Packer Mark, Alfonso Jose F, Aramberri Jaime, Elies Daniel, Fernandez Joaquin, Mertens Erik
Packer Research Associates, Boulder, CO, USA.
Ophthalmology Institute Fernández Vega, Oviedo, Asturias, Spain.
Clin Ophthalmol. 2020 Sep 18;14:2717-2730. doi: 10.2147/OPTH.S271858. eCollection 2020.
To evaluate the performance and safety of the Extended Depth of Focus Implantable Collamer Lens (EDOF ICL) for improvement of uncorrected near, intermediate and distance visual acuity in phakic subjects with myopia and presbyopia.
Prospective multicenter study.
Presbyopic subjects who required an EDOF ICL in the range of -0.50 D to -18.00 D, exhibited ≤ 0.75 D refractive astigmatism and required from +1.00 to +2.50 D reading add were implanted bilaterally. Assessments at 6 months included uncorrected near, intermediate and distance visual acuities, defocus curves, contrast sensitivity, responses to the National Eye Institute Refractive Error Quality of Life Questionnaire and a Task Assessment Questionnaire.
A total of 34 subjects completed the study. Investigators targeted emmetropia in all eyes. Mean binocular uncorrected near, intermediate and distance visual acuities measured logMAR -0.01 ± 0.05 (20/20), -0.02 ± 0.08 (20/19) and 0.07 ± 0.10 (20/23), respectively. Mean monocular uncorrected near, intermediate and distance visual acuities measured logMAR 0.068 ± 0.09 (20/23), 0.062 ± 0.10 (20/23) and 0.16 ± 0.12 (20/29). There were no clinically or statistically significant differences in contrast sensitivity between baseline and 6 months under any testing conditions. Subjects reported significant improvements in measures of vision-related quality of life and ability to perform tasks at all distances without glasses or contact lenses. Overall, satisfaction with the EDOF ICL was high: postoperatively, 91.2% of subjects were satisfied with their vision.
This multicenter, prospective clinical investigation demonstrated the ability of the EDOF ICL to correct myopia and presbyopia, resulting in improvement of uncorrected near, intermediate and distance visual acuity without compromising the quality of vision. The EDOF ICL allowed subjects to perform tasks of daily living without glasses or contact lenses. Subjects reported significant improvements in quality of life with high levels of spectacle independence and satisfaction.
评估扩展景深可植入式隐形眼镜（EDOF ICL）改善近视和老花眼有晶状体眼患者未矫正近、中、远距离视力的性能和安全性。
前瞻性多中心研究。
对双眼植入EDOF ICL的老花眼患者进行研究，这些患者的近视度数在-0.50 D至-18.00 D之间，屈光性散光≤0.75 D，阅读附加度数为+1.00至+2.50 D。6个月时的评估包括未矫正近、中、远距离视力、散焦曲线、对比敏感度、对美国国立眼科研究所屈光不正生活质量问卷和任务评估问卷的回答。
共有34名受试者完成了研究。所有眼睛的研究者目标均为正视。双眼未矫正近、中、远距离视力的平均值分别为logMAR -0.01±0.05（20/20）、-0.02±0.08（20/19）和0.07±0.10（20/23）。单眼未矫正近、中、远距离视力的平均值分别为logMAR 0.068±0.09（20/23）、0.062±0.10（20/23）和0.16±0.12（20/29）。在任何测试条件下，基线和6个月时的对比敏感度在临床或统计学上均无显著差异。受试者报告在视力相关生活质量和不戴眼镜或隐形眼镜进行所有距离任务的能力方面有显著改善。总体而言，对EDOF ICL的满意度较高：术后，91.2%的受试者对其视力感到满意。
这项多中心前瞻性临床研究证明了EDOF ICL矫正近视和老花眼的能力，可改善未矫正近、中、远距离视力，且不影响视觉质量。EDOF ICL使受试者无需戴眼镜或隐形眼镜即可进行日常生活任务。受试者报告生活质量有显著改善，眼镜依赖程度和满意度较高。
