Ignite Creation Date:
2024-05-06 @ 2:43 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04401982
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2020-05-20
Brief Title:
Measuring the Effects of Rhopressa on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Measuring the Effects of Rhopressa on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects Using Erythrocyte Mediated Angiography In Vivo
Status:
COMPLETED
Status Verified Date:
2022-03
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:
Rhopressa effectively lowers intra-ocular pressure by improving conventional outflow and decreasing episcleral venous pressure While this may result in improved episcleral venous flow current methods to quantify episcleral blood flow in vivo are rudimentary and unable to accurately and precisely determine flow Proof that Rhopressa effectively increases episcleral venous flow would differentiate it from other medications Furthermore this evidence could galvanize interest in the use of Rhopressa after popular Minimally Invasive Glaucoma Surgery MIGS procedures In future studies MIGS procedures could be used to improve the proximal outflow pathway and Rhopressa to enhance distal outflow
Specific Aim
To determine the effect of Rhopressa on episcleral venous outflow and retinal blood flow in a cohort of treatment-naïve ocular hypertensive and glaucoma suspect patients
Hypothesis
Rhopressa increases episcleral venous flow and retinal blood flow from baseline at both 1 hour and 1 week after initiation of therapy
Specific Aim
To determine the effect of Rhopressa on episcleral venous outflow and retinal blood flow in a cohort of treatment-naïve ocular hypertensive and glaucoma suspect patients
Hypothesis
Rhopressa increases episcleral venous flow and retinal blood flow from baseline at both 1 hour and 1 week after initiation of therapy
Detailed Description:
NeedRelevance
Rhopressa effectively lowers intra-ocular pressure by improving conventional outflow and decreasing episcleral venous pressure While this may result in improved episcleral venous flow current methods to quantify episcleral blood flow in vivo are rudimentary and unable to accurately and precisely determine flow Proof that Rhopressa effectively increases episcleral venous flow would differentiate it from other medications Furthermore this evidence could galvanize interest in the use of Rhopressa after popular Minimally Invasive Glaucoma Surgery MIGS procedures In future studies MIGS procedures could be used to improve the proximal outflow pathway and Rhopressa to enhance distal outflow
PurposeAim
The investigators have developed a technology to accurately and precisely determine episcleral and retinal blood flow in human subjects using ICG labeled erythrocytes via a technique the investigators have coined as Erythrocyte Mediated Angiography EMA The investigators propose conducting a pilot study to show the effect of Rhopressa on both improving episcleral blood flow as well as studying its effect on retinal blood flow With lower intraocular pressure and correspondingly higher ocular perfusion pressure Rhopressa may also improve retinal blood flow
Specific Aim
To determine the effect of Rhopressa on episcleral venous outflow and retinal blood flow in a cohort of treatment-naïve ocular hypertensive and glaucoma suspect patients
Hypothesis
Rhopressa increases episcleral venous flow and retinal blood flow from baseline at both 1 hour and 1 week after initiation of therapy
To test this hypothesis the investigators will measure and compare episcleral venous and retinal blood flow at baseline 1 hour after Rhopressa instillation and 1 week after initiation of Rhopressa
Rhopressa effectively lowers intra-ocular pressure by improving conventional outflow and decreasing episcleral venous pressure While this may result in improved episcleral venous flow current methods to quantify episcleral blood flow in vivo are rudimentary and unable to accurately and precisely determine flow Proof that Rhopressa effectively increases episcleral venous flow would differentiate it from other medications Furthermore this evidence could galvanize interest in the use of Rhopressa after popular Minimally Invasive Glaucoma Surgery MIGS procedures In future studies MIGS procedures could be used to improve the proximal outflow pathway and Rhopressa to enhance distal outflow
PurposeAim
The investigators have developed a technology to accurately and precisely determine episcleral and retinal blood flow in human subjects using ICG labeled erythrocytes via a technique the investigators have coined as Erythrocyte Mediated Angiography EMA The investigators propose conducting a pilot study to show the effect of Rhopressa on both improving episcleral blood flow as well as studying its effect on retinal blood flow With lower intraocular pressure and correspondingly higher ocular perfusion pressure Rhopressa may also improve retinal blood flow
Specific Aim
To determine the effect of Rhopressa on episcleral venous outflow and retinal blood flow in a cohort of treatment-naïve ocular hypertensive and glaucoma suspect patients
Hypothesis
Rhopressa increases episcleral venous flow and retinal blood flow from baseline at both 1 hour and 1 week after initiation of therapy
To test this hypothesis the investigators will measure and compare episcleral venous and retinal blood flow at baseline 1 hour after Rhopressa instillation and 1 week after initiation of Rhopressa
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None