ClinicalTrials.gg
RecruitingNCT02821767Updated Oct 13, 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 2026-10-13.

Sponsored by National Eye Institute (NEI) · Observational

From the registry’s dates

  • Started Aug 2016; still recruiting 10 years 3 months later.
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

In context

Eye Diseases

388 studies on the registry are indexed under Eye Diseases; 62 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 167 across 108 observational studies indexed under Eye Diseases.

Browse Eye Diseases studies →

Lead sponsor

National Eye Institute (NEI) is the lead sponsor of 272 studies on the registry; 17 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

06

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

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactprpl@cc.nih.gov · 800-411-1222
08

References and documents

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT02821767
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
Oct 13, 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