全视范围IOL与单焦IOL的视觉和患者报告结果:美国一项随机多中心试验
Mitchell C Shultz1, William F Wiley2, Eva Liang3
1Shultz Chang Vision, Northridge, CA.
American journal of ophthalmology
|August 31, 2025
概括
在白内障手术后,新的全视范围 (FVR) 内眼镜 (IOL) 与标准单焦内眼镜相比,提供了更好的中间和近视力. 患者使用FVR内视镜获得了很好的远距离,中等和近距离视力.
科学领域:
- 眼科 眼科
- 生物医学工程
- 光学学
背景情况:
- 眼手术包括用人工眼内透镜 (IOL) 取代阴暗的自然透镜.
- 目前的内镜技术旨在在不同距离恢复清晰的视力,单焦和多焦设计是常见的.
- 眼镜的进步旨在提供连续的视野范围, 尽量减少对校正眼镜的需求.
研究的目的:
- 将新型全视范围 (FVR) IOL与标准单焦 IOL的视觉,折射和患者报告的结果进行比较.
- 在接受双边白内障手术的患者中评估FVR IOL的疗效.
主要方法:
- 进行了一项前性,蒙面,多中心,受控的关键试验.
- 被试被随机分配到接受双边的新型FVR内射眼镜 (N=332) 或标准单焦内射眼镜 (N=169).
- 主要终点包括单眼纠正距离,中间和近视敏度;次要终点包括双眼未纠正和距离纠正视敏度在手术后120-180天.
主要成果:
- 与单焦眼镜相比,FVR眼镜在远距离视力敏度方面没有劣势,在中距离视力敏度和近距离视力敏度方面具有统计优势.
- 双眼未纠正和距离纠正的中间和近视敏度与FVR IOL显著改善 (p<0.0001).
- 术后平均折射误差在不同组之间是相似的;FVR IOL在不同距离提供了一致的视力敏度.
结论:
- 与单焦眼镜相比,FVR眼镜表现出更高的中距离和近距离视力敏度,远距离视力敏度也相当.
- 双边FVR内视镜植入导致远距离到近距离 (0.09 logMAR或更好) 良好的未经校正的视力敏度.
- 这种新型的FVR眼镜为寻求清晰视力的白内障患者提供了一个有前途的选择.
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