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. 2021 Apr 20:15:1647-1657.
doi: 10.2147/OPTH.S295008. eCollection 2021.

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

Robert Lehmann  1 , Andrew Maxwell  2 , David M Lubeck  3 , Raymond Fong  4 , Thomas R Walters  5 , Anna Fakadej  6
Affiliations

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

Robert Lehmann et al. Clin Ophthalmol. .

Abstract

Purpose: This study assessed effectiveness and safety of the novel Clareon intraocular lens (IOL; 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 SY60CL 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 SY60CL IOL. Visual acuity outcomes with the SY60CL IOL exceeded the SPE rates for monocular CDVA and AEs were within the limit of historic SPE rates. (Model number SY60WF is the Clareon lens approved by the FDA.).

Keywords: cystoid macular edema; dysphotopsia; glistenings; posterior capsule opacification; visual acuity.

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Conflict of interest statement

RL, AM, and DML are Alcon consultants. AF is a researcher and a speaker for Alcon. Dr David M Lubeck reports he is a consultant for NovaEye, consultant/investigator for Glaukos, outside the submitted work. Dr Andrew Maxwell reports personal fees from Alcon, outside the submitted work. Dr Robert Lehmann reports grants from Alcon, during the conduct of the study. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Representative SY60CL IOL images. aSY60CL IOL with the Nikon Eclipse Ti-U inverted microscope at 15× magnification (A) and slit lamp photography using retroillumination captured under pupil dilation conditions at 10× magnification, with a flash intensity of 75% and an aperture setting of 4 (B). aSY60CL was the designated lens model for clinical investigation; model number SY60WF is the Clareon lens that has been approved by the United States Food and Drug Administration.
Figure 2
Figure 2
Subject disposition.
Figure 3
Figure 3
Mean monocular CDVA at 4 m (A) and cumulative distribution of monocular CDVA (B) in subjects who received SY60CL IOL. Error bars represent 95% CIs.
Figure 4
Figure 4
Mean monocular UDVA at 4 m (A) and cumulative distribution of monocular UDVA (B) in subjects who received SY60CL IOL. Error bars represent 95% CIs.
Figure 5
Figure 5
Mean MRSE (A) and cumulative distribution of absolute MRSE (B) in subjects who received SY60CL IOL. Error bars represent 95% CIs.
See this image and copyright information in PMC

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Grants and funding

This study was funded by Alcon Research LLC. Alcon assisted with the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript.

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