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Clinical Trial Summary

Background: The National Eye Institute (NEI) wants to evaluate and provide standard treatment to people with eye diseases. Objective: To examine and treat people with eye diseases and learn more about eye diseases and how they are inherited. Eligibility: People with eye diseases who can give consent or have a guardian who can consent for them. Asymptomatic first-degree relatives willing to provide a blood sample may also be enrolled for the purpose of genetic testing. Design: Participants will be screened with an eye exam. Participants will have 1-12 visits per year depending on their eye disease for up to 5 years. Visits last about 4 hours and could include: Medical and family history Physical exam Eye exam and photography. Oculography: They put on contact lenses or goggles. They watch spots on a computer screen for 20-30 minutes. Electrooculography: Small metal disks are placed on the skin next to both eyes. They look left and right in the dark and light for about 30 minutes. Electroretinography: They sit in the dark with their eyes patched. A small metal disk is taped to the forehead. After 30 minutes, the patches are removed and contact lenses put in. They watch flashing lights. Fluorescein angiography: A needle guides a thin plastic tube into an arm vein. A dye is injected through the tube and travels up the blood vessels in the eyes. Pictures are taken of the eyes. Immunosuppressive treatment Eye cell sample: Samples are obtained from swabbing, pressing paper on, or taking a small biopsy sample from the surface of the eye. Blood tests Skin, tear, urine, saliva, stool, or hair sample Exam under anesthesia for some children At each visit participants could get medications, eye drops, eye injections, laser treatments, or surgery.


Clinical Trial Description

The National Eye Institute (NEI) is conducting a study to evaluate and provide standard treatment to participants with various diagnosed and undiagnosed ocular conditions. Objective: The primary objective of this protocol is to provide short term follow-up of patients, usually in conjunction with a referring physician. In addition, this protocol allows clinicians at the NEI to maintain their expertise in evaluating and treating various eye disorders for which there may not be specific research studies. The knowledge gained may lead to ideas for future clinical research studies. Study Population: The number of participants to be enrolled has no logical upper limit, but will be set to 1,000 patients with ocular diseases. Design: This is an observational natural history study of multiple ocular diseases and their progression and physiology. Outcome Measures: No formal outcomes will be measured; however, the clinical assessments of enrolled participants can be used to measure the response to standard treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02821767
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact Awilda V Holland, R.N.
Phone (301) 435-1831
Email aholland@mail.nih.gov
Status Recruiting
Phase
Start date August 3, 2016
Completion date July 1, 2026

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