Assessment of Scan Quality of Sparse OCT Retina Scanner (MimoStudy01)
Optical Coherence Tomography (OCT) is an established non-invasive medical imaging technique ophthalmologists use to diagnose and monitor retinal diseases such as age-related macular degeneration (AMD).
This study assesses the scanning performance of a newly developed sparse OCT retina scanner that is smaller and more compact than most commercially available medical OCT systems. The prototype device was developed at Artorg Center Bern and Berner Fachhochschule Biel.
In this study the device is first tested on human eyes. The scanning performance is compared to a reference device. Additionally patient feedback during the examination is acquired.
The findings of this study are used to improve the software and the ergonomics of the investigational device.
研究概览
详细说明
Background
Optical Coherence Tomography (OCT) is an established non-invasive medical imaging technique ophthalmologists use to diagnose and monitor retinal diseases such as age-related macular degeneration (AMD).
This study assesses the scanning performance of a newly developed sparse OCT retina scanner that is smaller and more compact than most commercially available medical OCT systems. The prototype device was developed at Artorg Center Bern and Berner Fachhochschule Biel.
In this study the device is first tested on human eyes. The scanning performance is compared to a reference device. Additionally patient feedback during the examination is acquired.
The findings of this study are used to improve the software and the ergonomics of the investigational device.
Objective
- Comparing scan quality of investigational device to scan quality of reference device.
- Obtaining patient feedback on the examination with investigational device.
Methods
Comparison of OCT scans made with standard device and investigational device.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
ZH
-
Zürich、ZH、瑞士、8006
- Augenklinik Univestitätspital Zürich
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18 years or older
- German speaking
- Suffering from age-related macular degeneration
- Written informed consent
Exclusion Criteria
- Epilepsy
- Parkinsonian syndrome
- Dementia
- Pregnant women
- Persons using electronic medical aids i.e. hearing aid, pacemaker..
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：All study participants
Patient's eyes are OCT-scanned with standard device and investigational device.
|
OCT scan (as yet unnamed) of the eye with investigational device; newly developed sparse OCT retina scanner by Artorg Center Bern and Berner Fachhochschule Biel
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Distance between ILM and RPE (IPD) measurement successful or not. Successful is defined as a) measurement performed/failed, and if performed, b) value obtained within ±10% of value of reference OCT device.
大体时间：During diagnostic intervention, expected to be ca. 30 minutes on average
|
During diagnostic intervention, expected to be ca. 30 minutes on average
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient comfort during examination
大体时间：Directly after diagnostic intervention, expected to be ca. 35 minutes on average
|
Assessed via interview with patient
|
Directly after diagnostic intervention, expected to be ca. 35 minutes on average
|
|
Duration of OCT examination with investigational device
大体时间：Directly after diagnostic intervention, expected to be ca. 35 minutes on average
|
Directly after diagnostic intervention, expected to be ca. 35 minutes on average
|
合作者和调查者
调查人员
- 首席研究员：Sandrine Zweifel, MD、Augenklinik Universitätspital Zürich
- 研究主任：Raphael Sznitman、ARTORG, University of Bern
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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