Natural History, Pathogenesis, and Outcome of Ocular Disorders
Study Details
Study Description
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
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.
...
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Individuals with various diagnosed and undiagnosed ocular conditions |
Outcome Measures
Primary 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. [ongoing]
response to standard care of treatment
Eligibility Criteria
Criteria
- INCLUSION CRITERIA:
To be eligible, the following inclusion criteria must be met, where applicable.
-
Have a diagnosed, undiagnosed or suspected eye disease.
-
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 legal guardian to provide consent for adults without consent capacity.
EXCLUSION CRITERIA:
A participant is not eligible if any of the following exclusion criteria are present.
-
Are unwilling to give informed consent or assent when applicable.
-
Are unwilling or unable to be followed as clinically indicated.
-
Have a systemic disease that compromises the ability of NEI clinicians to provide adequate ophthalmologic examination or treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institutes of Health Clinical Center | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Eye Institute (NEI)
Investigators
- Principal Investigator: M. Teresa Magone de Quadros Costa, M.D., National Eye Institute (NEI)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 160134
- 16-EI-0134