Imaging is becoming an ever more critical aspect of ophthalmic clinical trials. To begin with, the number of new imaging modalities available to evaluate ocular structures is exploding, with OCT, confocal microscopy, autofluorescence, and tear film interferometry just a few of the new technologies that are dramatically increasing our ability to visualize and evaluate ocular structures.
Using imaging to gauge the impact of an intervention on appropriate ocular structures allows trial sponsors and regulatory officials to determine both the efficacy of the intervention and its potential to cause harm. As a measure of both safety and efficacy, imaging has become central to today’s ophthalmic clinical trial process.
But with the larger number of images derived from multiple technologies comes a slew of new headaches. In any large trial, images are taken on different instruments by different people at different sites. And then those images have to be evaluated and scored. Maintaining uniformity in collection, image quality, and grading is a significant challenge.
EyeKor’s FDA-approved web app Excelsior™ helps to minimize error and maximize efficiency in large ophthalmic clinical trial databases by providing a platform for integrating all aspects of clinical image collection, storage, and evaluation. As a secure, cloud-based system, virtually any type of ophthalmic imaging —fundus photography, OCT, fluorescein angiography, endothelial cell analysis by specular microscope, and much more—may be uploaded, organized, and made comparable for readers.
Excelsior™ can do more than handle images, however. It can track and follow technician training and certification, recruitment efforts, and follow-up at each site. The trial sponsor or CRO can find out instantly and in real time exactly where each site stands and the quality of the images it has produced. If there problems, they can be spotted and fixed instantly. Similarly, reading center personnel can be trained and tracked, ensuring uniform judgments across images from multiple centers.
With its Excelsior™ software, EyeKor aims to improve ophthalmic clinical trial quality and efficiency and bring peace of mind to trial sponsors.
To learn more about how to streamline clinical trial image analysis with Excelsior™, contact Luca Sergio: 212-791-1440