How Real-World Data Can Reveal Insights on Unique Pediatric Populations with Cataracts
Author:
Aracelis Torres, PhD, MPH
SVP of Data & Science
Globally, an estimated 1 to 15 per 10,000 children experience cataracts, which are cloudy areas that form on the lens of the eye. If not immediately treated, the condition could worsen and lead to vision loss. Treatment for cataracts involves surgery that requires removing the clouded lens and inserting a clear artificial lens, known as an intraocular lens (IOL).
However, this type of surgery poses a myriad of challenges for children with cataracts, mainly due to anatomical differences compared with the adult eye. After surgery, children require more frequent visits to monitor for inflammation and intraocular pressures, as well as issues such as amblyopia. IOLs are not explicitly approved by the Food and Drug Administration (FDA) for this patient population and, until recently, were not widely used in children. Therefore, little is known about the efficacy of this treatment.
Pediatric Populations with Cataracts Research Study Process
To help examine the safety and effectiveness of IOL use among pediatric patients with cataracts, Verana Health and the American Academy of Ophthalmology partnered with the FDA on the largest IOL study to date. Utilizing Verana Health’s clinician-directed and artificial intelligence-enhanced VeraQ® population health data engine, our research team analyzed curated, de-identified real-world data from the Academy’s IRIS® Registry (Intelligent Research in Sight).
The team also relied on large language models to conduct this cataract research by using natural language processing approaches to understand at scale unstructured clinical notes. This helped to surface information on the type of IOL implanted, including the make and model. Unstructured data combined with other details available within electronic health records, such as the surgical technique used, changes in vision overtime, and the occurrence of complications after surgery, enabled a more comprehensive, longitudinal real-world view of the safety and effectiveness of IOLs in children.
The research identified more than 5,000 IOL implantations among nearly 4,000 pediatric patients with cataracts. These patients were less than 21 years of age between the time period of January 1, 2013 to December 31, 2022. It’s worthy to note that this is one of the few studies with patients between the ages of 10 to 21, which highlights how large scale databases can enable insights into new populations. Of the 563 patient eyes, 448 patients had an identified IOL brand and model number.
Pediatric Populations with Cataracts Research Study Results
Overall, the study results highlight the importance of leveraging retrospective observational data from real-world settings to effectively inform and support clinical outcomes.
Results from the study found significant improvements in visual acuity (VA) at all post-surgical timepoints following cataract surgery, with an average VA of 20/70 recorded within one year. However, those with an implantation of unilateral IOLs had poorer VA, which is consistent with prior literature where patients undergoing unilateral implantation had worse visual outcomes due to asymmetric deprivation amblyopia. Posterior capsular opacification was the most frequent overall adverse event.
Overall, the study results highlight the importance of leveraging retrospective observational data from real-world settings to effectively inform and support clinical outcomes.
“This study represents a pivotal step in understanding the challenges faced by a unique population of pediatric patients afflicted with cataracts,” said Malvina Eydelman, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices in the Office of Product Evaluation and Quality within the FDA’s Center for Devices and Radiological Health (CDRH). “This collaboration represents an important step forward in supporting CDRH’s strategic priority to advance health equity and the development of safe and effective technologies to meet the needs of all patients.”
The Verana Health team was honored to contribute data to such a meaningful cause in hopes of lending insight into important questions. The research study results for children with cataracts were recently presented during the 49th AAPOS Annual Meeting in Austin, Texas on April 10. A manuscript that will highlight the full results of the study is currently in development.
To view a Verana Health case study with these results, click here.
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