Largest FDA-Funded IOL Study Of Pediatric Patients Highlights Significance Of Real-World Data

With FDA grant support, the American Academy of Ophthalmology and Verana Health conducted the largest real-world study to date on intraocular lens (IOL) use in pediatric cataract patients. Using the IRIS^® Registry and Verana’s VeraQ^® data engine, researchers identified 5,048 surgeries in 3,832 patients under age 21 between 2013 and 2022.

The study addressed a critical gap in evidence, as pediatric IOL use remains off-label despite being common practice to prevent permanent visual impairment. Results showed consistent visual acuity (VA) improvement post-surgery, with mean VA reaching 20/70 at one year. However, unilateral IOL recipients had worse visual outcomes and higher rates of complications. Posterior capsular opacification (PCO) emerged as the most frequent adverse event. The most commonly identified IOL brand was the Alcon AcrySof^® SN60WF. These findings underscore the value of real-world data in evaluating safety and outcomes for pediatric IOL implantation, offering key insights to guide clinical decision-making and inform potential regulatory considerations.