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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

• 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.

Locations
Other Locations
Germany
Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz
RECRUITING
Mainz
Contact Information
Primary
Katrin Lorenz, Prof.
katrin.lorenz@unimedizin-mainz.de
+49 6131 174069
Time Frame
Start Date: 2025-04-02
Estimated Completion Date: 2027-09
Participants
Target number of participants: 50
Treatments
Sham_comparator: Sham group
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.
Experimental: TES group
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.
Sponsors
Leads: Okuvision GmbH
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)

This content was sourced from clinicaltrials.gov