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Aqueous Suppressant Versus Aqueous Outflow on Ocular Blood Flow

Examination of the Effect of Aqueous Suppressant Versus Aqueous Outflow Enhancing Glaucoma Medications on Ocular Perfusion Pressure and Blood Flow: A Mechanistic Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01308788
Enrollment
35
Registered
2011-03-04
Start date
2011-03-31
Completion date
2012-10-31
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

glaucoma blood flow

Brief summary

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.

Detailed description

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

Interventions

None listed

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients will meet all of the following inclusion criteria to enter the study: 1. Age: 30 years or older. 2. Diagnosis: confirmed open-angle glaucoma in at least one eye: 1. glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry 2. glaucomatous optic disc cupping 3. agreement between two baseline exams for reliability 3. Best corrected visual acuity at least 20/60 in at least one eye. 4. Prior Humphrey visual fields demonstrate acceptable reliability standards (see below).

Exclusion criteria

1. Extensive Humphrey visual field damage consisting of either a mean deviation (MD) \< -15 decibels or a clinically determined threat to fixation in both hemifields. 2. Evidence of exfoliation or pigment dispersion. 3. History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy. 4. History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis). 5. History or signs of intraocular trauma. 6. Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment. 7. Any abnormality preventing reliable applanation tonometry. 8. Current use of any ophthalmic or systemic steroid which may interfere with this investigation. 9. Cataract surgery within the past year. 10. Resting pulse \< 50 beats per minute. 11. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

Design outcomes

Primary

MeasureTime 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 PSVBaseline and 24 month visits
2-year Change in OA EDVBaseline and 24 month visits
2-year Change in OA RIBaseline and 24 month visits
2-year Change in CRA PSVBaseline and 24 month visits
2-year Change in CRA EDVBaseline and 24 month visits
2-year Change in CRA RIBaseline and 24 month visits
2-year Change in OPPBaseline and 24 month visits

Countries

United States

Participant flow

Recruitment details

recited over 6 months

Participants by arm

ArmCount
Aqueous Suppressant
aqueous suppressant treated
21
Aqueous Outflow
aqueous outflow treated
14
Total35

Withdrawals & dropouts

PeriodReasonFG000FG001
2-year Treatmentmedication change by treating physician411

Baseline characteristics

CharacteristicAqueous SuppressantAqueous OutflowTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
12 Participants6 Participants18 Participants
Age, Categorical
Between 18 and 65 years
9 Participants8 Participants17 Participants
Region of Enrollment
United States
21 participants14 participants35 participants
Sex: Female, Male
Female
13 Participants10 Participants23 Participants
Sex: Female, Male
Male
8 Participants4 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

2-year Change in CRA EDV

Time frame: Baseline and 24 month visits

Population: one participant was unable to be measured for this outcome

ArmMeasureValue (MEAN)Dispersion
Aqueous Outflow2-year Change in CRA EDV.43 cm/secStandard Error 0.24
Aqueous Suppressant2-year Change in CRA EDV.16 cm/secStandard Error 0.33
p-value: 0.25ANCOVA
Primary

2-year Change in CRA PSV

Time frame: Baseline and 24 month visits

Population: one participant was unable to be measured for this outcome

ArmMeasureValue (MEAN)Dispersion
Aqueous Outflow2-year Change in CRA PSV1.46 cm/secStandard Error 0.64
Aqueous Suppressant2-year Change in CRA PSV.19 cm/secStandard Error 0.5
p-value: 0.0684ANCOVA
Primary

2-year Change in CRA RI

Time frame: Baseline and 24 month visits

Population: one participant was unable to be measured for this outcome

ArmMeasureValue (MEAN)Dispersion
Aqueous Outflow2-year Change in CRA RI.005 unitlessStandard Error 0.017
Aqueous Suppressant2-year Change in CRA RI-.010 unitlessStandard Error 0.03
p-value: 0.6896ANCOVA
Primary

2-year Change in OA EDV

Time frame: Baseline and 24 month visits

Population: one participant was unable to be measured for this outcome

ArmMeasureValue (MEAN)Dispersion
Aqueous Outflow2-year Change in OA EDV-1.28 cm/secStandard Error 0.71
Aqueous Suppressant2-year Change in OA EDV.34 cm/secStandard Error 0.62
p-value: 0.1331ANCOVA
Primary

2-year Change in OA PSV

Time frame: Baseline and 24 month visits

Population: one participant was unable to be measured for this outcome

ArmMeasureValue (MEAN)Dispersion
Aqueous Outflow2-year Change in OA PSV1.39 cm/secStandard Error 3.05
Aqueous Suppressant2-year Change in OA PSV2.63 cm/secStandard Error 3.4
p-value: 0.7847ANCOVA
Primary

2-year Change in OA RI

Time frame: Baseline and 24 month visits

Population: one participant was unable to be measured for this outcome

ArmMeasureValue (MEAN)Dispersion
Aqueous Outflow2-year Change in OA RI.035 unitlessStandard Error 0.016
Aqueous Suppressant2-year Change in OA RI.019 unitlessStandard Error 0.029
p-value: 0.5431ANCOVA
Primary

2-year Change in OPP

Time frame: Baseline and 24 month visits

ArmMeasureValue (MEAN)Dispersion
Aqueous Outflow2-year Change in OPP-1.26 mm HgStandard Error 3.36
Aqueous Suppressant2-year Change in OPP-3.02 mm HgStandard Error 4.69
p-value: 0.7965ANCOVA
Primary

6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)

Time frame: Baseline and 6 month visits

ArmMeasureValue (MEAN)Dispersion
Aqueous Outflow6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)-.13 cm/secStandard Error 0.1
Aqueous Suppressant6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)-.03 cm/secStandard Error 0.11
p-value: 0.5058ANCOVA
Primary

6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)

Time frame: Baseline and 6 month visits

ArmMeasureValue (MEAN)Dispersion
Aqueous Outflow6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)-.16 cm/secStandard Error 0.28
Aqueous Suppressant6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV).09 cm/secStandard Error 0.25
p-value: 0.293ANCOVA
Primary

6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)

Time frame: Baseline and 6 month visits

ArmMeasureValue (MEAN)Dispersion
Aqueous Outflow6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI).029 unitlessStandard Error 0.018
Aqueous Suppressant6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI).005 unitlessStandard Error 0.01
p-value: 0.6156ANCOVA
Primary

6-month Change in Ocular Perfusion Pressures (OPP)

Time frame: Baseline and 6 month visits

ArmMeasureValue (MEAN)Dispersion
Aqueous Outflow6-month Change in Ocular Perfusion Pressures (OPP)-3.38 mm HgStandard Error 2.26
Aqueous Suppressant6-month Change in Ocular Perfusion Pressures (OPP)-.63 mm HgStandard Error 2.36
p-value: 0.5443ANCOVA
Primary

6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)

Time frame: Baseline and 6 month visits

ArmMeasureValue (MEAN)Dispersion
Aqueous Outflow6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)-.70 cm/secStandard Error 2.57
Aqueous Suppressant6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)1.84 cm/secStandard Error 0.96
p-value: 0.4414ANCOVA
Primary

6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)

Time frame: Baseline and 6 month visits

ArmMeasureValue (MEAN)Dispersion
Aqueous Outflow6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)-.36 cm/secStandard Error 0.78
Aqueous Suppressant6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV).12 cm/secStandard Error 0.44
p-value: 0.782ANCOVA
Primary

6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)

Time frame: Baseline and 6 month visits

ArmMeasureValue (MEAN)Dispersion
Aqueous Outflow6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI).003 unitlessStandard Error 0.011
Aqueous Suppressant6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI).014 unitlessStandard Error 0.013
p-value: 0.5496ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026