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NCT00001866 · ClinicalTrials.gov registry record · Phase 2
Eye Muscle Surgery to Treat Congenital Nystagmus
A Phase 2 study of Nystagmus, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT00001866 is a Phase 2 study of Nystagmus that has completed, run by National Eye Institute (NEI). The registered enrollment target is 15 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00001866, a Phase 2 study of Nystagmus, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the safety and effectiveness of a new surgical procedure to correct congenital nystagmus-a disorder of eye muscle-vision-brain coordination characterized by rapid to and fro eye movements (oscillation). Nystagmus usually begins in infancy or early childhood; its effect on vision varies greatly among patients. Current treatments, such as prism glasses, acupuncture, electronic nerve stimulation, contact lenses, various drug treatments, and others have had limited success. Patients with congenital nystagmus sometimes have other eye problems as well, such as cataracts, glaucoma, astigmatism or strabismus (cross-eyes). When these patients have eye muscle surgery to correct a problem, such as strabismus, their nystagmus also improves. Researchers think that simply cutting the muscles might produce this beneficial effect. This study will test this hypothesis-the horizontal muscles of the eye will be cut and then reattached in the same position. This procedure has been tried in one sheepdog with good results. This small preliminary trial will include five adult patients with congenital nystagmus who have no other treatment options. It will evaluate the safety of the surgery and its effect on eye oscillation and vision. If the procedure is found to be safe, additional patients will be studied. Patients will have a medical history, basic physical examination, complete eye examination, and electro-oculography (eye movement recordings) to determine if eligibility for the study. Those accepted into the study will undergo eye muscle surgery and followup eye examinations and electro-oculography at 1 week, 6 weeks, 6 months, 1 year, 2 years and 3 years after surgery.
Conditions Studied
Interventions
- PROCEDURE horizontal muscles of the eye will be cut and then reattached in the same position
Study Locations (1)
Maryland
- National Eye Institute (NEI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 1999-08 |
| Est. Completion | 2001-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001866
The ClinicalTrials.gov registry entry for NCT00001866 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 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 1 condition, with Nystagmus appearing as the primary indexed condition, and to 1 intervention - of which horizontal muscles of the eye will be cut and then reattached in the same position is the first listed.
NCT00001866 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001866 about?
NCT00001866 is a clinical study titled "Eye Muscle Surgery to Treat Congenital Nystagmus". This study will examine the safety and effectiveness of a new surgical procedure to correct congenital nystagmus-a disorder of eye muscle-vision-brain coordination characterized by rapid to and fro eye movements (oscillation). Nystagmus usually begins in infancy or early childhood; its effect on vis...
What is the current status of trial NCT00001866?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 1999-08. Estimated completion is 2001-11.
What conditions does trial NCT00001866 study?
This clinical trial studies the following conditions: Nystagmus.
What interventions are being tested in trial NCT00001866?
The interventions under investigation include: horizontal muscles of the eye will be cut and then reattached in the same position (PROCEDURE).
Who is sponsoring clinical trial NCT00001866?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001866 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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