Search / Trial NCT00001866

Eye Muscle Surgery to Treat Congenital Nystagmus

Launched by NATIONAL EYE INSTITUTE (NEI) · May 21, 2002

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Trial Information

Current as of July 23, 2024

Completed

Keywords

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

Description

This is a prospective open-label pilot study of a new surgical approach never before performed on humans. Subjects of this study are patients with congenital nystagmus and no other treatment options. Using standard surgical techniques we will determine if simple tenotomy with reattachment will reduce their nystagmus. An oculographic reduction of the nystagmus is measured by the Nystagmus Acuity Function (NAF), considered a primary outcome. Phase II of the study includes binocular visual acuity as a second primary outcome. A 20% improvement in NAF will be considered a clinically significant ...

Gender

All

Eligibility criteria

  • 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.

Attachments

readout_NCT00001866_2024-07-23.pdf

4.5 MB

NCT00001866_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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