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Purpose: To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema (DME).Design: Two randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols were conducted. Data were pooled for analysis.Participants: Patients (n = 1048) with DME, best-corrected visual acuity (BCVA) of 20/50 to 20/200 Snellen equivalent, and central retinal thickness (CRT) of ≥300 μm by optical coherence tomography.Methods: Patients were randomized in a 1:1:1 ratio to study treatment with DEX implant 0.7 mg, DEX implant 0.35 mg, or sham procedure and followed for 3 years (or 39 months for patients treated at month 36) at ≤40 scheduled visits. Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months.Main Outcome Measures: The predefined primary efficacy endpoint for the United States Food and Drug Administration was achievement of ≥15-letter improvement in BCVA from baseline at study end. Safety measures included adverse events and intraocular pressure (IOP).Results: Mean number of treatments received over 3 years was 4.1, 4.4, and 3.3 with DEX implant 0.7 mg, DEX implant 0.35 mg, and sham, respectively. The percentage of patients with ≥15-letter improvement in BCVA from baseline at study end was greater with DEX implant 0.7 mg (22.2%) and DEX implant 0.35 mg (18.4%) than sham (12.0%; P ≤ 0.018). Mean average reduction in CRT from baseline was greater with DEX implant 0.7 mg (−111.6 μm) and DEX implant 0.35 mg (−107.9 μm) than sham (−41.9 μm; P < 0.001). Rates of cataract-related adverse events in phakic eyes were 67.9%, 64.1%, and 20.4% in the DEX implant 0.7 mg, DEX implant 0.35 mg, and sham groups, respectively. Increases in IOP were usually controlled with medication or no therapy; only 2 patients (0.6%) in the DEX implant 0.7 mg group and 1 (0.3%) in the DEX implant 0.35 mg group required trabeculectomy.Conclusions: The DEX implant 0.7 mg and 0.35 mg met the primary efficacy endpoint for improvement in BCVA. The safety profile was acceptable and consistent with previous reports.

Purpose To determine risk factors associated with retinal hemorrhage (RH) in pediatric abusive head trauma (AHT) suspects. Methods Records of children aged 0–3 years hospitalized for suspected AHT from January 2007 to November 2011 were retrospectively reviewed in this case–control study. Children were classified into case and control groups based on RH presence. Medical history, presenting symptoms, reasons, and characteristics of injury were recorded. Logistic regression analysis was performed to identify risk factors. Results A total of 168 children (104 males) were included. Of these, 103 were classified as cases and 65 as controls. The mean age (with standard deviation) was 9.3 ± 8.3 months (range, 1 day-36 months). Of the 103 cases, 22 (21%) had subretinal hemorrhage, 9 (9%) had retinoschisis, and 1 (1%) had vitreous hemorrhage. Children presenting with lethargy or altered mental status (P < 0.0001), subdural hemorrhage (P < 0.0001), and other radiologic findings (eg, cerebral ischemia, diffuse axonal injury, hydrocephalus, or solid organ injury; P = 0.01546) were likely to have RH. All 23 children with skull or nonskull fracture without intracranial hemorrhage did not have RH (P < 0.0001 both categories). Conclusions Retinal hemorrhages were almost never found in the absence of intracranial hemorrhage and not found in the setting of fracture without intracranial hemorrhage.

West Nile virus (WNV) has emerged as an important vector-borne pathogen in North America, with more than 3 million estimated to have been infected. Retinopathy from WNV infection has been previously reported in acute cases, though those prior reports did not evaluate the risk of retinopathy based on clinical severity of neurologic disease. The purpose of this cross-sectional study was to perform comprehensive ophthalmological and neurological examinations on 111 patients with a history of West Nile virus infection and describe the ocular manifestations. Out of 111 patients, 27 (24%) had evidence for West Nile virus associated retinopathy (WNVR); this observation was higher (49%) in those patients who initially presented with encephalitis. Individuals with WNVR had more frequent involvement of the macula and peripheral involvement compared to those patients without WNVR (p 60 years), and was associated with higher rates of diabetes mellitus and a history of encephalitis (p

Study Objective: To evaluate the effects of alfentanil or lidocaine on the excitatory phenomena (myoclonus, cough, hiccough) caused by methohexital anesthesia and on the hemodynamic changes induced by retrobulbar block. Design: Prospective, randomized, placebo-controlled, double-blind study. Setting: University-affiliated, tertiary-care hospital. Patients: 60 ASA physical status II and III patients who were admitted for elective cataract extractions and intraocular lens implantations. Interventions: Patients were randomly assigned to one of three groups. After adequate preoxygenation in the holding area, Group 1 received alfentanil 5 μg/kg intravenously (IV), Group 2 received lidocaine 1 mg/kg IV, and Group 3 received the placebo (saline) IV. Immediately after the bolus injection of the study solution, sodium methohexital 1.5 mg/kg was injected IV over 30 seconds. As soon as the eyelid reflex was lost, the retrobulbar block was placed over 5 seconds. Measurements and Main Results: Occurrences of excitatory phenomena were recorded by an independent observer who was blinded as to treatment allocation. Other side effects such as oculocardiac reflex, nausea, vomiting, itching, or chest wall rigidity were recorded. Vital signs were recorded at baseline and 1, 3, and 5 minutes after placement of the block. In the alfentanil group, the incidence of myoclonus or cough was significantly less than in the lidocaine or placebo groups. Alfentanil also decreased systolic and diastolic blood pressure significantly at 1, 3, and 5 minutes after retrobulbar block. Changes in heart rate were not significantly different from baseline. Conclusion: A small dose of alfentanil (5 μg/kg IV) decreases myoclonus and cough induced by sodium methohexital anesthesia IV, resulting in improved quality of induction of anesthesia. Alfentanil also attenuates the cardiovascular responses caused by placement of a retrobulbar block.

PURPOSE: To report the evaluation and identification of herpes viruses associated with retinitis in a patient with Richter syndrome. METHODS: Diagnostic vitrectomy was performed on a patient with systemic leukemia and retinitis. The vitreous sample was evaluated by cytology, analysis of cytokines by ELISA, and detection of virus by polymerase chain reaction. RESULTS: The vitreous biopsy specimen showed no malignant cells but predominant CD8 + lymphocyte infiltration with elevated interferon gamma and interleukin-6. DNA amplification and Southern blot analysis demonstrated DNA of herpes simplex, varicella-zoster, and cytomegalovirus. CONCLUSION: Retinitis associated with multiple viruses in the vitreous biopsy may mimic leukemic infiltration in the eye.