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Transcorneal Electrical Stimulation (TES) for the Treatment of Amblyopia

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ClinicalTrials.gov Identifier: NCT02495935
Recruitment Status : Recruiting
First Posted : July 13, 2015
Last Update Posted : May 24, 2018
Sponsor:
Collaborators:
Harold P. Koller, MD
Judith B. Lavrich, MD
Information provided by (Responsible Party):
Dr. Leonard B. Nelson, Wills Eye

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.

Condition or disease Intervention/treatment Phase
Amblyopia Device: OkuStim® Device: Sham-OkuStim® Not Applicable

Detailed Description:

Amblyopia is defined as a decrease in visual acuity in one eye, despite the correction of any refractive error with glasses and in the absence of any ophthalmoscopically visible lesion of the retina, especially of the macular region. Amblyopia is associated with histologic and electrophysiologic abnormalities in the visual pathways.

Transcorneal electrical stimulation (TES), through neural stimulation, works by non-invasively stimulating the retina via passage of electrical current directly to the retina, bypassing the usual light activation pathway, resulting in the activation of the same areas of the brain as would be activated with a light stimulus alone. Electrical stimulation with TES has shown potential in recent reports as an efficacious treatment modality to improve visual function.

The success of electrical stimulation in neurodegenerative disorders provides a reasonable rationale and significant precedent to investigate its potential for use in disorders of the visual processing system, which functions via an integration of biochemical and electrical interactions transmitted from the retina.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility and Efficacy of Transcorneal Electrical Stimulation (TES) for the Treatment of Amblyopia
Actual Study Start Date : July 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
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.
Device: OkuStim®
Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany
Other Names:
  • TES
  • Transcorneal Electrical Stimulation

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.
Device: Sham-OkuStim®
Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany




Primary Outcome Measures :
  1. Mean change in Best Corrected Visual Acuity (ETDRS letters) [ Time Frame: 16 weeks ]
    Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) to Week 16 (4 weeks post last treatment).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495935


Contacts
Contact: Avrey Thau 215-928-3418 AThau@willseye.org
Contact: Nelson LNelson@willseye.org

Locations
United States, Pennsylvania
WillsEye Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Harold P. Koller, MD
Judith B. Lavrich, MD

Responsible Party: Dr. Leonard B. Nelson, MD, Wills Eye
ClinicalTrials.gov Identifier: NCT02495935     History of Changes
Other Study ID Numbers: IRB#15-478
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dr. Leonard B. Nelson, Wills Eye:
TES
Transcorneal Electrical Stimulation
Amblyopia

Additional relevant MeSH terms:
Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms