Department of Ophthalmology, Clinique Honoré Cave, Montauban, France
Department of Ophthalmology, Clinique Honoré Cave, Montauban, France.
BMJ Open Ophthalmol. 2023 Jun;8(1). doi: 10.1136/bmjophth-2023-001272. Epub 2023 Jun 26.
To compare subjective levels of comfort and visual experiences related to microscope light in patients undergoing their first cataract surgery with topical anaesthesia using a digital microscope (the NGENUITY three-dimensional (3D) visualisation system) or a conventional microscope.
A prospective, randomised, single-blinded, parallel-group, multicentre, interventional study. Patients (n=128) were randomly assigned to one of two treatment groups: the experimental group (n=63) had surgery using the digital microscope and the control group (n=65) had surgery with a conventional microscope. The primary outcome was patients' subjective experience of glare from the microscope light during surgery on a numerical scale from 0 to 10. Key secondary outcomes were patients' subjective levels of comfort and visual experiences related to the microscope light.
The experimental group reported significantly lower levels of glare; median levels were 1.0 (0.0-4.0) for the experimental group vs 3.0 (0.0-6.0) for the control group (p=0.027). They also reported higher levels of comfort; median ratings were 8.0 (6.5-10.0) in the experimental group and 7.0 (5.0-9.0) in controls (p=0.026). There were no group differences in ratings of subjective pain or visual disturbances. Median microscope light intensity was lower in the experimental group than controls; 3425.0 (2296.0-4300.0) Lux vs 24 279.0 (16 000.0-26 500.0) Lux (p<0.0001), respectively.
Compared with conventional microscopes, the NGENUITY 3D visualisation system allows surgeons to operate with lower levels of light exposure, resulting in significantly less glare and improved comfort in patients undergoing cataract surgery.
NCT05085314.
比较初次接受局部麻醉白内障手术的患者在使用数字显微镜(NGENUITY 三维(3D)可视化系统)或传统显微镜时对显微镜光的舒适度和视觉体验的主观感受。
一项前瞻性、随机、单盲、平行组、多中心、干预性研究。将患者(n=128)随机分为两组:实验组(n=63)使用数字显微镜手术,对照组(n=65)使用传统显微镜手术。主要结局是患者在手术过程中对显微镜光眩光的主观感受,采用 0 到 10 的数字评分。次要结局是患者对显微镜光的舒适度和视觉体验的主观水平。
实验组报告的眩光程度明显较低,中位数为 1.0(0.0-4.0),而对照组为 3.0(0.0-6.0)(p=0.027)。他们还报告了更高的舒适度水平,实验组的中位数评分为 8.0(6.5-10.0),对照组为 7.0(5.0-9.0)(p=0.026)。两组患者对主观疼痛或视觉障碍的评分无差异。实验组的显微镜光强度中位数低于对照组;分别为 3425.0(2296.0-4300.0)Lux 和 24279.0(16000.0-26500.0)Lux(p<0.0001)。
与传统显微镜相比,NGENUITY 3D 可视化系统允许外科医生以较低的光照水平进行操作,从而显著减少接受白内障手术的患者的眩光和提高舒适度。
NCT05085314。