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Recruiting

NCT Number: NCT02821767

Natural History, Pathogenesis, and Outcome of Ocular Disorders

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.

Recruiting

Interested in participating?

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Key information

Age range

1 month–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

800-411-1222 ext. TTY8664111010

About this study

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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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 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.

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

    response to standard care of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Awilda V Holland, R.N.

CONTACT

[email protected]

(301) 435-1831

Sponsors and collaborators

Lead sponsor

National Eye Institute (NEI)

Nih

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Jul 4, 2016
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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