NCT01930487已完成不适用
The Effects of an Antioxidant Formulation on Intraocular Pressure, Ocular Perfusion Pressure, Retrobulbar, Retinal Capillary and Choroidal Blood Flow
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Change in Superior Retinal Capillary Blood Flow (% Zero Pixels)
研究概览
简要总结
The objective is to evaluate the effects of an antioxidant formula versus placebo on ocular blood flow in a randomized double-blind, crossover design.
Based upon preliminary data, it is hypothesized that a dietary supplement containing a variety of ingredients with antioxidant properties will, compared to placebo, increase ocular perfusion pressure, retrobulbar, retinal capillary and choroidal blood flow, and maintain these effects over the course of the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30 years or older.
- •Confirmed diagnosis of open angle glaucoma by glaucoma specialist in the study eye, as evidenced from criteria representative of glaucomatous optic nerve damage such as specific optic disc or retinal nerve fiber layer structural abnormalities and/or visual field abnormalities.
- •Best corrected visual acuity at 20/60 or better in study eye.
- •Willingness to avoid caffeine and smoking for 12 hours before and during the study visits.
排除标准
- •History of acute angle-closure or a narrow, occluding of anterior chamber angle by gonioscopy.
- •History of chronic or recurrent inflammatory eye diseases or signs of intraocular trauma and/or unreliable applanation tonometry.
- •Severe, unstable or uncontrolled cardiovascular, renal or pulmonary disease
- •History of/or current renal or hepatic impairment.
- •History of/or current bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiogenic shock.
- •Recent surgery or surgery planned near study timeline
- •History of bleeding disorder
- •Use of blood thinning medications
- •Use of specified dietary supplements for three weeks prior to study entry and throughout study period.
结局指标
主要结局
Change in Superior Retinal Capillary Blood Flow (% Zero Pixels)
时间窗: baseline and 30 days
change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)
Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels)
时间窗: baseline and 30 days
change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)
次要结局
- Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)(baseline and 30 days)
- Change in Ocular Perfusion Pressure(baseline and 30 days)
- Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s)(baseline and 30 days)
- Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)(baseline and 30 days)
- Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s)(baseline and 30 days)
- Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)(baseline and 30 days)
- Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM(baseline and 30 days)
- Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM(baseline and 30 days)
- Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM(baseline and 30 days)
- Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM(baseline and 30 days)
- Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM(baseline and 30 days)
- Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM(baseline and 30 days)
- Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)(baseline and 30 days)
- Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM(baseline and 30 days)
- Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM(baseline and 30 days)
- Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM(baseline and 30 days)
- Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM(baseline and 30 days)
- Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s)(baseline and 30 days)
- Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s)(baseline and 30 days)
- Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)(baseline and 30 days)
- Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM(baseline and 30 days)
- Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM(baseline and 30 days)
- Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM(baseline and 30 days)
- Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM(baseline and 30 days)
- Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM(baseline and 30 days)
- Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM(baseline and 30 days)
- Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM(baseline and 30 days)
- Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio)(baseline and 30 days)
- Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio)(baseline and 30 days)
- Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)(baseline and 30 days)
- Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM(baseline and 30 days)
- Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM(baseline and 30 days)
- Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM(baseline and 30 days)
- Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM(baseline and 30 days)
- Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM(baseline and 30 days)
- Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM(baseline and 30 days)
- Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM(baseline and 30 days)
- Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM(baseline and 30 days)
- Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM(baseline and 30 days)
- Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM(baseline and 30 days)
- Change in Ocular Perfusion Pressure - DM(baseline and 30 days)
- Change in Ocular Perfusion Pressure - No DM(baseline and 30 days)
- Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM(baseline and 30 days)
研究者
研究点 (2)
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