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. 2022 Feb 15:16:401-409.
doi: 10.2147/OPTH.S348551. eCollection 2022.

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

Thomas R Walters  1 , Robert Lehmann  2 , Andrew Moyes  3 , John W French  4 , Vidhyapriya Sreenivasan  5 , Satish S Modi  6
Affiliations

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

Thomas R Walters et al. Clin Ophthalmol. .

Abstract

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.

Keywords: dilated retro-illuminated slit-lamp photography; ocular anatomical landmarks; post-operative intraocular lens rotation; toric markers.

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Conflict of interest statement

RL and SSM are consultants for Alcon. VS is an employee of Alcon. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Slit-lamp photograph of the Clareon SY60CL non-toric monofocal IOL. A line was drawn from the pre-selected blood vessel to the intersection of the crosshair (A) and the closest orthogonal axis (B) to obtain the IOL axis of orientation. The IOL axis orientation angle between A and B was determined. IOL rotation over subsequent visits was defined as the difference between IOL axis of orientation at baseline (within 1 hour after surgery) and each post-operative visit. SY60CL was the designated lens model for clinical investigation; model number SY60WF is the Clareon lens that has been approved by the FDA.
Figure 2
Figure 2
Mean absolute IOL rotation compared with day of surgery (A) and distribution of absolute IOL rotation over time (B) in subjects who received the Clareon IOL (n=141). Error bars represent 95% CIs. These data included an outlier-subject with ocular trauma.
Figure 3
Figure 3
Consecutive post-operative rotational stability. Absolute change in IOL axis between months 1 and 6 (n=129).
Figure 4
Figure 4
Subset analysis excluding the subject with >10° rotation because of ocular trauma. Mean absolute IOL rotation compared with day of surgery (A) and distribution of absolute IOL rotation over time (B) in subjects who received the Clareon IOL excluding the outlier (n=140). Error bars represent 95% CIs.
See this image and copyright information in PMC

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