モノビジョン非球面眼内レンズを用いた術中 aberrometry 測定および関連する視覚成績の多施設共同後ろ向き解析

To assess the real-world performance of Clareon^® monofocal non-Toric and Toric intraocular lenses (IOLs) using intraoperative aberrometry (IA).

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.

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.

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.