Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00487838
Status:
WITHDRAWN
Last Update Posted:
2017-07-02
First Post:
2007-06-16
Brief Title:
Effects of Sun Filters on Age-related Macular Degeneration in People With Lens Implants
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Noninvasive Optical Imaging of the Effects of External Spectral Filters on Macular Autofluorescence in Pseudophakic Eyes
Status:
WITHDRAWN
Status Verified Date:
2012-05-04
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 will test a new method for preventing worsening of age-related macular degeneration AMD and for developing imaging methods to follow the very earliest microscopic changes in the disease The macula is the part of the retina in the back of the eye that determines central vision AMD can impair central vision affecting a persons ability to read drive and carry out daily activities Some studies suggest that cumulative exposure to sunlight increases the risk for progression of AMD to the late stage that is often characterized by poor central vision This study will determine if wearing glasses with a yellow filter over one eye and a red-violet filter over the other eye when outdoors will decrease the rate of change of early-stage AMD in one or both eyes
Patients early-stage AMD who have had cataract surgery in both eyes with implanted lenses may be eligible for this study
Participants undergo the following procedures
Wear the filter glasses when outdoors between 1000 am and 400 pm
Record the time of day and light environment when they use the glasses
Have an eye examination pictures of the retina and a medical history taken at the beginning of the study and at set intervals during the study
The study lasts at least 12 months and may be extended for a longer period of time
Patients early-stage AMD who have had cataract surgery in both eyes with implanted lenses may be eligible for this study
Participants undergo the following procedures
Wear the filter glasses when outdoors between 1000 am and 400 pm
Record the time of day and light environment when they use the glasses
Have an eye examination pictures of the retina and a medical history taken at the beginning of the study and at set intervals during the study
The study lasts at least 12 months and may be extended for a longer period of time
Detailed Description:
Accumulation of the photoproduct N-retinylidene-n-retinylethaholamine A2E within the retina may be associated with the early age-related macular degeneration AMD Our biophysical model of retinal photochemistries predicts that as the lens yellows with age a spectral imbalance of the light reaching the retina causes steady-state A2E levels to rise in the RPE which induces increasing RPE stress leading to AMD progression If correct this rise in A2E levels and the initial injury could be prevented by appropriately chosen spectral filtering eg colored sunglasses Autofluorescence imaging of the retina currently allows noninvasive mapping of total accumulated lipofuscin fluorophores within the macular retinal pigment epithelium RPE but not A2E or its precursor alone By adding new sets of excitation and emission filters to existing fundus cameras and confocal scanning laser ophthalmoscopes we propose to map individually both A2E and its precursor A2PEH2 or their fractional contributions to the total retinal fluorescence By following A2E fluorescence in both eyes in subjects following bilateral cataract surgery and intra-ocular lens IOL implantation with early symmetric age-related maculopathy who wear our bicolored sunglasses whenever outdoors in the daylight we propose to test this hypothesis while efficiently controlling for hidden genetic physiological and environmental confounding variables between subjects This pilot protocol seeks to optimize recruitment of suitable subjects and the reproducibility of our spectral imaging and noninvasive analysis of A2E and A2PEH2 levels in the normal and microscopically abnormal regions of the macula The data from this pilot study will be used to design a clinical study to test our hypothesis
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 |
|---|---|---|---|
| 07-CH-0169 | None | None | None |