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The purpose of this study will be to compare the aqueous production suppressant to aqueous outflow drugs in terms of the response to known vascular parameters. Specifically; systemic perfusion pressure, retrobulbar blood flow and retinal microcirculation.
The purpose of this study will be to compare the aqueous production suppressant to aqueous outflow drugs in terms of the response to known vascular parameters. Specifically; systemic perfusion pressure, retrobulbar blood flow and retinal microcirculation.
A comparison of perfusion pressure, retinal microcirculation utilizing Heidelberg Retinal Flowmetry and retrobulbar circulation utilizing color Doppler ultrasound imaging
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aqueous suppressant | aqueous suppressant treated | ||
| aqueous outflow | aqueous outflow treated |
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| Measure | Description | Time Frame |
|---|---|---|
| 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV) | Baseline and 6 month visits | |
| 6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV) | Baseline and 6 month visits | |
| 6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI) | Baseline and 6 month visits | |
| 6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV) | Baseline and 6 month visits | |
| 6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV) | Baseline and 6 month visits | |
| 6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI) | Baseline and 6 month visits | |
| 6-month Change in Ocular Perfusion Pressures (OPP) | Baseline and 6 month visits | |
| 2-year Change in OA PSV | Baseline and 24 month visits | |
| 2-year Change in OA EDV | Baseline and 24 month visits | |
| 2-year Change in OA RI | Baseline and 24 month visits | |
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Inclusion Criteria:
Patients will meet all of the following inclusion criteria to enter the study:
Age: 30 years or older.
Diagnosis: confirmed open-angle glaucoma in at least one eye:
Best corrected visual acuity at least 20/60 in at least one eye.
Prior Humphrey visual fields demonstrate acceptable reliability standards (see below).
Exclusion Criteria:
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120 glacuoma patients
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| Name | Affiliation | Role |
|---|---|---|
| Alon Harris, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
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recited over 6 months
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| ID | Title | Description |
|---|---|---|
| FG000 | Aqueous Outflow | aqueous outflow treated |
| FG001 | Aqueous Suppressant | aqueous suppressant treated |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6-month Treatment |
| |||||||||||||
| 2-year Treatment |
|
There will be (as shown) differences in the number of subjects based upon the time of analysis due to patient loss, data of insufficient quality at visit, or change in the drug use during period of study (patient switched off treatment by their doctor) so the number of data points varies throughout the analysis by availability.
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| ID | Title | Description |
|---|---|---|
| BG000 | Aqueous Suppressant | aqueous suppressant treated |
| BG001 | Aqueous Outflow | aqueous outflow treated |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV) | Posted | Mean | Standard Error | cm/sec | Baseline and 6 month visits |
|
|
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Adverse events were not assessed/collected as a part of this study protocol
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aqueous Outflow | aqueous outflow treated |
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Small number of subjects at final endpoint, participation number various by analysis and date
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alon Harris | Indiana University | 3170278-0177 | alharris@indiana.edu |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| 2-year Change in CRA PSV |
| Baseline and 24 month visits |
| 2-year Change in CRA EDV | Baseline and 24 month visits |
| 2-year Change in CRA RI | Baseline and 24 month visits |
| 2-year Change in OPP | Baseline and 24 month visits |
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|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV) | Posted | Mean | Standard Error | cm/sec | Baseline and 6 month visits |
|
|
|
|
| Primary | 6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI) | Posted | Mean | Standard Error | unitless | Baseline and 6 month visits |
|
|
|
|
| Primary | 6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV) | Posted | Mean | Standard Error | cm/sec | Baseline and 6 month visits |
|
|
|
|
| Primary | 6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV) | Posted | Mean | Standard Error | cm/sec | Baseline and 6 month visits |
|
|
|
|
| Primary | 6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI) | Posted | Mean | Standard Error | unitless | Baseline and 6 month visits |
|
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|
| Primary | 6-month Change in Ocular Perfusion Pressures (OPP) | Posted | Mean | Standard Error | mm Hg | Baseline and 6 month visits |
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| Primary | 2-year Change in OA PSV | one participant was unable to be measured for this outcome | Posted | Mean | Standard Error | cm/sec | Baseline and 24 month visits |
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| Primary | 2-year Change in OA EDV | one participant was unable to be measured for this outcome | Posted | Mean | Standard Error | cm/sec | Baseline and 24 month visits |
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| Primary | 2-year Change in OA RI | one participant was unable to be measured for this outcome | Posted | Mean | Standard Error | unitless | Baseline and 24 month visits |
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| Primary | 2-year Change in CRA PSV | one participant was unable to be measured for this outcome | Posted | Mean | Standard Error | cm/sec | Baseline and 24 month visits |
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| Primary | 2-year Change in CRA EDV | one participant was unable to be measured for this outcome | Posted | Mean | Standard Error | cm/sec | Baseline and 24 month visits |
|
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| Primary | 2-year Change in CRA RI | one participant was unable to be measured for this outcome | Posted | Mean | Standard Error | unitless | Baseline and 24 month visits |
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| Primary | 2-year Change in OPP | Posted | Mean | Standard Error | mm Hg | Baseline and 24 month visits |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Aqueous Suppressant | aqueous suppressant treated | 0 | 0 | 0 | 0 |
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