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Screening for NEI Clinical Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001734
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : July 2, 2017
Information provided by:
National Institutes of Health Clinical Center (CC)

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
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.

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Study Type : Observational
Enrollment : 3000 participants
Official Title: Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Ocular Inflammatory or Immunologic Diseases
Study Start Date : March 23, 1998
Study Completion Date : October 3, 2008

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Participants will be able to enroll if they:

    1. Have a diagnosed ocular inflammatory eye disease; OR
    2. Have an unusual, interesting or unknown ocular condition that requires the establishment of a diagnosis; AND
    3. 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

Participants will be unable to enroll if they:

  1. Have no ocular medical conditions; OR
  2. Are unwilling or unable to cooperate with the procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001734

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI)
Layout table for additonal information Identifier: NCT00001734    
Other Study ID Numbers: 980085
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: October 3, 2008
Keywords provided by National Institutes of Health Clinical Center (CC):
Screening Protocol
Ocular Immunology
Eye Inflammation
Additional relevant MeSH terms:
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Uveal Diseases
Eye Diseases
Retinal Diseases
Conjunctival Diseases
Corneal Diseases
Iris Diseases
Uveitis, Anterior