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

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06682962 on ClinicalTrials.gov