Cataract surgery is one of the most effective and common procedures performed in all of medicine. Cataract surgery is transformative; it allows people to see as soon as the bandage is removed. However, in children, managing cataracts is tedious and often difficult, requiring many visits over many years. Treating cataracts is also more urgent in infants than adults because the condition can cause blindness. Treatment options are available, but many questions remain on the best way to manage cataracts in infants and children.
One way to answer some of those questions is by analyzing real-world data that reflects the care and outcomes of children with cataracts. That’s why the U.S. Food and Drug Administration recently granted nearly $400,000 to the American Academy of Ophthalmology 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.”
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.
“This grant signifies the FDA’s commitments to addressing the unique medical needs of pediatric populations and advancing health equity, through furthering opportunities to analyze real-world data to support the development of safe and effective technologies to meet the needs of diverse patient populations, particularly within ophthalmic care,” said Malvina Eydelman, MD, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health. “By harnessing this critical health data, along with assessing the utilization of artificial intelligence, the agency aims to better understand and evaluate patient characteristics to more effectively address current gaps in health care and use this data to further the development of safe and effective medical devices.”
The IRIS Registry is one of the largest specialty society clinical data registries and the first comprehensive eye disease clinical registry in the U.S. Launched in 2014, it has amassed data from 454 million patient visits, 75 million unique patients, 62 electronic health records systems and more than 16,000 ophthalmologists and other eye care providers in their practices across the U.S.
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.
Like adults, cataracts in children are treated by surgically removing the eye’s clouded lens and replacing it with an artificial lens or intraocular implant (IOL). But that’s where the similarity ends. In adults, the IOL is inserted immediately, and for most adults, that’s the end of their treatment journey. In children, because the eyes continue to grow and change shape, they must wear a contact lens, or very thick glasses until they get a little older, then the IOL is inserted during a second surgery if clinically appropriate.
Pediatric cataract surgery poses a myriad of challenges, mainly due to anatomical differences compared with the adult eye. IOL calculations in children are more difficult since eye growth is hard to predict and varies greatly among individuals. Children undergo surgery under general anesthesia, not local anesthesia as adults do. After surgery, children require more frequent visits to evaluate issues with inflammation and intraocular pressures, as well as issues like amblyopia. In the long-term, the risk of glaucoma and retinal detachments is significantly higher than in adults due to their age at surgery and the likelihood of multiple eye procedures over the child’s lifetime.
Dr. Mbagwu and the Verana Health team of scientists and clinicians will analyze de-identified data of pediatric cataract surgeries with IOL implantation performed over a seven-year period, from 2013 through 2020. They will be looking not only at structured electronic health record data and claims data but 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 over time, the type and frequency of complications after surgery, and who is more susceptible to those complications. Tracking patient outcomes over time will help provide a more comprehensive, real-world look at the safety and effectiveness of IOLs in children.
“Pediatric cataract surgery is one of the most impactful procedures that can be done for a young patient who needs it. In doing so, surgeons can give the gift of sight to children who may have otherwise gone blind,” Dr. Mbagwu said. “While there have been many technical advances with intraocular lenses in recent years, much of it has been focused on the adult population. We’re excited to contribute our data to something truly meaningful. It’s my hope we will lend insight to important questions that are otherwise difficult to study."
Study results are expected to be submitted to the FDA before the end of the year.(NJ/Newswise)
