Screening for NEI Clinical Studies

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001734
First received: November 3, 1999
Last updated: October 4, 2008
Last verified: October 2008
  Purpose

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
Conjunctivitis
Iritis
Keratitis
Retinitis
Uveitis

Study Type: Observational
Official Title: Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Ocular Inflammatory or Immunologic Diseases

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 3000
Study Start Date: March 1998
Estimated Study Completion Date: October 2008
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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001734

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00001734     History of Changes
Other Study ID Numbers: 980085, 98-EI-0085
Study First Received: November 3, 1999
Last Updated: October 4, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Uveitis
Conjunctivitis
Iritis
Retinitis
Keratitis
Screening Protocol
Ocular Immunology
Inflammation
Eye Inflammation

Additional relevant MeSH terms:
Uveitis
Conjunctivitis
Retinitis
Keratitis
Uveal Diseases
Eye Diseases
Conjunctival Diseases
Retinal Diseases
Corneal Diseases

ClinicalTrials.gov processed this record on September 30, 2014