Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Op… (NCT06682962) | Clinical Trial Compass
RecruitingNot Applicable
Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma
Germany50 participantsStarted 2025-04-02
Plain-language 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.
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕0. 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
✕1. 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.
What they're measuring
1
Difference in Humphrey visual field examination between the TES-treated group and the sham-treated group