tension, pseudoexfoliation, or pigment dispersion types) - Your visual field is still getting worse despite treatment (losing at least 1.5 dB per year) - Your vision loss is in the moderate range (mean defect between 6 and 12 dB) - Your remaining vision in the study eye is at least 0.2 decimal (20/100) **You may NOT be eligible if...** - Your glaucoma is well-controlled with no ongoing progression - You have other eye diseases that could affect vision - You have a pacemaker or other implanted electrical device - You have had recent eye surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscorneal 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.


Locations(1)

Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz

Mainz, Germany

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NCT06682962


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