NCT01425346已完成不适用
Freedom Meditech ClearPath DS-120 Clinical Study Protocol FM2-002-CTP
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Lens fluorescence
研究概览
简要总结
The goal of this study is to measure lens fluorescence in normal subjects at various chronological ages that could serves as a guide to clinicians in determining changes in eye health. A measure of lens fluorescence can be used by clinicians as an indication of degenerative changes occurring in the lens of the eye.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons between the ages of twenty-one (21) and seventy (70). Best efforts shall be made to include as many patients as possible between the ages of thirty-five (35) and sixty (60).
- •Subject must be able to read or understand and give informed consent.
- •Pass the medical health history and comprehensive ophthalmic examination (which is determined by the investigator if the test subject has a normal ophthalmic examination and is in overall good health). Ophthalmic examination includes a clinical evaluation of the subject's eyes and a complete manifest refraction producing a best aided visual acuity of <20/40.
排除标准
- •Subject has had the crystalline lens removed from the study eye or has had the crystalline lens removed and replaced with an intraocular lens (IOL) implant in the left eye.
- •Subject has been clinically diagnosed with cataracts in the study eye.
- •Subject has had a fluorescence angiogram within the last six months.
- •Subject has undergone a treatment using photodynamic drugs within the last year.
- •Subject has Type I or II diabetes or is not deemed healthy from Demographic and Health Questionnaire or the comprehensive eye exam.
- •Subject was fit with contact lens within the last 30 days.
- •Subject has ocular surface (dry eye) disease.
- •Subject is unable to cooperate with or understand clinical instructions.
- •Subject is unable to complete test sequence
结局指标
主要结局
Lens fluorescence
时间窗: Day 1
evaluate the ability of the ClearPath DS-120 instrument to measure the fluorescence and scattering responses of the human crystalline lens in a normal subject population with healthy eyes (as determined by standard comprehensive ophthalmic examination).
次要结局
未报告次要终点
研究者
研究点 (1)
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