NCT02138279已完成不适用
Comparative Study of the Topcon Tonometers - CT-800, CT-1, CT-1P and TRK-2P to Demonstrate Conformance to ANSI Z80.10-2009 Ophthalmic Instruments -Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for CT-1P and TRK-2P With the Konan CellChek Plus (Predicate)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Agreement of intraocular pressure measurements from predicate vs. investigational device
研究概览
简要总结
The primary objective of this clinical study is to collect clinical data to support FDA 510(k) submissions for the Topcon CT-800, CT-1, CT-1P and TRK-2P non-contact tonometers. The secondary objective is to evaluate any adverse events found during the clinical study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age of either sex and any race or ethnicity;
- •Willing and able to provide written informed consent prior to any study procedures being performed;
- •Willing and able to follow all instructions and attend all study visits;
- •Best Spectacle Corrected Visual Acuity (BSCVA) of 0.3 logMAR (20/40 Snellen equivalent) or better in both eyes as measured using an ETDRS chart.
排除标准
- •Only one functional eye;
- •Poor or eccentric fixation;
- •Corneal scarring or have had corneal surgery, including corneal laser surgery;
- •Microphthalmos;
- •Buphthalmos;
- •Contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months;
- •Dry eyes, meaning having been diagnoses by a physician with dry eyes and currently using a prescribed medication;
- •Lid squeezer - blepharospasm;
- •Nystagmus;
- •Keratoconus;
- •Any other corneal or conjunctival pathology or infection;
- •Condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
结局指标
主要结局
Agreement of intraocular pressure measurements from predicate vs. investigational device
时间窗: Single timepoint - 1 day
Agreement of central corneal thickness measurements from predicate vs. investigational device
时间窗: Single time point - 1 day
次要结局
未报告次要终点
研究者
研究点 (1)
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