BMJ open ophthalmology · 2023
Comparing microscope light-associated glare and comfort between heads-up 3D digital and conventional microscopes in cataract surgery: a randomised, multicentre, single-blind, controlled trial.
Рандомизированное исследованиеМногоцентровое исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Gualino Vincent, Pierne Kevin, Manassero Anthony, Bruneau Sébastien, Couturier Aude, Tadayoni Ramin
Аннотация
OBJECTIVE: 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.
METHODS AND ANALYSIS: 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.
RESULTS: 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.
CONCLUSION: 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.
TRIAL REGISTRATION NUMBER: NCT05085314.
METHODS AND ANALYSIS: 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.
RESULTS: 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.
CONCLUSION: 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.
TRIAL REGISTRATION NUMBER: NCT05085314.