The largest IOL study financed by the FDA with pediatric patients emphasizes the importance of the real data

With the support of the FDA Grant, the American Academy of Ophthalmology and Biera Health carried out the largest real study to use the intraocular lenses (IOL) in Pediatric cataract patients. Use the iris^® Registration and arranged veraq^® Between 2013 and 2022 5,048, data engine, researchers identified operations in 3,832 patients under the age of 21.

The study dealt with a critical gap in evidence, since the pediatric IOL use remains outside the label, although it is common to prevent permanent visual impairment. The results showed a consistent visual acuity (VA) after the operation, with the middle VA reaching 20/70 after one year. However, one -sided IOL recipients had poorer visual results and higher complication rates. Posterior Capsular OpenAcification (PCO) became the most common undesirable event. The most frequently identified iOL brand was the Alcon Acrysof^® Sn60Wf. These results underline the value of real data when evaluating security and results for pediatric IOL implantation and offer important insights to guide clinical decision-making and to inform potential regulatory considerations.