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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | October 4, 2008 |
| Start Date ICMJE | March 1998 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001734 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Screening for NEI Clinical Studies |
| Official Title ICMJE | 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 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. |
| 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 Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 3000 |
| Completion Date | October 2008 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE |
2.2 Exclusion Criteria Participants will be unable to enroll if they:
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| Gender | Both |
| Ages | 2 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001734 |
| Responsible Party | |
| Study ID Numbers ICMJE | 980085, 98-EI-0085 |
| Study Sponsor ICMJE | National Eye Institute (NEI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | October 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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