Could a mild eye zap help restore sight in glaucoma?
NCT ID NCT06682962
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a weak electrical current applied to the eye's surface can improve vision in people with open-angle glaucoma. Fifty adults with worsening vision loss will receive either real or sham stimulation over several sessions. The goal is to see if this safe, non-invasive approach can slow or partially reverse damage to the visual field.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Transcorneal electrical stimulation (TES) using the OkuStim 2 System
- What this could lead to
- If it works, this could offer a non-invasive way to slow or partially reverse vision loss in glaucoma patients, reducing the need for more aggressive treatments.
- What could go wrong
- This is a small, early pilot study with only 50 participants. The treatment may not improve vision, and effects could be temporary or vary widely between patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz
RECRUITINGMainz, 55131, Germany
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Other studies related to the condition(s) this trial covers.
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- Can better Follow-Up schedules save sight in glaucoma?
- Portable devices could take the guesswork out of eye pressure checks
- Eye drops may shield the cornea after cataract surgery
- Can a puff of air replace the eye pressure probe?