Evaluate the Safety and Efficacy of Repetitive, Transorbital Alternating Current Stimulation (rtACS) for the Treatment of Glaucoma

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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%.

• Visual Field Index between 10 and 90%

• Corrected visual acuity ≥ 1.00 (logMAR), 20/200 (Snellen), 0.10 (decimal)

• 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.

Locations
United States
California
Byers Eye Institute
RECRUITING
Palo Alto
New York
NYU- Langone
RECRUITING
New York
Pennsylvania
Wills Eye Hospital
RECRUITING
Philadelphia
Other Locations
Germany
Otto-von-Guericke University
RECRUITING
Magdeburg
Time Frame
Start Date: 2023-02-28
Estimated Completion Date: 2025-12
Participants
Target number of participants: 45
Treatments
Experimental: Active SAVIR Alpha Synch Mobile device (SASm)
Patients will receive active treatment with the device every other day over 8 weeks.
Sham_comparator: Sham SAVIR Alpha Synch Mobile device (SASm)
Patients will receive sham treatment (no active stimulation) with the device every other day over 8 weeks.
Sponsors
Collaborators: NYU Langone Health, Otto-von-Guericke University Magdeburg, Wills Eye
Leads: Stanford University

This content was sourced from clinicaltrials.gov