Faculty Bibliography

PURPOSE:: To compare the effect of 30-gauge versus 32-gauge needle size on postinjection reflux and immediate postinjection intraocular pressure (IOPimmed_post) spikes in eyes injected with anti-vascular endothelial growth factor agents. METHODS:: This was a prospective interventional case series of 65 eyes of 54 consecutive patients in a clinical practice setting who received intravitreal anti-vascular endothelial growth factor therapy. All eyes had preinjection IOP, IOPimmed_post, postinjection reflux, and axial lengths recorded. RESULTS:: There was a higher incidence of postinjection reflux in eyes injected with 30-gauge (53%) compared with those injected with 32-gauge (13%, P = 0.0007). Among 34 eyes injected with 30-gauge, 16 eyes without appreciable postinjection reflux had mean IOPimmed_post of 44.3 +/- 7.48 mmHg and mean IOPimmed_post elevation of 29.6 +/- 2.10 mmHg, which was significantly higher than the 18 eyes with reflux (mean IOPimmed_post of 18.8 +/- 7.15 mmHg and mean IOPimmed_post elevation of 4.5 +/- 1.74 mmHg, P < 0.0001). Among 31 eyes injected with 32-gauge, 27 eyes without appreciable postinjection reflux had mean IOPimmed_post of 44.4 +/- 10.82 mmHg and mean IOPimmed_post elevation of 29.5 +/- 1.99 mmHg, which was significantly higher than the 4 eyes with reflux (mean IOPimmed_post of 21.3 +/- 8.54 mmHg and mean IOPimmed_post elevation of 9.5 +/- 4.05 mmHg, P < 0.001). The differences in reflux and IOP between the two groups were unrelated to axial lengths (P = 0.451). CONCLUSION:: Eyes receiving injections with 32-gauge needles had a lower incidence of postinjection reflux and higher mean IOP immediately after injection.

Purpose Safety and efficacy of ocriplasmin to treat symptomatic vitreomacular adhesion (VMA), was established in phase 3 clinical trials using time-domain optical coherence tomography (TDOCT) to assess retinal anatomy. Using spectral domain optical coherence tomography (SDOCT) allows observation and measurement of subtle retinal changes and enables more accurate monitoring of disease progression and response to therapy. A Phase 4 study was designed to retrospectively review and further characterize anatomic and symptomatic changes, using SD-OCT, following treatment of VMA with JETREA (ocriplasmin). Methods The Phase 4 OZONE study will include 200 patients from ~30 US sites. Anatomic and symptomatic changes over 6-months in patients treated with ocriplasmin for VMA and imaged with SD-OCT. Images will be masked and uploaded to a Central Reading Center (CRC) for review and analysis. The primary endpoint is the proportion of patients with ellipsoid zone disruption by Day 21 post-ocriplasmin injection, which was not present at baseline. Secondary endpoints include: incidence, time to onset and/or resolution of ellipsoid zone disruption, subretinal fluid development, VMA status, macular hole changes, vitrectomy, visual acuity changes from baseline and adverse drug reactions (Table 1). Results As of 11/12/14, preliminary data from 52 patients at 11 clinics were available. Preliminary data on baseline characteristics include: mean age: 71 years; gender: 61.5% female; baseline lens status in study eye: phakic= 67%, pseudophakic= 33%, and aphakic=0%; baseline visual acuity in study eye (Snellen) 20/40 or better=29%, 20/50-20/80=52%, and 20/100 or worse= 17%, 10/200= 2%; injection position: supine=83%, sitting=2%, sitting at 45degree=12%. Conclusions The OZONE study utilizing SD-OCT in post-ocriplasmin patients will further characterize anatomic and symptomatic changes post-ocriplasmin. Data from the full population and image analysis will be available

Purpose To determine the rate of neovascularization (NV) in eyes with acquired vitelliform lesion (AVL) during and following vitelliform collapse. To correlate the optical coherence tomography (OCT) and histopathological characteristics of these neovascular membranes. Methods Retrospective cohort analysis of 112 patients with AVL. Patients that demonstrated evidence of vitelliform collapse, defined as a temporal reduction in the size of subretinal vitelliform material clinically, using OCT and fundus autofluorescence imaging, were included for further analysis. Clinical and OCT characteristics of neovascular membranes were determined. A correlation between OCT and histopathological characteristics of an eye that was clinically diagnosed as non-neovascular but demonstrated a type 1 membrane on post mortem examination was also performed. Results Twenty-six patients (16 males and 10 females) demonstrated evidence of vitelliform collapse, and 7 (26.9%) of these developed NV. 5 of these patients were diagnosed with NV following acute subretinal hemorrhage or exudation. Mean age of patients was 81.1 +/- 11.6 years, and mean period of follow up was 9.0 +/- 4.2 years. All neovascular membranes were type 1. Persistent OCT findings prior to the development of NV included: (1) Irregular elevation of the retinal pigment epithelium (RPE) layer at the site of NV. (2) Separation of the RPE layer and Bruch's membrane (BrM) by a hyporeflective material containing punctate hyper-reflectivity (figure 1). Three patients had fluorescein angiography (FA) within 6 months preceding the diagnosis of neovascular disease that did not demonstrate leakage. Histopathologic examination demonstrated a fibrovascular scar and thick basal laminar deposit (BlamD) under the fovea with hemorrhage between the scar and BrM. These lesions correlated with the split RPE-BrM band on OCT images acquired 8 months before the patient's death (figure 2). Conclusions The rate of Type 1 NV during and following vitelliform collapse in AVLs is significant. In this subgroup of patients, neovascular membranes appear to remain dormant in the anatomic space between BrM and BLamD before the clinical signs of NV, including exudation and hemorrhage, become manifest. Interval review of these patients is therefore indicated as is a prospective study of this topic