How RWE From the IRIS Registry Can Transform Pediatric Ophthalmology
Author:
Mike Mbagwu, MD
I am proud to announce that the Food and Drug Administration (FDA) has awarded a two-year, $400,000 grant to the American Academy of Ophthalmology (Academy). The goal for a portion of this funding is to assess the safety outcomes for intraocular lenses (IOLs) in children following cataract surgery. Verana Health will be leading the analysis of real-world data (RWD) from the Academy’s IRIS® Registry (Intelligent Research In Sight).
Verana Health is the Academy’s exclusive end-to-end data curation and analytics partner for the IRIS Registry. Launched in 2014, the IRIS Registry is the first comprehensive eye disease clinical registry in the U.S. It includes anonymized data from 484 million patient visits, 79 million unique patients, nearly 60 electronic health records systems (EHRs) and approximately 16,000 ophthalmologists and other eye care providers across the U.S.
Much like a camera, your eye has a lens. When this natural lens becomes cloudy, it can impair vision because light can’t enter the eye as it normally would. When this process occurs, the result is a cataract.
Worldwide, about three out of 10,000 children have what are called pediatric cataracts. Cataracts typically develop over many years, leading to blurry vision as people age. But children, including newborns, can also develop cataracts.
Worldwide, about three out of 10,000 children have what are called pediatric cataracts. Cataracts typically develop over many years, leading to blurry vision as people age. But children, including newborns, can also develop cataracts.
Surgical intervention is the only way to address a cataract. During this procedure, the cloudy lens is removed and replaced with an IOL. In adults, cataract surgery is performed during an outpatient visit and has a very high rate of success. The vast majority of adults who undergo cataract surgery have improved vision and experience no complications.
Unique Challenges of Pediatric Cataract Surgery
Pediatric cataracts present far more challenges than cataracts in adults, primarily because the eyes of children continue to grow and change shape throughout their adolescent and teen years. Therefore, young children who have a cataract removed must wear a contact lens, or very thick glasses, until they get older. Then, an IOL may be inserted if it’s deemed clinically appropriate. If a child has a cataract in one eye, it must be removed in the first few weeks of life, with the IOL implanted many years later – a far different treatment journey than that of typical adults.
As none of the IOL lenses that we use to replace cataracts have an FDA market approval in the pediatric population, their use is considered “off label.” There remains a debate in pediatric ophthalmology as to which IOLs are most appropriate for pediatric patients given the unanswered questions regarding the long-term safety and efficacy in this population.
Using Real-World Evidence to Better Understand Pediatric IOL
For both the FDA and medical device manufacturers, it is critical to gain insight into the long-term real-world outcomes of pediatric IOLs.
For both the FDA and medical device manufacturers, it is critical to gain insight into the long-term real-world outcomes of pediatric IOLs. That’s the goal of the FDA grant project. The Academy will work with the Verana Health team, using the IRIS Registry’s longitudinal data, to assess real-world evidence (RWE) regarding the safety and outcomes of IOLs in pediatric patients.
Verana Health researchers will utilize our VeraQ® population health data engine to analyze curated, de-identified IRIS Registry data on pediatric cataract surgery. Our team of scientists and clinicians will analyze de-identified data of pediatric cataract surgeries with IOL implantation spanning a period of seven years from 2013 through 2020.
Specifically, we’ll seek to do the following:
- Profile the demographic and clinical characteristics of pediatric patients who have undergone IOL insertion
- Explore the feasibility of developing a natural language processing (NLP) algorithm, using clinical and surgical notes from physicians participating in the IRIS Registry, to identify the type of IOL, model numbers, device brands, and unique device identifier (UDI) for lenses implanted
- Describe demographic and clinical characteristics of pediatric patients with identifiable IOL type, model number, device brand or UDI
- Estimate the cumulative incidence rates, post-IOL implantation, for several adverse events (AEs)
RWD from the IRIS Registry will help us gain a better understanding of how IOLs are used and what can happen after they are implanted in a child’s eye. For instance, what trends in use have occurred over the years? What unique adverse events are specific to a pediatric population? Does this vary by IOL design or materials they are made from?
We are excited to work with the Academy and the FDA to gain a better understanding of the outcomes associated with pediatric IOL implantation.
The IRIS Registry helps us to track a patient across the entire patient journey, offering opportunities to answer these questions and more. We are excited to work with the Academy and the FDA to gain a better understanding of the outcomes associated with pediatric IOL implantation. It is our goal that our research will make a significant contribution to pediatric ophthalmology.
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