Evaluation and Treatment of Pediatric Eye Diseases

NCT00006422 | Completed

• 2 other identifiers: 01002301-EI-0023
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study offers evaluation and treatment for patients with pediatric eye diseases, particularly amblyopia and strabismus. The protocol is not designed to test new treatments; rather, patients will receive current standard of care treatments. The purpose of the study is twofold: 1) to allow National Eye Institute physicians to increase their knowledge of inflammatory eye conditions and identify possible new avenues of research in this area; and 2) to establish a pool of patients who may be eligible for new studies as they are developed. (Participants in this protocol will not be required to join a new study; the decision will be voluntary.) Patients age 6 months and older with pediatric eye diseases, including amblyopia, strabismus, cataracts, glaucoma, and developmental abnormalities may be eligible for this study. Candidates will be screened with a medical history, eye examination, and diagnostic procedures that may include routine laboratory testing, X-rays, questionnaires, physical examination, and other standard or specialized tests or procedures as needed. The eye examination includes measurements of eye pressure and visual acuity (ability to see the vision chart), examination of the pupils and eye movements, and dilation of the pupils to examine the lens and retina. In addition, patients will undergo a procedure to record eye movements called oculography, in which special detectors measure infrared light reflected off the patient's eyes while he or she watches lights on a computer screen. Participants will be followed for at least 3 years. Visits will be scheduled from 1 to 6 times a year, according to the standard of care for the individual patient's eye problem. Vision will be checked at each visit, and some of the screening tests described above may be repeated to follow the progress of disease and evaluate the response to treatment.

Conditions

Ocular Motility Disorder

Keywords

Lazy Eye; Amblyopia; Nystagmus; Eye Movements; Child Vision

Interventions

current standard of care treatments PROCEDURE

Eligibility Criteria

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

Must have a disorder of ocular motility or a pediatric specific eye disease. Must have the ability to understand and sign an informed consent form or have a legal guardian/parent with the ability to do the same. Patients must have the ability to be followed at the NEI clinical center for at least the next 3 years. Presence of severe systemic diseases such as developmental delay, cancer and others that may compromise the evaluation of the eye disease may exclude patient from this protocol.

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

MeSH Terms

Conditions

Ocular Motility Disorders; Amblyopia; Nystagmus, Pathologic

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases; Brain Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 2000
• First Posted: October 30, 2000
• Study Start: October 1, 2000
• Study Completion: October 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-10

Locations

US (1)