Examination of the Effect of Aqueous Suppressant Versus Aqueous Outflow Enhancing Glaucoma Medications on Ocular Perfusion Pressure and Blood Flow: A Mechanistic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 2-year Change in OA EDV
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
- •glaucomatous optic disc cupping
- •agreement between two baseline exams for reliability
- •Best corrected visual acuity at least 20/60 in at least one eye.
- •Prior Humphrey visual fields demonstrate acceptable reliability standards (see below).
排除标准
- •Extensive Humphrey visual field damage consisting of either a mean deviation (MD) < -15 decibels or a clinically determined threat to fixation in both hemifields.
- •Evidence of exfoliation or pigment dispersion.
- •History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
- •History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
- •History or signs of intraocular trauma.
- •Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment.
- •Any abnormality preventing reliable applanation tonometry.
- •Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
- •Cataract surgery within the past year.
- •Resting pulse < 50 beats per minute.
- •Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
结局指标
主要结局
2-year Change in OA EDV
时间窗: Baseline and 24 month visits
2-year Change in OA RI
时间窗: Baseline and 24 month visits
2-year Change in CRA PSV
时间窗: Baseline and 24 month visits
2-year Change in CRA EDV
时间窗: Baseline and 24 month visits
6-month Change in Ocular Perfusion Pressures (OPP)
时间窗: Baseline and 6 month visits
2-year Change in OA PSV
时间窗: Baseline and 24 month visits
6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)
时间窗: Baseline and 6 month visits
6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)
时间窗: Baseline and 6 month visits
6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)
时间窗: Baseline and 6 month visits
6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)
时间窗: Baseline and 6 month visits
6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)
时间窗: Baseline and 6 month visits
6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)
时间窗: Baseline and 6 month visits
2-year Change in CRA RI
时间窗: Baseline and 24 month visits
2-year Change in OPP
时间窗: Baseline and 24 month visits
次要结局
未报告次要终点