Feasibility Investigation of Biometry and Tomography Measurements in a Heterogeneous Patient Cohort (BioBase)
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Data collection for algorithm development - Cornea to retina Scan
研究概览
简要总结
The planned clinical investigation will be conducted to acquire raw data for the development of the algorithm. The data acquisition is intended to obtain first impressions of the potential performance of the changed hardware and software components and to confirm the safety profile assessed by risk analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 21 years of age and older
- •Able and willing to make the required study visit
- •Able and willing to provide consent and follow study instructions
- •Patients must have understood and signed the informed consent
排除标准
- •Any performed contact measurements or examinations in which the eye is touched on the same day prior to the investigation measurement
- •Physical inability to be positioned at the study devices (e.g. torticollis, head tremor, injuries at forehead or chin, etc.)
- •Principal Investigator's determination that the subject is not suitable due to other medical condition (reasons to be listed on eCRF)
- •Known Pregnancy
结局指标
主要结局
Data collection for algorithm development - Cornea to retina Scan
时间窗: day 1
- Cornea to retina Scan (all axial measurements) The data will be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Data collection for algorithm development - Corneal topography
时间窗: day 1
- Corneal topography (raw data and images) including keratometry The data will then be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Data collection for algorithm development - - Anterior-segment OCT data
时间窗: day 1
- Anterior-segment OCT data The data will be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Data collection for algorithm development - Extended retina-scan
时间窗: day1
- Extended retina-scan The data will be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Data collection for algorithm development - Reference pictures for markerless alignment of toric IOL (sclera images)
时间窗: day 1
- Reference pictures for markerless alignment of toric IOL (sclera images) The data will be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Data collection for algorithm development - White-to-white determination
时间窗: day 1
- White-to-white determination The data will then be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Data collection for algorithm development - IOL Imaging pictures
时间窗: day 1
- IOL Imaging pictures The data will then be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Affected measurements - - WTW measurements
时间窗: day 1
It will be investigated, whether the measurements with the study prototype device are affected by the base movement. - WTW measurements This outcome will be investigated by comparing the raw data of the study prototype device with the data measured with the marketed IOLMaster 700 and Pentacam / MS-39 devices. Non-optimal positioning and movement could possibly cause blurred images that would prevent a detailed analysis
Affected measurements - Keratometry and Topography measurements
时间窗: day 1
It will be investigated, whether the measurements with the study prototype device are affected by the base movement. - Keratometry and Topography measurements This outcome will be investigated by comparing the raw data of the study prototype device with the data measured with the marketed IOLMaster 700 and Pentacam / MS-39 devices. Non-optimal positioning and movement could possibly cause blurred images that would prevent a detailed analysis
Affected measurements - OCT measurements
时间窗: day 1
It will be investigated, whether the measurements with the study prototype device are affected by the base movement. - OCT measurements This outcome will be investigated by comparing the raw data of the study prototype device with the data measured with the marketed IOLMaster 700 and Pentacam / MS-39 devices. Non-optimal positioning and movement could possibly cause blurred images that would prevent a detailed analysis
次要结局
未报告次要终点