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| Name | Class |
|---|---|
| Harold P. Koller, MD | UNKNOWN |
| Judith B. Lavrich, MD | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OkuStimĀ® | Experimental | The OkuStimĀ® 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 OkuStimĀ® 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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| Sham-OkuStimĀ® | Sham Comparator | Subjects in the Sham-OkuStimĀ® 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OkuStimĀ® | Device | Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Best Corrected Visual Acuity (ETDRS letters) | 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). | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Avrey Thau | Contact | 215-928-3418 | AThau@willseye.org | |
| Nelson | Contact | LNelson@willseye.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WillsEye Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
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| Sham-OkuStimĀ® | Device | Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany |
|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |