Title: Multispectral Imaging Retinal Densitometer
Funder: Department of Health (England)

Abstract: The outline project plan is shown in the attached Gantt chart. The project work packages and key milestones are described below. Work Package 0: Project Management (1-Nov-2013 to 31-Oct-2016) This work package includes all on-going work such as project management, commercialisation development, systems engineering, quality management and regulatory issues (maintaining a quality management plan, contracting a notified body, creation of a technical file etc.) The commercialisation activities will include management of the IP, market analysis and creation of a full business plan. Work Package 1: Engineering Model: Design & Build (1-Nov-13 to 31-Oct-14) Define Requirements; Define Design Specifications; Detailed Design; Procurement; Assembly, Integration & Test. Milestones : Design Review - 18th April 2014 Deliver Engineering Model to Cardiff – 31st October 2014 STFC will follow their well-established standard instrumentation design and build process. A postdoctoral researcher with expertise in data analysis and computer programming, employed by Cardiff, will travel to Edinburgh to work with the team at UKATC to ensure a seamless link between equipment development and clinical testing. Work Package 2: Engineering Model Trial (8-Aug-14 to 31-Jul-15) Commissioning & Calibration; System Optimisation; Assessment of Repeatability on 20 healthy adults. Milestone: Trial Review – 31st July 2015 This period will include calibration of the densitometer using a model eye (to determine absolute reflectance of the retina at each wavelength) and initial clinical testing. The optimal bleaching and stimulus parameters for the densitometer will be determined, along with further development of the eye alignment algorithms and data analysis software. The aim will be to use feedback from clinical data in an iterative manner to optimise the system performance. During the last 2 months at Cardiff 20 healthy adults will participate in a study to assess repeatability. Work Package 3: Qualification Models Design & Build (20-Mar-15 to 31-Mar-16) Define Requirements; Define Design Specifications; Detailed Design; Industrial Design; Procurement; Assembly, Integration & Test. Milestones : Design Review – 18th September 2015 Deliver Qualification Models to Cardiff – 31st March 2016 This design iteration will be based on feedback from Cardiff and participant feedback. It will also take into account the need for any design to be compatible with small volume commercial manufacture at a later stage. Additionally there will be an element of industrial design to give the densitometer a professional “look and feel” in order to begin to stimulate interest within the optometry/ophthalmology community. Work Package 4: Qualification Models Diagnostic Evaluation (7-Jan-16 to 30-Sep-16) Commissioning & Calibration; System Optimisation; Diagnostic Evaluation; Data analysis. Milestone: Evaluation Review – 30th September 2016 Thirty participants with AMD (early AMD in at least one eye, the fellow eye may have early or advanced AMD) along with thirty healthy controls will be recruited from Bristol Eye Hospital Lucentis Clinics and from the database of volunteers at the University Eye Clinic in Cardiff. A diagnostic evaluation will be carried out of these data, including Receiver Operating Characteristics (ROC) curves. Work Package 5: Data Analysis Development (11-Jul-14 to 18-Aug-16) Data analysis algorithm and software development using the Engineering Model; definition, design and build of analysis software for the Qualification Model; analysis software support during the diagnostic evaluation. Work Package 6: Final Reporting (30-Sep-16 to 31-Oct-16) Completion of data analysis. Final report and peer reviewed paper writing. Milestone: Final Report Submission - 31st October 2016


Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES
Health categories: EYE