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Device
Electrical Stimulation for Glaucoma (rtACS Trial)
N/A
Recruiting
Led By Jeffrey L Goldberg, MD PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through month 6
Awards & highlights
rtACS Trial Summary
This trial tests whether a home device can help treat Glaucoma, a disease where the nerves in the back of the eye die off faster than normal.
Who is the study for?
Adults with open-angle glaucoma, stable eye pressure, and specific visual field loss can join this trial. They must be able to follow the study plan and give informed consent. Excluded are those with certain eye conditions, seizures in the last 10 years, electronic implants like pacemakers, skin damage or acute diseases, pregnant or lactating women, recent vision study participants, uncontrolled hypertension or diabetes.Check my eligibility
What is being tested?
The trial is testing a home device that provides long-term electrical stimulation (rtACS) to see if it's effective and safe for treating optic nerve damage caused by open-angle glaucoma.See study design
What are the potential side effects?
Potential side effects of rtACS may include discomfort at the stimulation site or temporary visual disturbances. Since it involves electrical currents near the eyes, there might also be a risk of inducing seizures in susceptible individuals.
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 Mean Deviation (MD).
Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI).
Secondary outcome measures
Change from baseline in OCT angiography
Change from baseline in adaptive optics retinal imaging.
Change from baseline in ganglion cell layer as measured by optical coherence tomography (OCT, visible light and/or infrared).
+5 morertACS Trial Design
1Treatment groups
Experimental Treatment
Group I: Active SASmExperimental Treatment1 Intervention
Patients will receive active treatment with the device every other day over 8 weeks.
Find a Location
Who is running the clinical trial?
Otto-von-Guericke University MagdeburgOTHER
9 Previous Clinical Trials
2,684 Total Patients Enrolled
2 Trials studying Glaucoma
85 Patients Enrolled for Glaucoma
Stanford UniversityLead Sponsor
2,394 Previous Clinical Trials
17,341,590 Total Patients Enrolled
12 Trials studying Glaucoma
583 Patients Enrolled for Glaucoma
NYU Langone HealthOTHER
1,368 Previous Clinical Trials
839,706 Total Patients Enrolled
7 Trials studying Glaucoma
1,679 Patients Enrolled for Glaucoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have pink eye.I am either a child or currently in a coma.I have cloudy or unclear vision due to my cornea.I have a brain tumor that has not been surgically removed.I am at least 18 years old.I have skin damage.I have had an epileptic seizure in the last 10 years.I can travel and follow the study's schedule and requirements.I have serious eye conditions due to diabetes or retinitis pigmentosa.If both my eyes qualify, I can choose which one to enter into the study or let it be chosen randomly.I have an active autoimmune disease.I have high blood pressure or diabetes that is not well-managed.I have been diagnosed with involuntary eye movements.My glaucoma diagnosis shows a Mean Deviation worse than -3 on my visual field test.I have inflammation in my eye.My glaucoma diagnosis shows a mean deviation worse than -3 and my visual field test results are reliable.
Research Study Groups:
This trial has the following groups:- Group 1: Active SASm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 any available spots left for participants in this experiment?
"Data from clinicaltrials.gov suggests that this study is no longer actively recruiting candidates, as the trial was last updated on November 15th 2022. Nonetheless, there are presently 360 other trials looking for participants to join them in their research endeavours."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I'm hoping this clinical trial will help improve my glaucoma.
PatientReceived 2+ prior treatments
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