- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02495935
Transcorneal Electrical Stimulation (TES) for the Treatment of Amblyopia
Feasibility and Efficacy of Transcorneal Electrical Stimulation (TES) for the Treatment of Amblyopia
Study Overview
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Avrey Thau
- Phone Number: 215-928-3418
- Email: AThau@willseye.org
Study Contact Backup
- Name: Nelson
- Email: LNelson@willseye.org
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- WillsEye Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 years
- 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.
- Strabismus less than 10 prism diopters.
Exclusion Criteria:
- 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)
- Women who are pregnant or women with childbearing potential who are unwilling to use medically acceptable means of birth control for study duration.
- Presence of a pacemaker, any metal artifacts in head and trunk, any history of epileptic seizure or severe psychiatric disease (schizophrenia, etc.)
- Inability to detect phosphenes above 0.5mA at time of threshold detection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
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Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany
Other Names:
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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.
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Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change in Best Corrected Visual Acuity (ETDRS letters)
Time Frame: 16 weeks
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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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16 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#15-478
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amblyopia
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Universitat Politècnica de CatalunyaParc Sanitari Sant Joan de Déu; Hospital Mutua de TerrassaCompletedAmblyopia | Anisometropic Amblyopia | Strabismic Amblyopia | Amblyopia Occlusion | Unilateral AmblyopiaSpain
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Vedea Healthware BVElisabeth-TweeSteden Ziekenhuis; Jeroen Bosch Ziekenhuis; Health Holland; Oogziekenhuis... and other collaboratorsRecruitingAmblyopia | Amblyopia, Anisometropic | Amblyopia StrabismicNetherlands
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Alaska Blind Child DiscoveryCompletedStrabismus | Strabismic Amblyopia | Refractive AmblyopiaUnited States
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University of BaselUniversity Medical Center NijmegenWithdrawnStrabismic Amblyopia
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Wenzhou Medical UniversityUnknown
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