Purpose

To report the 3-year assessment of feasibility and usefulness of microscope-integrated intraoperative OCT (iOCT) during ophthalmic surgery.

Design

Prospective, consecutive case series.

Participants

Adult participants undergoing incisional ophthalmic surgery with iOCT imaging who consented to be enrolled in the Determination of Feasibility of Intraoperative Spectral-Domain Microscope Combined/Integrated OCT Visualization during En Face Retinal and Ophthalmic Surgery (DISCOVER) study.

Methods

The DISCOVER study is a single-site, multisurgeon, institutional review board-approved investigational device prospective study. Participants included patients undergoing anterior or posterior segment surgery who underwent iOCT imaging with 1 of 3 prototype microscope-integrated iOCT systems (i.e., Zeiss Rescan 700, Leica EnFocus, or Cole Eye iOCT systems). Clinical characteristics were documented, iOCT was directed by the operating surgeon at predetermined surgical time points, and each surgeon completed a questionnaire after surgery to evaluate the usefulness of iOCT during surgery.

Main Outcome Measures

Feasibility of iOCT based ability to obtain an OCT image during surgery and usefulness of iOCT based on surgeon reporting during surgery.

Results

Eight hundred thirty-seven eyes (244 anterior segment cases and 593 posterior segment cases) were enrolled in the DISCOVER study. Intraoperative OCT demonstrated feasibility with successful image acquisition in 820 eyes (98.0%; 95% confidence interval [CI], 96.8%–98.8%). In 106 anterior segment cases (43.4%; 95% CI, 37.1%–49.9%), the surgeons indicated that the iOCT information impacted their surgical decision making and altered the procedure. In posterior segment procedures, surgeons reported that iOCT enabled altered surgical decision making during the procedure in 173 cases (29.2%; 95% CI, 25.5%–33.0%).

Conclusions

The DISCOVER iOCT study demonstrated both generalized feasibility and usefulness based on the surgeon-reported impact on surgical decision making. This large-scale study confirmed similar findings from other studies on the potential value and impact of iOCT on ophthalmic surgery.

中文翻译：

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探索研究3年结果

目的

报告为期三年的在眼科手术中显微镜集成术中OCT（iOCT）的可行性和实用性评估。

设计

前瞻性，连续案例系列。

参加者

接受iOCT影像切开眼科手术的成年参与者同意参加在面对面视网膜和眼科手术（DISCOVER）研究期间确定术中光谱域显微镜组合/集成OCT可视化的可行性。

方法

DISCOVER研究是单站点，多外科医生，机构审查委员会批准的研究设备前瞻性研究。参加者包括接受前或后段手术的患者，他们使用3种原型显微镜集成的iOCT系统（即Zeiss Rescan 700，Leica EnFocus或Cole Eye iOCT系统）中的1种进行了iOCT成像。临床特征已记录在案，iOCT由手术外科医生在预定的手术时间点指导，并且每位外科医生在手术后均完成了一份问卷，以评估iOCT在手术期间的有效性。

主要观察指标

基于iOCT的能力在手术过程中获得OCT图像的可行性以及基于手术过程中外科医生报告的iOCT的实用性。

结果

在DISCOVER研究中纳入了837眼（前段为244例，后段为593例）。术中OCT证实了成功获得820眼图像的可行性（98.0％； 95％置信区间[CI]，96.8％–98.8％）。在106例前节段病例中（43.4％； 95％CI，37.1％–49.9％），外科医生表示iOCT信息影响了他们的手术决策并改变了手术程序。在后段手术中，外科医生报告说，iOCT使173例手术中的手术决策得以改变（29.2％； 95％CI，25.5％–33.0％）。

结论

DISCOVER iOCT研究表明，根据外科医生报告的对手术决策的影响，通用可行性和实用性。这项大规模研究证实了其他研究对iOCT对眼科手术的潜在价值和影响的类似发现。