Search...
The FDA recently gave the Academy $400,000 to support research using de-identified data curated from the Academy’s IRIS Registry® (Intelligent Research in Sight). It’s an exciting investment that may improve patient health and safety. The FDA’s overall goal is to evaluate the potential of using real-world evidence from a data registry to help the agency evaluate the long-term safety, efficacy and use of drugs, devices, and software algorithms post FDA approval. One of the studies will help provide a more comprehensive, real-world look at the safety and efficacy of intraocular lenses (IOL) in children. Like adults, cataracts in children are treated by surgically removing the eye’s clouded lens and replacing it with an artificial lens or IOL. But that’s where the similarity ends. Managing cataracts in children is tedious and often difficult, requiring many visits over many years. This video from David A. Plager, MD, offers some insight into the increased difficulty. Check out the link in bio for the Academy’s Master Class video series on pediatric cataract surgery. Using de-identified data from the IRIS Registry, researchers will look not only at structured electronic health record data and claims data, but will also relying on natural language processing models to understand unstructured clinician notes at scale. This is intended to help surface information on the type of IOL implanted, including the make and model, the surgical technique used, changes in vision overtime, the type and frequency of complications after surgery, and who is more susceptible to those complications. The FDA contract award also includes a project to evaluate IDx-DR, an FDA-approved software program that uses artificial intelligence to screen for diabetic retinopathy. This study seeks to identify any racial or ethnic biases in the software algorithm as the IDx-DR system is used in a wi
By aaoeye
Published
From the Health Care Hub community. Empowering medical learners with innovative insights for healthcare advancement.
Posted in Ophthalmologists 👁️. Explore innovative insights and empower medical learners for healthcare advancements.
3 views
1 likes