ClinicalTrials.gg
RecruitingNCT00655096Updated Oct 29, 2026

Screening for Research Participants

An observational study in Eye Diseases, sponsored by National Eye Institute (NEI). Recruiting at 1 site in United States. Open to participants aged 2 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by National Eye Institute (NEI) · Observational

From the registry’s dates

  • Started Aug 2008; still recruiting 18 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
10,000
Ages
2 Years to 100 Years
Sex
All
01

Study summary

This study will allow National Eye Institute (NEI) doctors the opportunity to examine people with eye disease, whether the diagnosis is known or not, to determine if they are eligible for other NEI research studies. No treatment is offered in this study.

People of all ages with various eye conditions, including genetic conditions, eye movement disorders, inflammatory eye diseases, retinal diseases and external eye diseases, may be eligible for this study.

Participants undergo various tests and procedures to diagnose or evaluate their eye disease. The procedures may include the following:

  • Personal and family medical history
  • Physical examination and blood tests, including genetic testing.
  • Eye examination with dilation to measure visual acuity and eye pressure and to examine the front and back parts of the eye.
  • Questionnaire about vision and daily activities.
  • Conjunctival swab or lacrimal bland biopsy, or both: A sample of cells from the eyes is collected by swabbing the surface of the eye or by surgically removing a small sample of the surface of the eye or tear gland.
  • Electroretinogram to examine retinal function: The subject sits in the dark with his or her eyes patched for 30 minutes. The patches are removed, the surface of the eyes is numbed, and contact lenses that can sense signals from the retina are placed on the eyes. The subject then watches flashing lights.
  • Fluorescein angiography to examine the blood vessels in the eye: A dye is injected into a vein in the arm. The dye travels through the veins to the blood vessels in the eyes. A camera takes pictures of the dye as it flows through the blood vessels.
  • Optical coherence tomography to measure retinal thickness: A machine used to examine the eyes produces cross-sectional pictures of the retina.
  • Microperimetry to test how sensitive different parts of the retina are to changing levels of light. The subject sits in front of a computer and presses a button when he or she sees a light on the screen.
  • Oculography to record eye movements: Eye movements are measured by contact lenses or goggles that the subject wears while watching a series of spots on a computer screen.
Read the detailed description

This protocol is designed for the screening of potential research participants with or without a defined diagnosis. This protocol will serve as a point of entry for individuals who may be eligible and wish to participate in the National Eye Institute (NEI) clinical research studies.

Patients who are referred or self-referred will be screened and evaluated during the screening process to determine whether they are suitable participants for any of the ongoing NEI research studies. The screening process may include past and current medical history, a physical examination, diagnostic procedures, and required testing used to establish a patient s diagnosis and determine his/her potential eligibility for research participation. Once the screening process is complete, patients will be informed of their options to participate in one or more of the NEI's current clinical research protocols or natural history studies. If no appropriate research protocol is available for their participation, the patient may receive potential treatment recommendations, which will be shared with the patient s primary provider and referring physician.

This protocol's secondary aim is to collect and store human biospecimens and health information for basic science laboratory research and to generate and test hypotheses. Through such studies, research investigators hope to find possible new ways to detect, treat, and even prevent or cure ophthalmological diseases. Genetic and genomic testing, and biospecimen samples such as blood, body fluid (e.g., urine), and tissue (e.g., skin) may be collected from affected or unaffected adult participants. Biospecimen samples can be obtained at the time of screening or any time after screening. These samples, combined with other clinical data, may be used for basic science laboratory research or stored and used in future research studies. Biospecimen sample collection is voluntary for all participants.

02

Conditions studied

  • Eye Diseases

Browse trials for

Keywords

  • Eye
  • Photograph
  • Retina
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 10,000 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
Yes
Sampling method
Non-probability sample

Study population

Participants can be self-referred or be referrals from medical practitioners, clinics, hospitals, or medical institutions.

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

Participants will be able to enroll if they:

  • Have a diagnosed ocular disease/disorder; OR
  • Potentially have an unusual, interesting, or unknown ocular condition that requires the establishment of a diagnosis; OR
  • Potentially participate as a disease-free control participant in an NEI clinical research study; OR
  • Are an unaffected first-degree relative of a participant with either a diagnosed or undiagnosed ocular disorder; AND
  • Have the ability to understand and sign an OR if they are minor children have a legal parent/guardian with the ability to do the same.
  • Adults with impaired capacity to consent must have a Legally Authorized Representative (LAR) who is able to provide informed consent.

Exclusion criteria

EXCLUSION CRITERIA:

Participants will be unable to enroll if they:

  • Are unwilling or unable to cooperate with the study procedures.
  • Female participants of who are pregnant are not eligible for enrollment.
Terms in these criteria, in plain language(2)

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
10,000 participants (estimated)

Groups and cohorts

  • Affected participants

    Adults and children with either diagnosed or un-diagnosed ocular conditions.

  • Disease free control

    Adults and children without any ocular disorders.

  • Unaffected relative

    Unaffected first degree relative of a genetic ocular disease participant.

06

What researchers measure

Primary outcomes

  1. ascertain eligibility

    Determine eligibility for additional NEI protocols.

    Time frame: At screening

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00655096
First posted
Apr 9, 2008
Start date
Aug 20, 2008
Last update
Oct 29, 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 ↗

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