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

NCT06682962 | Recruiting

• 2 other identifiers: TES-GPSCIV-24-02-045997
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

TES; TcES; POAG; OkuStim; Okuvision; Glaucoma; Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

• Difference in Humphrey visual field examination between the TES-treated group and the sham-treated group

  18 months

Secondary Outcomes (9)

• Visual field - Changes in the average in the Mean Deviation

  6/12/18 months

• Visual field - Changes in local visual field defects in at least 3 positions

  18 months

• Visual acuity

  18 months

• Intraocular pressure

  18 months

• OCT

  18 months

Other Outcomes (1)

• Safety

  18 months

Study Arms (2)

Sham group

SHAM COMPARATOR

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.

Device: Transcorneal electrical stimulation (TES) with the OkuStim 2 System

TES group

EXPERIMENTAL

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.

Device: Transcorneal electrical stimulation (TES) with the OkuStim 2 System

Interventions

Transcorneal electrical stimulation (TES) with the OkuStim 2 System 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.

Also known as: OkuStim 2 System, OkuStim System, OkuStim

Sham group; TES group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to participate in the study, the subjects signed and dated informed consent must be submitted before the start of the screening
• Age ≥ 40 years
• Primary open-angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or normal tension glaucoma (according to the EGS criteria) in the study eye
• 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)
• Visual acuity ≥ 0.2 decimal in the study eye (corresponds to a visual acuity of 0.7 logMAR)
• The patient must master home stimulation after extensive training.
• Ability of subject to understand the scope, significance and individual consequences of participation in the study
• Ability of subject to give consent

You may not qualify if:

• 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
• 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.
• Neovascularisations of any origin in the study eye
• Condition after arterial or venous occlusions in the study eye
• Condition after intraocular surgery in the last 3 months before the screening examination in the study eye
• Acute (intra)ocular inflammation in any eye
• Non-proliferative or proliferative diabetic retinopathy in the study eye
• Condition after retinal detachment in the study eye
• Dry age-related macular degeneration affecting the visual field in the study eye
• Exsudative age-related macular degeneration in the study eye
• Macular edema of any origin in the study eye
• Other relevant retinal diseases in the study eye
• Any form of corneal degeneration that limits vision in the study eye
• Any disease other than glaucoma affecting the central 30° visual field in the study eye
• 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)

Sponsors & Collaborators

• Okuvision GmbH: lead
• University Medical Center of the Johannes Gutenberg University Mainz, Department of Ophthalmology: collaborator
• Sponsored by the German Federal Ministry of Education and Research (FKZ 13GW0732A): collaborator
• Interdisciplinary Center for Clinical Trials, University Medical Center Mainz: collaborator

Study Sites (1)

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

Mainz, 55131, Germany

RECRUITING

Related Publications (1)

• Lorenz K, Schuster A, Michel HM, Ruckes C, Kronfeld K, Schippert R, Stett A, Beck A. 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. BMJ Open. 2026 Feb 9;16(2):e112879. doi: 10.1136/bmjopen-2025-112879.

  PMID: 41663170 DERIVED

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Exfoliation Syndrome; Low Tension Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Iris Diseases; Uveal Diseases; Optic Nerve Diseases

Study Officials

• Katrin Lorenz, Prof.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrin Lorenz, Prof.

CONTACT

+49 6131 174069; katrin.lorenz@unimedizin-mainz.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient is masked to the treatment group he or she has been assigned to. The determination of the tolerance threshold and the programming of the stimulation parameters on the OkuStim 2 is carried out by unmasked members of the study team as it is impossible to program the OkuStim 2 without knowing the assignment of the patient to the study group. Examinations relating to the primary, secondary or exploratory endpoints are carried out only by masked team members.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients are assigned 1:1 to one of two different groups: Sham group (sham treatment) or TES group.

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 12, 2024
• Study Start: April 2, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)