Retina Associates of Florida

In 2024, the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee became aware of reports of coring of vial stoppers in relation to preparation of intravitreal injections. A literature review was performed to further understand and characterize this occurrence within the context of retina practice and the broader medical community. Relevant articles were identified through a systematic search of PubMed using predefined criteria. Coring can be observed when a needle punctures the rubber stopper of a medication vial, pushing a small piece or pieces of the stopper material into the container and introducing extrinsic particles into the drug product. Factors associated with coring include larger gauge needles, perpendicular needle entry, multiple-use vials, and thicker rubber stoppers. Rubber stopper thickness and composition also influence the likelihood of coring. To prevent patient safety issues from coring, filter needles are commonly used to draw up medications from vials because they are effective in mitigating particulate matter from entering syringes. No documented cases of clinical complications related to coring in ophthalmology have been identified. Coring represents an unreported phenomenon in the preparation of intraocular medications. Although there have been no safety implications in retina practice related to coring and intravitreal drug vials, these reports underscore the importance of careful medication preparation, inspection of vials, the use of appropriate needles, and adherence to best clinical practices.

Early identification and treatment of mental illness symptoms results in better outcomes, yet few screeners are available that can be efficiently used in community settings. The Mental Illness Needs Detection (MIND) Screener was developed to identify the need for mental health treatment and administered to 820 adults across the USA. Confirmatory factor analysis supported the internal consistency of the MIND. The MIND significantly correlated with the Kessler-10 (K10; a well-validated screener), reported mental illness, mental health treatment, and the need for treatment. The MIND's ability to accurately assess treatment needs was further demonstrated through high sensitivity (84%; 83%), specificity (71%; 62%), and AUC values (0.77; 0.73) when compared to both the K10 and reported need for treatment, respectively. These findings support the validity and reliability of the MIND and indicate its promise as a means of detecting a wide range of mental health needs across a variety of settings.

Mutations in the ORF15 exon of the RPGR gene cause a common form of X-linked retinitis pigmentosa, which often results in severe loss of vision. In dogs and mice, gene augmentation therapy has been shown to arrest the progressive degeneration of rod and cone photoreceptors. However, the distribution of potentially treatable photoreceptors across the human retinas and the rate of degeneration are not known. Here, we have defined structural and functional features of the disease in 70 individuals with ORF15 mutations. We also correlated the features observed in patients with those of three Rpgr-mutant (Rpgr-ko, Rd9, and Rpgr-cko) mice. In patients, there was pronounced macular disease. Across the retina, rod and cone dysfunction showed a range of patterns and a spectrum of severity between individuals, but a high symmetry was observed between eyes of each individual. Genotype was not related to disease expression. In the Rpgr-ko mice, there were intra-retinal differences in rhodopsin and cone opsin trafficking. In Rd9 and Rpgr-cko mice, retinal degeneration showed inter-ocular symmetry. Longitudinal results in patients revealed localized rod and cone dysfunction with progression rates of 0.8 to 1.3 log per decade in sensitivity loss. Relatively retained rod and cone photoreceptors in mid- and far-peripheral temporal-inferior and nasal-inferior visual field regions should be good targets for future localized gene therapies in patients.

To evaluate the responsiveness of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) in patients with diabetic macular edema using data from the RIDE and RISE trials. Patients were randomized to monthly intravitreal ranibizumab 0.3 mg, 0.5 mg, or sham injections for 2 years. The NEI VFQ-25 was administered at baseline and at Months 6, 12, 18, and 24. The least-squares mean change in NEI VFQ-25 for ≥15 letters gained or lost was derived from analysis of covariance models. The mean improvement in NEI VFQ-25 composite score associated with a ≥15-letter gain in best-corrected visual acuity over 24 months was 9.0 (95% confidence interval, 6.3-11.7) points in RIDE and 7.1 (95% confidence interval, 4.7-9.6) points in RISE. In patients who lost ≥15 letters, the mean worsening in overall NEI VFQ-25 composite score was -6.6 (95% confidence interval, -13.6 to 0.5) in RIDE and -2.7 (95% confidence interval, -8.9 to 3.5) in RISE. This exploratory analysis of data from the RIDE and RISE studies supports the responsiveness of the NEI VFQ-25 to changes in best-corrected visual acuity over time in patients with diabetic macular edema.

Mutations in the ORF15 exon of the RPGR gene cause a common form of X-linked retinitis pigmentosa, which often results in severe loss of vision. In dogs and mice, gene augmentation therapy has been shown to arrest the progressive degeneration of rod and cone photoreceptors. However, the distribution of potentially treatable photoreceptors across the human retinas and the rate of degeneration are not known. Here, we have defined structural and functional features of the disease in 70 individuals with ORF15 mutations. We also correlated the features observed in patients with those of three Rpgr-mutant (Rpgr-ko, Rd9, and Rpgr-cko) mice. In patients, there was pronounced macular disease. Across the retina, rod and cone dysfunction showed a range of patterns and a spectrum of severity between individuals, but a high symmetry was observed between eyes of each individual. Genotype was not related to disease expression. In the Rpgr-ko mice, there were intra-retinal differences in rhodopsin and cone opsin trafficking. In Rd9 and Rpgr-cko mice, retinal degeneration showed inter-ocular symmetry. Longitudinal results in patients revealed localized rod and cone dysfunction with progression rates of 0.8 to 1.3 log per decade in sensitivity loss. Relatively retained rod and cone photoreceptors in mid- and far-peripheral temporal-inferior and nasal-inferior visual field regions should be good targets for future localized gene therapies in patients.

BackgroundThe off-label use of recombinant activated factor VII (rFVIIa) for intractable bleeding is associated with a risk of thrombotic events. The objective of this study was to evaluate the incidence and predictors of rFVIIa-related thrombotic events and its efficacy in the reduction of transfusion requirements during various surgeries.MethodsNinety-two cases received rFVIIa for uncontrollable bleeding despite medical and surgical hemostasis. The incidence and risk factors of thrombotic events were analyzed. Blood products transfused in the 24 h before and after rFVIIa injection were calculated. Subgroup analysis was performed to see which types of surgeries benefited most from rFVIIa.ResultsThe main indication for rFVIIa administration was uncontrollable bleeding during cardiothoracic surgery followed by coagulopathy due to liver failure followed by neurosurgical procedures. Requirements of blood products after rFVIIa decreased significantly by 45 % (p = 0.012), 52 % (p = 0.0001), and 75 % (p = 0.0001) for red blood cells, plasma, and cryoprecipitate, respectively. Subgroup analysis showed that cardiothoracic surgery was the sole group that benefited from rFVIIa with a reduction in transfusion of red blood cells (p = 0.013), plasma (p = 0.0001), and cryoprecipitate (p = 0.0001). Thrombotic events occurred in 9.8 % of the cases mostly on the arterial side (89 %) and have not contributed to mortality.ConclusionrFVIIa can significantly reduce transfusion requirements when given for intractable bleeding during cardiothoracic surgery at the expense of thrombotic events in approximately one tenth of the cases. Further prospective studies are necessary to study if this effect of rFVIIa is translated to a favorable outcome.Electronic supplementary materialThe online version of this article (doi:10.1007/s40268-015-0093-9) contains supplementary material, which is available to authorized users.

Nasogastric tube intubation of a patient under general anesthesia with an endotracheal tube in place can pose a challenge to the most experienced anesthesiologist. Physiologic and pathologic variations in a patient’s functional anatomy can present further difficulty. While numerous techniques to the difficult nasogastric tube intubation have been described, there is no consensus for a standard approach. Therefore, selecting the most appropriate approach requires a working knowledge of the techniques available, mindful consideration of individual patient and clinical factors, and the operator’s experience and preference. This article reviews the relevant literature regarding various approaches to the difficult nasogastric tube intubation with descriptions of techniques and results from comparative studies if available. Additionally, we present a novel approach using a retrograde technique for the difficult intraoperative nasogastric tube intubation.