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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

habits. Design: Observational case series. Participants: Thirty-four university-based and private ophthalmology clinics. Methods: In a prospective multicenter study, clinics representative of every region of the country sampled their fixed immersion biometry equipment (i.e., ultrasound probe, immersion shell, and infusion tubing) for bacteria and fungi. Assessment of the cleaning habits for this equipment was conducted by way of a standard questionnaire that included type of fluid and delivery method, frequency of fluid change, method of cleaning the probe and shell, and frequency of tubing change and/or cleaning. Main Outcome Measures: Frequency (prevalence), descriptive statistics, and type of microorganisms. Results: Eighteen samples (53% [18/34]) grew organisms from either the probe/shell or tubing. Positive cultures were found in 32% (11/34) of the immersion shell/probes and in 31% (10/32) of the infusion tubing samples. The bacteria most commonly cultured from both probe/shell and tubing was coagulase-negative Staphylococcus, whereas Penicillium species was the most commonly cultured fungus (exclusively from the probe/shell). Overall, fungi (Penicillium and Alternaria species) were cultured in 12% of the probe/shell samples. Only 14% of the study sites adequately disinfected the probe/shell according to Centers for Disease Control and Prevention (CDC) guidelines, which recommend a 5-minute soak in antiseptic. Conclusions: The bacteria and fungi that colonize biometry equipment are not being adequately eliminated by the cleaning/disinfecting techniques employed in most ophthalmology clinics. These results also may apply to contact biometry, pachymetry, and tonometry equipment as well. Clinicians should follow the CDC recommendations for disinfecting instruments that come in contact with the eye, and the infusion tubing should be changed after each patient. Ophthalmology 2005;112:e13–e18 © 2005 by the American Academy of Ophthalmology.

A 55-yr-old African American man was referred for evaluation of a mass involving the anterior choroid/ciliary body in his left eye. Dilated fundus examination revealed a large, deeply pigmented mass associated with an exudative retinal detachment. Ultrasonography demonstrated an elevated mass which involved the anterior uvea and showed low reflectivity by standardized A-scan. Cytologic examination of fine needle aspiration (FNA) biopsy from the tumor was interpreted as a melanocytoma. The patient developed a total retinal detachment and secondary glaucoma which led to enucleation of the eye. Histopathologic examination confirmed the diagnosis of melanocytoma. To our knowledge, this is the first report in which the diagnosis of uveal melanocytoma was established by FNA biopsy and later confirmed histopathologically.

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.

Ninety-six patients with metastatic melanoma treated with two consecutive tirapazamine-cisplatin combination chemotherapy regimens were followed for signs of therapy-related ocular toxicity. Baseline and follow-up data were obtained such that each patient acted as his own control. A battery of vision-related tests was performed. These included: best corrected visual acuity, color vision, retinal fundus examination and electro-oculograms (EOG). A brief health-related quality of vision test was administered at each follow-up visit to detect and evaluate self-perceived changes in visual status. In the first study, 48 patients received i.v. tirapazamine over 2 h at 260 mg/m2 (group 1) while in the second study 48 patients (group 2) received i.v. tirapazamine at 390 mg/m2. Visual system assessment was conducted at three timepoints: first at baseline, then at 6 weeks post-baseline, i.e. after two courses of chemotherapy and visit two upon discontinuation of therapy. There was no difference in visual acuity between group 1 and group 2 at baseline, follow-up 1 or at follow-up 2. Grouped data indicate that visual acuity was not affected by either dosage of chemotherapy. Group 1 at baseline found 15% below the normal EOG cutoff point, increasing to 23% at follow-up 1 and increasing at follow-up visit 2 to 33%. Group 2 demonstrated the same EOG findings, but the results were more magnified: baseline, 24%; follow-up 1, 44%; and follow-up 2, 44%. After eliminating those with abnormal color vision baselines, 21% (nine of 42) group 1 patients demonstrated abnormal color vision total error scores at follow-up 1 and 16.7% (four of 24) at follow-up 2. Few individuals showed changes in the higher dosage group. With the exception of one person in each dosage group, all changes were along the blue-yellow (tritan) axis, which is associated with acquired color defects. Of 96 patients examined, proven fundus changes were found in only four subjects. These fundus findings included retinal hemorrhages, retinal nerve fiber layer infarcts (cotton wool spots) and small retinal pigment epithelium detachments. There was no systematic statistical significant difference among the various measures of visual system outcome between groups or test times. Data from all tests for individual patients in both groups reveals a sporadic distribution of changes in visual system tests. If toxicity were pronounced, one would expect consistency in the findings and all or most of the assessment tests would be abnormal for a particular patient. However, patients who were abnormal on one measure of acuity were not necessarily abnormal on the other measures.

Tube shunt complications of the retina and vitreous can threaten vision. It is important to understand how to recognize, prevent, and manage these complications. While many retrospective studies regarding retinal complications of tube shunts are in the literature, there are now 2 major prospective studies that can be looked to for the incidence of retinal complications. In the Tube Versus Trabeculectomy (TVT) Study, at 3 years of follow-up, 4 eyes out of 107 total eyes (4%) with tube shunts had required pars plana vitrectomies due to a retinal complication (e.g., vitreous occlusion of the tube, retinal detachment, choroidal detachment). Drainage of a choroidal effusion was performed in 2 patients. Early postoperative retinal complications (onset at 1 month or less after tube shunt implantation) included choroidal effusion (15 eyes; 14%), suprachoroidal hemorrhage (2 eyes; 2%), and vitreous hemorrhage (1 eye; 1%). Late postoperative retinal complications (onset more than 1 month after tube shunt implantation) included choroidal effusion (2 eyes; 2%) and retinal detachment (1 eye; 1%). In the Ahmed Baerveldt Comparison (ABC) Study, at one year of follow-up, one eye of 276 total eyes (0.4%) required a pars plana vitrectomy to clear a postoperative hemorrhage and one eye (0.4%) required reoperation for drainage of a suprachoroidal hemorrhage. Early postoperative retinal complications (3 months of less after implantation of the tube shunt) reported included choroidal effusion (34 eyes; 12%), suprachoroidal hemorrhage (2 eyes; 1%), endophthalmitis (1 eye; 0.4%), and vitreous hemorrhage (5 eyes; 2%). Late retinal postoperative complications (more than 3 months after tube shunt implantation) included choroidal effusion (3 eyes; 1%), endophthalmitis (2 eyes; 1%), vitreous hemorrhage (3 eyes; 1%), and retinal detachment (2 eyes; 1%). Both of these studies indicate a similar incidence of retinal complications after tube shunt implantation. Tube shunt surgery is performed in cases of uncontrolled glaucoma where medications are inadequate. A pars plana tube is most often indicated for anatomic reasons, such as a small eye, or an eye that already has coexisting corneal disease.

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.

We examined a 73-year-old woman with bilateral malignant melanoma of the choroid associated with multiple nonocular malignancies. Fine-needle aspiration biopsy was performed in the left eye to provide a tissue diagnosis. Cytologic examination of the lesion in the left eye confirmed the diagnosis of primary malignant choroidal melanoma. This case demonstrates that bilateral malignant melanoma of the choroid occurs more frequently than expected, and may be associated with nonocular malignancies.