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

"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.
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