The rate of adverse events was low in this higher risk, difficult-to-manage population of special-needs children, noted Margaret Reynolds, MD.
Margaret Reynolds, MD, and colleagues from the St. Louis Children's Hospital at Washington University Medical Center, St. Louis, conducted a study to evaluate the safety of the Visian Intraocular Collamer Lens (ICL) (Staar Surgical) in highly myopic special-needs pediatric cases. The most common adverse event was pupillary block due to closure of the iridotomy.
This retrospective case series1 included 95 special-needs children (160 eyes) with high ametropia who had been implanted with the Visian ICL over the previous 5 years. The surgeries were performed with the children under general anesthesia.
The children were followed for a mean follow-up period of 2.0 ± 1.4 years (range, 0.5-5.2) to determine the safety of the lens in this patient population. The investigators collected the rates and case specifics of perioperative and longer term adverse events.
The patients were a mean age of 9.3 ± 5.2 years (range, 1.8-25) at the time the lens was implanted. The mean preoperative spherical equivalent refractive error was −11.20 ± 3.90 diopters (range, 4-22). Of the 95 children, 62 children (65%) had a neurodevelopmental disorder.
A minor adverse event was ocular hypertension in response to steroids that occurred in 3 eyes (2%) and resolved when the steroids were stopped.
The most frequently occurring major adverse event was postoperative pupillary block that required revision of the peripheral iridotomy in 7 eyes (4%).
Other adverse events that developed in 1 eye each (0.6%) included a wound leak in a 1 child who was self-injurious and required repair; a cataract in 1 child with Down syndrome 2.8 years after the ICL surgery, and a traumatic retinal detachment in 1 child with severe autism spectrum disorder 1.2 years after the ICL implantation.
The endothelial cell loss over the follow-up period averaged 8.1%, which was comparable to that in adults implanted with the ICL.
Reynolds commented, “The rate of adverse events was low in this higher risk, difficult-to-manage population of special-needs children.”