Electrical Stimulation for the Treatment of Glaucoma (NCT05626491) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Electrical Stimulation for the Treatment of Glaucoma
United States, Germany45 participantsStarted 2023-02-28
Plain-language summary
The overall aim of this study is to see whether long-term electrical stimulation with a home-stimulation device works well and is safe for the treatment of open-angle glaucoma. Open-Angle Glaucoma is a disease where the nerves in the back of your eye die off faster than expected regardless of your eye pressure.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant must be at least 18.
✓. Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
✓. Participant's clinical diagnosis must be consistent with glaucoma characterized by the following features: Mean deviation (MD) worse than -3 on Humphrey Visual Field 24-2 testing. Reliable visual field measures, fixation losses do not exceed 20% and false positives do not exceed 20%.
✓. In the opinion of the investigator the participant's eye pressure must be clinically stable.
✓. If a participant has two eyes meeting study criteria, the worse eye as determined by mean deviation. If both eyes qualify and have the same MD, the patient may choose which eye they are willing to enter, or else a randomization procedure will assign one eye to the study.
✓. Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.
Exclusion criteria
✕. Participant is unable to comply with study procedures or follow-up visits.
✕. Participant has a history of ocular herpes zoster.
What they're measuring
1
Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI).