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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-24-02-045997 | Other Identifier | EUDAMED |
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| Name | Class |
|---|---|
| Interdisciplinary Center for Clinical Trials, University Medical Center Mainz | UNKNOWN |
| University Medical Center of the Johannes Gutenberg University Mainz, Department of Ophthalmology | UNKNOWN |
| Sponsored by the German Federal Ministry of Education and Research (FKZ 13GW0732A) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Humphrey visual field examination between the TES-treated group and the sham-treated group | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety endpoints are the long-term safety of the device, its tolerability assessed by adverse events and the use of rescue treatments. | 18 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katrin Lorenz, Prof. | Contact | +49 6131 174069 | katrin.lorenz@unimedizin-mainz.de |
| Name | Affiliation | Role |
|---|---|---|
| Katrin Lorenz, Prof. | Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz | Recruiting | Mainz | 55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41663170 | Derived | 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. |
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Patients are assigned 1:1 to one of two different groups: Sham group (sham treatment) or TES group.
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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.
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| Visual acuity |
Visual acuity measurements will be done using the 4 meter Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. |
| 18 months |
| Intraocular pressure | 18 months |
| OCT | GCL-OCT (macular cube), thickness | 18 months |
| OCT | OCT optic nerve (RNFL), thickness | 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). | 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. | 18 months |
| Additional antiglaucoma therapies | Comparison between groups regarding additional antiglaucomatous therapies (nature and number of e.g. eye drops, surgery, laser treatments) | 18 months |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| D017889 | Exfoliation Syndrome |
| D057066 | Low Tension Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007499 | Iris Diseases |
| D014603 | Uveal Diseases |
| D009901 | Optic Nerve Diseases |
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