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Microscope-Integrated OCT Feasibility and Utility With the EnFocus System in the DISCOVER Study.

ABSTRACT: 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.].

SUBMITTER: Runkle A

PROVIDER: S-EPMC5512284 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Microscope-Integrated OCT Feasibility and Utility With the EnFocus System in the DISCOVER Study.

Runkle Anne A Srivastava Sunil K SK Ehlers Justis P JP

Ophthalmic surgery, lasers & imaging retina 20170301 3

<h4>Background and objective</h4>To evaluate the feasibility and utility of a novel microscope-integrated intraoperative optical coherence tomography (OCT) system.<h4>Patients and methods</h4>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 ...[more]

PMID: 28297033

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Project description: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.

Project description: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 effect on surgical decision making of a microscope-integrated intraoperative OCT (iOCT) system.Report highlighting the 1-year results (March 2014-February 2015) of the RESCAN 700 portion of the DISCOVER (Determination of Feasibility of Intraoperative Spectral Domain Microscope Combined/Integrated OCT Visualization During En Face Retinal and Ophthalmic Surgery) study, a single-site, multisurgeon, prospective consecutive case series regarding this investigational device. Participants included patients undergoing ophthalmic surgery. Data on clinical characteristics were collected, and iOCT was performed during surgical milestones, as directed by the operating surgeon. A surgeon questionnaire was issued to each surgeon and was completed after each case to evaluate the role of iOCT during surgery and its particular role in select surgical procedures.Percentage of cases with successful acquisition of iOCT (ie, feasibility). Percentage of cases in which iOCT altered surgical decision making (ie, utility).During year 1 of the DISCOVER study, a total of 227 eyes (91 anterior segment cases and 136 posterior segment cases) underwent imaging with the RESCAN 700 system. Successful imaging (eg, the ability to acquire an OCT image of the tissue of interest) was obtained for 224 of 227 eyes (99% [95% CI, 98%-100%]). During lamellar keratoplasty, the iOCT data provided information that altered the surgeon's decision making in 38% of the cases (eg, complete graft apposition when the surgeon believed there was interface fluid). In membrane peeling procedures, iOCT information was discordant with the surgeon's impression of membrane peel completeness in 19% of cases (eg, lack of residual membrane or presence of occult membrane), thus affecting 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 effect of these changes in decision making on outcomes remains unknown. A prospective randomized masked trial is needed to confirm these results.

Dataset Information

Microscope-Integrated OCT Feasibility and Utility With the EnFocus System in the DISCOVER Study.

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Microscope-Integrated OCT Feasibility and Utility With the EnFocus System in the DISCOVER Study.

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