Recruiting

TES

Sponsor:

Wills Eye

Code:

NCT02495935

Conditions

Amblyopia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OkuStim®

Sham-OkuStim®

Study Details

Brief summary:

This is a prospective, randomized, parallel group sham-controlled blinded clinical trial to assess the feasibility and efficacy of transcorneal electrical stimulation (TES) in the improvement of visual function outcomes in adults with amblyopia. The trial will assess the treatment effect of TES to Sham TES in the amblyopic eye of affected patients.

Conditions

Amblyopia

Study ID

NCT02495935

Start date

Jul, 2015

Status verified date

Mar, 2020

Completion date

Aug, 2020

Anticipated

Primary completion date

Aug, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 years
2. Diagnosis of amblyopia made by the principal investigators.
3. Best corrected visual acuity in the amblyopic eye equal to or worse than 20/70
4. Willing and able to give informed consent and to participate for the full duration of the study.
5. Strabismus less than 10 prism diopters.

Exclusion Criteria:

1. Any other significant ophthalmologic disorder or condition with relevant effect upon visual function as evaluated by principal investigator. (eg. Retinal degeneration, proliferative diabetic retinopathy, age related macular degeneration, optic nerve abnormality)
2. Women who are pregnant or women with childbearing potential who are unwilling to use medically acceptable means of birth control for study duration.
3. Presence of a pacemaker, any metal artifacts in head and trunk, any history of epileptic seizure or severe psychiatric disease (schizophrenia, etc.)
4. Inability to detect phosphenes above 0.5mA at time of threshold detection.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OkuStim®

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.

sham comparator: Sham-OkuStim®

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.

Interventions

OkuStim®

Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany

Sham-OkuStim®

Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany

Primary outcome measure

  • Mean change in Best Corrected Visual Acuity (ETDRS letters) [ Time Frame: 16 weeks ]

Central Contacts and Locations

Locations

WillsEye Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

More Information

Sponsor

Wills Eye

Last update posted

Mar 5, 2020

Last verified

Mar, 2020

Keywords

  • TES
  • Transcorneal Electrical Stimulation
  • Amblyopia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Wills Eye on 2020-03-05.