OBJECTIVES: The improvements in surgical technique has made cataract surgery an increasingly safe procedure, posterior capsule opacification (PCO), however, remains the most common complication post-cataract surgery. PCO development has been associated with IOL design, IOL biomaterial, and other factors. Nd:YAG laser capsulotomy is used to treat clinically significant PCO.

METHODS: An electronic search of MEDLINE, Embase, Cochrane Library, European and American Society for Cataract and Refractive Surgeons congress databases for articles published between Nov-01-2017 to Dec-31-2022 were included. Incidence of PCO requiring Nd: YAG post Clareon IOL implantation and the weighted average of Nd:YAG capsulotomy incidence was reported.

RESULTS: Eight clinical trials encompassing Europe, Australia, Japan, Korea, and India reporting the incidence of PCO requiring Nd: YAG were identified. Nd: YAG incidence of 0.0% was reported in studies conducted in Australia (N=40), Spain (N=60), Korea (N=126), and India (N=151). In a multi-center (Japan), single-arm long term (N=20) study with subjects followed up for nine years a 5.0% Nd: YAG capsulotomy incidence rate was reported. In a prospective multi-center (Europe) single-arm study assessing the long-term (3-years) safety and effectiveness of the Clareon IOL, at one year (interim analysis) reported Nd: YAG incidence of 0.9% in the 1^st eye (N=215) and 0.0% in the 2^nd eye (N=209), at two years (interim analysis) Nd: YAG incidence was 1.4% in the 1^st eye (N=215) and 1.9% in the 2^nd eye (N=209), at three year (final analysis) reported Nd: YAG incidence of 3.3% in the 1^st eye (N=215) and 6.7% in the 2^nd eye (N=209). The weighted average YAG capsulotomy incidence at 1 year was 0.74%, 2 years was 1.47%, and at three years was 2.20%.

CONCLUSIONS: Global clinical studies have demonstrated that Clareon IOL biomaterial and its squared edge design protect against PCO with low incidence rates of Nd: YAG capsulotomy.