Latest News American Academy of Ophthalmology Awarded FDA Grant for Pediatric Cataract Surgery By Staff Monday, January 23, 2023 12:15 AM SAN FRANCISCO, Calif.—The U.S. Food and Drug Administration (FDA) has granted nearly $400,000 to the American Academy of Ophthalmology (the Academy) to support research into pediatric cataract surgery, powered by real-world data curated from the Academy’s IRIS Registry (Intelligent Research in Sight). Verana Health—the Academy’s exclusive end-to-end data curation and analytics partner for the IRIS Registry—will be leading the data analysis with clinical expertise and input from the Academy. “Asking questions and identifying improvements for pediatric cataract surgery is very important,” said Michael Mbagwu, MD, adjunct clinical instructor of ophthalmology at Stanford University School of Medicine and senior medical director at Verana Health.“The FDA understands this, and that the only way to get an accurate view of real-world evidence on treatment is through research using a data registry.” Dr. Mbagwu and a team of Verana Health researchers will use its VeraQ population health data engine to analyze curated, de-identified IRIS Registry data on pediatric cataract surgery.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 wider population. The FDA’s broader 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 after FDA approval.As VMAIL reported in December, Verana Health and the Academy previously launched the Verana Research Network, an IRIS Registry initiative intended to help advance data-driven clinical research and care. The network consists of academic medical centers (AMCs) and ophthalmology practices joining together to utilize IRIS Registry data and Verana Health capabilities to help improve patients' access to, and streamline health care providers' execution of clinical trials.