Compounded 0.01% Atropine-What's in the Bottle?

OBJECTIVE: To describe the labeling, packaging practices, and characteristics of compounded 0.01% ophthalmic atropine. METHODS: A convenience sample of parents of children who had previously been prescribed low-concentration atropine for myopia management were randomized to obtain 0.01% atropine ophthalmic solution from one of nine compounding pharmacies. The products were analyzed for various important quality attributes. The main outcomes were labeling practices, concentration of atropine and degradant product tropic acid, pH, osmolarity, viscosity, and excipients in 0.01% atropine samples obtained from nine US compounding pharmacies. RESULTS: Twenty-four samples from nine pharmacies were analyzed. The median bottle size was 10 mL (range 3.5-15 mL), and eight of nine pharmacies used clear plastic bottles. Storage recommendations varied and were evenly split between refrigeration (33%), room temperature (33%), and cool, dark, dry location (33%). Beyond use dates ranged from 7 to 175 days (median, 91 days). Median pH of samples was 7.1 (range, 5.5-7.8). Median measured concentration relative to the prescribed concentration was 93.3% (70.4%-104.1%). One quarter of samples were under the 90% minimum target concentration of 0.01%. CONCLUSIONS: An inconsistent and wide variety of formulation and labeling practices exist for compounding 0.01% atropine prescribed to slow pediatric myopia progression.

Retrospective review of the effectiveness of orthokeratology versus soft peripheral defocus contact lenses for myopia management in an academic setting.

PURPOSE: To evaluate the relative efficacy of peripheral defocus contact lenses (PDCLs) and orthokeratology (OK) in a real-world clinical population, and compare these results with previous randomised controlled clinical trials. METHODS: Records from a university practice were reviewed to identify children who were treated with OK or PDCLs. The analysed sample contained 273 visits from 77 patients. Annualised rates of axial length (AL) progression were calculated and used as the response variable in both linear mixed-effects (LME) and nonlinear regression models. RESULTS: On average, children were 10.7 years of age at baseline (p = 0.14 between treatments), and most patients were female. More Asian children wore OK lenses compared with PDCLs (p < 0.01). At baseline, children had ~3.00 D of myopia and 0.75 D of astigmatism in both treatment groups (p > 0.20 between treatments). LME regression models using only baseline covariates showed no evidence that the annualised change in AL differed between treatments, with or without the inclusion of age, race, sex, baseline AL or spherical equivalent refractive error. Across all possible subsets of models, age at baseline was the best predictor of annualised AL change. There was no statistical difference between parameters of an exponential decay model fitted within treatment using follow-up age as a time-varying predictor, indicating that the rate of annualised change in AL was similar for OK and PDCL. CONCLUSIONS: Retrospective analysis of real-world clinical data found no difference in annualised AL growth between PDCL and OK. Importantly, the AL progression from this clinical setting is consistent with that reported in randomised clinical trials. Therefore, continued research of real-world performance is warranted to understand the safety and efficacy of modern myopia control treatments in the broader population.

A comparison of subjective and objective conjunctival hyperaemia grading with AOS® Anterior software.

CLINICAL RELEVANCE: This study evaluates a commercially available conjunctival hyperaemia grading system, providing validation of an important tool for ocular surface research and clinical trials. BACKGROUND: Bulbar conjunctival hyperaemia is a sign of ocular surface inflammation, and proper measurement is essential to clinical care and trials. The aim of this study was to assess the validity and repeatability of an objective grading system in comparison with subjective grading. METHODS: This study was a retrospective, randomised analysis of 300 bulbar conjunctival images that were collected at an academic institution. The images used were de-identified and collected from the Keratograph K5 and Haag-Streit slitlamp. Six investigators graded the images with either a 0.1 or 0.5 unit scaling using a 0-4 Efron grading scale. Three of the investigators also imported the images into the AOS ® Anterior software and graded them objectively. All measurement techniques were assessed for repeatability and comparability to each other. RESULTS: Mean hyperaemia with the objective system (1.1 ± 0.7) was significantly less than the subjective grading (2.0 ± 0.8) (P < 0.001). Both inter- and intra-subject repeatability of the objective system (0.15) was better than the subjective methods (1.70). CONCLUSION: The results showed excellent repeatability of the AOS ® Anterior objective conjunctival hyperaemia grading software, although they were not found to be interchangeable with subjective scores. This system has value in monitoring levels of hyperaemia in contact lens wearers and patients in clinical care and research trials.

A measure of tear inflow in habitual scleral lens wearers with and without midday fogging.

PURPOSE: The purpose of this pilot study was to evaluate tear inflow in a scleral lens system using fluorophotometry, and indirectly assess the exchange of the tear reservoir in habitual scleral lens wearers with the presence or absence of midday fogging (MDF). METHODS: Habitual scleral lens wearers (n=23) and normal scleral lens neophytes (n=10) were recruited. Of the 23 habitual wearers, 11 of them experienced MDF and 12 did not have a diagnosis of MDF. Contact lens-fitting characteristics were evaluated using ocular coherence tomograpy (OCT) and biomicroscopy. High molecular weight fluorescein (FITC) Dextran was instilled into the tear reservoir beneath the scleral lens, and the tear fluid fluorescein concentration was measured using the Fluorotron fluorophotometer. Calculated fluorescein concentrations were plotted over time to measure the fluorescein decay rate of the tear fluid beneath the scleral lens, which was used to calculate the tear exchange rate. RESULTS: There was no significant difference in tear inflow between the MDF group (mean: 0.111%) and the non-MDF group (mean: 0.417%), and there was a high amount of variability seen in the rates (p = 0.26). In addition, there was no significance between the tear reservoir thickness in the MDF (283um) and non-MDF (326um) groups (p = 0.53). CONCLUSIONS: The relationship between the amount of tear exchange during scleral lens wear and the incidence of MDF was not significant. Additional studies are needed to further examine the role of tear exchange in MDF and address the causes of variability to improve measurement techniques with fluorophotometry in the scleral lens system.