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Electrical Stimulation
Electrical Stimulation for Glaucoma (rtACS Trial)
N/A
Recruiting
Led By Joel Schuman, MD,FACS
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be at least 18
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 with fixation losses not exceeding 20% and false positives not exceeding 20%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through month 6
Awards & highlights
rtACS Trial Summary
This trial tests to see if electrical stimulation with a home device can safely treat Open-Angle Glaucoma, where nerves in the back of your eye die faster than expected.
Who is the study for?
Adults with open-angle glaucoma, stable eye pressure, and certain visual field measures can join. They must be able to follow the study plan and give informed consent. Excluded are those with significant retinopathy, unclear corneas, autoimmune diseases, recent participation in other drug trials for the eyes or systemically, pregnancy or lactation, mental conditions affecting study compliance or safety concerns like implanted non-MRI-compatible metals.Check my eligibility
What is being tested?
The trial is testing a home device that provides electrical stimulation to the eye (rtACS) against a sham treatment to see if it's effective and safe for treating open-angle glaucoma over the long term. Participants will randomly receive either real rtACS or a fake version without actual stimulation.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of stimulation, headache, dizziness or temporary vision changes due to electrical current application. The risk of more serious side effects is not specified but would be monitored throughout the trial.
rtACS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old.
Select...
My glaucoma diagnosis shows a mean deviation worse than -3 on my visual field test.
rtACS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI).
Secondary outcome measures
Change from baseline in visual acuity as assessed by the Snellen visual acuity test.
Change from baseline in visual field assessed by Humphrey Mean Deviation (MD).
Change from baseline in visual field assessed by Pelli-Robson Contrast Sensitivity.
rtACS Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active SAVIR Alpha Synch Mobile device (SASm)Experimental Treatment1 Intervention
Patients will receive active treatment with the device every other day over 8 weeks.
Group II: Sham SAVIR Alpha Synch Mobile device (SASm)Placebo Group1 Intervention
Patients will receive sham treatment (no active stimulation) with the device every other day over 8 weeks.
Find a Location
Who is running the clinical trial?
Wills EyeOTHER
79 Previous Clinical Trials
10,391 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,378 Previous Clinical Trials
17,333,318 Total Patients Enrolled
NYU Langone HealthOTHER
1,363 Previous Clinical Trials
816,391 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cloudy or unclear vision due to my cornea.I have been diagnosed with involuntary eye movements.I have pink eye.I have inflammation in my eye.I am at least 18 years old.I have an active autoimmune disease.If both my eyes qualify, I can choose which one to enter into the study or let it be chosen randomly.My glaucoma diagnosis shows a mean deviation worse than -3 on my visual field test.I have a serious eye condition like diabetic retinopathy.
Research Study Groups:
This trial has the following groups:- Group 1: Active SAVIR Alpha Synch Mobile device (SASm)
- Group 2: Sham SAVIR Alpha Synch Mobile device (SASm)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to participate in the research trial?
"The details on clinicaltrials.gov suggest that this trial has already reached its recruitment goal, as the last update was posted in November of 2022. Nonetheless, there are still 215 other trials actively searching for willing participants."
Answered by AI
Who else is applying?
What site did they apply to?
Byers Eye Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
2
Why did patients apply to this trial?
I lost my sight. I am in need of help to regain my vision.
PatientReceived 2+ prior treatments
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