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Device
Electrical Stimulation for Glaucoma
N/A
Waitlist Available
Research Sponsored by Glaucoma Center of San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects 18 years or older who have glaucoma
Be older than 18 years old
Must not have
Arterial hypertension without appropriate treatment
Acute retinal hemorrhage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if using electrical stimulation on the optic nerve with the Eyetronic Nextwave System device can help treat glaucoma. The study will evaluate if this treatment can slow down the
Who is the study for?
This trial is for individuals with glaucoma who are interested in a non-drug treatment option. Participants will need to attend multiple study visits over the course of a year.
What is being tested?
The Eyetronic Nextwave System, which electrically stimulates the optic nerve through the facial skin, is being tested to see if it can slow down vision loss in glaucoma patients.
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site on the face, headache, or temporary visual disturbances following treatment sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with glaucoma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have high blood pressure that is not being treated.
Select...
I have recently experienced bleeding in my eye.
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I have epilepsy.
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I have a brain tumor.
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I am under 18 years old.
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My eye pressure is not controlled.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in visual field mean deviation (MD) from baseline to post-treatment
Secondary study objectives
Change in retinal nerve fiber layer (RNFL) thickness from baseline to post-treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with glaucoma undergoing electrical stimulation of the optic nerveExperimental Treatment1 Intervention
Single arm study of patients with glaucoma undergoing electrical stimulation of the optic nerve
Find a Location
Who is running the clinical trial?
Glaucoma Center of San FranciscoLead Sponsor