Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385333
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-10-06
Brief Title:
Metabolic Mapping to Measure Retinal Metabolism
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Novel Non-Invasive In Vivo Imaging System to Measure Retinal Metabolism
Status:
COMPLETED
Status Verified Date:
2010-09-16
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 whether a new non-invasive technique can quickly and precisely measure retinal metabolism the amount of energy retinal cells use The retina is the part of the eye that sends information to the brain
Participants in current NEI studies who have age-related macular degeneration AMD diabetic retinopathy or von Hippel-Landau disease may be eligible for this study Healthy volunteers will participate as controls Patients with AMD must be 60 years of age or older those with VHL disease or diabetic retinopathy must be 18 or older
Participants undergo the tests and procedures required in the NEI study in which they previously enrolled In addition for the current study they undergo metabolic mapping For this procedure the subjects eyes are dilated and different amounts of low-level light are shone into the eye to see how different cells respond with changes in metabolism Measurements are taken while the subject breathes room air and while he or she breathes medical grade oxygen for about 1 minute The entire procedure takes about 15 minutes
Participants in current NEI studies who have age-related macular degeneration AMD diabetic retinopathy or von Hippel-Landau disease may be eligible for this study Healthy volunteers will participate as controls Patients with AMD must be 60 years of age or older those with VHL disease or diabetic retinopathy must be 18 or older
Participants undergo the tests and procedures required in the NEI study in which they previously enrolled In addition for the current study they undergo metabolic mapping For this procedure the subjects eyes are dilated and different amounts of low-level light are shone into the eye to see how different cells respond with changes in metabolism Measurements are taken while the subject breathes room air and while he or she breathes medical grade oxygen for about 1 minute The entire procedure takes about 15 minutes
Detailed Description:
Background Alterations in retinal metabolism are associated with blinding conditions and vision loss We propose to apply a non-invasive in vivo retinal imaging system to investigate key physiologic processes affecting retinal metabolism The imaging system is designed to quantify and characterize the topology of retinal metabolism in 3-dimensional space across 40--130 picosecond time periods and allows dynamic measurement of physiologically relevant events
Objectives The primary objectives of our study are to 1 evaluate the utility of this system in a clinical setting and 2 examine variation in retinal metabolism within retinal cell subtypes under environmental conditions optimized to support this metabolism The working hypothesis of our first objective is that the imaging system will be easily and efficiently implemented in a clinical setting and will yield stable and repeatable results The working hypothesis for our second objective is that people with or at high risk for progression to sight threatening retinal disease will exhibit different metabolic profiles than an age- and sex-matched disease-free comparison group Their peers with less severe disease may exhibit differences with severe diseased and non-diseased groups The long-term goal of the project is to address the following research questions Are metabolic profiles generated by the imaging system effective for determining presence and severity of retinal diseases and if so are these metabolic profiles useful in identifying people at risk for progression to sight threatening forms of retinal diseases
Study Population We will first apply the systems in 3 groups of 10 people exhibiting a range of severity in retinal diseases that influence retinal metabolism these diseases are age-related macular degeneration AMD diabetic retinopathy DR and von-Hippel-Lindau VHL disease
Design Cross-sectional sampling design If the system yields accurate stable and repeatable results it will be applied in longitudinal studies to evaluate prognostic utility for estimating the risk of progression to sight-threatening AMD DR or VHL disease
Outcome Measures The magnitude and 3-D topographic profile of fluorescence anisotropy values across physiologically meaningful time periods for a 20 degree field centered on the macula Fluorescence anisotropy of our system provides a measure of retinal metabolism
Objectives The primary objectives of our study are to 1 evaluate the utility of this system in a clinical setting and 2 examine variation in retinal metabolism within retinal cell subtypes under environmental conditions optimized to support this metabolism The working hypothesis of our first objective is that the imaging system will be easily and efficiently implemented in a clinical setting and will yield stable and repeatable results The working hypothesis for our second objective is that people with or at high risk for progression to sight threatening retinal disease will exhibit different metabolic profiles than an age- and sex-matched disease-free comparison group Their peers with less severe disease may exhibit differences with severe diseased and non-diseased groups The long-term goal of the project is to address the following research questions Are metabolic profiles generated by the imaging system effective for determining presence and severity of retinal diseases and if so are these metabolic profiles useful in identifying people at risk for progression to sight threatening forms of retinal diseases
Study Population We will first apply the systems in 3 groups of 10 people exhibiting a range of severity in retinal diseases that influence retinal metabolism these diseases are age-related macular degeneration AMD diabetic retinopathy DR and von-Hippel-Lindau VHL disease
Design Cross-sectional sampling design If the system yields accurate stable and repeatable results it will be applied in longitudinal studies to evaluate prognostic utility for estimating the risk of progression to sight-threatening AMD DR or VHL disease
Outcome Measures The magnitude and 3-D topographic profile of fluorescence anisotropy values across physiologically meaningful time periods for a 20 degree field centered on the macula Fluorescence anisotropy of our system provides a measure of retinal metabolism
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 |
|---|---|---|---|
| 06-EI-0252 | None | None | None |