Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
ID06682962

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

Led by Okuvision GmbH · Updated on 2026-03-12

50

Participants Needed

1

Research Sites

N/A

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 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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willingness to participate with signed informed consent before screening
  • Age 40 years or older
  • Diagnosis of primary open-angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma, or normal tension glaucoma in the study eye
  • Progression of visual field loss of at least 1.5 dB per year in the study eye
  • Mean defect in the study eye between 6 and 12 dB (Octopus) or between -6 and -12 dB (Humphrey) in screening exams
  • Visual acuity of 0.2 decimal (0.7 logMAR) or better in the study eye
  • Ability to perform home stimulation after training
  • Ability to understand study scope and give consent
  • If both eyes qualify, selection of study eye based on visual field and acuity criteria
  • Negative pregnancy test for women of childbearing potential
  • Women of childbearing potential must use effective contraception or abstain throughout treatment
Not Eligible

You will not qualify if you...

  • Neovascularization in the study eye
  • Past arterial or venous occlusions in the study eye
  • Intraocular surgery within 3 months before screening in the study eye
  • Acute intraocular inflammation in any eye
  • Diabetic retinopathy in the study eye
  • Retinal detachment in the study eye
  • Dry or exudative age-related macular degeneration affecting the study eye
  • Macular edema of any origin in the study eye
  • Other relevant retinal diseases in the study eye
  • Corneal degeneration limiting vision in the study eye
  • Diseases other than glaucoma affecting central 30° visual field in the study eye
  • Planned cataract or other eye surgery during the study in the study eye (except laser trabeculoplasty)
  • Active implants
  • Difficult to control general illnesses that could interfere with study routines
  • Poor general condition per investigator
  • Mental illness or dementia reducing understanding of study procedures
  • Participation in another interventional study or recent interventions within 30 days
  • Breastfeeding women
  • Inability to give consent
  • Previous enrollment in this TES study
  • Allergies or hypersensitivity to silver preventing use of OkuStim 2 System

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 18 months

Participants receive transcorneal electrical stimulation (TES) or sham treatment once a week for 30 minutes in the study eye to slow the progression of visual field defects.

Weekly visits for TES or sham stimulation

Trial Site Locations

Total: 1 location

1

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

Mainz, Germany, 55131

Actively Recruiting

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Research Team

K

Katrin Lorenz, Prof.

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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Published Research Related To This Trial

Transcorneal electrical stimulation for the treatment of visual field defects in patients with open-angle glaucoma: a monocentric, randomised, double-masked, sham-controlled pilot study: the TES-GPS study protocol.

Katrin Lorenz, Alexander Schuster, Helena Maria Michel...

https://pubmed.ncbi.nlm.nih.gov/41663170