Recruiting

Ocular Disorders

Sponsor:

National Eye Institute (NEI)

Code:

NCT02821767

Conditions

Eye Disease

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

...

Conditions

Eye Disease

Study ID

NCT02821767

Start date

Aug 3, 2016

Status verified date

May 12, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants

subjects with diagnosed or undiagnosed ocular conditions and/or their first-degree relatives

Primary outcome measure

  • No formal outcomes will be measured; however, the clinical assessments of enrolled participants can be used to measure the response to standard treatment. [ Time Frame: ongoing ]

Central Contacts and Locations

Central contacts

Awilda V Holland, R.N.

(301) 435-1831aholland@nei.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

National Eye Institute (NEI)

Last update posted

Sep 1, 2026

Last verified

May 12, 2026

Keywords

  • Eye Disease
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Eye Institute (NEI) on 2026-09-01.