Status:
COMPLETED
Visual Cortex Stimulation in Patients With Amblyopia
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Amblyopia
Anisometropic Ambyopia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will examine whether direct current (DC) polarization (electrical stimulation) of the visual cortex can cause a temporary improvement of vision in an amblyopic eye of an adult. Amblyopia (a...
Detailed Description
Background: Amblyopia is a disorder of reduced visual function in an eye, without ocular disease, which arises as a result of an abnormal visual experience in early life. It is attributed to a cortica...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Amblyopia as defined by at least 2 logMAR units difference in the visual acuity between the two eyes as measured by ETDRS chart
- VA in the sound eye 20/40 or better
- VA in amblyopic eye 20/40-20/400
- Amblyopia due to anisometropia, strabismus or both
- No ocular cause of reduced VA and no prior ocular surgery
- EXCLUSION CRITERIA:
- Deprivation amblyopia
- Structural ocular disease or prior ocular trauma/surgery
- Current serious medical or psychiatric condition of any kind
- History of any significant trauma or medical condition affecting the brain or skull
- History of epileptic seizure
- History of significant psychiatric illness, i.e., requiring medication or hospitalization
- Current use of neuroactive medication or recreational drugs
- Pregnancy
- Presence of metal in the head other than dental hardware
- Broken skin in the area of the stimulating electrodes
- Presence of implantable pacemaker or defibrillator
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00097162
Start Date
November 1 2004
End Date
June 1 2006
Last Update
June 26 2006
Active Locations (1)
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1
National Eye Institute (NEI)
Bethesda, Maryland, United States, 20892