Nystagmus Clinical Trial
Official title:
Horizontal Rectus Tenotomy in the Treatment of 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 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.
Status | Completed |
Enrollment | 15 |
Est. completion date | November 2001 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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) or have a family history of malignant hyperthermia. Patients must not be pregnant at the time of surgery. Patients must not be less than or equal to 6 months of age. |
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Eye Institute (NEI) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) |
United States,
Dell'Osso L, Gauthier G, Liberman G, Stark L. Eye movement recordings as a diagnostic tool in a case of congenital nystagmus. Am J Optom Arch Am Acad Optom. 1972 Jan;49(1):3-13. — View Citation
Dell'Osso LF. Fixation characteristics in hereditary congenital nystagmus. Am J Optom Arch Am Acad Optom. 1973 Feb;50(2):85-90. — View Citation
Stang HJ. Developmental disabilities associated with congenital nystagmus. J Dev Behav Pediatr. 1991 Oct;12(5):322-3. — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT03603301 -
Vision in Children Born to Opioid-dependent Methadone-maintained Mothers
|
||
Completed |
NCT00001861 -
Screening for Studies on Nystagmus and Strabismus
|
N/A | |
Completed |
NCT00702832 -
Effect of Vestibular Rehabilitation - a Randomized Controlled Trial
|
N/A | |
Completed |
NCT00928954 -
Cross-over Comparison of Gabapentin and Memantine as Treatment for Acquired Nystagmus
|
N/A |