Marshall B. Ketchum University
  • California City, United States
Recent publications
SIGNIFICANCE Clinicians and researchers would benefit from being able to predict the onset of myopia for an individual child. This report provides a model for calculating the probability of myopia onset, year-by-year and cumulatively, based on results from the largest, most ethnically diverse study of myopia onset in the United States. PURPOSE This study aimed to model the probability of the onset of myopia in previously nonmyopic school-aged children. METHODS Children aged 6 years to less than 14 years of age at baseline participating in the Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study who were nonmyopic and less hyperopic than +3.00 D (spherical equivalent) were followed up for 1 to 7 years through eighth grade. Annual measurements included cycloplegic autorefraction, keratometry, ultrasound axial dimensions, and parental report of children's near work and time spent in outdoor and/or sports activities. The onset of myopia was defined as the first visit with at least −0.75 D of myopia in each principal meridian. The predictive model was built using discrete time survival analysis and evaluated with C statistics. RESULTS The model of the probability of the onset of myopia included cycloplegic spherical equivalent refractive error, the horizontal/vertical component of astigmatism ( J 0 ), age, sex, and race/ethnicity. Onset of myopia was more likely with lower amounts of hyperopia and less positive/more negative values of J 0 . Younger Asian American females had the highest eventual probability of onset, whereas older White males had the lowest. Model performance increased with older baseline age, with C statistics ranging from 0.83 at 6 years of age to 0.92 at 13 years. CONCLUSIONS The probability of the onset of myopia can be estimated for children in the major racial/ethnic groups within the United States on a year-by-year and cumulative basis up to age 14 years based on a simple set of refractive error and demographic variables.
Importance Increased myopic shift was found to be associated with 1 year of overminus spectacle treatment for children with intermittent exotropia (IXT). Persistence of myopic shift after discontinuing overminus spectacles is unknown. Objective To compare refractive error change over 3 years in children with IXT originally treated with overminus vs nonoverminus spectacles. Design, Setting, and Participants This study was an 18-month extension of the Trial of Overminus Spectacle Therapy for Intermittent Exotropia cohort, which previously randomized children aged 3 to 10 years with IXT and baseline spherical equivalent refractive error (SER) between −6.00 diopters (D) and 1.00 D to overminus spectacles (−2.50 D for 12 months, −1.25 D for 3 months, and nonoverminus for 3 months) or nonoverminus spectacles. Children were recruited from 56 sites from July 2010 to February 2022. Data were analyzed from February 2022 to January 2024. Interventions After trial completion at 18 months, participants were followed up at 24 and 36 months. Treatment was at investigator discretion from 18 to 36 months. Main Outcomes and Measures Change in SER (cycloplegic retinoscopy) from baseline to 36 months. Results Of 386 children in the Trial of Overminus Spectacle Therapy for Intermittent Exotropia, 223 (57.8%) consented to 18 months of additional follow-up, including 124 of 196 (63.3%) in the overminus treatment group and 99 of 190 (52.1%) in the nonoverminus treatment group. Of 205 children who completed 36-month follow-up, 116 (56.6%) were female, and the mean (SD) age at randomization was 6.2 (2.1) years. Mean (SD) SER change from baseline to 36 months was greater in the overminus group (−0.74 [1.00] D) compared with the nonoverminus group (−0.44 [0.85] D; adjusted difference, −0.36 D; 95% CI, −0.59 to −0.12; P = .003), with 30 of 112 (26.8%) in the overminus group having more than 1 D of myopic shift compared with 14 of 91 (15%) in the nonoverminus group (risk ratio, 1.8; 95% CI, 1.0-3.0). From 12 to 36 months, mean (SD) myopic shift was −0.34 (0.67) D and −0.36 (0.66) D in the overminus and nonoverminus groups, respectively (adjusted difference, −0.001 D; 95% CI, −0.18 to 0.18; P = .99). Conclusions and Relevance The greater myopic shift observed after 1 year of −2.50-D overminus lens treatment remained at 3 years. Both groups had similar myopic shift during the 2-year period after treatment weaning and cessation. The risk of myopic shift should be discussed with parents when considering overminus lens treatment. Trial Registration ClinicalTrials.gov Identifier: NCT02807350
Purpose This article discusses key considerations regarding ticagrelor’s reported effect on heparin-induced thrombocytopenia functional assays, such as literature gaps and possible management strategies. Summary Limited data indicate that ticagrelor may induce false-negative results in functional assays used in the diagnosis of heparin-induced thrombocytopenia. False-negative functional assays for heparin-induced thrombocytopenia could have catastrophic consequences. The manufacturer labeling of ticagrelor now includes a warning for this potential drug-laboratory interaction. This article suggests areas that would benefit from further research and strategies in navigating this possible interaction. Conclusion Clinicians should exercise caution when evaluating functional assays for heparin-induced thrombocytopenia in patients receiving ticagrelor. This article offers suggestions for future areas of research and potential management strategies.
Background: Meibomian gland dysfunction (MGD) is the most common underlying cause of dry eye disease (DED). MGD leads to pathological alteration of the composition or quantity of meibum, or both, which subsequently results in tear evaporation and the typical signs and symptoms associated with DED. The LipiFlow Thermal Pulsation System (LipiFlow) is a medical device used to treat MGD in office; however, it is unclear if LipiFlow can outperform other DED treatments. Objectives: To evaluate the effectiveness of LipiFlow for treating DED signs and symptoms and the safety of LipiFlow compared with sham or other available treatments for MGD in adults. Search methods: The Cochrane Eyes and Vision Information Specialist searched the electronic databases for randomized controlled trials. There were no restrictions on language or date of publication. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, including the Cochrane Eyes and Vision Trials Register; 2022, Issue 6), MEDLINE Ovid, Embase.com, PubMed, LILACS (Latin American and Caribbean Health Science Information database), ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) electronic databases. We also examined the reference lists of identified trials, review articles, and guidelines for information about relevant trials that may not have been identified by our search strategy. We contacted investigators regarding ongoing trials. The last database search was performed on 24 October 2022. Selection criteria: We included studies conducted in adults (over 18 years of age) with DED or MGD as defined by the primary trial investigators. We imposed no restrictions on race, ethnicity, or sex. We considered trials involving contact lens wearers if they were equally represented between groups. Data collection and analysis: We applied standard Cochrane methodology. Main results: We included 13 trials that randomized a total of 1155 participants (28 to 236 participants randomized per study). Six trials were conducted in the USA, three in China, two in Thailand, one in France, and one in Italy. Eight trials were of single-center design, while four trials were of multicenter design; one trial did not report the number of participating centers. Study characteristics The study population of the included trials was 66% female (range 48% to 80%), with an age range of 19 to 86 years. LipiFlow, used as a stand-alone intervention, was compared with basic warm compresses in five studies, thermostatic device in five studies, oral intervention in one trial, and topical dry eye medications in one trial. LipiFlow was also evaluated together with eyelid hygiene product versus eyelid hygiene products alone in one trial. Findings Five trials compared LipiFlow with a basic warm compress applied for varying durations and frequencies during the trial period; only one of these trials combined a warm compress with eyelid massage. Analyzing symptom scores by different questionnaires (Ocular Surface Disease Index [OSDI] and Standard Patient Evaluation of Eye Dryness [SPEED]) yielded conflicting evidence of a difference in symptoms between LipiFlow and basic warm compresses after four weeks. There was no evidence of a difference in meibomian gland expression, meibum quality, or tear breakup time when comparing LipiFlow with basic warm compresses. Another five trials compared LipiFlow with thermostatic devices. Analysis of symptom scores at four weeks showed that thermostatic devices had reduced OSDI scores by a mean difference (MD) of 4.59 (95% confidence interval [CI] 1.23 to 7.95; I2 = 0, P = 0.007; 553 participants; very low certainty evidence) as compared with LipiFlow. When we compared LipiFlow plus eyelid hygiene with eyelid hygiene alone, there was no evidence of difference in signs or symptoms at any time point evaluated. Only one trial compared LipiFlow with a topical DED medication (lifitegrast 5%). The single-trial estimate suggested that 5% lifitegrast may increase meibomian gland expression scores compared with LipiFlow at day 42 (MD -1.21, 95% CI -2.37 to -0.05; 50 participants; low certainty evidence) by using a meibomian gland expression scale of 0 to 8. One trial compared LipiFlow with an oral intervention (doxycycline), finding that LipiFlow may result in significantly better SPEED scores than doxycycline at three months (MD -4.00, 95% CI -7.33 to -0.67; 24 participants; very low certainty evidence). No other significant differences in signs or symptoms were found between LipiFlow and doxycycline at three months. We did not find any other statistically significant differences in symptoms or signs for any other analysis performed in this review at the one- to four-week time point. Adverse events No trial reported any intervention-related, vision-threatening adverse events. Authors' conclusions: LipiFlow performs similarly to other commonly used DED treatments with regard to DED signs and symptoms. The best available evidence was deemed to have a high level of bias, leading to low or very low certainty evidence. Additional research with adequate masking, a standardized testing methodology, and a sample representative of the MGD population is therefore needed before any firm conclusions can be drawn regarding comparative benefits and harms.
Purpose To determine how vision correction habits changed after the 2019 coronavirus disease (COVID-19) pandemic onset. Methods Participants reported vision correction habits, refractive error, screen time, mask wearing time, and dry eye symptoms since the COVID-19 pandemic onset through email survey. Results A total of 133 participants completed the survey. Worsening dry eye symptoms were associated with increased screen time ( P =0.04). Hours per day of spectacle wear increased by approximately 1 hr ( P =0.001) and was associated with increased screen time ( P =0.002). Worsening dry eye symptoms were associated with increased days per week of spectacle wear ( P =0.02). Participants wore contact lenses about one day per week less than before the pandemic ( P =0.0001). Increased mask wearing time was associated with increased days per week of contact lens wear ( P =0.03). Conclusions After pandemic onset, hours per day of spectacle wear increased, and days per week of contact lens wear decreased. Increases in hourly spectacle wear were associated with increased screen time, whereas increased daily contact lens wear was associated with increased mask wear time, suggesting that spectacles may be preferred for screen time activities and contact lenses for mask wear.
Objective: To report 8-year outcomes from a randomized controlled trial (RCT) comparing bilateral lateral rectus muscle recessions (BLRc) with unilateral recess-resect (R&R) for childhood intermittent exotropia (IXT). Design: Eight-year follow-up of RCT cohort PARTICIPANTS: 123 of 197 randomized participants agreed to continue follow-up after the 3-year outcome visit (baseline age 3 to <11 years with basic-type IXT 15-40 prism diopters (Δ) by prism and alternate cover test (PACT), baseline stereoacuity of 400 arcsec or better, no prior surgery) METHODS: Following the RCT primary outcome at 3 years, annual follow-up from 4 through 8 years with treatment at investigator discretion. Main outcome measures: Suboptimal surgical outcome by 8 years after randomization, defined as any of the following at any visit: exotropia ≥10Δ by simultaneous prism cover test (SPCT) at distance or near; constant esotropia (ET) ≥6Δ by SPCT at distance or near; loss of near stereoacuity by ≥0.6 log arcsec from baseline; or reoperation. Secondary outcomes included 1) reoperation by 8 years and 2) complete or near-complete resolution at 8 years: exodeviation <10Δ by SPCT and PACT at distance and near and ≥10Δ reduction from baseline PACT at distance and near; ET <6Δ at distance and near; no decrease in stereoacuity by ≥0.6 log arcsec from baseline; no reoperation or nonsurgical treatment for IXT. Results: The Kaplan-Meier cumulative probability of suboptimal surgical outcome through 8 years was 68% (55 events among 101 at risk) for BLRc and 53% (42 events among 96 at risk) for R&R (difference = 15%, 95% CI: -2% to 32%, P = 0.08). Complete or near-complete resolution at 8 years occurred in 14% (6/42) for BLRc and 37% (16/43) for R&R (difference = -22%, 95% CI: -44% to -0.1%, P = 0.049). The cumulative probability of reoperation was 30% for BLRc and 11% for R&R (difference = 19%, 95% CI=2% to 36%, P = 0.049). Conclusions: Despite no significant difference at primary outcome, the 95% CI did not exclude a moderate benefit of R&R, which together with secondary outcomes, suggests that unilateral R&R followed by usual care may yield better long-term outcomes than BLRc followed by usual care, for basic-type childhood IXT, using our surgical doses.
Introduction Multiple randomized trials are currently underway evaluating the safety and efficacy of middle meningeal artery embolization (MMAE) in chronic subdural hematoma (cSDH) utilizing different embolic materials. Multiple opinions exist in terms of embolic materials preferences between different operators with liquid embolics thought to allow more distal penetration while particles being associated with lower risk of non-advertent target embolization. Despite this, scarce amount of comparative data currently exists regarding the difference in clinical and radiographic endpoints between these embolic materials. Therefore, we sought to compare these different embolic materials utilizing large multicenter database. Methods Series of consecutive patients undergoing MMAE for cSDH at 15 North-American centers (2018-2023) were included. Patients were classified according to the materials utilized in MMA embolization: a) particles (with or without coils), b) Onyx, c) n-BCA. The endpoints of comparison were: 1) clinical failure rates defined as requiring unplanned rescue surgery (during initial or subsequent admission) 2) radiographic success defined as at least 50% reduction in maximal hematoma thickness at last follow-up, with minimum of 2 weeks imaging follow-up time. Initial unmatched analysis was performed between the 3 groups. Subsequent matched analysis via propensity score matching (PSM) was performed between the particles (group A) versus the liquid group (groups b & c combined; Onyx and n-BCA). Additional subgroup PSM analysis compared the endpoints between the Onyx and the n-BCA cohort. All the matched analyses controlled for the following: age, gender, pre-procedural maximal hematoma thickness, and concurrent surgical evacuation. Results 770 patients [median age 73 years (IQR 63 - 81), 26.8% females] undergoing 956 MMAE procedures were included [186 underwent bilateral treatments (24.2%)]. On presentation, median cSDH maximal thickness was 14 mm (IQR 10-18). The most utilized embolic agent was particles (43.6%), followed by Onyx and n-BCA (36.3% and 14.8%, respectively). Retreatment rates were not significantly different between the particles, Onyx, n-BCA (9.9% vs 7% vs 10.6% respectively, p=0.27). Similarly, radiographic success rates were comparable (79.9% vs 85.1%, 79.6% respectively, p=0.15). Upon running the PSM algorithm to compare the particles vs liquid group, 106 matched pairs were generated with similar baseline characteristics. There were no significant differences in retreatment rates between the 2 groups (9.5% vs 10.5%; p=0.82), or radiographic success rates (76.4% vs 78.3%; p=0.74). Concurrently, the PSM comparing Onyx vs n-BCA resulted in 30 matched pairs; there were no significant differences in radiographic success between the group (76.5% vs 64.7%; p=0.45). There was a trend for higher retreatment rates in the n-BCA group (17.7% vs 0%; p=0.07), but did not reach statistical significance. Finally, no significant differences in procedural complications were noted between the groups across the previous analyses. Conclusion In our data, there were no significant differences in clinical and radiographic efficacy between the particles and the liquid embolic in MMAE. In the liquid embolic, matched subgroup analysis did not reveal significant differences in radiographic/clinical endpoints between Onyx and nBCA, however, the limited post-matching sample size precludes definitive conclusions. Post-hoc comparative analyses from the prospective trials can provide more insight into this. Disclosures M. Salem None. J. Khalife None. O. Kuybu None. K. Caroll None. A. Nguyen Hoang None. A. Baig None. M. Khorasanizadeh None. C. Baker None. A. Mendez None. G. Cortez None. Z. Abecassis None. J. Rodriguez None. J. Davies None. C. Cawley None. H. Riina None. J. Moore None. A. Spiotta None. A. Khalessi None. B. Howard None. R. Hanel None. O. Tanweer None. D. Tonetti None. E. Levy None. R. Grandhi None. M. Lang None. A. Siddiqui None. P. Kan None. M. Levitt None. C. Ogilvy None. T. Jovin None. B. Gross None. B. Jankowitz None. A. Thomas None. J. Burkhardt None.
Importance: Controlling myopia progression is of interest worldwide. Low-dose atropine eye drops have slowed progression in children in East Asia. Objective: To compare atropine, 0.01%, eye drops with placebo for slowing myopia progression in US children. Design, setting, and participants: This was a randomized placebo-controlled, double-masked, clinical trial conducted from June 2018 to September 2022. Children aged 5 to 12 years were recruited from 12 community- and institution-based practices in the US. Participating children had low to moderate bilateral myopia (-1.00 diopters [D] to -6.00 D spherical equivalent refractive error [SER]). Intervention: Eligible children were randomly assigned 2:1 to 1 eye drop of atropine, 0.01%, nightly or 1 drop of placebo. Treatment was for 24 months followed by 6 months of observation. Main outcome measures: Automated cycloplegic refraction was performed by masked examiners. The primary outcome was change in SER (mean of both eyes) from baseline to 24 months (receiving treatment); other outcomes included change in SER from baseline to 30 months (not receiving treatment) and change in axial length at both time points. Differences were calculated as atropine minus placebo. Results: A total of 187 children (mean [SD] age, 10.1 [1.8] years; age range, 5.1-12.9 years; 101 female [54%]; 34 Black [18%], 20 East Asian [11%], 30 Hispanic or Latino [16%], 11 multiracial [6%], 6 West/South Asian [3%], 86 White [46%]) were included in the study. A total of 125 children (67%) received atropine, 0.01%, and 62 children (33%) received placebo. Follow-up was completed at 24 months by 119 of 125 children (95%) in the atropine group and 58 of 62 children (94%) in the placebo group. At 30 months, follow-up was completed by 118 of 125 children (94%) in the atropine group and 57 of 62 children (92%) in the placebo group. At the 24-month primary outcome visit, the adjusted mean (95% CI) change in SER from baseline was -0.82 (-0.96 to -0.68) D and -0.80 (-0.98 to -0.62) D in the atropine and placebo groups, respectively (adjusted difference = -0.02 D; 95% CI, -0.19 to +0.15 D; P = .83). At 30 months (6 months not receiving treatment), the adjusted difference in mean SER change from baseline was -0.04 D (95% CI, -0.25 to +0.17 D). Adjusted mean (95% CI) changes in axial length from baseline to 24 months were 0.44 (0.39-0.50) mm and 0.45 (0.37-0.52) mm in the atropine and placebo groups, respectively (adjusted difference = -0.002 mm; 95% CI, -0.106 to 0.102 mm). Adjusted difference in mean axial elongation from baseline to 30 months was +0.009 mm (95% CI, -0.115 to 0.134 mm). Conclusions and relevance: In this randomized clinical trial of school-aged children in the US with low to moderate myopia, atropine, 0.01%, eye drops administered nightly when compared with placebo did not slow myopia progression or axial elongation. These results do not support use of atropine, 0.01%, eye drops to slow myopia progression or axial elongation in US children. Trial registration: ClinicalTrials.gov Identifier: NCT03334253.
Objective: To determine the economic considerations, including cost-saving strategies, associated with nonsterile compounding education for students in schools and colleges of pharmacy across the United States. Methods: An electronic survey was sent to American Association of Colleges of Pharmacy Pharmaceutics Section and Laboratory Instructor's Special Interest Group members. Quantitative and qualitative data were collected about the institution, student cohorts, compounding courses, equipment, budgets, personnel, and cost-saving measures. Descriptive statistics were calculated using SPSS. Open-ended responses were used by respondents if the primary question could not adequately capture their institution specific information. These answers were added to the study findings. Results: Of 555 surveys sent, 46 were completed. Reported annual compounding budgets ranged from $3,000 and $96,000. Reported annual equipment maintenance costs ranged from $400 and $18,000. Fifty percent of respondents reported students shared equipment, and 29.6% collected a lab fee from students to offset costs. Approximately half of respondents reported use of cost-saving measures, including contract pricing, purchasing supplies in bulk, price comparisons, use of simulated drugs, re-use of personal protective equipment, and procurement of donations. Fifty percent of respondents employed laboratory assistants to support nonsterile compounding sessions, with paid positions ranging from $200-$1,000 per semester. Conclusion: Findings from this study may assist pharmacy administrators and course directors in evaluating the costs associated with nonsterile compounding education across the Academy and, more importantly, determining ways to reduce such costs while maintaining the intent and quality of these courses.
SIGNIFICANCE This pilot randomized trial, the first to evaluate a specific base-in relieving prism treatment strategy for childhood intermittent exotropia, did not support proceeding to a full-scale clinical trial. Defining and measuring prism adaptation in children with intermittent exotropia are challenging and need further study. PURPOSE This study aimed to determine whether to proceed to a full-scale trial of relieving base-in prism spectacles versus refractive correction alone for children with intermittent exotropia. METHODS Children 3 years old to those younger than 13 years with distance intermittent exotropia control score of ≥2 points on the Intermittent Exotropia Office Control Scale (Strabismus 2006;14:147–150; 0 [phoria] to 5 [constant]), ≥1 episode of spontaneous exotropia, and 16 to 35∆ by prism-and-alternate-cover test, who did not fully prism adapt on a 30-minute in-office prism-adaptation test were randomized to base-in relieving prism (40% of the larger of distance and near exodeviations) or nonprism spectacles for 8 weeks. A priori criteria to conduct a full-scale trial were defined for the adjusted treatment group difference in mean distance control: “proceed” (≥0.75 points favoring prism), “uncertain” (>0 to <0.75 points favoring prism), or “do not proceed” (≥0 points favoring nonprism). RESULTS Fifty-seven children (mean age, 6.6 ± 2.2 years; mean baseline distance control, 3.5 points) received prism (n = 28) or nonprism (n = 29) spectacles. At 8 weeks, mean control values were 3.6 and 3.3 points in prism (n = 25) and nonprism (n = 25) groups, respectively, with an adjusted difference of 0.3 points (95% confidence interval, −0.5 to 1.1 points) favoring nonprism (meeting our a priori “do not proceed” criterion). CONCLUSIONS Base-in prism spectacles, equal to 40% of the larger of the exodeviations at distance or near, worn for 8 weeks by 3- to 12-year-old children with intermittent exotropia did not yield better distance control than refractive correction alone, with the confidence interval indicating that a favorable effect of 0.75 points or larger is unlikely. There was insufficient evidence to warrant a full-scale randomized trial.
Importance: Lensectomy with primary intraocular lens (IOL) implantation is often used in the management of nontraumatic pediatric cataract, but long-term data evaluating the association of age and IOL location with the incidence of complications are limited. Objective: To describe the incidence of complications and additional eye surgeries through 5 years following pediatric lensectomy with primary IOL implantation and association with age at surgery and IOL location. Design, setting, and participants: This prospective cohort study used Pediatric Eye Disease Investigator Group cataract registry data from 61 institution- and community-based practices over 3 years (June 2012 to July 2015). Participants were children younger than 13 years without baseline glaucoma who had primary IOL implantation (345 bilateral and 264 unilateral) for nontraumatic cataract. Data analysis was performed between September 2021 and January 2023. Exposures: Lensectomy with primary IOL implantation. Main outcome and measures: Five-year cumulative incidence of complications by age at surgery (<2 years, 2 to <4 years, 4 to <7 years, and 7 to <13 years) and by IOL location (sulcus vs capsular bag) were estimated using Cox proportional hazards models. Results: The cohort included 609 eyes from 491 children (mean [SD] age, 5.6 [3.3] years; 261 [53%] male and 230 [47%] female). Following cataract extraction with primary IOL implantation, a frequent complication was surgery for visual axis opacification (VAO) (cumulative incidence, 32%; 95% CI, 27%-36%). Cumulative incidence was lower with anterior vitrectomy at the time of IOL placement (12%; 95% CI, 8%-16%) vs without (58%; 95% CI, 50%-65%), and the risk of undergoing surgery for VAO was associated with not performing anterior vitrectomy (hazard ratio [HR], 6.19; 95% CI, 3.70-10.34; P < .001). After adjusting for anterior vitrectomy at lens surgery, there were no differences in incidence of surgery for VAO by age at surgery (<2 years, HR, 1.35 [95% CI, 0.63-2.87], 2 to <4 years, HR, 0.86 [95% CI, 0.44-1.68], 4 to <7 years, HR, 1.06 [95% CI, 0.72-1.56]; P = .74) or by capsular bag vs sulcus IOL fixation (HR, 1.22; 95% CI, 0.36-4.17; P = .75). Cumulative incidence of glaucoma plus glaucoma suspect by 5 years was 7% (95% CI, 4%-9%), which did not differ by age after controlling for IOL location and laterality. Conclusions and relevance: In this cohort study, a frequent complication following pediatric lensectomy with primary IOL was surgery for VAO, which was associated with primary anterior vitrectomy not being performed but was not associated with age at surgery or IOL location. The risk of glaucoma development across all ages at surgery suggests a need for long-term monitoring.
We evaluated the effect of part-time patching versus observation on distance exodeviation control in post hoc analyses of 3- to <11-year-olds with intermittent exotropia who were assigned to either patching 3 hours/day or observation in a previously reported randomized clinical trial. The present analysis was limited to a subgroup of 306 participants who at distance fixation spontaneously manifested either a constant or intermittent exotropia or had prolonged recovery after monocular occlusion (a distance control score of 2 or worse using the 0-5 Office Control Score scale) at baseline. We assessed change in control at distance and near fixation, from baseline to 3 months and baseline to 6 months (1 month after discontinuing patching). We found greater improvement in the distance control score with patching than with observation at 3 months (mean difference, 0.4 points; 95% CI, 0.1-0.7) and 6 months (mean difference, 0.3 points; 95% CI, 0.02-0.6). These analyses suggest that part-time patching may improve distance control in children with intermittent exotropia and a control score ≥ 2; however, because this conclusion is based on post hoc subgroup analyses, further studies are needed.
Objective: To determine economic considerations associated with the facilitation of sterile compounding education for students in schools and colleges of pharmacy across the United States. Methods: An online survey was sent to members of the American Association of Colleges of Pharmacy Pharmaceutics Section and Laboratory Instructor's Special Interest Group. Quantitative and qualitative data were collected on general information about the institution, student cohorts, compounding courses, types of compounds prepared, equipment, budgets, personnel, and cost-saving measures. Descriptive statistics were calculated using SPSS. Open-ended responses were used by respondents if the primary question could not adequately capture their institution-specific information. These answers were added to the study findings. Results: Of 555 surveys sent, 40 were completed. Reported annual sterile compounding budgets ranged from $500 to $95,500. Twenty-two percent of respondents reported collecting a lab fee from students to offset associated costs. Seventy percent of respondents specified cost-saving measures, including the use of expired drugs, reusing supplies or personal protective equipment, price comparisons, simulated drugs, and donations. Conclusion: Findings from this study may assist pharmacy administrators and faculty in evaluating the costs associated with sterile compounding education and determining ways to reduce costs while maintaining the intent and quality of these courses.
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.
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108 members
Jozef Stec
  • Department of Pharmaceutical Sciences
Corina Van de Pol
  • Southern California College of Optometry
Arjun Dutta
  • Department of Pharmacy
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