Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001734
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Screening for NEI Clinical Studies
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Ocular Inflammatory or Immunologic Diseases
Status:
COMPLETED
Status Verified Date:
2008-10-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 subjects 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
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 subjects 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-EI-0085 | None | None | None |