Three-year multinational clinical study on an aspheric hydrophobic acrylic intraocular lens

Abstract

Purpose: To present the results of a study investigating the 3-year effectiveness and safety of the Clareon single-piece intraocular lens (IOL).

Setting: 19 multinational sites.

Design: Prospective multicenter single-arm study.

Methods: Patients were bilaterally implanted with Clareon IOLs. Assessments included uncorrected distance visual acuity, corrected distance visual acuity (CDVA), manifest refraction, tilt, decentration, applanation tonometry, and fundus examination, including glistenings and posterior capsule opacification (PCO) evaluation. The primary outcomes for effectiveness and safety were evaluated at 1 year and compared with ISO historical safety and performance endpoint (SPE) rates. Patients were followed for up to 3 years after implantation.

Results: 424 eyes of 215 patients were implanted (n = 215 first eye, n = 209 second eye), and 183 patients completed the trial at 3 years (with 364 binocular and 1 monocular patient). At 1 year, the cumulative and persistent adverse event rates were below SPE targets, and 99.5% of eyes achieved a monocular CDVA of ≤0.3 logMAR (vs the SPE target of 92.5%). At 3 years, the mean monocular CDVA was -0.032, with 93.4% (341/365) of eyes achieving a CDVA of 0.1 logMAR or better, 100% of eyes presented with grade 0 glistenings ≤25 MV/mm 2 , and 92.9% of eyes (394/424) had either no PCO or clinically nonsignificant PCO.

Conclusions: This study supports the long-term safety and effectiveness of the Clareon IOL. The visual outcomes were excellent and stable over the 3-year study period, PCO rates were very low, and 100% of IOLs had grade 0 glistenings.