Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005784
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2000-06-03
Brief Title:
Evaluation and Treatment of Patients With Retinal Disease
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation and Treatment Protocol for Patients With Retinal Disease
Status:
COMPLETED
Status Verified Date:
2008-08-08
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 study offers evaluation and treatment for patients with certain diseases of the retina the layer of light-sensitive tissue that lines the inside of the eyeball The protocol is not designed to test new treatments rather patients will receive the current standard of care for his or her specific condition The purpose of the study is twofold 1 to allow National Eye Institute physicians to increase their knowledge of retinal eye diseases and identify possible new avenues of research in this area and 2 to establish a pool of patients who may be eligible for new studies as they are developed Participants in this protocol will not be required to join a new study the decision will be voluntary
Patients with diabetic retinopathy age-related macular degeneration vascular occlusive disease central serous retinopathy or another retinal disease may be eligible for this study Candidates will be screened with a medical history brief physical examination thorough eye examination and blood test The eye examination includes measurements of eye pressure and visual acuity ability to see the vision chart examination of the pupils and eye movements and dilation of the pupils to examine the lens and retina Patients will also undergo fundus photography and fluorescein angiography as follows
Fundus photography - Special photographs of the inside of the eye to help evaluate the status of the retina and evaluate changes that may occur in the future From 2 to 20 pictures may be taken depending on the eye condition The camera flashes a bright light into the eye for each picture
Fluorescein angiography - Procedure to evaluate the eyes blood vessels A yellow dye injected into an arm vein travels to the blood vessels in the eyes Pictures of the retina are taken using a camera that flashes a blue light into the eye The pictures show if any dye has leaked from the vessels into the retina indicating possible blood vessel abnormality
Participants will be followed at least 3 years Follow-up visits are scheduled according to the standard of care for the individual patients eye problem It is estimated that most patients will have from one to four follow-up visits each year Vision will be checked at each visit and some of the screening tests described above may be repeated to follow the progress of disease and evaluate the response to treatment
Patients with diabetic retinopathy age-related macular degeneration vascular occlusive disease central serous retinopathy or another retinal disease may be eligible for this study Candidates will be screened with a medical history brief physical examination thorough eye examination and blood test The eye examination includes measurements of eye pressure and visual acuity ability to see the vision chart examination of the pupils and eye movements and dilation of the pupils to examine the lens and retina Patients will also undergo fundus photography and fluorescein angiography as follows
Fundus photography - Special photographs of the inside of the eye to help evaluate the status of the retina and evaluate changes that may occur in the future From 2 to 20 pictures may be taken depending on the eye condition The camera flashes a bright light into the eye for each picture
Fluorescein angiography - Procedure to evaluate the eyes blood vessels A yellow dye injected into an arm vein travels to the blood vessels in the eyes Pictures of the retina are taken using a camera that flashes a blue light into the eye The pictures show if any dye has leaked from the vessels into the retina indicating possible blood vessel abnormality
Participants will be followed at least 3 years Follow-up visits are scheduled according to the standard of care for the individual patients eye problem It is estimated that most patients will have from one to four follow-up visits each year Vision will be checked at each visit and some of the screening tests described above may be repeated to follow the progress of disease and evaluate the response to treatment
Detailed Description:
This Evaluation and Treatment Protocol will allow the retinal specialists at the NEI to identify follow and provide standard of care treatment to patients with various retinal diseases A primary purpose of the protocol is to accumulate a cohort of patients with retinal diseases for possible participation in new clinical trials and epidemiological protocols Also by providing long-term follow-up and treatment for a variety of retinal diseases the retinal specialists at NEI will be better able to identify research hypotheses about these diseases in addition to maintaining their clinical skills The availability of cohorts of patients with a spectrum of retinal diseases will be valuable for the training of retinal fellows an important mission of the NEI The ability to provide long-term follow-up and care will also facilitate referral efforts for new NEI protocols
The retinal specialists at the National Eye Institute will be free to choose those retinal diseases that interest them However the total number of patients that can be enrolled in the protocol will be restricted This protocol is not designed to test any new treatments Any evaluations or treatment under this protocol will be based on the current standard of care for each retinal disease
Participants in this patient evaluation and treatment protocol will be evaluated for potential eligibility in any new NEI clinical trials or epidemiologic protocols as they are developed If eligible patients may be asked to participate in the new protocol However they will not be required to enter any protocol and their decision to participate will be entirely voluntary No more than 150 patients will be accepted in this Evaluation and Treatment Protocol
The retinal specialists at the National Eye Institute will be free to choose those retinal diseases that interest them However the total number of patients that can be enrolled in the protocol will be restricted This protocol is not designed to test any new treatments Any evaluations or treatment under this protocol will be based on the current standard of care for each retinal disease
Participants in this patient evaluation and treatment protocol will be evaluated for potential eligibility in any new NEI clinical trials or epidemiologic protocols as they are developed If eligible patients may be asked to participate in the new protocol However they will not be required to enter any protocol and their decision to participate will be entirely voluntary No more than 150 patients will be accepted in this Evaluation and Treatment Protocol
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 |
|---|---|---|---|
| 00-EI-0139 | None | None | None |