Development of a Next-Generation Optical Biometer for Eyes With Cataract
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Ocular parameters of cataractous eyes measured with a novel biometer
研究概览
简要总结
The Helioscope (Cassini Technologies B.V.) is a novel device under development that aims at combining LED-based corneal topography and SS-OCT to provide accurate and fast measurements of both the corneal shape and the ocular biometry. To that end, the hardware and software of the Cassini color-LED topographer (Cassini Technologies B.V.) is combined with a novel SS-OCT device.
While the new Helioscope can largely be evaluated using data acquired with healthy eyes, one of its main use-cases is providing input for IOL power formulae for cataract surgery. Thus, it is essential that the device can perform measurements in eyes with (dense) cataract. As cataract changes the optical properties of the crystalline lens and the OCT measurement is optical, this is not a given. This study therefore seeks a dataset of Helioscope measurements performed in eyes with cataract that can be used to develop the software algorithms of the Helioscope.
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
- 否
入选标准
- •The presence of cataract in at least one eye.
- •Minimally 21 years of age.
- •Provided written informed consent.
排除标准
- •The inability to properly fixate on a fixation target for several seconds
- •The inability to provide informed consent.
研究组 & 干预措施
All enrolled subjects
All eligible subjects will undergo ocular biometry using three devices:
- the investigational optical biometer,
- Comparator Device A, and
- Comparator Device B. Measurements from all devices will be obtained at the same visit and used only for diagnostic comparison. No treatment assignment occurs.
干预措施: New Investigational Optical Biometer (Device) (Device)
All enrolled subjects
All eligible subjects will undergo ocular biometry using three devices:
- the investigational optical biometer,
- Comparator Device A, and
- Comparator Device B. Measurements from all devices will be obtained at the same visit and used only for diagnostic comparison. No treatment assignment occurs.
干预措施: Comparator Device A (Cassini Ambient) (Device)
All enrolled subjects
All eligible subjects will undergo ocular biometry using three devices:
- the investigational optical biometer,
- Comparator Device A, and
- Comparator Device B. Measurements from all devices will be obtained at the same visit and used only for diagnostic comparison. No treatment assignment occurs.
干预措施: omparator Device B (Argos) (Device)
结局指标
主要结局
Ocular parameters of cataractous eyes measured with a novel biometer
时间窗: Overall study to complete up to 12 months
Primary endpoint: Biometric ocular parameters of axial length, anterior chamber depth, central corneal thickness, keratometry, lens thickness and limbal white to white will be measured by the Helioscope device in 200 eyes.
次要结局
- Comparison of ocular biometry measured by a novel biometer against FDA approved devices for planning cataract surgery(Overall study to complete up to 12 months)