Abstract
Purpose :
Intraoperative OCT (iOCT) has emerged as a promising potential tool for ophthalmic surgeons. Microscope-integrated OCT has been a significant leap forward in iOCT technology. The purpose of this study is to assess the EnFocus prototype results.
Methods :
The DISCOVER study is a prospective IRB-approved multi-surgeon investigational device study for evaluating microscope-integrated iOCT during ophthalmic surgery. Multiple integrated iOCT systems were utilized in the DISCOVER study, including the Bioptigen EnFocus Prototype (Bioptigen, NC, USA). Two different system configurations were assessed: a deep-range imaging system and a high-resolution imaging system. Surgeons utilized iOCT system during various surgical milestones. The impact on surgical decision-making was assessed with a surgeon feedback form. Clinical characteristics and iOCT workflow feedback were collected.
Results :
Fifty eyes were enrolled in the EnFocus arm. The most common surgical indications were proliferative diabetic retinopathy (n=10), epiretinal membrane (8), retinal detachment (7), and macular hole (6). In 46 of 50 eyes (92%), iOCT imaging was successfully obtained. The most common reason for lack of iOCT imaging was OCT system malfunction (e.g., software issues, aiming beam challenges). In membrane peeling cases, iOCT revealed occult residual membranes in 24% of cases and confirmed completion of surgical objectives prior to surgeon realization in 17% of cases. Overall, the surgeon indicated the iOCT provided valuable feedback in 65% of membrane peeling cases. The system interfered with the surgery in 10% of cases, most frequently due to iOCT/microscope malfunction.
Conclusions :
Utilizing an add-on microscope-integrated iOCT system is feasible and provides potentially important feedback related to completion of surgical objectives that may impact surgeon decision-making. Further research is needed to continue to define the impact of iOCT on the functional/anatomic outcomes.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.