Aleksandra V Rachitskaya

Intraoperative OCT Imaging of the Argus II Retinal Prosthesis System

BACKGROUND AND OBJECTIVE Optimal placement of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Sylmar, CA) is critical. Intraoperative optical coherence tomography (OCT) allows for intrasurgical visualization and confirmation of array placement. In this study, two different OCT systems were evaluated to assess the feasibility and utility of this technology during Argus II surgery. PATIENTS AND METHODS Intraoperative OCT was performed on five patients undergoing Argus II implantation at Cole Eye Institute from June 2015 to July 2016. The EnVisu portable OCT (Bioptigen, Morrisville, NC) and microscope-integrated RESCAN 700 (Zeiss, Oberkochen, Germany) intraoperative OCT systems were utilized. The EnVisu was used in three patients and the RESCAN 700 in three of the five patients. Following array tacking, intraoperative OCT was performed over the entire array including the edges and tack. RESULTS Intraoperative OCT allowed for visualization of the array/retina interface. Microscope integration of the OCT system facilitated ease of focusing, real-time feedback, surgeon-directed OCT scanning to the areas of interest, and enhanced image quality at points of interest. CONCLUSIONS Intraoperative imaging of the Argus II electrode array is feasible and provides information about electrode array-retina interface and distance to help guide a surgeon. Microscope integration of OCT appears to provide an optimal and efficient approach to intraoperative OCT during Argus II array placement. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:999-1003.].

Comparison of anti-VEGF therapies on fibrovascular pigment epithelial detachments in age-related macular degeneration

Background The aim is to compare the therapeutic effects of three antivascular endothelial growth factor (VEGF) drugs (bevacizumab, aflibercept and ranibizumab) on fibrovascular pigment epithelial detachments (fvPEDs) in age-related macular degeneration (AMD). Methods This was a retrospective, comparative, consecutive case series of 88 unique eyes with fvPEDs in neovascular AMD treated with anti-VEGF monotherapy for a minimum of 6 months. All eyes were treatment naive. Diagnosis was confirmed retrospectively by fluorescein angiography and spectral-domain optical coherence tomography. Exclusion criteria included serous/drusenoid PEDs or patients who switched anti-VEGF. Mean follow-up across all therapies was 313.9±85.3 days. Results Average age of all patients was 80.6 years. Baseline maximum subfoveal PED height was 326.8±185.1 μm, 394.5±238.6 μm and 258.0±145.3 μm for bevacizumab, aflibercept and ranibizumab, respectively (p=0.05). All patients had subretinal fluid, intraretinal fluid or a combination of the two at an initial presentation. Central retinal thickness decreased at all time points compared with baseline across all three anti-VEGF therapies. Subfoveal PED height decreased in patients treated with aflibercept at all time points and decreased in patients treated with bevacizumab at 1-month, 3-month and 6-month time points. Aflibercept reduced PED height more than bevacizumab at 1-month and 12-month follow-ups (p=0.02 and p=0.03, respectively) and ranibizumab at 1-month and 6-month follow-ups (p=0.03 and p=0.02, respectively). No differences in best-corrected visual acuity were appreciated at any time point between drugs. Conclusions There was a significant reduction in subfoveal PED height for aflibercept and bevacizumab compared with baseline. A direct comparison of drugs demonstrated a beneficial reduction of PED height, albeit inconsistently, favouring aflibercept. There were no differences in visual acuity across the groups at any time point.

Impact of initial visual acuity on anti-VEGF treatment outcomes in patients with macular oedema secondary to retinal vein occlusions in routine clinical practice

Aim To determine the impact of initial visual acuity (VA) on anti-vascular endothelial growth factor (VEGF) treatment outcomes in patients with macular oedema secondary to retinal vein occlusions in routine clinical practice. Methods A retrospective study was conducted at a single academic institution to identify 177 treatment naïve patients with macular oedema secondary to branch retinal vein occlusion (BRVO), hemiretinal vein occlusion (HRVO) and central retinal vein occlusion (CRVO) treated with intravitreal anti-VEGFs. Exclusion criteria included prior intravitreal injection or presence of active confounding ocular disease. Patients were stratified by initial VA; main outcomes measured were average change in VA and mean absolute change in central subfield thickness (CST) at 6 and 12 months. Results Patients with BRVO with initial VA of 20/40 or better had no significant changes in average letters gained and CST from baseline (+2.6 letters, p=0.42; −48.94 µm, p=0.12) compared with patients with initial VA between 20/50 and 20/300 (+13.2 letters, p<0.001; −98.20 µm, p<0.001) after 12 months. Patients with CRVO/HRVO with initial VA of 20/320 or worse had the most improvement in average letters gained and CST from baseline (+42.2 letters, p<0.001; −182.84 µm, p=0.004) with anti-VEGF therapy compared with patients with initial VA between 20/50 and 20/300 (+9.4 letters, p=0.016; −160.87 µm, p<0.001) and patients with initial VA of 20/40 or better (−9.6 letters, p=0.14; −47.92 µm, p=0.38). Conclusions For macular oedema secondary to retinal vein occlusion, anti-VEGF treatment can result in a greater improvement in average letters gained and in CST for those with poor initial VA compared with those with better initial VA.

Open Payments Database: Anti–Vascular Endothelial Growth Factor Agent Payments to Ophthalmologists

PURPOSE To analyze anti-vascular endothelial growth factor (anti-VEGF) agent-associated industry payments to ophthalmologists using the Centers for Medicare and Medicaid Services (CMS) Open Payments and Provider Utilization and Payment data. DESIGN Retrospective database review using 2 national databases. METHODS Payments from 2013 to 2014 were analyzed by anti-VEGF agent, payment category, and dollar amount. Ranibizumab and aflibercept usage was correlated by performing log-ratio analysis. RESULTS A total of 3207 ophthalmologists received 13 449 payments totaling

Argus II retinal prosthesis system: An update

4 454 325 associated with ranibizumab and aflibercept. As 7% of ophthalmologists received 90% of payments, the Gini index was 0.92, demonstrating unequal distribution of payments. Consulting fees and speaker fees were associated with highest payment amounts to fewest providers. For 2383 providers (74%), greater than 90% of the anti-VEGF payments were associated exclusively with either ranibizumab or aflibercept. A total of 1382 ophthalmologists were matched in both databases. Providers receiving >90% of payments from ranibizumab were more likely to use ranibizumab, and those receiving >90% of payments from aflibercept were more likely to use aflibercept over bevacizumab as compared to those who received no payments. CONCLUSIONS The distribution of all anti-VEGF payments is unequal. Ophthalmologists who received aflibercept or ranibizumab payments were more likely to receive the majority of payments from one source or the other, but not both. Those who received anti-VEGF payments were more likely to use ranibizumab or aflibercept, as compared to off-label bevacizumab, than those who did not receive any payment.

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

ABSTRACT This review focuses on a description of the Argus II retinal prosthesis system (Argus II; Second Sight Medical Products, Sylmar, CA) that was approved for humanitarian use by the FDA in 2013 in patients with retinitis pigmentosa with bare or no light perception vision. The article describes the components of Argus II, the studies on the implant, and future directions.

RAPID MACULAR HOLE FORMATION, SPONTANEOUS CLOSURE, AND REOPENING AFTER PARS PLANA VITRECTOMY FOR MACULA-SPARING RETINAL DETACHMENT.

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.

Comparison of ranibizumab and bevacizumab for macular edema secondary to retinal vein occlusions in routine clinical practice

Background/Purpose: To report a single case of macular hole (MH) opening, spontaneous closure, and reopening in the 3-month period after pars plana vitrectomy for rhegmatogenous retinal detachment (RRD). Methods: Case report. Results: A 59-year-old man with a macula-sparing RRD underwent uncomplicated pars plana vitrectomy with gas tamponade. The patient developed a FTMH 2 months postoperatively. The hole was noted to spontaneously close 3 months postoperatively, but then reopened 4 months postoperatively and required repeat pars plana vitrectomy and inner limiting membrane peel for definitive closure. The rapidity with which the MH developed after pars plana vitrectomy for macula-sparing RRD and its dynamic behavior have not been previously reported. Conclusion: Full-thickness macular holes may rarely develop rapidly, spontaneous close, and reopen after pars plana vitrectomy for RRD, even in macula-sparing cases.

Optical Coherence Tomography Angiography in Eyes with Indeterminate Choroidal Neovascularization: Results from the AVATAR Study

BACKGROUND AND OBJECTIVE To determine outcomes of intravitreal ranibizumab (IVR) (Lucentis; Genentech, South San Francisco, CA) versus bevacizumab (IVB) (Avastin; Genentech, South San Francisco, CA) for treatment of macular edema (ME) secondary to retinal vein occlusion (RVO) in routine clinical practice. PATIENTS AND METHODS A retrospective study identified treatment-naïve patients with ME secondary to RVO where treatment with either IVB or IVR was initiated. Retreatment criteria were based on ophthalmic examination and/or spectral-domain optical coherence tomography findings. RESULTS Central RVO/hemi-RVO cohort: At 12 months, change in visual acuity (VA) (IVR: +12.9 letters, IVB +6.9 letters; P = .53), central subfield thickness (CST) (IVR: -144.1 μm, IVB: -153.9 μm; P = .88), and number of injections (IVR: 5.40 injections, IVB: 5.64 injections; P = .70) were not different between groups. Branch RVO cohort: At 12-month follow-up, no differences in change in VA (IVR: +15.2 letters, IVB: +10.6 letters; P = .46), CST (IVR: -23.1 μm, IVB: -91.4 μm; P = .16), or number of injections (IVR: 5.93 injections, IVB: 5.13 injections; P = .15) were noted. CONCLUSION There is no notable difference in outcome between IVR and IVB when treating ME from RVO in routine clinical practice. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:465-472.].

Choriocapillaris and retinal vascular plexus density of diabetic eyes using split-spectrum amplitude decorrelation spectral-domain optical coherence tomography angiography

Objective To evaluate the use of optical coherence tomography angiography (OCTA) to detect choroidal neovascularization (CNV) in eyes with indeterminate CNV features on conventional imaging. Design The AVATAR study is a prospective observational study of OCTA in patients undergoing routine spectral-domain optical coherence tomography (SD-OCT) for macular disease. Participants Subjects enrolled in the AVATAR study for which CNV was considered as part of a differential diagnosis based on clinical exam and/or prior imaging, but in whom the presence of CNV was not definitive on SD-OCT and fluorescein angiography (FA) imaging. interventions All patients were imaged with the Avanti RTVue XR HD (Optovue, Fremont, CA) and the Cirrus HD-OCT (Zeiss, Oberkochen, Germany) systems. Main Outcome Measures OCTA scans were assessed for the presence or absence of CNV. SD-OCT scans were assessed for the presence of fluid, hyperreflective material, serous pigment epithelial detachment (PED), shallow irregular PED, vitreomacular adhesion, epiretinal membrane, retinal pigment epithelium atrophy and central subfield retinal thickness. Univariate and multivariate logistic regression analyses were performed to identify features on SD-OCT associated with the presence of CNV on OCTA. Results Twenty-nine eyes of 29 patients met the criteria for inclusion. A CNV lesion was detected on OCTA in 8 (28%) eyes; 21 (72%) eyes were negative for CNV. After adjusted for age, gender and central subfield retinal thickness, the presence of shallow irregular PED [odds ratio, 148; 95% confidence interval, 3.22-6830; p = 0.011], as well as the combinations of intraretinal fluid and sub-retinal pigment epithelium material [odds ratio, 16.8; 95% confidence interval, 1.43-198; p = 0.025] on SD-OCT were significantly associated with the presence of CNV on OCTA. Conclusions OCTA enabled the identification of CNV that was otherwise indeterminate with prior imaging in select eyes. The presence of a shallow irregular PED as well as intraretinal fluid combined with sub-retinal pigment epithelium material were both associated with the presence of CNV. OCTA may be a valuable adjunct to conventional SD-OCT and FA imaging in the detection and surveillance of CNV, particularly in diagnostic dilemmas.