Eye Muscle Surgery to Treat Congenital Nystagmus (NCT00001866) | Clinical Trial Compass
CompletedPhase 2
Eye Muscle Surgery to Treat Congenital Nystagmus
United States15 participantsStarted 1999-08
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Patients must have a clinical and oculographic diagnosis of CN, and no other treatment options.
Patients must have binocular best corrected visual acuity of 20/200 to 20/30.
Patients must be 18 years of age or older for the pilot study (Phase I and for the first 5 patients of Phase II).
Patients must be able to undergo a complete ophthalmic evaluation.
Patients must be able to undergo and cooperate for standard eye movement recordings.
Patients must be able to medically undergo extraocular muscle surgery.
Patients must be available for 1 year of post-surgical follow-up.
Patients must understand and sign an informed consent, or have their legal guardian sign an informed consent.
Patients must have three oculographic recordings performed within 4 months prior to surgery.
No previous extraocular muscle surgery.
No plan to have extraocular muscle surgery for strabismus.
Patients must not have a clinically significant null position greater than 15 degrees from primary position horizontally, 5 degrees vertically, or 5 degrees torsionally.
Patients must not be on systemic medication known to affect ocular oscillations.
No acquired eye disease other than refractive error that is known to decrease visual acuity (e.g., cataracts, glaucoma, age related macular disease, etc.).
No previous ophthalmic or orbital surgery.
No concurrent medical conditions or known risks which would increase their chance of an adverse event due to general anesthesia (Greater than an ASA Class 1…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.