Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample

Purpose: This study assessed effectiveness and safety of the novel Clareon intraocular lens (TOL; model SY60CL, Alcon Vision LLC). Patients and Methods: This was a prospective, single-arm, unmasked clinical trial at 16 investigative clinical sites in the United States. Included were adults >= 22 years who required cataract extraction by phacoemulsification. Following phacoemulsification, 350 subjects received SY60CL IOL unilaterally; 342 completed the study. Monocular best corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA) were evaluated. The primary effectiveness endpoint was the percentage of subjects with CDVA <= 0.3 logMAR at month 12. Safety was assessed by monitoring adverse events (AEs). Visual acuity and safety outcomes were compared with historical safety and performance endpoint (SPE) rates. Results: At 12 months post-implantation, 99.7% of subjects receiving the SY6OCL IOL achieved monocular CDVA <= 0.3 logMAR (primary effectiveness endpoint; 1-sided 95% upper confidence limit >SPE rate); 99.7% and 86.8% of subjects achieved monocular CDVA of <= 0.34 (20/40 Snellen or better) and <= 0.04 logMAR (20/20 Snellen or better), respectively. At 12 months, >95% of subjects achieved mean monocular UDVA <= 0.3 logMAR; 97.1% and 57.6% of subjects achieved monocular CDVA of <= 0.34 and <= 0.04 logMAR, respectively. Mean monocular CDVA and UDVA were -0.05 and 0.04 logMAR, respectively. AEs were within SPE limits. The most common nonserious ocular AE was posterior capsule opacification (5.4%). Serious AEs were <1%, and no serious ocular AEs were assessed as related to the device. There were no observations for IOL glistenings at 12 months. Conclusion: Results of this study supported effectiveness and safety of the SY6OCL IOL. Visual acuity outcomes with the SY6OCL IOL exceeded the SPE rates for monocular CDVA and AEs were within the limit of historic SPE rates. (Model number SY6OWF is the Clareon lens approved by the FDA.)