Ducloyer Jean-Baptiste, Poinas Alexandra, Duchesne Léa, Caillet Pascal, Ivan Catherine, Lejus-Bourdeau Corinne, Limousin Nadège, Desmidt Thomas, Pladys Patrick, Pisella Pierre-Jean, Bernard Anne, Lardy Hubert, Gohier Philippe, Martin Ludovic, Mouriaux Frederic, Lebranchu Pierre, Khanna Raoul Kanav
Ophthalmology Department, Nantes University-CHU Nantes, Nantes, France.
Centre d'Investigation Clinique 1413 (CIC 1413), Nantes University-CHU Nantes INSERM, Nantes, France.
Ophthalmol Ther. 2023 Oct;12(5):2801-2812. doi: 10.1007/s40123-023-00774-1. Epub 2023 Aug 2.
Cataract surgery is the most common surgical procedure performed in France. While the incidence of intraoperative complications affecting visual prognosis is extremely low, given the large number of patients operated on, the absolute number of patients affected by complications is quite high. Complication rates are significantly higher when ophthalmology residents (ORs) perform the surgery. Although lack of experience remains the main risk factor, sleep deprivation may adversely affect ORs' successful surgery rate. The value of the EyeSi® surgical simulator in initial training has been demonstrated to increase cataract surgery safety through the transfer of surgical skills from the simulator to the operating room. However, there is no consensus regarding how much training is needed before the first-time ORs are allowed to operate. There is also no scientific evidence that sleep deprivation is associated with a decrease in surgical performance. Establishing a validated protocol for cataract surgery training using the EyeSi surgical simulator (referred to further as the EyeSi) and identifying risk factors for intraoperative complications related to sleep deprivation will improve cataract surgery safety and lead to the reorganization of our healthcare systems.
This multi-centre educational cohort study will include two distinct axes which will both aim to reduce the risks of cataract surgery. Enrollment will include 16 first-year ORs for Axis 1 and 25 experienced residents for Axis 2, all from the University Hospitals of Nantes, Tours, Angers and Rennes. Axis 1 will focus on investigating the learning curve of first-year ORs using the EyeSi, following the training program recommended by the "College des Ophtalmologistes Universitaires de France" in order to set up a future "licence to operate." Axis 2 will evaluate the impact of sleep deprivation on the surgical performance of experienced ORs using the EyeSi.
ClinicalTrial.gov identifier: NCT05722080.
白内障手术是法国最常见的外科手术。虽然影响视觉预后的术中并发症发生率极低，但鉴于手术患者数量众多，受并发症影响的患者绝对数量相当高。眼科住院医师（ORs）进行手术时，并发症发生率显著更高。尽管经验不足仍是主要风险因素，但睡眠不足可能会对ORs的手术成功率产生不利影响。EyeSi®手术模拟器在初始培训中的价值已得到证明，可通过将手术技能从模拟器转移到手术室来提高白内障手术的安全性。然而，对于首次允许ORs进行手术前需要多少培训，尚无共识。也没有科学证据表明睡眠不足与手术表现下降有关。建立一个使用EyeSi手术模拟器进行白内障手术培训的有效方案（以下简称EyeSi），并确定与睡眠不足相关的术中并发症风险因素，将提高白内障手术的安全性，并导致我们医疗保健系统的重组。
这项多中心教育队列研究将包括两个不同的方向，均旨在降低白内障手术风险。纳入的受试者中，第一组有16名一年级ORs，第二组有25名经验丰富的住院医师，他们均来自南特、图尔、昂热和雷恩的大学医院。第一组将专注于使用EyeSi研究一年级ORs的学习曲线，遵循“法国大学眼科医生学院”推荐的培训计划，以便建立未来的“手术许可”。第二组将使用EyeSi评估睡眠不足对经验丰富的ORs手术表现的影响。
ClinicalTrial.gov标识符：NCT05722080。
