Screening for Studies on Nystagmus and Strabismus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001861
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : July 2, 2017
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

This screening protocol is designed to help recruitment patients for National Eye Institute (NEI) studies on nystagmus and strabismus. Patients must meet specific requirements of a research study, and this protocol serves as a first step for admitting patients to an appropriate program.

Candidates will undergo a medical history, physical examination, eye examination and blood test. The eye examination includes measurement of eye pressure and dilation of the pupils to fully examine the lens, vitreous and retina. Specialized tests will be done only if needed to determine eligibility for a nystagmus or strabismus study. These include routine laboratory tests, non-invasive imaging, questionnaires, and other standard tests. If needed, a test called oculography may be done to record eye movements. There are two procedures for recording and documenting these movements. In the infrared system, the patient wears a pair of glasses or goggles and looks at a red light while the head is kept steady. In the search coil system, the eye is numbed with anesthetic eye drops and a soft contact lens is placed on the eye. Then the patient looks at a red light while the head is held still. Each oculography session lasts 20 to 30 minutes. Photographs of the eye may be taken.

When the screening is completed, patients will be informed of their options to participate in a study. Patients who are ineligible for a current study will be informed of alternative treatments or options. No treatment is offered under this protocol.

Condition or disease
Nystagmus Strabismus

Detailed Description:

This protocol is designed for the screening of patients with either diagnosed or undiagnosed conditions, and serves as a first step for individuals who may be eligible and wish to participate in National Eye Institute (NEI) clinical research studies.

Each individual will be thoroughly evaluated during the screening process to determine if they are suitable candidates for inclusion in any of the NEI ongoing studies. The screening evaluation will include past and current medical histories, and an appropriate physical examination. Other routine diagnostic procedures and tests may also be completed in order to help determine a subject's eligibility. These tests and procedures are of minimal risk. Once the screening process is completed and their eligibility assessed, the subjects will be informed of their options to participate in one or more of the current clinical research studies. If no appropriate protocol is identified, recommendations for other treatment options may be given to the individual, their primary doctor or referring physician.

Study Type : Observational
Enrollment : 1500 participants
Official Title: Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Nystagmus or Strabismus
Study Start Date : January 29, 1999
Study Completion Date : December 10, 2007

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened.

In addition to those diagnoses currently under study, subjects with unusual, interesting, or unknown conditions that require the establishment of a diagnosis may be eligible for inclusion in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001861

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI)

Publications: Identifier: NCT00001861     History of Changes
Other Study ID Numbers: 990035
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: December 10, 2007

Keywords provided by National Institutes of Health Clinical Center (CC):
Eye Movements
Lazy Eye
Eye Development
Screening Protocol
Eye Movement Disorders

Additional relevant MeSH terms:
Nystagmus, Pathologic
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases