Non-inferiority of Cataract Surgery in a Stand-Alone Unidirectional Airflow System Versus in a Conventional Operating Room: A Retrospective Study.

PURPOSE: To demonstrate the non-inferiority of a stand-alone unidirectional airflow system, the SurgiCube (Surgi-Cube International BV), for cataract surgery compared to a conventional operating theater (OT).

METHODS: This was a retrospective and comparative cross-sectional study conducted at the Rothschild Foundation, Paris, France. All patients who underwent cataract surgery using the SurgiCube between February 2020 and February 2023 were included and compared to a separate group of patients with cataract surgery performed in a conventional OT and under topical anesthesia during the same period. Patients with less than 1 month of follow-up after surgery were excluded. We collected relevant information from the patient's medical records. Main outcome measures, incidence of endophthalmitis, intraoperative and postoperative complication incidence, 1-month logarithm of minimum angle of resolution (logMAR) visual acuity and intraocular pressure, and operating times were analyzed.

RESULTS: A total of 1,901 eyes in the SurgiCube group were compared to 5,474 eyes in the OT group. The occurrence of endophthalmitis was 0.05% (n = 1) in the SurgiCube group versus 0.07% (n = 4) in the OT group (P = 1.00; odds ratio = 0.72 [95% CI = 0.01 to 7.28]). The percentage of procedures with at least one perioperative complication was 2.6% in the SurgiCube group and 2.7% in the OT group (P = .87; odds ratio = 0.96 [95% CI = 0.68 to 1.34]). The percentage of procedures with a postoperative complication was 6.31% in the SurgiCube group and 6.6% in the OT group (P = .59; odds ratio = 0.94 [95% CI = 0.75 to 1.17]. Average visual acuity at 30 days was 0.04 logMAR in the SurgiCube group and 0.07 logMAR in the OT group (P = .62). The average operating times were 16.8 and 19.7 minutes for the SurgiCube and OT groups, respectively (P < .001). The average occupation room times were 26.2 and 32.3 minutes for the SurgiCube and OT groups, respectively (P < .001).

CONCLUSIONS: Cataract surgery in the SurgiCube seems to be non-inferior to cataract surgery in a conventional OT. [J Refract Surg. 2024;40(11):e884-e891.].