London 2014 Registration Visa Letters Programme Satellite Meetings Glaucoma Day 2014 Exhibition Hotel Booking Virtual Exhibition Star Alliance
london escrs

Course handouts are now available
Click here


Come to London

video-icon

WATCH to find out why


Site updates:

Programme Updates. Programme Overview and - Video Symposium on Challenging Cases now available.


Posters

Search Abstracts by author or title
(results will display both Free Papers & Poster)

Cloud-based medical image/data management software and its application in post-market surveillance clinical trials for intraocular lenses

Poster Details

First Author: M.Mrochen SWITZERLAND

Co Author(s):    M. Talary   Y. Huang           

Abstract Details

Purpose:

To define the critical functions required for conducting post-market surveillance clinical trials of intraocular lenses (IOLs). Post-market surveillance of IOLs has become necessary due to strict application of European medical device regulations. Such trials usually require multiple ophthalmic imaging modalities—such as corneal topography, anterior optical coherence tomography, and specular microscopy—to characterize safety and efficacy. The challenges of collecting, storing, manipulating, and distributing images between clinical sites, reading centers, sponsors, and regulatory bodies have become central to conducting successful trials.

Setting:

Institut für Refraktive und Ophthalmo-Chirurgie, Zurich

Methods:

We reviewed the critical functions required for conducting efficient post-market surveillance clinical trials of IOLs and describe how one cloud-based image management software platform fulfills these functions.

Results:

Critical functions for surveillance clinical trials of IOLs include secure login, compliance with privacy and safe harbor regulations, the ability to harmonize data sources from multiple imaging devices, the ability to view images collected at geographically dispersed locations, and an information technology infrastructure that supports large data sets. The EXCELSIOR™ system, a secure cloud-based platform uniquely approved by the US FDA for image analysis and data management in ophthalmic clinical trials, demonstrates one approach to fulfilling these functions.

Conclusions:

Secure cloud-based medical image/data management software may help increase the efficiency of ophthalmic clinical trials and support post-market surveillance.

Financial Disclosure:

One or more of the authors gains financially from product or procedure presented, One or more of the authors travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One or more of the authors is employed by a for-profit company with an interest in the subject of the presentation, One or more of the authors has significant investment interest in a company producing, developing or supplying product or procedure presented

Back to Poster listing