Safety of Phakic Intraocular Collamer Lens (Visian ICL) Implantation in 95 Highly Myopic Special-Needs Children.

Purpose Children with high ametropia who have difficulties with spectacle or contact lens wear benefit from gains in visual function after intraocular collamer lens (ICL) surgery. Here we assess safety by reporting rates and case specifics of peri-operative and longer-term adverse events (AE).[LINE SEPARATOR] SETTING:: St. Louis Children's Hospital at Washington University Medical Center. Design Retrospective Case Series. Methods Clinical data were collated retrospectively for 95 special-needs children (160 eyes) implanted with a Visian ICL over the last 5 years. All surgeries were performed at St Louis Children's Hospital under brief general anesthesia. Follow-up was a mean 2.0 ±1.4 years (range 0.5-5.2). Results Average age at implantation was 9.3 ± 5.2 years (range 1.8-25) and mean pre-operative SEQRE was -11.2 ± 3.9 D (range - 4-22). Sixty-two children (65%) had a neurodevelopmental disorder. The minor AE rate was 2% (3 eyes), consisting of steroid-response ocular hypertension (OHT), which resolved with cessation of topical steroid drops. Endothelial cell loss averaged 8.1 % over 2 years, comparable to that reported in ICL implanted adults. The most common major AE (4%, 7 eyes) was post-operative pupillary block, requiring revision of the peripheral iridotomy. One child (0.6%, 1 eye) with self-injurious behavior required repair of a wound leak. One child (0.6%, 1 eye) with Down syndrome developed a cataract 2.8 years after ICL surgery. And one child (0.6%, 1 eye) with severe Autism Spectrum Disorder experienced traumatic retinal detachment 1.2 years after implantation. Conclusion The most common major AE among our Visian ICL cohort was pupillary block due to closure of the iridotomy. Overall, the AE rate was low in this higher risk, difficult-to-manage population of special-needs children.