Karen W. Jeng-Miller

Post-Marketing Survey of Adverse Events Following Ocriplasmin

BACKGROUND AND OBJECTIVE To study the post-marketing safety profile of ocriplasmin (Jetrea; ThromboGenics, Iselin, NJ) as experienced by retinal physicians in the United States. STUDY DESIGN/MATERIALS AND METHODS Two thousand four hundred sixty-five retinal physicians were surveyed regarding their frequency of use of ocriplasmin and reports of ocular adverse events. RESULTS There were 270 respondents (11%) who reported treating 1,056 eyes with ocriplasmin. The reports of adverse events (AE) were as follows: acute decline in visual acuity (16.95%), development of submacular fluid or serous retinal detachment (10.23%), dyschromatopsia (9.09%), progression of vitreomacular traction to macular hole (8.71%), development of retinal detachment (2.65%), development of retinal tear (1.99%), development of afferent pupillary defect (1.80%), electroretinography abnormalities (0.57%), crystalline lens instability (0.38%), and vasculitis (0.28%). CONCLUSION Although the frequency of some ocular AEs reported in this study are comparable to those reported in the phase 3 registration trials, additional phase 4 safety studies are warranted to better understand the pathophysiology and clinical relevance of ocular AEs of ocriplasmin.

Retina specialists treating cystoid macular oedema secondary to retinal vein occlusion recommend different treatments for patients than they would choose for themselves

Aims To evaluate the presence of cognitive bias among retinal specialists when recommending treatment options for cystoid macular oedema (CMO) secondary to retinal vein occlusion (RVO). Methods Two randomly chosen samples of retina specialists were surveyed regarding their treatment and dosing regimen choices among three antivascular endothelial growth factor (anti-VEGF) biologics (aflibercept, bevacizumab and ranibizumab), intravitreal steroid, focal laser and observation for the treatment of CMO secondary to RVO. The first group was asked to make recommendations for two hypothetical patients: one with CMO secondary to branch RVO (BRVO) and the second with CMO secondary to central RVO (CRVO). The second group was asked to make recommendations as if they themselves were the hypothetical patient with the same disease processes. Results The survey was completed by 492 respondents (20.1%). When comparing anti-VEGF agents for patients with BRVO, a majority of physicians recommended bevacizumab (60.5%) over ranibizumab (37.8%) and aflibercept (1.7%; p<0.0001). For themselves, physicians were more likely to recommend ranibizumab (44.9%) over bevacizumab (39.2%) and aflibercept (15.9%; p<0.0001). When comparing among the anti-VEGF agents chosen for patients with CRVO, a majority of physicians recommended bevacizumab (56.7%) over ranibizumab (28.2%) and aflibercept (15.1%; p<0.0001), but when choosing for themselves, retina specialists were equally divided among the three biologics (aflibercept 30.6%, bevacizumab 36.5% and ranibizumab 32.9%; p=0.559). The results were influenced by geographical location but not by the gender, the length of practice or the type of practice. Conclusions Physicians should be aware that cognitive biases exist and take this into consideration when making treatment recommendations for their patients.

Current Practice Patterns for Treatment of Retinopathy of Prematurity.

UNLABELLED To evaluate current practice patterns for the treatment of retinopathy of prematurity (ROP) and characterize factors influencing clinical decisions, a database of all ophthalmologists subspecializing in pediatrics and retina was compiled from membership directories of subspecialty societies and academic institutions in the United States. A web-based survey was emailed to these subspecialists to obtain information regarding demographics, treatment practices, and preferences in hypothetical clinical scenarios. From 2,977 retina and pediatric ophthalmology subspecialists surveyed, 302 self-reported as treating ROP, of whom 56% reported having performed intra-vitreal anti-VEGF injection for ROP. Anti-vascular endothelial growth factor (VEGF) injection was the initial treatment for posterior type 1 high risk ROP preferred by the majority of surveyed ROP treaters, whereas 66% reported uncertainty regarding long-term side effects as the largest barrier to its use. Geographic practice location was associated with anti-VEGF use (P = .019). Anti-VEGF injection as ROP therapy was preferred in some scenarios in our sample. Concerns regarding potential anti-VEGF side effects warrant further investigation. CLINICAL IMPLICATIONS Intravitreal anti-VEGF injection was chosen as the initial therapeutic option by the majority of ROP treatment providers for posterior type 1 ROP in this survey that assessed treatment preferences for a range of clinical scenarios. Uncertainty regarding long-term side effects was the largest reported barrier to use of anti-VEGF for ROP treatment. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:491-495.].

ONE-YEAR OUTCOMES OF A NOVEL TECHNIQUE FOR RESCUING AND SCLERAL FIXATING A POSTERIOR DISLOCATED INTRAOCULAR LENS-BAG COMPLEX WITHOUT CONJUNCTIVAL OPENING (HOFFMAN POCKETS).

Purpose: To present the 1-year follow-up of a novel surgical technique that allows for suture fixation of a posteriorly dislocated lens–bag complex without the need for conjunctival incision. Methods: A retrospective chart review of 19 patients who underwent posterior chamber intraocular lens rescue using the novel surgical technique was performed. Data were collected 1 year after surgery for all patients. Results: Average preoperative vision was 20/500, whereas 3 months and 12 months postoperatively, the vision was 20/65 and 20/54, respectively. Three of 15 eyes had decentration of the sutured intraocular lens, 2 of which required additional surgical repair. Conclusion: Outcome data at 1 year support this novel technique as a viable option for the surgical repair of a dislocated lens–capsular bag complex.

Retina Specialists Treating Diabetic Macular Edema Recommend Different Approaches for Patients Than They Would Choose for Themselves.

BACKGROUND AND OBJECTIVE Prior investigation shows retina specialists may select different treatment for age-related macular degeneration for themselves than for a hypothetical patient. The authors sought to investigate whether a similar bias exists for treatment decisions by retina specialists with regard to diabetic macular edema (DME). PATIENTS AND METHODS Two surveys asked retina specialists to select treatment for hypothetical patients with DME or for themselves. In Survey 2, a distinction was drawn between a visual acuity (VA) of 20/40 or better and 20/50 or worse. RESULTS In Survey 1, 54% to 61% of respondents selected bevacizumab (Avastin; Genentech, South San Francisco, CA) for patients and 36% to 40% selected the drug for themselves (P < .0004). It was found that 14% to 17% selected aflibercept (Eylea; Regeneron, Tarrytown, NY) for patients versus 31% to 38% who selected it for themselves (P < .0001). For a VA of 20/40 or better, 42% to 50% selected bevacizumab for their patients versus 32% to 39% (P < .0005) for themselves, and 20% to 23% selected aflibercept for patients versus 39% to 48% (P < .0007) for themselves. For a VA of 20/50 or worse, 24% to 28% chose bevacizumab for patients versus 17% to 20% for themselves (P value was not significant), and 59% to 66% selected aflibercept for their patients versus 66% to 78% for themselves (P < .05). CONCLUSION Physicians recommend different treatment for their patients than for themselves, though not for a VA of 20/50 or worse, where data support the use of aflibercept over bevacizumab. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:544-554.].

Genetics of Diabetic Retinopathy

Diabetic retinopathy is a leading cause of vision loss among industrialized nations. Landmark studies such as the Diabetes Control and Complications Trial have identified risk factors for the development and progression of diabetic retinopathy, including glycemic control, duration of diabetes mellitus, hypertension, and male sex. However, there are circumstances when individuals with similar metabolic profiles and risk factors demonstrate disparate degrees of diabetic retinopathy. One consideration is whether genetic factors can affect the phenotype of diabetic retinopathy. Methodologies thus far to identify genetic factors that may play a role in diabetic retinopathy include familial studies, candidate gene studies, linkage studies, epigenetic studies, and systematic genome-wide scans. Epigenetic factors are also being evaluated for potential to modify the diabetic retinopathy phenotype. This chapter reviews the literature regarding genetics and epigenetics of diabetic retinopathy and the implications for future research.

Case 23: Zone I Open Globe Injury with Foreign Body Extending Through the Cornea, Lens, and into Vitreous

A 46-year-old man presented with a penetrating Zone I open globe injury of the right eye with a retained intraocular foreign body. The foreign body extended from the cornea, through the anterior chamber and central crystalline lens, stopping in the vitreous cavity. The patient underwent repair via removal of the intraocular foreign body, pars plana lensectomy (PPL) and pars plana vitrectomy (PPV). He had an uncomplicated post-operative course. In an ideal clinical setting, removal of intraocular foreign bodies within the anterior segment spanning into the vitreous benefit from a combined anterior removal with pars plana vitrectomy in an effort to reduce the risk of associated complications (e.g., retinal break or detachment). However, when posterior segment surgeons are not accessible or media opacity, such as corneal clouding, limits adequate visualization, then primary closure takes precedence.

Prosthetic Replacement of the Ocular Surface Ecosystem Treatment of Ocular Surface Disease After Skull Base Tumor Resection

BACKGROUND Prosthetic replacement of the ocular surface ecosystem (PROSE) treatment is an effective, nonsurgical therapeutic option for patients with ocular surface disease related to cranial nerve deficits secondary to skull base tumor resection. METHODS This case series describes the impact of PROSE treatment in patients with symptomatic exposure keratopathy or neurotrophic keratitis after skull base tumor surgery. RESULTS All patients improved symptomatically and functionally with PROSE treatment, and have had sustained improvement for as long as 3 years. CONCLUSIONS In postneurosurgical cases in which neurologic function may recover, PROSE treatment offers a safe, nonsurgical treatment option to support the ocular surface during the period of observation awaiting neurologic recovery.

Congenital anomalies of the optic disc: insights from optical coherence tomography imaging

Purpose of review Congenital anomalies of the optic nerve are rare but significant causes of visual dysfunction in children and adults. Accurate diagnosis is dependent on a thorough funduscopic examination, but can be enhanced by imaging information garnered from optical coherence tomography (OCT). We review common congenital optic nerve anomalies, including optic disc pit, optic nerve coloboma, morning glory disc anomaly, and hypoplasia of the optic nerve, review their systemic associations, and discuss insights from OCT imaging. Recent findings Optic disc pits are a result of a defect in the lamina cribrosa and abnormal vitreomacular adhesions have been shown to cause maculopathy. In patients with optic nerve colobomas, OCT can be instrumental in diagnosing choroidal neovascularization, a rare but visually devastating complication. The pathogenesis of morning glory disc anomaly has been more clearly elucidated by OCT as occurring from a secondary postnatal mesenchymal abnormality rather than only the initial neuroectodermal dysgenesis of the terminal optic stalk in isolation. OCT studies of optic nerve hypoplasia have demonstrated significant thinning of the inner and outer retinal layers of the perifoveal region and thicker layers in the fovea itself, resulting in a foveal hypoplasia-like pathology, that is, significantly correlated to poorer visual outcomes. Summary OCT provides detailed in-vivo analysis of these anatomic anomalies and their resulting pathologies, shedding new insights on the pathogenesis, diagnosis, and potential visual outcomes of these conditions in children. Further study employing OCT to elucidate structure–function relationships of congenital optic nerve anomalies will help expand the role of OCT in clinical practice related to diagnosis, prognosis, and management of these entities.