A Single-Center, Open-Label, Randomized Clinical Study Measuring Time Needed for Testing Between the Haag-Streit Lenstar 900 Version i4 and the Carl Zeiss IOL Master 500 Instruments
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Time to complete a full examination
研究概览
简要总结
The objectives of this study are to determine the time needed to complete a full set of measurements (Total Ophthalmic Exam, Subject Data Entry and Acquisition of the Measurement) by each test device, the Lenstar 900 Version i4 and IOL Master 500.
详细描述
This is an open-label study randomized by sequence. Each eligible subject who signs a consent form and fulfills all Inclusion/Exclusion criteria will undergo ophthalmic measurements by the two test products:
A. Haag-Streit Lenstar Version i4
B. Zeiss IOL Master 500
The order of measurements for the IOL Master 500 and the Haag-Streit Lenstar Version i4 will he randomized. The two possible sequences will be balanced (approximately 22 eyes each: AB,BA). One eye of each subject will be measured. Time needed to complete testing will be measured utilizing a stop-watch. Total time needed to complete all measurements of the study eye using each of the test products to capture a complete ophthalmic exam with the devices standard operating settings set to automatic measurement and analysis will be calculated by the following start and stop points:
First Timed Measurement: Measurement Acquisition Start: When the technician starts to acquire tbe first measurement Stop: When the technician has completed all measurements
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Subjects wbo meet all of the following criteria are eligible to participate in tbe study:
- •Male or female l8 years of age or older on the date of Informed Consent.
- •At least one eye of each subject must be a phakic eye.
- •Subject must be able to fixate on a target.
- •Able to understand and willing to sign tbe informed consent.
排除标准
- •Subjects will be excluded from the study if the following applies:
- •History of corneal surgery.
- •Use of contact lenses during tbe ophthalmic exam or up to two hours prior to the exam.
- •Any ophthalmic condition preventing use of either of the instruments used in the study.
- •Any ophthalmic condition which might impair tbe validity of results from any of the instruments used in the study.
- •Any medical condition, which, in tbe Investigator's judgment, interferes with the subjects ability to comply with tbe protocol, compromises subject safety, or interferes with tbe interpretation of the study results.
结局指标
主要结局
Time to complete a full examination
时间窗: At Study Visit (study consists of 1 visit only)
Time to complete a full ophthalmic exam(as measured from the time of subject placement just prior to the technician completing data entry at the test product, to the beginning of data printing) for each, the IOL Master 500 and the Haag-Streit Lenstar Version i4.
次要结局
- Data Entry Time Measurement(At Study Visit (study consists of 1 visit only))
- Measurement Acquisition Time Measurement(At Study Visit (study consists of 1 visit only))
- Adverse Events(Duration of study from signing informed consent to Study Visit (study consists of 1 visit only))