Ellen Peskin

Postinjection Endophthalmitis in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT)

OBJECTIVE To describe the incidence and outcomes of endophthalmitis after intravitreal injections of anti-vascular endothelial growth factor agents in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) and to assess the effect of prophylactic topical antimicrobials on incidence. DESIGN Cohort study within a randomized clinical trial. PARTICIPANTS Patients enrolled in CATT. METHODS Patients with neovascular age-related macular degeneration received intravitreal injections of ranibizumab or bevacizumab under 1 of 3 dosing regimens. The study protocol specified preinjection preparation to include use of a sterile lid speculum and povidone iodine (5%). Use of preinjection and postinjection antibiotics was at the discretion of the treating ophthalmologist. Patients were followed up monthly for 2 years. MAIN OUTCOME MEASURES Development of endophthalmitis and visual acuity. RESULTS Endophthalmitis developed after 11 of 18 509 injections (1 per 1700 [0.06%]; 95% confidence interval, 0.03%-0.11%), and in 11 of 1185 patients (0.93%; 95% confidence interval, 0.52-1.66). Incidence of endophthalmitis was 0.15% among injections with no antibiotic use, 0.08% among injections with preinjection antibiotics only, 0.06% among injections with postinjection antibiotics only, and 0.04% among injections with preinjection and postinjection antibiotics (P = 0.20). All eyes were treated with intravitreal antibiotics and 4 underwent vitrectomy. Among the 11 affected eyes, the final study visual acuity was 20/40 or better in 4 eyes (36%), 20/50 to 20/80 in 2 eyes (18%), 20/100 to 20/160 in 3 eyes (27%), and worse than 20/800 in 2 eyes (18%). The final visual acuity was within 2 lines of the visual acuity before endophthalmitis in 5 eyes (45%). CONCLUSIONS Rates of endophthalmitis were low and similar to those in other large-scale studies. Use of topical antibiotics either before or after injection does not seem to reduce the risk for endophthalmitis.

Visual Function of Moderately Hyperopic 4- and 5-Year-Old Children in the Vision in Preschoolers - Hyperopia in Preschoolers Study.

PURPOSE To compare visual performance between emmetropic and uncorrected moderately hyperopic preschool-age children without strabismus or amblyopia. DESIGN Cross-sectional study. METHODS setting: Multicenter, institutional. patient or study population: Children aged 4 or 5 years. intervention or observation procedures: Visual functions were classified as normal or reduced for each child based on the 95% confidence interval for emmetropic individuals. Hyperopic (≥3.0 diopters [D] to ≤6.0 D in the most hyperopic meridian; astigmatism ≤1.50 D; anisometropia ≤1.0 D) and emmetropic status were determined by cycloplegic autorefraction. MAIN OUTCOME MEASURES Uncorrected monocular distance and binocular near visual acuity (VA); accommodative response; and near random dot stereoacuity. RESULTS Mean (± standard deviation) logMAR distance visual acuity (VA) among 248 emmetropic children was better than among 244 hyperopic children for the better (0.05 ± 0.10 vs 0.14 ± 0.11, P < .001) and worse eyes (0.10 ± 0.11 vs 0.19 ± 0.10, P < .001). Mean binocular logMAR near VA was better in emmetropic than in hyperopic children (0.13 ± 0.11 vs 0.21 ± 0.11, P < .001). Mean accommodative response for emmetropic children was lower than for hyperopic subjects for both Monocular Estimation Method (1.03 ± 0.51 D vs 2.03 ± 1.03 D, P < .001) and Grand Seiko (0.46 ± 0.45 D vs 0.99 ± 1.0 D, P < .001). Median near stereoacuity was better in emmetropic than in than hyperopic children (40 sec arc vs 120 sec arc, P < .001). The average number of reduced visual functions was lower in emmetropic than in hyperopic children (0.19 vs 1.0, P < .001). CONCLUSIONS VA, accommodative response, and stereoacuity were significantly reduced in moderate uncorrected hyperopic preschool children compared to emmetropic subjects. Those with higher hyperopia (≥4 D to ≤6 D) were at greatest risk, although more than half of children with lower magnitudes (≥3 D to <4 D) demonstrated 1 or more reductions in function.

Red Blood Cell Fatty Acid Analysis for Determining Compliance with Omega3 Supplements in Dry Eye Disease Trials

PURPOSE To evaluate pill counts and red blood cell (RBC) membrane fatty acid profiles as measures of compliance with oral omega3 polyunsaturated fatty acids (ω3 PUFAs) and to compare the two techniques. METHODS Sixteen dry eye disease subjects were given oral ω3 PUFA or placebo for 3 months. Compliance was measured by pill counts and blood tests at baseline and 3 months. The Wilcoxon signed-rank tests and rank-sum tests were used to compare changes from baseline and the difference between the two groups; Spearman correlation coefficients were used to assess the relationship of pill counts to changes in blood FAs. RESULTS Pill counts for the ω3 (n=7) and placebo (n=9) groups showed a mean consumption of 4.39 and 4.76 pills per day, respectively. In the ω3 group, the median change from baseline was +1.46% for eicosapentaenoic acid (EPA) (P=0.03), +1.49% for docosahexaenoic acid (DHA) (P=0.08), and -1.91% for arachidonic acids (AA) (P=0.02). In the placebo group, median changes in all measured FAs were small and not statistically significant. The difference in change in FA levels between the two groups was significantly greater for EPA (P=0.01) and AA (P=0.04). The correlations between pill counts and changes in EPA (r=0.36, P=0.43) and DHA (r=0.17, P=0.70) were not strong. CONCLUSIONS RBC FA analysis can be used to measure compliance in the active group and also monitor the placebo group for nonstudy ω3 intake. Low correlation of pill counts with blood levels suggests that pill counts alone may be inaccurate and should be replaced or supplemented with objective measures.

Iontophoretic delivery of dexamethasone phosphate for non-infectious, non-necrotising anterior scleritis, dose-finding clinical trial

Abstract Currently available treatment options for non-infectious scleritis, including non-steroidal anti-inflammatory drugs, systemic corticosteroids and immunosuppressive therapies, have both efficacy and side effect limitations. Iontophoretic delivery of corticosteroids has been demonstrated to be effective for anterior uveitis and represents a potential new approach to scleritis therapy. We hypothesised that iontophoretic delivery would provide effective and precise medication delivery to the sclera, while limiting systemic exposure and side effects. This first-in-human randomised, double-masked, dose-escalating study of iontophoretic administration of dexamethasone phosphate for scleritis suggests the treatment to be well tolerated and safe (within the limitations of the 18 patients sample size). There was a suggestion of efficacy in the lowest (1.2 mA/min at 0.4 mA) dose group (corresponding to the superficial location of scleritis compared with anterior uveitis), with 5/7 eyes meeting the primary efficacy outcome within 28 days. Our results suggest iontophoretic delivery of corticosteroids is a promising potential treatment for scleritis, with favourable safety and preliminary efficacy results in this phase 1 trial. Trial registration number NCT01059955.