OkuStim® for Lazy Eye

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

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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