Screening for NEI Clinical Studies

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Brief Title

Screening for NEI Clinical Studies

Official Title

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

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

      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.

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 Type





* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment


Start Date

March 23, 1998

Completion Date

October 3, 2008

Eligibility Criteria

        -  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.




2 Years - N/A

Accepts Healthy Volunteers



, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Study Sponsor

National Eye Institute (NEI)

Study Sponsor

, , 

Verification Date

October 3, 2008