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Electrical Stimulation
Transcorneal Electrical Stimulation (TES) for the Treatment of Amblyopia
N/A
Waitlist Available
Research Sponsored by Wills Eye
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
Summary
This trial is testing if using small electrical currents on the eye can improve vision in adults with amblyopia, a condition where one eye has reduced vision. The treatment works by activating brain areas responsible for vision, similar to how light does. Recently, it has been shown that a new video game-based treatment for amblyopia can improve visual function in adult patients by reducing inhibition of inputs from the weaker eye to the visual cortex.
Eligible Conditions
- Lazy Eye
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
80 Previous Clinical Trials
15,396 Total Patients Enrolled
Harold P. Koller, MDUNKNOWN
Judith B. Lavrich, MDUNKNOWN