Determination of feasibility and utility of microscope-integrated optical coherence tomography during ophthalmic surgery: the DISCOVER Study RESCAN Results.
Determination of feasibility and utility of microscope-integrated optical coherence tomography during ophthalmic surgery: the DISCOVER Study RESCAN Results.
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DOI：
10.1001/jamaophthalmol.2015.2376
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发表时间：
2015-10
影响因子：
8.1
通讯作者：
Srivastava SK
中科院分区：
文献类型：
--
作者：
Ehlers JP;Goshe J;Dupps WJ;Kaiser PK;Singh RP;Gans R;Eisengart J;Srivastava SK
光学相干断层扫描 (OCT) 改变了多种眼科疾病的临床管理。将 OCT 应用于眼科手术可能会对手术决策和患者结果产生影响。评估显微镜集成术中 OCT (iOCT) 系统的可行性及其对手术决策的影响。 DISCOVER 是 IRB 批准的单站点多外科医生研究设备前瞻性连续病例系列。参与者包括接受眼科手术的受试者。根据手术外科医生的指导，在手术里程碑期间收集临床特征并获得 iOCT 成像。向每位外科医生发出一份外科医生调查问卷，并在每个病例后填写，以评估 iOCT 在手术过程中的作用及其在选定手术过程中的特殊作用。本报告重点介绍了 RESCAN 700 部分研究的 1 年结果（2014 年 3 月至 2015 年 2 月）。成功获取 iOCT 成像的病例百分比（即可行性）。 iOCT 成像改变手术决策（即效用）的病例百分比 在 DISCOVER 研究的第一年，共招募了 227 只眼睛（91 例眼前节病例和 136 例后节病例）使用 RESCAN 700 系统进行成像。 227 只眼睛中的 224 只 (99%) 获得了成功的成像（例如，获取感兴趣组织的 OCT 图像的能力）。在板层角膜移植术期间，iOCT 数据提供的信息改变了 38% 病例的外科医生决策（例如，当外科医生认为存在界面液时，完全植入移植物）。在膜剥离手术中，19% 的病例中 iOCT 信息与外科医生对膜剥离完整性的印象不一致（例如，缺乏残膜、存在隐膜），从而影响了额外的手术操作。 DISCOVER 研究证明了使用显微镜集成 iOCT 系统进行实时 iOCT 进行眼科手术的可行性。从 iOCT 获得的信息似乎允许外科医生从标准的面部可视化中以独特的视角评估微妙的细节，这有时会影响手术决策，尽管这些决策变化对结果的影响仍然未知。需要进行前瞻性随机屏蔽试验来证实这些结果。
Optical coherence tomography (OCT) has transformed the clinical management of a myriad of ophthalmic conditions. Applying OCT to ophthalmic surgery may have implications for surgical decision-making and patient outcomes. To assess the feasibility and impact on surgical-decision making of microscope-integrated intraoperative OCT (iOCT) system. DISCOVER is an IRB-approved single-site multi-surgeon investigational device prospective consecutive case series. Participants included subjects undergoing ophthalmic surgery. Clinical characteristics were collected and iOCT imaging was obtained during surgical milestones as directed by the operating surgeon. A surgeon questionnaire was issued to each surgeon and completed after each case to evaluate the role of iOCT during surgery and its particular role in select surgical procedures. This report highlights the 1-year results (March 2014-February 2015) of the RESCAN 700 portion of the study. Percentage of cases with successful acquisition of iOCT imaging (i.e., feasibility). Percentage of cases that iOCT imaging altered surgical decision-making (i.e., utility) During year-1 of the DISCOVER study, 227 total eyes were enrolled (91 anterior segment cases and 136 posterior segment) to undergo imaging with the RESCAN 700 system. Successful imaging (e.g., the ability to acquire an OCT image of the tissue of interest) was obtained in 224 of 227 eyes (99%). During lamellar keratoplasty, the iOCT data provided information that altered surgeon decision-making in 38% of the cases (e.g., complete graft apposition when the surgeon believed there was interface fluid). In membrane peeling procedures, iOCT information was discordant with surgeon impression of membrane peel completeness in 19% of cases (e.g. lack of residual membrane, presence of occult membrane) impacting additional surgical maneuvers. The DISCOVER study demonstrates the feasibility of real-time iOCT with a microscope-integrated iOCT system for ophthalmic surgery. The information gained from iOCT appears to allow surgeons to assess subtle details in a unique perspective from standard en face visualization which can affect surgical decision-making some of the time, although the impact of these changes in decision-making on outcomes remains unknown. A prospective randomized masked trial is needed to confirm these results.