Purpose:

his registration study assessed effectiveness and safety of the novel Clareon intraocular lens (IOL; model SY60WF; Alcon Vision LLC).

Methods:

This was a prospective, single-arm, unmasked clinical trial in subjects requiring cataract surgery at 16 investigative clinical sites in the United States. Subjects were adults ≥22 years old. Following phacoemulsification, 350 subjects received the Clareon IOL unilaterally; 342 completed the study. Monocular best corrected distance visual acuity (BCDVA) and uncorrected distance visual acuity (UDVA) were evaluated. The primary effectiveness endpoint was the percentage of subjects with BCDVA ≥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-mo post-op, 99.7% of subjects achieved monocular BCDVA ≤0.3 logMAR; 99.7% and 86.8% of subjects achieved monocular BCDVA of ≤0.34 (20/40 Snellen or better) and ≤0.04 logMAR (20/20 Snellen or better), respectively. Over 95% of subjects achieved mean monocular UDVA ≤0.3 logMAR; 97.1% and 57.6% achieved monocular BCDVA of ≤0.34 and ≤0.04 logMAR, respectively. Mean monocular BCDVA and UDVA were −0.052 and 0.043 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.="" and="" no="" serious="" ocular="" aes="" were="" assessed="" as="" related="" to="" the="" device.="" there="" were="" no="" observations="" for="" iol="" glistenings="" at="" 12="">

Conclusions:

Results of this study supported effectiveness and safety of the Clareon IOL. Visual acuity outcomes with the Clareon IOL exceeded the SPE rates for monocular BCDVA and AEs were within the limit of historic SPE rates.