Rotational stability and refractive outcomes of a new hydrophobic acrylic toric intraocular lens.

Purpose: To assess rotational stability and refractive outcomes of a new toric hydrophobic acrylic intraocular lens (IOL).

Design: Single-center, prospective, interventional clinical trial.

Methods: A total of 130 eyes of 82 patients with age-related cataract and total corneal astigmatism of greater than 1.0 diopters (D) received a hydrophobic acrylic toric IOL Clareon CNW0T3-9. Baseline measurement for rotational stability evaluation was performed at the end of surgery (EOS), with the patient still supine on the operating table, using non-movable vessels as reference landmarks. Postoperative retroillumination pictures were taken at 1 h, 1 week, 1 month and 4-6 months postoperatively. Subjective manifest refraction was assessed at the 6 months follow-up visit.

Results: Final results were obtained in 126 eyes of 80 patients. Mean absolute rotation from EOS to 6 months was 1.33 ± 2.00 [0.01, 19.80] degrees. Rotational stability values from EOS to 1 h, 1 h to 1 week, 1 week to 1 month and 1 month to 6 months were 0.86 ± 0.82 [0.00, 3.90], 1.06 ± 1.94 [0.00, 19.45], 0.47 ± 0.42 [0.00, 2.03] and 0.38 ± 0.40 [0.00, 2.56] degrees. Mean preoperative corneal astigmatism was 1.78 ± 0.83 [1.00, 4.76] D which changed to a mean postoperative refractive astigmatism of 0.33 ± 0.27 [0.00, 1.25] D at 6 months.

Conclusion: The Clareon toric IOL presented very good rotational stability with a mean absolute rotation below 1.4° from EOS to 6 months. Only two IOLs rotated more than 5° with none of them requiring repositioning surgery. Refractive outcomes were satisfying with a mean residual refractive astigmatism below 0.50 D.

Trial registration: Registered at Clinicaltrials.gov NCT03803852 ; on May 17, 2022.