Comparative Study of the Optical Biometer for the Measurements of Axial Length, Anterior Chamber Depth, Keratometry, Corneal Cylinder Axis, Corneal Thickness, White-to-White Distance, and Pupil Diameter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Agreement and Precision Endpoints Analyses
研究概览
简要总结
The primary purpose of this comparative clinical study is to collect clinical data to demonstrate the equivalence of the investigational device to the predicate device for measurements of the eye. The secondary purpose is to evaluate any adverse events that occur during the clinical study.
详细描述
This is a prospective clinical study to be conducted at a single clinical site located in the United States. This study will assess the agreement of an investigational device to the predicate device and an ultrasound reference device and the precision of the investigational device with a comparison to the precision of the predicate. Any adverse events associated with the investigational device can or the predicate device will be assessed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who can follow the instructions by the Principal/Clinical Investigator or clinical staff at the clinical site, and can visit on scheduled examination dates.
- •Subjects who sign an informed consent form to participate in the clinical trial.
- •Subjects who agree to take the qualifying eye examination and a series of devices measurements.
- •Subjects able to fixate on a target.
- •Subjects must meet at lease one of the following criteria:
- •Normal eyes: Subjects with a natural lens without a cataract, corneal abnormalities or prior keratorefractive surgery.
- •Eyes with Cataracts: Subjects with a pre-existing cataract without corneal abnormalities or prior keratorefractive surgery.
- •Eyes without a Natural Lens: Subjects that are pseudophakic or aphakic without corneal abnormalities or prior keratorefractive surgery.
- •Eyes with Corneal Abnormality: Subjects with a corneal abnormality and a natural lens without a cataract, or Subjects post keratorefractive surgery and a natural lens without a cataract.
排除标准
- •Any eye condition preventing use of any of the instruments used in the study.
- •Any eye condition which might impair the validity of results from any of the instruments used in the study.
- •Any medical condition, which, in the Investigator's judgment, interferes with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results.
结局指标
主要结局
Agreement and Precision Endpoints Analyses
时间窗: Subjects will be followed for the duration of the procedure, up to one day.
The agreement of the Nidek optical biometer with the predicate device will be assessed for the following measures: * Axial Length; * Keratometry; * Corneal Cylinder Axis; * Anterior Chamber Depth; * Central Corneal Thickness; * White-to-White Distance; and * Pupil Diameter. In addition, the agreement of the Nidek optical biometer with the ultrasound reference device will be assessed for axial length and anterior chamber depth. The precision of Nidek optical biometer and the predicate device will be assessed for the following measures: * Axial Length; * Keratometry; * Corneal Cylinder Axis; * Anterior Chamber Depth; * Central Corneal Thickness; * White-to-White Distance; and * Pupil Diameter.
次要结局
- Evaluation of Adverse Events Found During the Study(Subjects will be followed for the duration of the procedure, up to one day.)