Programming and implementation of a clinical trials visual testing app platform for assessment of advances in tissue engineering

“所有组织工程都需要在获得许可之前进行临床试验，该博士将开发所需的工具，以支持在基线和治疗后的时间点进行有效和详细的临床眼科指标收集。研究团队之前的研究开发并验证了基于智能手机/平板电脑的视觉功能评估测试，如更快速、全面地评估对比度灵敏度和阅读速度；在任务随机化方面，这些方法比传统的基于纸张的方法有优势，使用内置传感器记录开始和停止阅读时间和单词识别（使用麦克风），监控工作距离的变化（使用摄像头）以及检测现实世界的任务补偿（例如屏幕倾斜（使用陀螺仪传感器））。人们还希望在临床环境之外，在现实世界中收集更多的患者数据，以更好地捕捉自然变化，以及组织工程如何日复一日地造福患者。跨应用平台可以让应用程序下载到患者自己的设备上，监测视觉指标，但也可能支持他们的依从性，但这是一个需要更多研究的领域。该项目将涉及学者与一家初创医疗设备公司密切合作，体验医疗应用程序开发和ISO 13485认证的所有阶段，开发患者管理仪表板和模块，利用移动/智能手机内置的摄像头和传感器进行视觉功能测试。数据分析将应用于机器学习，以帮助未来的临床医生做出个性化医疗决策。此外，该学者将开发和临床验证用于家庭监测患者的应用程序，以帮助和评估依从性，并提供实际工作的症状数据。”

"All tissue engineering requires clinical trials prior to licensing and this PhD will develop the tools required to support efficient and detailed clinical ophthalmic metric collection at baseline and at timepoints after treatment. Previous research by the research team has developed and validated smartphone / tablet based visual function assessment tests such as to more quickly and comprehensively assess contrast sensitivity and reading speed; these have the advantage over more traditional paper based approaches in terms of task randomisation, using the inbuilt sensors to record start and stop reading times and word recognition (with the microphone), to monitor changes in working distance (with the camera) and to detect real world task compensations (such as screen tilt (with the gyro sensors). There is also a desire to collect more patient data in the real world, outside of the clinical setting, to better capture natural variations and how the tissue engineering might benefit a patient day by day. Cross-app platforms can allow apps to be developed to download onto the patients own device to monitor visual metrics, but also potentially to support their compliance, but this is an area requiring more research.The project will involve the scholar working closely with a start-up medical device company to experience all the stages of medical app development and certification within ISO 13485 to develop a patient management dashboard and modules to conduct visual function tests, utilising mobile / smartphones inbuilt camera and sensors. Data analytics will be applied to allow machine learning to aid future clinician decision making for personalized medicine. In addition, the scholar will develop and clinically validate apps for home monitoring of patients to aid and assess compliance and to give real-work symptomology data. "