Screening for NEI Clinical Studies
Primary Purpose
Conjunctivitis, Iritis, Keratitis
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Conjunctivitis focused on measuring Uveitis, Conjunctivitis, Iritis, Retinitis, Keratitis, Screening Protocol, Ocular Immunology, Inflammation, Eye Inflammation
Eligibility Criteria
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 Participants will be unable to enroll if they: Have no ocular medical conditions; OR Are unwilling or unable to cooperate with the procedures.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001734
First Posted
November 3, 1999
Last Updated
June 30, 2017
Sponsor
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT00001734
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
Study Type
Observational
2. Study Status
Record Verification Date
October 3, 2008
Overall Recruitment Status
Completed
Study Start Date
March 23, 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 3, 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Eye Institute (NEI)
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis, Iritis, Keratitis, Retinitis, Uveitis
Keywords
Uveitis, Conjunctivitis, Iritis, Retinitis, Keratitis, Screening Protocol, Ocular Immunology, Inflammation, Eye Inflammation
7. Study Design
Enrollment
3000 (false)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Participants will be unable to enroll if they:
Have no ocular medical conditions; OR
Are unwilling or unable to cooperate with the procedures.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
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Screening for NEI Clinical Studies
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