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.
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)
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.
Neovascularisations of any origin in the study eye
Condition after arterial or venous occlusions in the study eye
Parallel
Transcorneal electrical stimulation (TES) with the OkuStim 2 System
DeviceRetinal 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.
Difference in Humphrey visual field examination between the TES-treated group and the sham-treated group
Visual field - Changes in the average in the Mean Deviation
Visual field - Changes in local visual field defects in at least 3 positions
Visual acuity
Visual acuity measurements will be done using the 4 meter Early Treatment Diabetic Retinopathy Study (ETDRS) protocol.
Intraocular pressure
Safety
Safety endpoints are the long-term safety of the device, its tolerability assessed by adverse events and the use of rescue treatments.
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Okuvision GmbH
Lead sponsor
Interdisciplinary Center for Clinical Trials, University Medical Center Mainz
Collaborator
University Medical Center of the Johannes Gutenberg University Mainz, Department of Ophthalmology
Collaborator
Sponsored by the German Federal Ministry of Education and Research (FKZ 13GW0732A)
Collaborator
