Rotational Stability of the Clareon Monofocal Aspheric Hydrophobic Acrylic Intraocular Lens 6 Months After Implantation

PURPOSE: To determine the rotational stability of the Clareon(®) aspheric, monofocal, intraocular lens (IOL) up to 6 months after implantation. METHODS: This prospective, single-arm clinical study evaluated rotational stability of the Clareon IOL in a subset of subjects (n=141, 6 sites) that participated in an investigational device exemption trial for the Clareon IOL. The Clareon model (SY60CL) used in this subset was a non-toric IOL with toric axis markings to measure IOL rotation. All subjects (adults aged ≥22 years who required cataract extraction by phacoemulsification) received the Clareon IOL unilaterally. The position of the toric markings was captured using dilated retro-illumination slit-lamp photography and ocular anatomical landmarks. Post-operative rotational stability was assessed by an independent reading center. IOL rotation was defined as the difference between IOL axis of orientation on the day of surgery (≤1 hour after surgery) and each post-operative visit. Post-operative IOL-based rotational stability was evaluated at day 0 (day of surgery), day 1, week 1, month 1, and month 6 post-operatively. RESULTS: Compared with day 0, mean absolute IOL rotation was 1.85° on day 1 (n=127) and 2.27° at month 6 (n=124). Absolute IOL rotation ≤5° was observed in 95.3% of subjects on day 1 and 92.7% of subjects at month 6, compared with day 0. Between consecutive months 1 and 6 visits, mean absolute rotation was <1°; 100% of subjects had <10° rotation and 98.4% had ≤5°. The range of rotation on day 1 was 0° to 40.0° because of a subject with ocular trauma; when the trauma-outlier was removed, the mean absolute IOL rotation was 1.6° on day 1 (n=126) and 2.0° at month 6 (n=123). CONCLUSION: These results support the high rotational stability of the Clareon monofocal IOL and serve as reference of the rotational stability of Clareon toric IOLs.