In ophthalmic clinical trials aimed at achieving regulatory approval—particularly those where tissue morphology is a primary outcome measure—standardized, masked, and controlled image analysis is essential to the validity and credibility of the results. Contracting with an ophthalmic reading center adds expertise and quality control to improve the capture, integrity, and analysis of image data.
Ophthalmic reading centers typically specialize in imaging of certain tissue types or anatomical locations—eg, the retina, optic disc, or cornea. Reading centers can perform more detailed image analysis than is typically possible in the clinic, and repeat evaluation by rigorously trained, masked graders helps to minimize variability. Repetition is central to the process, making it possible for centers to document the reproducibility of measurements and, in turn, for study investigators to make more confident statistical analyses.
The quality checks put in place by a reading center begin even before images are collected; as study sites and technicians are certified and trained to capture images according to defined protocols. (Even for experienced technicians, the demands of imaging for routine clinical practice may differ from the rigorous standards required in a clinical trial.) Once image collection commences, reading centers also record and alert study personnel to any lapses in image quality, allowing issues to be rectified rapidly.
EXCELSIOR™ clinical trial management software from EyeKor, LLC, is designed to facilitate image data collection and management in both large and small ophthalmic clinical trials. This secure, cloud-based web application features a centralized data system, customizable (and trackable) workflows, and the potential to access EyeKor’s network of best-in-class ophthalmic reading centers. EXCELSIOR’s sophisticated image enhancement enables investigators, clinicians, and image graders to work accurately with diverse images within a platform developed specifically to conform to the workflow structure, resource needs, and processes of reading centers.
Want to know more about how EyeKor’s software and network of ophthalmic reading centers can benefit your clinical trial? Contact Luca Sergio: 212-791-1440