BackgroundA position paper based on the collective experiences of Argus II Retinal Prosthesis System investigators to review strategies to optimize outcomes in patients with retinitis pigmentosa undergoing retinal prosthesis implantation.MethodsRetinal surgeons, device programmers, and rehabilitation specialists from Europe, Canada, Middle East, and the United States were convened to the first international Argus II Investigator Meeting held in Ann Arbor, MI in March 2015. The recommendations from the collective experiences were collected. Factors associated with successful outcomes were determined.ResultsFactors leading to successful outcomes begin with appropriate patient selection, expectation counseling, and preoperative retinal assessment. Challenges to surgical implantation include presence of staphyloma and inadequate Tenon’s capsule or conjunctiva. Modified surgical technique may reduce risks of complications such as hypotony and conjunctival erosion. Rehabilitation efforts and correlation with validated outcome measures following implantation are critical.ConclusionsBringing together Argus II investigators allowed the identification of strategies to optimize patient outcomes. Establishing an on-line collaborative network will foster coordinated research efforts to advance outcome assessment and rehabilitation strategies.
PurposeThe goals of this study were to evaluate the safety of office-based vitreous sampling, and determine the utility of these samples with multiplex cytokine analysis.MethodsVitreous samples were collected from office-based needle aspiration and the rate of adverse events during follow-up was reviewed. The vitreous cytokine concentrations in a subset of patients with diabetic macular edema (DME) were analyzed using a 42 plex-cytokine bead array. These results were compared with vitreous cytokine concentrations in proliferative diabetic retinopathy (PDR) and controls (macular hole, epiretinal membrane, symptomatic vitreous floaters) from pars plana vitrectomy.ResultsAn adequate volume of vitreous fluid (100–200 μL) was obtained in 52 (88%) of 59 office-based sampling attempts. The average length of follow-up was 300 days (range, 42–926 days). There were no complications, including cataract, retinal tear or detachment, and endophthalmitis. Two patients (3%) had posterior vitreous detachments within 3 months. Vitreous cytokine concentrations were measured in 44 patients: 14 controls, 13 with DME, and 17 with PDR. The concentration of ADAM11, CXCL-10, IL-8, and PDGF-A were higher in PDR compared with controls and DME. The concentration of IL-6 was higher in PDR compared with controls, but not compared with DME.ConclusionsOffice-based vitreous aspiration is safe and yields high-quality samples for multiplex vitreous cytokine analysis. Significant elevations of vitreous cytokines were found in PDR compared with DME and controls, including the novel finding of elevated ADAM11. As such, office-based aspiration is a safe and effective means to identify vitreous factors associated with vitreoretinal disease.
Purpose To quantify the amount of drug loss from cadaveric human eyes which are injected via the pars plana with a known volume of dye at variable intraocular pressures. Methods Eight cadaver eyes were divided into two intraocular pressure groups: normal (15 mmHg, 4 eyes) or high (30 mmHg, 4 eyes). Each eye was injected with 50 µl of hematoxylin dye and the subsequent reflux was immediately collected on a Schirmers test strip. The test strip was scanned and digitally analyzed to determine the area of saturation and total color intensity present. Using a previously established equation, total volume of reflux and amount of dye within that reflux were calculated. Results The average total volume of refluxed fluid was 1.68 µL (median: 0.62 µL), with a range of 0 µL to 8.05 µL. The average volume of refluxed dye was 0.37 µL (median: 0.08 µL), with a range of 0 µL to 2.15 µL. On average only 0.74% of the original 50 µL of injected dye was lost (median: 0.15%), with a range from 0% to 4.30%. Conclusion Although the presence of subconjunctival bleb formation after intravitreal injection may be concerning to the clinician, our data shows that only a very small amount of the injected therapeutic agent is lost in the reflux.
Purpose To determine if oral fluoroquinolone exposure is associated with an increased hazard for having a retinal tear or detachment. Methods A retrospective cohort study was performed using individuals who met inclusion criteria from The Health Improvement Network (THIN) database. Cohorts were created for individuals who had a prescription written for either an oral fluoroquinolone or an oral β-lactam antibiotic (comparison group). Subjects were excluded if they had a previous diagnosis of a retinal tear or detachment (hereafter retinal break, or RB) or a procedure code to treat an RB, were in the practice for less than 365 days, had a previous prescription for either antibiotic within 365 days of the index date, or had intraocular surgery or a diagnosis of endophthalmitis within 90 days prior to the antibiotic prescription. Covariates of interest were age, gender, diabetes and year of index. The primary outcome measure of interest was the hazard ratio of undergoing a procedure to treat a RB within 7, 30, 90 or 365 days after exposure to an oral fluoroquinolone prescription versus an oral β-lactam prescription. Results After exclusions, 6,604,423 prescriptions (290,393 fluoroquinolone; 6,314,030 β-lactam) from 3,413,498 patients (247,073 fluoroquinolone; 3,303,641 β-lactam) and, 2,685 RB procedures were eligible for analysis (661 retinal tears, 2,024 retinal detachments). For fluoroquinolones, zero, one, five, and 23 retinal breaks occurred at the 7-, 30-, 90-, and 365-day time points, respectively. For β-lactam prescriptions, 7, 28, 87, 373 retinal breaks occurred at the 7-, 30-, 90-, and 365-day time points, respectively. Due to zero events occurring in the fluoroquinolone cohort during the 7-day observation period an unadjusted or an adjusted hazard ratio (and subsequent p-value or confidence intervals) were unable to be calculated. Univariate and multivariate analysis demonstrated that fluoroquinolones were not significantly associated with RB in the 30-, 90- or 365-day observation periods (30-day HR=0.78, p=0.80, 95% CI: 0 .11, 5.71; 90-day HR=1.25, p=0.63, 95% CI: 0.51, 3.08; 365-day HR= 1.35, p=0.16, 95% CI: 0.89 2.06). Conclusions Our results do not support an association between oral fluoroquinolone use and subsequent procedures to treat a retinal break.
Objective To determine the frequency of clinical management changes resulting from inpatient ophthalmic consultations for fungemia and the associated costs. Design Retrospective case series Participants 348 inpatients at a tertiary care center between 2008–2012 with fungal positive blood cultures, 238 of whom received ophthalmologic consultation. Methods Inpatient charts of all fungemic patients were reviewed. Costs were standardized to the year 2014. Student’s t-test was used for all continuous variables and Pearson’s chi-squared test was used for categorical variables Main Outcome Measures Prevalence of ocular involvement, rate of change in clinical management, mortality rate of fungemic patients, and costs of ophthalmic consultation. Results 22 of 238 consulted patients with fungemia (9.2%) had ocular involvement. 20 patients had chorioretinitis and 2 had endophthalmitis. Only 9 patients (3.7%) had a change in management due to ophthalmic consultation. 1 patient had bilateral intravitreal injections. Thirty percent of consulted patients died prior to discharge or were discharged to hospice. The total cost of new consults was $36,927.54 ($204.19/initial level 5 visit and $138.63/initial level 4). The cost of follow-up visits was $13,655.44 ($104.24/visit). On average, 26.4 patients were evaluated to find one patient needing change in management with an average cost of $5,620.33 per change in one patient’s management. Conclusions Clinical management changes due to ophthalmic consultation in fungemic patients were uncommon. Associated costs were high for these consults in a patient population with a high mortality rate. Together, this data suggests that the utility of routine ophthalmic consultation for all fungemic patients is likely to be low.
Background Reflux following intravitreal injection is a common phenomenon, but it is unknown how much, if any, medication is lost as a result. Reflux is known to be a combination of vitreous and the injected agent, but the relative composition is unknown. This paper describes a novel method for the measurement of the volume and composition of reflux and presents data from porcine eyes. Methods Twenty porcine eyes were injected with 0.05 ml of dye at intraocular pressures (IOPs) of 15, 20, 25 and 30 mmHg (5 eyes per subgroup). Reflux was captured on filter paper and the area of saturation and color intensity of the dye were digitally analyzed. Total refluxed volume and proportion of dye vs. vitreous fluid were calculated from linear regression lines created from known standards. Results Average (median) total volume of reflux from all eyes was 1.19 μL (0.93 μL), volume of injected dye refluxed was 0.47 μL (0.11 μL), and composition of reflux was 20.8% dye (15.5%). Less than 1% of the injected dye was lost to reflux. There were no differences between IOP groups in the total volume refluxed, the total amount of dye refluxed, the average composition of the reflux, or the amount of injected dye refluxed (df=3 for all comparisons; p=0.58, p=0.51, p=0.55, p=0.51, respectively). Conclusions This novel method allows for measurement of quantity and composition of reflux following intravitreal injection in vitro. While reflux occurs frequently, it is predominantly composed of vitreous, not the injected agent. In fact, less than one percent of the original injection was lost to reflux.
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