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

NCT ID: NCT06682962

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-02
• Study Completion Date: 2027-09-30

Brief 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.

Detailed Description

Electrical stimulation therapy with the OkuStim System can help patients with retinitis pigmentosa and other hereditary retinal diseases slow the progression of visual field defects and thus preserve usable vision for longer. Since degenerative processes in the retina also lead to loss of vision in patients with glaucoma, the desired clinical benefit in this group of patients is also to slow down the decline in the visual field.

This is a prospective, single-center, randomized, sham-controlled, double-masked pilot study in a parallel group design. Patients are assigned 1:1 to one of two different groups: Sham group (sham treatment) or TES with maximum tolerated current intensity below the pain threshold (tolerance threshold). Patients are stimulated in one eye (study eye). Since these are patients with progressive visual field defects and the experimental therapy is being compared with a sham treatment, the patients also receive pressure-lowering eye drops ("treatment as usual", "TAU") to ensure the safety of the study participant. Treatment duration is 18 months for each patient, with application of TES once a week for 30min.

Conditions

Glaucoma; Primary Open Angle Glaucoma; Pseudoexfoliation Glaucoma; Pigment Dispersion Glaucoma; Normal Tension Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sham group

0µA to therapy amplitude, ramping up in 30 seconds; directly followed by 0µA stimulation for 30 minutes.

Stimulation will be performed once per week, for 30 minutes, for 18 months.

Group Type: SHAM_COMPARATOR

Transcorneal electrical stimulation (TES) with the OkuStim 2 System

Intervention Type: DEVICE

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.

TES group

0µA to therapy amplitude, ramping up in 30 seconds; directly followed by stimulation with the therapy amplitude for 30 minutes.

Stimulation will be performed once per week, for 30 minutes, for 18 months.

Group Type: EXPERIMENTAL

Transcorneal electrical stimulation (TES) with the OkuStim 2 System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

OkuStim 2 System; OkuStim System; OkuStim

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

Exclusion Criteria

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.

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Interdisciplinary Center for Clinical Trials, University Medical Center Mainz

UNKNOWN

Sponsor Role: collaborator

University Medical Center of the Johannes Gutenberg University Mainz, Department of Ophthalmology

UNKNOWN

Sponsor Role: collaborator

Sponsored by the German Federal Ministry of Education and Research (FKZ 13GW0732A)

UNKNOWN

Sponsor Role: collaborator

Okuvision GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katrin Lorenz, Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Mainz, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Katrin Lorenz, Prof.

Role: CONTACT

katrin.lorenz@unimedizin-mainz.de

+49 6131 174069

Facility Contacts

Katrin Lorenz, Prof.

Role: primary

klinisches-studienzentrum-augenklinik@unimedizin-mainz.de

+49 6131 173612

Other Identifiers

CIV-24-02-045997

Identifier Type: OTHER

Identifier Source: secondary_id

TES-GPS

Identifier Type: -

Identifier Source: org_study_id