Effectiveness and safety of cataract surgery in laminar air flow device versus traditional scrubs: A 1-year non-inferiority pilot study

Frontiers in Medicine

Medicine

Arnaud Artus¹  Filippo Fabro¹  Georges Caputo¹  Christophe Panthier¹  Isabelle Cochereau¹  Olivier Galatoire¹  Catherine Vignal¹  Damien Gatinel²  Ramin Tadayoni³  Flore Salviat⁴ 

[1]Department of Ophthalmology, Rothschild Foundation Hospital, Paris, France

[2]Department of Ophthalmology, Rothschild Foundation Hospital, Paris, France

[3]Center of Expertise and Research in Optics for Clinicians (CEROC), Paris, France

[4]Department of Ophthalmology, Rothschild Foundation Hospital, Paris, France

[5]Hôpital Lariboisière, Paris, France

[6]RMD - Service de Recherche Clinique, Rothschild Foundation Hospital, Paris, France

关键词: Surgicube;    cataract;    surgery;    endophthalmitis;    ophthalmology;   

DOI  :  10.3389/fmed.2023.987505

 received in 2022-07-06, accepted in 2023-01-13,  发布年份 2023

来源: Frontiers

【 摘 要 】

PurposeThe study aimed to assess the safety and the non-inferiority of cataract surgery outside an operating room using the Surgicube®, a mobile laminar airflow (LAF) device.SettingsThis single-center study was conducted at the Rothschild Foundation, Paris, France.DesignThis is a retrospective cross-sectional study.MethodsAll patients operated on for cataracts using the Surgicube® between February 2020 and February 2021 were included and controlled by a cohort of patients operated on for cataracts in the traditional theater during the same period. Patients with a postoperative follow-up of less than 1 month were excluded. Data collection was carried out using the patient’s medical record. The primary endpoint was the evaluation of the number of endophthalmitis in the two groups. The secondary judgment criteria were the analysis of the various complications and the Logmar visual acuity at 1 month in the two groups. All the patients underwent an OCT retinal examination.ResultsA total of 923 randomized patients who underwent cataract surgery between 2020 and 2021 have been included in the study. Among them, 448 patients were operated on using the Surgicube, and 475 patients underwent surgery in the traditional operating room using the same lens phacoemulsification technique. There are no significant differences between the two groups (p > 0.05).ConclusionCataract surgery using the Surgicube® outside a conventional operating room seems non-inferior to conventional scrub.

【 授权许可】

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Copyright © 2023 Artus, Fabro, Cochereau, Caputo, Tadayoni, Vignal, Galatoire, Salviat, Gatinel and Panthier.