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Protocol Details

Studies of the Natural History, Pathogenesis and Outcome of Ocular Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-EI-0134

Sponsoring Institute

National Eye Institute (NEI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 1 mo
Max Age: 100 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Eye Disease;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Eye Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Eye Institute

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.

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Eligibility

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 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.

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

M. Teresa Magone de Quadros Costa, M.D.
National Eye Institute (NEI)
BG 10 RM 10C432A
10 CENTER DR
BETHESDA MD 20814
(301) 435-4562
teresa.magonedequadroscosta@nih.gov

Awilda V. Holland, R.N.
National Eye Institute (NEI)
National Institutes of Health
Building 10
Room 10D45
10 Center Drive
Bethesda, Maryland 20892
(301) 435-1831
aholland@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT02821767

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