A Randomized, Sham Controlled, Masked Study to Evaluate the Efficacy of Alternating Current Stimulation Using the Eyetronic System for the Treatment of Normal Tension Glaucoma

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of the study is to evaluate the efficacy, transorbital alternating current stimulation (rtACS) using the EYETRONIC for the treatment in patients with glaucoma.

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 normal tension glaucoma characterized by the following features: Mean deviation (MD) worse than -6 but better than -20 on reliable Humphrey Visual Field 24-2 testing

• Participant's eye pressure must be clinically stable, with IOP \< 18.

• If a participant has two eyes meeting study criteria, the worse eye as determined by visual field index (VFI) or patient preference, will be deemed includable. If both eyes qualify and have the same VFI, 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 at Stanford University
RECRUITING
Palo Alto
Contact Information
Primary
Study Team
glaucomatrials@stanford.edu
650-497-5942
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 30
Treatments
Experimental: rtACS treatment
Participants will receive 10 days of rtACS treatment in office.
Placebo_comparator: Sham
Participants will be wearing device but no stimulation will occur for 10 treatments in office.
Sponsors
Leads: Stanford University
Collaborators: EYETRONIC, Inc

This content was sourced from clinicaltrials.gov