Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001733
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Screening for Studies on Retinovascular Diseases
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 Retinovascular Diseases
Status:
COMPLETED
Status Verified Date:
2008-07-02
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 help recruit patients for National Eye Institute NEI studies of the retina such as diabetic retinopathy and macular degeneration Patients must meet the specific criteria of a research study and this protocol serves as a first step for admitting patients to a retinal disease study
Candidates will undergo a medical history and comprehensive eye examination The eye examination includes dilation of the pupils to fully examine the retina In some studies photographs of the eye are required This is done using fluorescein angiography In this procedure a dye called sodium fluorescein is injected into the blood stream through a vein After the dye reaches the blood vessels of the eye photographs are taken of the retina Other diagnostic procedures may include physical examination questionnaires routine laboratory tests and other standard or specialized tests as needed
When the screening is completed patients will be informed of their options to participate in a study Patients who are ineligible for a current study will be informed of alternative treatments or options No treatment is offered under this protocol
Candidates will undergo a medical history and comprehensive eye examination The eye examination includes dilation of the pupils to fully examine the retina In some studies photographs of the eye are required This is done using fluorescein angiography In this procedure a dye called sodium fluorescein is injected into the blood stream through a vein After the dye reaches the blood vessels of the eye photographs are taken of the retina Other diagnostic procedures may include physical examination questionnaires routine laboratory tests and other standard or specialized tests as needed
When the screening is completed patients will be informed of their options to participate in a study Patients who are 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 presumed retinovascular diseases It serves as a first step for individuals who may be eligible and wish to participate in National Eye Institute clinical research studies of retinovascular diseases
Each individual will be thoroughly evaluated during the screening process to determine if they are suitable candidates for inclusion in any of the National Eye Institute ongoing studies The screening evaluation will include past and current medical histories and an appropriate physical examination namely a comprehensive eye exam 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 National Eye Institute ongoing studies The screening evaluation will include past and current medical histories and an appropriate physical examination namely a comprehensive eye exam 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-0076 | None | None | None |