Transcorneal Electrical Stimulation (TES) for the Treatment of Amblyopia

Overseen By Avrey Thau

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wills Eye

Disqualifiers: Retinal degeneration, Pregnancy, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 12 weeks

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Diagnosis of amblyopia made by the principal investigators.

Best corrected visual acuity in the amblyopic eye equal to or worse than 20/70

Willing and able to give informed consent and to participate for the full duration of the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcorneal electrical stimulation (TES) or sham treatment for 12 weeks

12 weeks

12 visits (in-person, weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• OkuStim®
• Sham-OkuStim®

Participant Groups

Group I: OkuStim® Experimental Treatment 1 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 Group 1 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.

Who Is Running the Clinical Trial?

Wills Eye

Lead Sponsor

Trials

81

Recruited

15,400+

Harold P. Koller, MD

Collaborator

Trials

1

Recruited

40+

Judith B. Lavrich, MD

Collaborator

Trials

1

Recruited

40+