Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-01-02 @ 4:59 AM
Study NCT ID:
NCT02495935
Status:
UNKNOWN
Last Update Posted:
2020-03-05
First Post:
2015-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcorneal Electrical Stimulation (TES) for the Treatment of Amblyopia
Sponsor:
Wills Eye
Organization:
Study Overview
Official Title:
Feasibility and Efficacy of Transcorneal Electrical Stimulation (TES) for the Treatment of Amblyopia
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: