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

BACKGROUND AND OBJECTIVE: To evaluate the feasibility and utility of a novel microscope- integrated intraoperative optical coherence tomography (OCT) system. PATIENTS AND METHODS: 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. RESULTS: 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%). CONCLUSION: 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 decisionmaking.