{"title":"独立单向气流系统与传统手术室中白内障手术的非劣效性：回顾性研究。","authors":"Sarah Partouche, Filippo Fabro, Artus Arnaud, Lucile Senicourt, Damien Gatinel, Christophe Panthier","doi":"10.3928/1081597X-20241009-01","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 (<i>P</i> = 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 (<i>P</i> = .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 (<i>P</i> = .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 (<i>P</i> = .62). The average operating times were 16.8 and 19.7 minutes for the SurgiCube and OT groups, respectively (<i>P</i> < .001). The average occupation room times were 26.2 and 32.3 minutes for the SurgiCube and OT groups, respectively (<i>P</i> < .001).</p><p><strong>Conclusions: </strong>Cataract surgery in the SurgiCube seems to be non-inferior to cataract surgery in a conventional OT. <b>[<i>J Refract Surg</i>. 2024;40(11):e884-e891.]</b>.</p>","PeriodicalId":16951,"journal":{"name":"Journal of refractive surgery","volume":"40 11","pages":"e884-e891"},"PeriodicalIF":2.9000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Non-inferiority of Cataract Surgery in a Stand-Alone Unidirectional Airflow System Versus in a Conventional Operating Room: A Retrospective Study.\",\"authors\":\"Sarah Partouche, Filippo Fabro, Artus Arnaud, Lucile Senicourt, Damien Gatinel, Christophe Panthier\",\"doi\":\"10.3928/1081597X-20241009-01\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 (<i>P</i> = 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 (<i>P</i> = .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 (<i>P</i> = .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 (<i>P</i> = .62). The average operating times were 16.8 and 19.7 minutes for the SurgiCube and OT groups, respectively (<i>P</i> < .001). The average occupation room times were 26.2 and 32.3 minutes for the SurgiCube and OT groups, respectively (<i>P</i> < .001).</p><p><strong>Conclusions: </strong>Cataract surgery in the SurgiCube seems to be non-inferior to cataract surgery in a conventional OT. <b>[<i>J Refract Surg</i>. 2024;40(11):e884-e891.]</b>.</p>\",\"PeriodicalId\":16951,\"journal\":{\"name\":\"Journal of refractive surgery\",\"volume\":\"40 11\",\"pages\":\"e884-e891\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of refractive surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3928/1081597X-20241009-01\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of refractive surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3928/1081597X-20241009-01","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
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.].
期刊介绍：
The Journal of Refractive Surgery, the official journal of the International Society of Refractive Surgery, a partner of the American Academy of Ophthalmology, has been a monthly peer-reviewed forum for original research, review, and evaluation of refractive and lens-based surgical procedures for more than 30 years. Practical, clinically valuable articles provide readers with the most up-to-date information regarding advances in the field of refractive surgery. Begin to explore the Journal and all of its great benefits such as:
• Columns including “Translational Science,” “Surgical Techniques,” and “Biomechanics”
• Supplemental videos and materials available for many articles
• Access to current articles, as well as several years of archived content
• Articles posted online just 2 months after acceptance.
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