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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 16 weeks
Awards & highlights
Study Summary
This trial will compare the effects of transcorneal electrical stimulation (TES) to sham TES in adults with amblyopia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change in Best Corrected Visual Acuity (ETDRS letters)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OkuStim®Experimental Treatment1 Intervention
The OkuStim® group will undergo 30-minute treatments once a week for 12 weeks at 200% threshold level according to their individual phosphene threshold (IPT) readings from the OkuStim® device at the pre-treatment visit (week 1). Rectangular biphasic current pulses (1-ms positive, directly followed by 1-ms negative) will be applied at a frequency of 20 Hz.
Group II: Sham-OkuStim®Placebo Group1 Intervention
Subjects in the Sham-OkuStim® group will wear treatment glasses and corneal electrodes for 30 minutes weekly for 12 weeks, but corneal electrodes will not be activated.
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Who is running the clinical trial?
Wills EyeLead Sponsor
79 Previous Clinical Trials
10,396 Total Patients Enrolled
Harold P. Koller, MDUNKNOWN
Judith B. Lavrich, MDUNKNOWN
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What site did they apply to?
WillsEye Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I have had 27 eye surgeries and would like to see if anything would work.
PatientReceived 2+ prior treatments
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