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NCT00097162 · ClinicalTrials.gov registry record · Phase 1
Visual Cortex Stimulation in Patients With Amblyopia
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00097162 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 10 participants.
The verdict
NCT00097162, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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 (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: * Examination: Before each session, the patients' distance vision, contrast sensitivity (ability to see fading letters), and ability to read small print are checked in both eyes. * DC polarization: Patients receive either 20 minutes of electrical stimulation or 20 minutes of sham stimulation (each patient will receive both el
Interventions
- PROCEDURE Anodal stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2004-11 |
| Est. Completion | 2006-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00097162
The ClinicalTrials.gov registry entry for NCT00097162 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Anodal stimulation is the first listed.
NCT00097162 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00097162 about?
NCT00097162 is a clinical study titled "Visual Cortex Stimulation in Patients With Amblyopia". 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 info...
What is the current status of trial NCT00097162?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2004-11. Estimated completion is 2006-06.
What interventions are being tested in trial NCT00097162?
The interventions under investigation include: Anodal stimulation (PROCEDURE).
Who is sponsoring clinical trial NCT00097162?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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