To Investigate the Precision and Agreement of SS-1000 and the Predicate Device Pentacam in a Repeatability and Reproducibility Trial (PASP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Precision
研究概览
简要总结
This study is to support the substantial equivalence of the SS-1000 to the predicate device Pentacam.
Primary Objective -The primary objective of the trial is to evaluate the precision of the SS-1000 and Pentacam in measuring the anterior segment parameters in an eye, including Corneal Curvature, Corneal Thickness, Anterior Chamber Depth and Cornea Volume.
Secondary Objectives
- To investigate the repeatability (intra-instrument) of SS-1000 and Pentacam in measuring the anterior segment parameters in an eye
- To investigate the reproducibility (inter-instrument) of SS-1000 and Pentacam in measuring the anterior segment parameters in an eye
- To investigate the agreement between SS-1000 and Pentacam in measuring the anterior segment parameters in an eye
Study design
-The trial design is a prospective precision trial with the following factors: The trial will be conducted at one investigational site. The site will have three SS-1000 devices and three Pentacam devices available. Three certified operators (#1, #2 and #3) will be randomly assigned to one set of devices (one SS-1000 and one Pentacam), such that operator effect are confounded with instrument effect. All participants will have one visit and undergo the same set of assessments. Each assessment will consist of 2 consecutive readings (M1, M2).
详细描述
- Nonsignificant Risk (NSR) Devices
The two devices SS-1000 and Pentacam are considered non-significant risk devices and the conduct of the trial will adhere to the abbreviated requirements of Investigational Device Exemption (21CFR812.2, 2011). 2. Overall Trial Design
The trial design is a prospective precision trial with the following factors:
The trial will be conducted at one investigational site. The site will have three SS-1000 devices and three Pentacam devices available. Three certified operators (#1, #2 and #3) will be randomly assigned to one set of devices (one SS-1000 and one Pentacam), such that operator effect are confounded with instrument effect. All participants will have one visit and undergo the same set of assessments. Each assessment will consist of 2 consecutive readings (M1, M2).
To ensure the highest physiological stability of the eyes all measurements will be done at least 3 hours after subject awake (Lattimore MR, 1999). To decrease the diurnal variation each subject will have, all measurements excluding screening measurements are performed within a 2 hour window. All measurements are performed in constant dim lighting conditions.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or male age 22 years or older at time of screening
- •Able to fixate at the internal fixation
- •Able to open eyes sufficiently to enable a full image area
- •Written informed consent obtained from subject before any investigational assessment
- •Eyes with one of the following cornea conditions (Francis BA, 2008):
- •Normal cornea (CCT between 511-580 µm with or without pathology)
- •Thin cornea, i.e. previous refractive surgery, corneal ectasia, keratoconus (CCT ≤510 µm with or without pathology)
- •Thick cornea, i.e. Fuchs' dystrophy, bullous keratopathy, corneal edema (CCT >580 µm with or without pathology)
排除标准
- •Use of rigid contact lenses within one week from start of trial
- •Use of soft contact lenses within 24 hours of any trial measurement
- •Aphakic eyes
- •Eyes with a history of intraocular, corneal surgery, except refractive surgery
- •Currently on mydriatic and/or miotic medication that can affect ocular physiology
- •Seriously ill or unconscious subject, mentally ill person, mentally handicapped person, person who is unable to read or write
结局指标
主要结局
Precision
时间窗: within 2 hours
Corneal Curvature 1. AKf: axial power value of the flattest meridian \[Anterior\] (mm) 2. AKs: axial power value of the steepest meridian \[Anterior\] (mm) 3. PKf: axial power value of the flattest meridian \[Posterior\] (mm) 4. PKs: axial power value of the steepest meridian \[Posterior\] (mm) Corneal thickness 1. CCT: thickness value of central cornea (µm) 2. PCT2: thickness value of peripheral cornea at intersection between the 2-mm diameter circle and the nasal horizontal meridian (µm) 3. PCT4: thickness value of peripheral cornea at intersection between the 4-mm diameter circle and the nasal horizontal meridian (µm) 4. PCT6: thickness value of peripheral cornea at intersection between the 6-mm diameter circle and the nasal horizontal meridian (µm) ACD: Anterior Chamber Depth (mm) Cornea Volume (mm3)
次要结局
- Repeatability, reproducibility and agreement(within 2 hours)