Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05344274
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2022-04-18
Brief Title:
Retinal Blood Flow and Autoregulation
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Direct Measures of Retinal Blood Flow and Autoregulation as Robust Biomarkers for Early Glaucoma
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The purpose of this study is to establish autoregulation of retinal blood flow in arterioles and capillaries as a biomarker for early primary open angle glaucoma
Detailed Description:
There is strong evidence for a vascular component in the development and progression of primary open angle glaucoma POAG Specifically glaucoma is associated with impaired retinal blood flow RBF and autoregulation of RBF Autoregulatory impairment may precede retinal ganglion cell RGC loss and has been proposed as a potentially early reversible biomarker The rationale underlying this proposal is that highly precise and accurate direct measures of RBF are necessary to study dynamic changes in RBF and their effect on RGCs Current methods of quantifying RBF remain limited as the majority of imaging modalities provide indirect relative measurements of RBF The investigators will directly measure RBF using two robust direct measures erythrocyte mediated angiography flowmetry EMAf and multimodal adaptive optics mAO Both techniques allow for the highly accurate and precise measurement of RBF down to the capillary level in the human eye in vivo The investigators hypothesize that these direct measures of determining absolute RBF will show impaired autoregulation of microvascular RBF in early glaucoma and that this will correlate with glaucomatous damage The research program will test this hypothesis through two specific aims In Specific Aim 1 the investigators will determine the extent of impaired autoregulation associated with early glaucoma and measure its ability to predict further glaucoma damage In Specific Aim 2 the investigators will determine the relationship of capillary density and RGC density in glaucoma subjects and controls The investigators predict that early glaucoma subjects will exhibit significant measurable impaired vascular autoregulation as compared to controls and that local changes in these parameters will predict structural glaucomatous deficits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None