Actively Recruiting
An Open-Label Study to Evaluate Safety and Effectiveness of Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies
Led by Stanford University · Updated on 2025-07-08
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of long-term electrical stimulation using a home-based device for treating open-angle glaucoma, a condition where the optic nerve deteriorates faster than usual regardless of eye pressure. This open-label study focuses on patients who are safe to participate but do not meet the exact criteria for a randomized trial. The goal is to understand how repetitive transorbital alternating current stimulation (rtACS) affects optic neuropathies. Participants will receive active electrical stimulation treatment every other day for eight weeks using a headband device that delivers current to the retina. This treatment period is part of a study designed to monitor changes over time in the visual field and other eye health markers using specialized tests and imaging. Throughout the study, participants will undergo regular assessments including visual field tests (Humphrey Visual Field Index and Mean Deviation), optical coherence tomography for retinal layers, visual acuity tests, and various imaging techniques to evaluate retinal and optic nerve health. These evaluations occur from baseline through six months. The study includes monitoring for safety and effectiveness, with participants involved in scheduled visits and follow-ups to track their progress and any changes in vision.
CONDITIONS
Brief Title
Electrical Stimulation for the Treatment of Optic Neuropathies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be at least 18 years old.
- Participant must be able to follow study requirements and complete the schedule of events.
- Clinical diagnosis of glaucoma with mean deviation worse than -3 on Humphrey Visual Field 24-2 test.
- Reliable visual field measures with fixation losses and false positives not exceeding 20%.
- Eye pressure must be clinically stable according to investigator.
- If two eyes qualify, the worse eye or participant's choice will be enrolled.
- Participant must understand and sign informed consent; assistance provided if vision is impaired.
You will not qualify if you...
- Inability to comply with study procedures or follow-up visits.
- History of ocular herpes zoster.
- Pathological nystagmus.
- Visually significant retinopathy such as diabetic retinopathy or retinitis pigmentosa.
- Corneal opacification or lack of optical clarity.
- Uveitis or other ocular inflammatory diseases.
- Presence of any electronic implants like pacemakers.
- Acute conjunctivitis.
- Acute autoimmune disease.
- Pregnancy or lactation.
- Physical or mental conditions increasing risk or interfering with study, including dementia.
- Unresected brain tumors.
- Implanted intracranial magnetic metals incompatible with MRI.
- Skin damage.
- Children and comatose patients.
- History of epileptic seizure within last 10 years.
- Uncontrolled hypertension or diabetes.
- Inability or unwillingness to travel or complete study schedule.
- Prior participation in vision training/stimulation study within last 12 months.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive electrical stimulation treatment every other day via a headband that delivers stimulation to the retina.
Approximately 28 treatment sessions every other day
Duration - Up to 6 months
Participants are monitored for safety and effectiveness with assessments continuing through 6 months after treatment.
Follow-up visits at scheduled intervals up to 6 months
Trial Site Locations
Total: 1 location
1
Byers Eye Institute
Palo Alto, California, United States, 94303
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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