CClinicalTrials.gg
RecruitingNCT02821767Updated Sep 24, 2026

Natural History, Pathogenesis, and Outcome of Ocular Disorders

An observational study in Eye Disease, sponsored by National Eye Institute (NEI). Recruiting at 1 site in United States. Open to participants aged 2 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by National Eye Institute (NEI) · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000
Ages
2 Years to 100 Years
Sex
All
01

Study 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.

Read the 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 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.

02

Conditions studied

  • Eye Disease

Browse trials for

Keywords

  • Eye Disease
  • Natural History
03

Who can participate

Ages eligible
2 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary Clinical

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 (LAR) to provide consent for adults without consent capacity.

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)

Groups and cohorts

  • Participants

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

05

What researchers measure

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.

    response to standard care of treatment

    Time frame: ongoing

06

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contact · prpl@cc.nih.gov · 800-411-1222
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT02821767
Lead sponsor
National Eye Institute (NEI)
Responsible party
Sponsor
First posted
Jul 4, 2016
Start date
Aug 3, 2016
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Sep 24, 2026

Study contacts

Awilda V Holland, R.N.
Contact
aholland@nei.nih.gov
(301) 435-1831
Awilda V Holland, R.N.
principal investigator · National Eye Institute (NEI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion