NCT00001732

Brief Summary

This screening protocol is designed to help recruit patients for National Eye Institute (NEI) studies on inherited eye diseases. Patients must meet specific requirements of a research study, and this protocol serves as a first step for admitting patients to an appropriate program. Candidates will undergo a medical history, physical examination, eye examination and blood test. The eye examination includes measurement of eye pressure and dilation of the pupils to fully examine the lens, vitreous and retina. Specialized tests will be done only if needed to determine eligibility for a specific study in NEI's Ophthalmic Genetics Clinic. These include routine laboratory tests, non-invasive imaging, questionnaires and other standard tests, as well as specialized tests and procedures where needed, including genetic testing. Photographs of the eye may be taken. Patients will be asked questions about family history, especially relating to eye disease or cataracts, and a family tree will be drawn. A blood sample will also be drawn. When the screening is completed, patients will be informed of their options to participate in a study. Patients who are ineligible for a current study will be informed of alternative treatments or options. No treatment is offered under this protocol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 1998

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
8.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2008

Completed
Last Updated

July 2, 2017

Status Verified

May 20, 2008

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Keywords

GeneticsDiagnosisScreening ProtocolOphthalmic Genetic DiseasesGenetic TestingFamily Studies

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • The subjects source for this study will be from referrals by medical practitioners in the private sector, clinics, hospitals, medical institutions, and the Occupational Medical Services at the National Institutes of Health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Eye Diseases, HereditaryDisease

Condition Hierarchy (Ancestors)

Eye DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

February 25, 1998

Study Completion

May 20, 2008

Last Updated

July 2, 2017

Record last verified: 2008-05-20

Locations