Determination of Feasibility and Utility of Microscope-Integrated Optical Coherence Tomography During Ophthalmic Surgery

Abstract

IMPORTANCE 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.OBJECTIVE To assess the feasibility and effect on surgical decision making of a microscope-integrated intraoperative OCT (iOCT) system. DESIGN, SETTING, AND PARTICIPANTSReport 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. MAIN OUTCOMES AND MEASURESPercentage of cases with successful acquisition of iOCT (ie, feasibility). Percentage of cases in which iOCT altered surgical decision making (ie, utility). RESULTSDuring 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. CONCLUSIONS AND RELEVANCEThe 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.

Intraoperative optical coherence tomography: past, present, and future

“…The Zeiss Rescan 700 was the first FDA-cleared system and the second worldwide commercially available microscope-integrated intraoperative OCT system ( Figure 1). 27,28 The Rescan 700 is built on the Lumera 700 (Zeiss) microscope platform. The overall external form factor of the surgical microscope is unaltered compared with the Lumera system.…”

“…The OCT system is also integrated into the microscope foot-pedal with surgeon directed control of aiming, orientation, and size of the OCT scan pattern. 27,28 A heads-up display provides combined visualization of the surgical field and the OCT data stream. Anterior segment imaging and posterior segment imaging is feasible.…”

“…In its initial release, no analysis software was incorporated into the Rescan system and automated tracking was also not available. 27,28 The Haag-Streit iOCT system (Haag-Streit, Koeniz, Switzerland) was the first globally commercially available and 2nd FDA-cleared microscope-integrated intraoperative OCT system. The Haag-Streit system uses a side port for OCT access using the OPMedT (OPMedT, Lubeck, Germany) OCT system, which is coupled to the microscope platform.…”

“…[6][7][8][9][11][12][13][14][15][16][17][18][21][22][23]27,28,[32][33][34][35][36][37][38][39][40][41] The PIONEER study was a large prospective clinical study (n = 531) examining the role of intraoperative OCT with a microscope-mounted portable OCT system in ophthalmic surgery. 13 The DISCOVER study is a subsequent prospective clinical study (n = 227) examining microscope-integrated OCT in ophthalmic surgery.…”

“…13 The DISCOVER study is a subsequent prospective clinical study (n = 227) examining microscope-integrated OCT in ophthalmic surgery. 27 Both of these studies along with several other smaller studies have helped to establish the potential clinical utility of this technology for multiple ophthalmic conditions and procedures.…”