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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00097162 |
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 (also called lazy eye) is reduced vision in an eye, caused by abnormal brain processing of visual information. In amblyopia, the visual cortex (the part of the brain that processes visual information) favors the other eye and suppresses the image from the amblyopic eye.
Amblyopia in children is treated by patching or blurring the good eye, which forces the child to use the amblyopic eye and overcome suppression by the brain. This treatment only works in children 8 years old and younger, however. Electrical stimulation of the brain can temporarily change the function of the visual cortex in adults with good vision, but its influence on the visual function of people with amblyopia is unknown. If DC polarization can improve vision in amblyopic eyes in adults, it would show that the visual cortex is still plastic, and it might help researchers develop a treatment for adults with amblyopia in the future.
Patients 18 years of age and older with amblyopia caused by crossing in or turning out of the eyes in childhood or by a difference in near- or farsightedness between the eyes may be eligible for this study. Candidates are screened with a medical history and complete eye examination, including a glaucoma screening and checks of vision, in- or out-turning of the eyes, depth perception, need for glasses, and the interior structures of the eyes.
Participants undergo two study sessions, scheduled at least 24 hours apart, involving the following procedures:
Condition | Intervention | Phase |
---|---|---|
Amblyopia Anisometropic Ambyopia Amblyopia, Suppression |
Procedure: Anodal stimulation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Investigation of Visual Plasticity by a Direct Current Stimulation of Occipital Cortex in Adult Amblyopia |
Estimated Enrollment: | 10 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | June 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Study ID Numbers: | 050005, 05-EI-0005 |
Study First Received: | November 17, 2004 |
Last Updated: | June 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00097162 History of Changes |
Health Authority: | United States: Federal Government |
Anisometropia Strabismus Cortical Suppression Impaired Vision |
Cortical Plasticity Amblyopia Adult Amblyopia |
Signs and Symptoms Sensation Disorders Vision Disorders Amblyopia Eye Diseases Strabismus |
Neurologic Manifestations Central Nervous System Diseases Brain Diseases Anisometropia Vision, Low |
Signs and Symptoms Sensation Disorders Vision Disorders Amblyopia Eye Diseases |
Nervous System Diseases Neurologic Manifestations Central Nervous System Diseases Brain Diseases |