NCT02821767 Natural History, Pathogenesis, and Outcome of Ocular Disorders
| NCT ID | NCT02821767 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Eye Institute (NEI) |
| Condition | Eye Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2016-08-03 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2016-08-03 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
* INCLUSION CRITERIA: To be eligible, the following inclusion criteria must be met, where applicable. 1. Have a diagnosed, undiagnosed or suspected eye disease. 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: A participant is not eligible if any of the following exclusion criteria are present. 1. Are unwilling to give informed consent or assent when applicable. 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.
Contact & Investigator
Awilda V Holland, R.N.
PRINCIPAL INVESTIGATOR
National Eye Institute (NEI)
Frequently Asked Questions
Who can join the NCT02821767 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 100 Years, studying Eye Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02821767 currently recruiting?
Yes, NCT02821767 is actively recruiting participants. Contact the research team at aholland@nei.nih.gov for enrollment information.
Where is the NCT02821767 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT02821767 clinical trial?
NCT02821767 is sponsored by National Eye Institute (NEI). The principal investigator is Awilda V Holland, R.N. at National Eye Institute (NEI). The trial plans to enroll 1,000 participants.