Multicenter Retrospective Analysis of Intraoperative Aberrometer Measurements and Associated Visual Outcomes with a Monofocal Aspheric Intraocular Lens

Purpose: To assess the real-world performance of Clareon ® monofocal non-Toric and Toric intraocular lenses (IOLs) using intraoperative aberrometry (IA). Patients and Methods: This retrospective, postmarket analysis included anonymized data from a multicenter study conducted in the US. Data were collected from patients implanted with Clareon ultraviolet-absorbing (UVA) monofocal or monofocal Toric IOL(s), utilizing the WaveTec ORA System and had available corrected distance visual acuity (CDVA) data at 28 days to 3 years postoperative. The primary endpoint was the percentage of eyes achieving monocular CDVA of 20/40 at ≥ 1 month postoperative. Secondary and exploratory endpoints included monocular uncorrected distance visual acuity (UDVA), residual refractive cylinder, stratified visual acuity (VA) thresholds, manifest refraction spherical equivalent (MRSE), and prediction error comparisons between ORA and preoperative biometry. Results: Based on 1404 eyes, 98.4% achieved CDVA of 20/40 or better (mean logMAR 0.04 non-Toric, 0.03 Toric). Among emmetropia targeted eyes, 93.9% achieved UDVA of 20/40 or better. The mean residual refractive cylinder for Toric models was 0.40 diopters (D). The mean (standard deviation) MRSE was − 0.15 (0.45) D. The mean prediction error for emmetropia targeted eyes was − 0.10 (0.49) D. Additionally, 78.7% had prediction error differences within ± 0.25 D between ORA and preoperative biometry. In 40.8% of cases, the implanted IOLs match the preoperative selection with no clinically significant VA differences between match and unmatch eyes. Conclusion: Most patients implanted with the Clareon UVA IOLs, using WaveTec ORA IA achieved CDVA of 20/40 or better at ≥ 1 month postoperatively, with minimal residual refractive error and enhanced target accuracy, indicating ORA may support optimize IOL power calculation and axis positioning to improve refractive outcomes. Plain Language Summary: Clareon intraocular lenses (IOLs) are used during cataract surgery to restore clear vision and are designed to reduce visual disturbances like glare, halos, and lens-related complications such as clouding behind the lens (posterior capsule opacification). Intraoperative aberrometry (IA) is a technology that helps surgeons fine-tune lens selection during surgery, but previous studies have shown mixed results about its real-world value. This study was done to evaluate whether IA improves lens power accuracy and visual outcomes when using Clareon IOLs. We analyzed data from 1,404 eyes treated with Clareon IOLs across 87 US sites using the WaveTec AnalyzOR TM system, which collects information from surgeries using IA. The study results showed that nearly 98.4% of patients achieved good distance vision (20/40 or better) one month or more after surgery. The accuracy of IA in selecting the correct lens power was found to be comparable to traditional pre-surgery measurements, suggesting that IA can be a useful tool to support clinical decision-making in everyday cataract surgery.