Eye Muscle Surgery to Treat Congenital Nystagmus

NCT00001866 | Completed Phase 2

• 2 other identifiers: 99015299-EI-0152
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Nystagmus

Keywords

Eye Movements; Eye Oscillations; Extraocular Muscles; Eye Development; Pediatric Ophthalmology; Congenital Nystagmus

Interventions

horizontal muscles of the eye will be cut and then reattached in the same position PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1097/00006324-197201000-00002. No abstract available.

  PMID: 4500610 BACKGROUND

• Dell'Osso LF. Fixation characteristics in hereditary congenital nystagmus. Am J Optom Arch Am Acad Optom. 1973 Feb;50(2):85-90. No abstract available.

  PMID: 4511863 BACKGROUND

• Stang HJ. Developmental disabilities associated with congenital nystagmus. J Dev Behav Pediatr. 1991 Oct;12(5):322-3. No abstract available.

  PMID: 1719034 BACKGROUND

MeSH Terms

Conditions

Nystagmus, Pathologic; Nystagmus, Congenital

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: May 22, 2002
• Study Start: August 1, 1999
• Study Completion: November 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2001-11

Locations

US (1)