Screening for participants with eye diseases
Screening Protocol for the Evaluation and Diagnosis of Potential Research Participants
This study is looking for people with eye diseases to see if they can join other research studies and to collect samples for future eye disease research.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 2 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00655096 on ClinicalTrials.gov |
What this trial studies
This observational study allows doctors at the National Eye Institute (NEI) to examine individuals with known or unknown eye diseases to assess their eligibility for other NEI research studies. Participants of all ages may undergo a variety of tests, including medical history reviews, physical examinations, eye exams, and genetic testing. The study aims to identify suitable candidates for ongoing clinical research and to collect biospecimens for future laboratory research on eye diseases. No treatment is provided in this study, but participants may receive recommendations for their primary care.
Who should consider this trial
Good fit: Ideal candidates include individuals with diagnosed ocular diseases, those with unusual or unknown eye conditions, or unaffected relatives of affected individuals.
Not a fit: Patients who are unwilling or unable to cooperate with study procedures or are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding and treatment options for various eye diseases.
How similar studies have performed: Other studies have successfully utilized similar screening approaches to identify participants for clinical research in ophthalmology.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 informed consent 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: Participants will be unable to enroll if they: * Are unwilling or unable to cooperate with the study procedures. * Female participants of childbearing potential who are pregnant are not eligible for enrollment.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Awilda V Holland, R.N. — National Eye Institute (NEI)
- Study coordinator: Awilda V Holland, R.N.
- Email: aholland@nei.nih.gov
- Phone: (301) 435-1831
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.