Electrical stimulation treatment for visual field defects in glaucoma patients

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

This study is testing if a new electrical stimulation treatment can help people with glaucoma keep their vision from getting worse while they continue using their regular eye drops.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Okuvision GmbH (industry)
• Locations: 1 site (Mainz)
• Trial ID: NCT06682962 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the safety and effectiveness of transcorneal electrical stimulation (TES) using the OkuStim 2 System for treating visual field defects in patients with various forms of glaucoma. Participants will be randomly assigned to receive either TES or a sham treatment while continuing their usual pressure-lowering eye drops. The study aims to determine if TES can slow the progression of visual field loss over an 18-month treatment period, with weekly sessions lasting 30 minutes. The study is designed as a double-masked, randomized, sham-controlled trial to ensure unbiased results.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with specific types of glaucoma experiencing progressive visual field defects.

Not a fit: Patients with stable visual fields or those not meeting the inclusion criteria for glaucoma types may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could help preserve vision and slow the progression of visual field loss in glaucoma patients.

How similar studies have performed: While electrical stimulation has shown promise in treating other retinal diseases, this specific application for glaucoma is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Willingness to participate in the study, the subjects signed and dated informed consent must be submitted before the start of the screening
2. Age ≥ 40 years
3. Primary open-angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or normal tension glaucoma (according to the EGS criteria) in the study eye
4. Current progression in perimetry of at least 1.5 dB per year in the study eye and mean defect (MD) in the study eye between ≥ 6 and ≤ 12 dB (Octopus visual field) or ≤ -6 and ≥ -12 dB (Humphrey visual field) in the screening examination as the mean value of the two visual field examinations carried out as part of the screening (permitted deviation maximum 2 dB)
5. Visual acuity ≥ 0.2 decimal in the study eye (corresponds to a visual acuity of 0.7 logMAR)
6. The patient must master home stimulation after extensive training.
7. Ability of subject to understand the scope, significance and individual consequences of participation in the study
8. Ability of subject to give consent
9. If both eyes meet the inclusion/exclusion criteria, the eye with the higher MD is selected as the study eye. If the MD is the same in both eyes, the eye with the worse visual acuity will be selected as the study eye. If there is no difference between the eyes, the right eye will be selected as the study eye
10. Negative serum or urine pregnancy test at screening in women of childbearing potential. Participants are considered to be of nonchildbearing potential if they are postmenopausal and have not menstruated for at least 12 months prior to screening or if they are surgically sterile
11. Women of childbearing potential must agree to be abstinent or to use highly effective methods of contraception that result in a failure rate of less than 1% per year. This applies consistently throughout the duration of the treatment once you have given your consent to participate in the study.

Exclusion Criteria:

1. Neovascularisations of any origin in the study eye
2. Condition after arterial or venous occlusions in the study eye
3. Condition after intraocular surgery in the last 3 months before the screening examination in the study eye
4. Acute (intra)ocular inflammation in any eye
5. Non-proliferative or proliferative diabetic retinopathy in the study eye
6. Condition after retinal detachment in the study eye
7. Dry age-related macular degeneration affecting the visual field in the study eye
8. Exsudative age-related macular degeneration in the study eye
9. Macular edema of any origin in the study eye
10. Other relevant retinal diseases in the study eye
11. Any form of corneal degeneration that limits vision in the study eye
12. Any disease other than glaucoma affecting the central 30° visual field in the study eye
13. No cataract surgery or other eye surgery may be planned for the patient in the study eye during the duration of the study (except laser trabeculoplasty)
14. Patients with active implants
15. General illnesses that are difficult to control/adjust and which, in the opinion of the investigator, could jeopardize regular study routines
16. Poor general condition according to the investigators assessment
17. Mental illness or dementia, that, in the opinion of the investigator, reduces the understanding of the study procedures and use of the Okustim 2 System
18. Simultaneous participation in another interventional study or past interventions whose effect may still be ongoing (30 days)
19. Breastfeeding women
20. Patients unable to consent
21. Previous enrolment in the TES-GPS study
22. Contraindications to the use of OkuStim 2 such as allergies/hypersensitivity to silver

Where this trial is running

Mainz

• Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz — Mainz, Germany (RECRUITING)

Study contacts

• Principal investigator: Katrin Lorenz, Prof. — Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz
• Study coordinator: Katrin Lorenz, Prof.

Conditions: Glaucoma, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma, Pigment Dispersion Glaucoma, Normal Tension Glaucoma, TES, TcES, POAG