NCT01621503已完成不适用
Prospective Comparative Clinical Study to Investigate the Use of the NON CONTACT TONO/PACHYMETER NT-530P
Nidek Co. LTD.3 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2011年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- central corneal thickness
研究概览
简要总结
The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek Non Contact Tono/ Pachymeter NT-530P. The secondary objective is to evaluate any adverse events found during the clinical study.
详细描述
Following data analysis will be conducted for tonometer and pachymeter readings. One of eyes of one patient becomes an object of the analysis. Regarding the intraocular pressure, higher IOP readings of either right or left eye are used for analysis. Regarding CCT, the readings of either right or left eye are randomly assigned to analysis in the order of registration.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IOP Measurement
- •20 years or older who voluntarily agree to participate in this study after receiving adequate explanation
- •Possible to participate in the study regardless of existence of glaucoma
- •CCT Measurement
- •20 years or older who voluntarily agree to participate in this study after receiving adequate explanation
- •Possible to participate in the study regardless of existence of glaucoma
- •Possible to participate in the study regardless of existence of corneal diseases (such as Keratoconus, post-LASIK, and corneal scars)
排除标准
- •IOP Measurement
- •Those with only one functional eye
- •Those with one eye having poor or eccentric fixation
- •Those with corneal scarring or who have had corneal surgery such as laser surgery
- •Microphthalmus
- •Buphthalmos
- •Contact lens wearers
- •Blepharospasm
- •Keratoconus
- •Those who have been diagnosed as having corneal conjunctivitis or other infectious disease
- •Those with central corneal thickness greater than 600 μm or less than 500 μm
- •A subject judged to be ineligible for participating in the study by the physicians in charge
- •CCT Measurement
- •Those with only one functional eye
- •Those with one eye having poor or eccentric fixation
- •Blepharospasm
- •Those who have been diagnosed as having corneal conjunctivitis or other infectious disease
- •A subject judged to be ineligible for participating in the study by the physicians in charge
结局指标
主要结局
central corneal thickness
时间窗: one day
intraocular pressure
时间窗: one day
次要结局
未报告次要终点
研究者
研究点 (3)
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