Clinical trial NCT02495935: Transcorneal Electrical Stimulation (TES) for the Treatment of Amblyopia
Official title: Feasibility and Efficacy of Transcorneal Electrical Stimulation (TES) for the Treatment of Amblyopia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amblyopia
Keywords: TES
Transcorneal Electrical Stimulation
Amblyopia
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Harold P. Koller, MD
name: Judith B. Lavrich, MD
First posted: 2015-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Mean change in Best Corrected Visual Acuity (ETDRS letters)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: WillsEye Hospital
state: Pennsylvania
Study officials:
References: