Natural History, Pathogenesis, and Outcome of Ocular Disorders
NCT ID: NCT02821767
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2016-08-03
2026-07-01
Brief Summary
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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.
Detailed Description
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Objective: The primary objective of this protocol is to collect data and specimens generated
through clinical care procedures. Through this primary objective, the secondary objectives (establish a resource of patients with ocular conditions to facilitate recruitment into new research protocols at the NEI, gain additional knowledge about the course of specific ocular diseases and characterize the natural history of such diseases (to generate hypotheses for future clinical research studies), and evaluate the effects of standard of care treatments) may be achieved.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Participants
subjects with diagnosed or undiagnosed ocular conditions and/or their first-degree relatives
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Have the ability to understand and sign an informed consent or have a parent/legal guardian do so if they are minor children or a legally authorized representative to provide consent for adults without consent capacity.
Exclusion Criteria
2. Are unwilling or unable to be followed as clinically indicated.
3. Have a systemic disease that compromises the ability of NEI clinicians to provide adequate ophthalmologic examination or treatment.
1 Month
100 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Responsible Party
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Principal Investigators
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Awilda V Holland, R.N.
Role: PRINCIPAL_INVESTIGATOR
National Eye Institute (NEI)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Role: primary
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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160134
Identifier Type: -
Identifier Source: org_study_id
16-EI-0134
Identifier Type: -
Identifier Source: secondary_id