Department of Medicine, Surgery and Health Sciences, University of Trieste, Ospedale Maggiore, Piazza Ospedale 1, 34129, Trieste, Friuli-Venezia Giulia, Italy.
Department of Biomedical Engineering, Lublin University of Technology, 20-618, Lublin, Poland.
Int Ophthalmol. 2024 Feb 26;44(1):112. doi: 10.1007/s10792-024-02946-9.
To evaluate and compare the visual outcomes of an enhanced monofocal intraocular lens (IOL) with two different monofocal IOLs.
Eye Clinic, Department of Medicine, Surgery and Health Sciences, University of Trieste, Trieste, Italy.
Prospective, single-center, single-masked, randomized controlled clinical study.
The study included patients undergoing phacoemulsification and IOL implantation. Patients were consecutively randomized by block randomization and assigned in a 1:1:1 allocation ratio to three study arms to bilaterally receive Tecnis Eyhance™ (model ICB00) or Tecnis monofocal 1-piece (model PCB00) or Clareon monofocal (model CNA0T0), respectively. Monocular and binocular (both corrected and uncorrected) visual acuities for far, intermediate and near were registered and compared among groups at 3 months. To track changes in patient quality of life, the Catquest-9SF questionnaire was administered to each patient before and after cataract extraction.
Ninety patients (30 for each group) were enrolled. At 3 months follow-up, statistically significant differences for intermediate visual acuities were found between the three groups. Nonstatistically significant differences were observed for distance visual acuities and the changes in Catquest-9SF scores.
Tecnis Eyhance™ provided better results in intermediate visual outcomes without adverse effects on patients' quality of life.
评估和比较增强型单焦点人工晶状体（IOL）与两种不同的单焦点 IOL 的视觉效果。
意大利的里雅斯特大学医学、外科学和健康科学系眼科诊所。
前瞻性、单中心、单盲、随机对照临床研究。
该研究纳入了接受超声乳化白内障吸除术和 IOL 植入术的患者。患者采用区组随机化方法连续随机分组，并按 1:1:1 的比例分配至 3 个研究组，分别双侧植入 Tecnis Eyhance（型号 ICB00）、Tecnis 单焦点 1 件式（型号 PCB00）或 Clareon 单焦点（型号 CNA0T0）。术后 3 个月时，分别记录各组的单眼和双眼（矫正和未矫正）远、中、近视力，并进行比较。为了追踪患者生活质量的变化，在白内障摘除术前和术后，使用 Catquest-9SF 问卷对每位患者进行评估。
共纳入 90 例患者（每组 30 例）。术后 3 个月随访时，三组之间的中间视力存在统计学显著差异。而距离视力和 Catquest-9SF 评分的变化则无统计学差异。
Tecnis Eyhance 在中间视力结果方面表现更好，且对患者的生活质量无不良影响。
