Runkle Anne, Srivastava Sunil K, Ehlers Justis P
Ophthalmic Surg Lasers Imaging Retina. 2017 Mar 1;48(3):216-222. doi: 10.3928/23258160-20170301-04.
To evaluate the feasibility and utility of a novel microscope-integrated intraoperative optical coherence tomography (OCT) system.
The DISCOVER study is an investigational device study evaluating microscope-integrated intraoperative OCT systems for ophthalmic surgery. This report focuses on subjects imaged with the EnFocus prototype system (Leica Microsystems/Bioptigen, Morrisville, NC). OCT was performed at surgeon-directed milestones. Surgeons completed a questionnaire after each case to evaluate the impact of OCT on intraoperative management.
Fifty eyes underwent imaging with the EnFocus system. Successful imaging was obtained in 46 of 50 eyes (92%). In eight cases (16%), surgical management was changed based on intraoperative OCT findings. In membrane peeling procedures, intraoperative OCT findings were discordant from the surgeon's initial impression in seven of 20 cases (35%).
This study demonstrates the feasibility of microscope-integrated intraoperative OCT using the Bioptigen EnFocus system. Intraoperative OCT may provide surgeons with additional information that may influence surgical decision-making. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:216-222.].
评估一种新型显微镜集成式术中光学相干断层扫描(OCT)系统的可行性和实用性。
DISCOVER研究是一项评估用于眼科手术的显微镜集成式术中OCT系统的研究性器械研究。本报告聚焦于使用EnFocus原型系统(徕卡显微系统公司/生物光子公司,北卡罗来纳州莫里斯维尔)成像的受试者。在外科医生指定的关键节点进行OCT检查。每位外科医生在每例手术后完成一份问卷,以评估OCT对术中管理的影响。
50只眼睛使用EnFocus系统进行了成像。50只眼中有46只(92%)成功获得成像。在8例(16%)中,手术管理根据术中OCT检查结果进行了改变。在膜剥除手术中,20例中有7例(35%)术中OCT检查结果与外科医生的初始印象不一致。
本研究证明了使用生物光子公司EnFocus系统进行显微镜集成式术中OCT的可行性。术中OCT可为外科医生提供可能影响手术决策的额外信息。[《眼科手术、激光与视网膜成像》。2017年;48:216 - 222。]