GlaucomaTES-GPSNCT06682962
Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma
A study testing Transcorneal electrical stimulation (TES) with the OkuStim 2 System in people with Glaucoma and Primary Open Angle Glaucoma, run by Okuvision GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glaucoma, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
- What is being tested?
- Transcorneal electrical stimulation (TES) with the OkuStim 2 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 2 Apr 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Ability of subject to understand the scope, significance and individual consequences of participation in the study
- Ability of subject to give consent
- 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
- 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.
Who cannot join
- 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
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- 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)
- Patients with active implants
- General illnesses that are difficult to control/adjust and which, in the opinion of the investigator, could jeopardize regular study routines
- Poor general condition according to the investigators assessment
- 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
- Simultaneous participation in another interventional study or past interventions whose effect may still be ongoing (30 days)
- Breastfeeding women
- Patients unable to consent
- Previous enrolment in the TES-GPS study
- Contraindications to the use of OkuStim 2 such as allergies/hypersensitivity to silver
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz
Mainz, 55131
Katrin Lorenz, Prof., +49 6131 173612, klinisches-studienzentrum-augenklinik@unimedizin-mainz.de
About this study
Official title: 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
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.
Read the 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
- Being tested
- Transcorneal electrical stimulation (TES) with the OkuStim 2 System
- Keywords
- TES, TcES, POAG, OkuStim, Okuvision, Glaucoma, Electrical Stimulation
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Exfoliation Syndrome, Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcorneal electrical stimulation (TES) with the OkuStim 2 SystemDevice
Also called OkuStim 2 System, OkuStim System, OkuStim
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcorneal electrical stimulation (TES) with the OkuStim 2 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Humphrey visual field examination between the TES-treated group and the sham-treated group
Measured: 18 months
Secondary outcomes (9)
Visual field - Changes in the average in the Mean Deviation
Measured: 6/12/18 months
Visual field - Changes in local visual field defects in at least 3 positions
Measured: 18 months
Visual acuity
Visual acuity measurements will be done using the 4 meter Early Treatment Diabetic Retinopathy Study (ETDRS) protocol.
Measured: 18 months
Intraocular pressure
Measured: 18 months
OCT
GCL-OCT (macular cube), thickness
Measured: 18 months
OCT
OCT optic nerve (RNFL), thickness
Measured: 18 months
Flavoprotein fluorescence
Flavoprotein fluorescence (FPF) will be measured with the OcuMet Beacon. FPF will be reported both by intensity (a cumulative value reflecting global signal strength), and heterogeneity (measures variation of the relative intensity across the image).
Measured: 18 months
NEI-VFQ-25
Original numeric values from the survey are converted to a 0 to 100 scale (scores represent the achieved percentage of the total possible score).
To calculate an overall composite score for the VFQ-25, the vision-targeted subscale scores are averaged.
Measured: 18 months
Additional antiglaucoma therapies
Comparison between groups regarding additional antiglaucomatous therapies (nature and number of e.g. eye drops, surgery, laser treatments)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start2 Apr 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are assigned 1:1 to one of two different groups: Sham group (sham treatment) or TES group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okuvision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Interdisciplinary Center for Clinical Trials, University Medical Center Mainz, University Medical Center of the Johannes Gutenberg University Mainz, Department of Ophthalmology, Sponsored by the German Federal Ministry of Education and Research (FKZ 13GW0732A)
- Responsible party
- Sponsor
- Investigators
- Katrin Lorenz, Prof., Principal investigator, Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682962
- Sponsor's protocol ID
- TES-GPS
- Other IDs
- CIV-24-02-045997
- Acronym
- TES-GPS
- Status last verified
- Mar 2026
- First submitted
- 4 Nov 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41663170
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06682962
- Acronym / sponsor ID
- TES-GPS / TES-GPS
- Conditions
- Glaucoma, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma, Pigment Dispersion Glaucoma, Normal Tension Glaucoma
- Keywords
- TES, TcES, POAG, OkuStim, Okuvision, Glaucoma, Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Okuvision GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Interdisciplinary Center for Clinical Trials, University Medical Center Mainz, University Medical Center of the Johannes Gutenberg University Mainz, Department of Ophthalmology, Sponsored by the German Federal Ministry of Education and Research (FKZ 13GW0732A)
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are assigned 1:1 to one of two different groups: Sham group (sham treatment) or TES group.
| Arm | Type | Receives |
|---|---|---|
| Sham group | Sham comparator | Device: Transcorneal electrical stimulation (TES) with the OkuStim 2 System0µA 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. |
| TES group | Experimental | Device: Transcorneal electrical stimulation (TES) with the OkuStim 2 System0µA 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcorneal electrical stimulation (TES) with the OkuStim 2 SystemAlso: OkuStim 2 System, OkuStim System, OkuStimRetinal 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. | Device | Sham group, TES group |
Primary outcome
Difference in Humphrey visual field examination between the TES-treated group and the sham-treated group
Time frame: 18 months
9 secondary outcomes
Visual field - Changes in the average in the Mean Deviation
Time frame: 6/12/18 months
Visual field - Changes in local visual field defects in at least 3 positions
Time frame: 18 months
Visual acuity
Time frame: 18 months
Intraocular pressure
Time frame: 18 months
OCT
Time frame: 18 months
OCT
Time frame: 18 months
Flavoprotein fluorescence
Time frame: 18 months
NEI-VFQ-25
Time frame: 18 months
Additional antiglaucoma therapies
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Derived from this study: PubMed 41663170Lorenz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katrin Lorenz, Prof. principal investigator
Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcorneal electrical stimulation (TES) with the OkuStim 2 System in people with Glaucoma and Primary Open Angle Glaucoma, run by Okuvision GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katrin Lorenz, Prof. (+49 6131 174069, katrin.lorenz@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Humphrey visual field examination between the TES-treated group and the sham-treated group (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06682962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.