Clinical trial NCT06682962: Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Primary Open Angle Glaucoma
Pseudoexfoliation Glaucoma
Pigment Dispersion Glaucoma
Normal Tension Glaucoma
Keywords: TES
TcES
POAG
OkuStim
Okuvision
Glaucoma
Electrical Stimulation
Lead sponsor: Okuvision GmbH
Sponsor class: INDUSTRY
Collaborators: name: Interdisciplinary Center for Clinical Trials, University Medical Center Mainz
name: University Medical Center of the Johannes Gutenberg University Mainz, Department of Ophthalmology
name: Sponsored by the German Federal Ministry of Education and Research (FKZ 13GW0732A)
First posted: 2024-11-12
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are assigned 1:1 to one of two different groups: Sham group (sham treatment) or TES group.
Primary purpose: TREATMENT

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.

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
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

Primary outcomes:
measure: Difference in Humphrey visual field examination between the TES-treated group and the sham-treated group
timeFrame: 18 months
Secondary outcomes:
measure: Visual field - Changes in the average in the Mean Deviation
timeFrame: 6/12/18 months
measure: Visual field - Changes in local visual field defects in at least 3 positions
timeFrame: 18 months
measure: Visual acuity
timeFrame: 18 months
measure: Intraocular pressure
timeFrame: 18 months
measure: OCT
timeFrame: 18 months
measure: OCT
timeFrame: 18 months
measure: Flavoprotein fluorescence
timeFrame: 18 months
measure: NEI-VFQ-25
timeFrame: 18 months
measure: Additional antiglaucoma therapies
timeFrame: 18 months
Other outcomes:
measure: Safety
timeFrame: 18 months
Locations:
city: Mainz
country: Germany
facility: Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz
Study officials:
affiliation: Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz
name: Katrin Lorenz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: