Aqueous Suppressant Versus Aqueous Outflow on Ocular Blood Flow
2014年1月23日 更新者:Indiana University
Examination of the Effect of Aqueous Suppressant Versus Aqueous Outflow Enhancing Glaucoma Medications on Ocular Perfusion Pressure and Blood Flow: A Mechanistic Study
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.
研究概览
地位
完全的
条件
详细说明
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
研究类型
观察性的
注册 (实际的)
35
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Indiana
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Indianapolis、Indiana、美国、46202
- Department of Ophthalmology Indiana University School of Medicine
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
120 glacuoma patients
描述
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:
- 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).
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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aqueous suppressant
aqueous suppressant treated
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aqueous outflow
aqueous outflow treated
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)
大体时间:Baseline and 6 month visits
|
Baseline and 6 month visits
|
6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)
大体时间:Baseline and 6 month visits
|
Baseline and 6 month visits
|
6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)
大体时间:Baseline and 6 month visits
|
Baseline and 6 month visits
|
6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)
大体时间:Baseline and 6 month visits
|
Baseline and 6 month visits
|
6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)
大体时间:Baseline and 6 month visits
|
Baseline and 6 month visits
|
6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)
大体时间:Baseline and 6 month visits
|
Baseline and 6 month visits
|
6-month Change in Ocular Perfusion Pressures (OPP)
大体时间:Baseline and 6 month visits
|
Baseline and 6 month visits
|
2-year Change in OA PSV
大体时间:Baseline and 24 month visits
|
Baseline and 24 month visits
|
2-year Change in OA EDV
大体时间:Baseline and 24 month visits
|
Baseline and 24 month visits
|
2-year Change in OA RI
大体时间:Baseline and 24 month visits
|
Baseline and 24 month visits
|
2-year Change in CRA PSV
大体时间:Baseline and 24 month visits
|
Baseline and 24 month visits
|
2-year Change in CRA EDV
大体时间:Baseline and 24 month visits
|
Baseline and 24 month visits
|
2-year Change in CRA RI
大体时间:Baseline and 24 month visits
|
Baseline and 24 month visits
|
2-year Change in OPP
大体时间:Baseline and 24 month visits
|
Baseline and 24 month visits
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Alon Harris, PhD、Indiana University School of Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年3月1日
初级完成 (实际的)
2012年10月1日
研究完成 (实际的)
2012年10月1日
研究注册日期
首次提交
2011年3月2日
首先提交符合 QC 标准的
2011年3月3日
首次发布 (估计)
2011年3月4日
研究记录更新
最后更新发布 (估计)
2014年1月27日
上次提交的符合 QC 标准的更新
2014年1月23日
最后验证
2014年1月1日
更多信息
与本研究相关的术语
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.