The DISCOVER Study 3-Year Results: Feasibility and Usefulness of Microscope-Integrated Intraoperative OCT during Ophthalmic Surgery.

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.

Primary dermatofibrosarcoma protuberans invading the orbit.

A 38-year-old man presented with a slow-growing, firm cutaneous mass beneath his left eyebrow. Histopathology and immunohistochemistry confirmed the diagnosis of dermatofibrosarcoma protuberans. The mass infiltrated the medial canthal tendon and anterior orbital fat and could not be completely excised with Mohs micrographic surgery. The patient underwent exenteration and dacryocystectomy with margin-controlled excision and remained free of disease 9 months after surgery. To our knowledge, no prior case of primary dermatofibrosarcoma protuberans involving the orbit has been reported.

High-Dose Oral Posaconazole for the Treatment of Recalcitrant Fungal Keratitis.

PURPOSE: To report the successful treatment of 3 cases of recalcitrant fungal keratitis (FK) with high-dose oral posaconazole. METHODS: This is a series of 3 patients from a single academic center with a culture-positive FK who were treated with oral posaconazole after failing to respond to conventional treatments. RESULTS: All 3 patients had a history of contact lens wear. Two of the 3 cases were culture positive for Fusarium and the other for Paecilomyces . The infections of all 3 failed to respond to conventional antifungal therapies including varying combinations of topical, systemic, and intraocular antifungal therapies. All 3 cases rapidly responded to high-dose oral posaconazole ranging from 500 to 600 mg once daily. In 1 case, multiple courses of high-dose therapy were required to treat delayed recurrences of a latent infection. There were no significant adverse effects with the elevated dose, and treatment was administered with the guidance of an infectious disease specialist. CONCLUSIONS: In cases of recalcitrant FK failing to respond to conventional therapies, high-dose posaconazole, in the delayed-release tablet formulation, can be an effective treatment option.

Myeloma-associated orbital amyloidosis.

Orbital amyloidosis is extremely rare and may be localized finding or secondary to a systematic process. The majority of the patients with orbital amyloidosis have primary localized disease. We report a 55 year old male with multiple myeloma and secondary amyloidosis who presented with incidental bilateral orbital masses on MRI. Biopsy revealed amyloid deposition. We review the previously published cases of the orbital amyloidosis secondary to systematic light chain (AL) amyloidosis, including one patient with multiple myeloma. The clinical signs and symptoms, histopathologic findings, and radiographic features of orbital amyloidosis are discussed.

Intraoperative Interface Fluid Dynamics and Clinical Outcomes for Intraoperative Optical Coherence Tomography-Assisted Descemet Stripping Automated Endothelial Keratoplasty From the PIONEER Study.

PURPOSE: To correlate intraoperative interface fluid dynamics during Descemet stripping automated endothelial keratoplasty (DSAEK) using intraoperative optical coherence tomography (iOCT) in the Prospective Intraoperative and Perioperative Ophthalmic Imaging with Optical Coherence Tomography (PIONEER) study with postoperative outcomes. DESIGN: Prospective consecutive, interventional, comparative case series. PARTICIPANTS: One hundred seventy-eight eyes of 173 patients undergoing DSAEK from the Cole Eye Institute, Cleveland, Ohio. METHODS: Eyes that underwent DSAEK between October 2011 and March 2014 from the PIONEER intraoperative and perioperative OCT study were included. An automated interface fluid segmentation algorithm evaluated intraoperative dynamics of interface fluid before and after surgical manipulations. iOCT images were also captured at multiple intraoperative time points for 2 different DSAEK techniques, 1 that used an active air infusion system and 1 that did not. MAIN OUTCOME MEASURES: Interface fluid metrics, graft nonadherence. RESULTS: iOCT measurements of interface fluid after final surgical manipulations and immediately before leaving the operating room identified that total fluid volume (P = .002), largest fluid volume pocket (P = .002), max fluid area (P = .006), mean fluid thickness (P = .03), and max fluid thickness (P = .01) significantly correlated with graft nonadherence rates within the first postoperative week. After placement and optimization of intraoperative lenticle adherence, iOCT revealed a significant difference between the area, volume, and thickness of maximum fluid pockets between the 2 surgical techniques, but both techniques resulted in significant reduction of interface fluid during the procedure. CONCLUSIONS: Larger residual interface fluid volume, area, and thickness at the end of surgery detected with iOCT are associated with early graft nonadherence and can be quantified with an automated algorithm. iOCT imaging can successfully capture technique-dependent differences in fluid dynamics during DSAEK.

Determination of feasibility and utility of microscope-integrated optical coherence tomography during ophthalmic surgery: the DISCOVER Study RESCAN Results.

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 PARTICIPANTS: 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. MAIN OUTCOMES AND MEASURES: Percentage of cases with successful acquisition of iOCT (ie, feasibility). Percentage of cases in which iOCT altered surgical decision making (ie, utility). RESULTS: 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. CONCLUSIONS AND RELEVANCE: 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.

The Prospective Intraoperative and Perioperative Ophthalmic ImagiNg with Optical CoherEncE TomogRaphy (PIONEER) Study: 2-year results.

PURPOSE: To evaluate the feasibility, safety, and utility of intraoperative optical coherence tomography (OCT) for use during ophthalmic surgery. DESIGN: Prospective, consecutive case series. METHODS: A prospective, single-center, consecutive case series was initiated to assess intraoperative OCT in ophthalmic surgery. Intraoperative scanning was performed with a microscope-mounted spectral-domain OCT system. Disease-specific or procedure-specific imaging protocols (eg, scan type, pattern, size, orientation, density) were used for anterior and posterior segment applications. A surgeon feedback form was recorded as part of the study protocol to answer specific questions regarding intraoperative OCT utility immediately after the surgical procedure was completed. RESULTS: During the first 24 months of the PIONEER study, 531 eyes were enrolled (275 anterior segment cases and 256 posterior segment surgical cases). Intraoperative OCT imaging was obtained in 518 of 531 eyes (98%). Surgeon feedback indicated that intraoperative OCT informed surgical decision making and altered surgeon understanding of underlying tissue configurations in 69 of 144 lamellar keratoplasty cases (48%) and 63 of 146 membrane peeling procedures (43%). The most common anterior segment surgical procedure was Descemet stripping automated endothelial keratoplasty (DSAEK, n = 135). Vitrectomy with membrane peeling was the most common procedure for posterior segment surgery (n = 154). The median time that surgery was paused to perform intraoperative OCT was 4.9 minutes per scan session. No adverse events were specifically attributed to intraoperative OCT scanning during the procedure. CONCLUSIONS: Intraoperative OCT is feasible for numerous anterior and posterior segment ophthalmic surgical procedures. A microscope-mounted intraoperative OCT system provided efficient imaging during operative procedures. The information gained from intraoperative OCT may impact surgical decision making in a high frequency of both anterior and posterior segment cases.