NCT01272102已完成不适用
Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 4
- 主要终点
- To determine the area under the Receiver Operator Characteristic Curve (AUC) for the GCA average thickness, and 7 more GCA parameters.
研究概览
简要总结
To determine the area under the Receiver Operator Characteristic Curve (AUC) for the Ganglion Cell Analysis (GCA) average thickness.
详细描述
To determine the area under the Receiver Operator Characteristic Curve (AUC) for the following GCA parameters:
- Minimum thickness
- Supero-temporal thickness
- Superior thickness
- Supero-nasal thickness
- Infero-temporal thickness
- Inferior thickness
- Infero-nasal thickness
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 40 years or older
- •Diagnosed to have glaucoma by the Principal Investigator or co-investigator
- •Able and willing to make the required study visits
- •Able and willing to give consent and follow study instructions
排除标准
- •Ophthalmic:
- •Best corrected visual acuity in either eye worse than 20/40 on a Snellen chart or on a Snellen equivalent acuity chart.
- •Refractive error outside -12.00D to +8.00D spherical range or >-3.00D cylinder.
- •Previous vitreoretinal surgery in study eye.
- •Vitreoretinal traction or epiretinal membrane in the study eye.
- •Any active infection of anterior or posterior segments.
- •Evidence of diabetic retinopathy, diabetic macular edema, or other vitreoretinal disease in the study eye upon dilated examination, or upon evaluation of retinal photos.
- •History of diabetes, leukemia, AIDS, uncontrolled systemic hypertension, dementia or multiple sclerosis.
- •A life threatening or debilitating disease.
- •Participation in any study involving a non-FDA approved investigational drug (IND) within the past month, or ongoing participation in a study with a non-FDA approved or cleared investigational device (IDE).
- •Current or recent (within the past 14 days) use of an agent with photosensitizing properties by any route (e.g., Visudyne®, ciprofloxacin, Bactrim®, doxycycline, etc.).
- •Concomitant use of hydrochloroquine and/or chloroquine.
结局指标
主要结局
To determine the area under the Receiver Operator Characteristic Curve (AUC) for the GCA average thickness, and 7 more GCA parameters.
时间窗: Study was released before December 1, 2012
次要结局
未报告次要终点
研究者
研究点 (4)
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