Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma
Trial Parameters
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.
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. Ab