Screening for NEI Clinical Studies

Sponsor

National Eye Institute (NEI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00001734

Collaborator

(none)

3,000

Enrollment

Location

126.4

Duration (Months)

23.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This screening protocol is designed to facilitate patient recruitment to National Eye Institute (NEI) clinical research studies. Patients must meet specific requirements of a research study; this protocol serves as a first step for admitting patients to an appropriate program.

Candidates may have a diagnosed or undiagnosed eye condition. They will be screened with a medical history, physical examination, eye examination and blood test. Other screening procedures may include routine laboratory tests, non-invasive imaging, and questionnaires. The eye examination includes measurement of eye pressure and dilation of the pupils to fully examine the lens, vitreous and retina. Specialized eye tests will be done only if needed to determine eligibility for a specific study. When the screening is completed, patients will be informed of their options to participate in a study. Patients who are found ineligible for a current study will be informed of alternative treatments or options. No treatment is offered under this protocol.

Condition or Disease	Intervention/Treatment	Phase
Conjunctivitis Iritis Keratitis Retinitis Uveitis

Detailed Description

This protocol is designed for the screening of patients with either diagnosed or undiagnosed conditions, and serves as a first step for individuals who may be eligible, and wish to participate in NEI- National Eye Institute clinical research studies.

Each individual will be thoroughly evaluated during the screening process to determine if they are suitable candidates for inclusion in any of the NEI ongoing studies. The screening evaluation will include past and current medical histories, and an appropriate physical examination. Other routine diagnostic procedures and tests may also be completed in order to help determine a subject's eligibility. These tests and procedures are of minimal risk and will be described in more detail in section III: "Study Procedures". Once the screening process is completed and their eligibility is assessed, the subjects will be informed of their options to participate in one or more of the current clinical research studies. If no appropriate protocol is identified, recommendations for other treatment options may be given to the individual, their primary doctor, or referring physician.

Study Design

Study Type:

Observational

Official Title:

Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Ocular Inflammatory or Immunologic Diseases

Study Start Date :

Mar 23, 1998

Study Completion Date :

Oct 3, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Participants will be able to enroll if they:

Have a diagnosed ocular inflammatory eye disease; OR
Have an unusual, interesting or unknown ocular condition that requires the establishment of a diagnosis; AND
Have the ability to understand and sign an informed consent OR have a legal parent/guardian with the ability to do the same.

2.2 Exclusion Criteria