Randomized Trial to Evaluate the Efficacy of the Nanodropper Device for Pupillary Dilation and Cycloplegia in Children.

PURPOSE: We evaluated the noninferiority of 10.4 µl of eye drops eluted with a commercially available eye drop adapter, the Nanodropper (Nanodropper, Inc), on pupillary dilation and cycloplegia in children compared with the standard of care (SOC), 50 µl of eye drops. DESIGN: Prospective randomized trial. PARTICIPANTS: Pediatric patients scheduled for routine pupillary dilation at the University of California, San Francisco, at the Pediatric Ophthalmology Clinic were enrolled. Each participant provided 1 eye for the intervention group (Nanodropper) and 1 eye for the control group (SOC). METHODS: Participants were randomized to receive small-volume dilating drops in 1 eye (Nanodropper) and SOC dilating drops in the other eye. Dilation was performed using 1 drop each of 1% cyclopentolate, 1% tropicamide, and 2.5% phenylephrine. Refraction and pupillometry were obtained before and 30 minutes after dilation. A noninferiority analysis was performed to assess change from before to after dilation in spherical equivalent and in pupil constriction percentage and maximum pupil diameter after dilation. MAIN OUTCOME MEASURES: Spherical equivalent, maximum pupil diameter, and pupil constriction percentage. RESULTS: One hundred eyes of 50 patients were included, with a mean ± standard deviation age of 9 ± 3 years. After controlling for baseline measurements, the spherical equivalent after dilation was 0.05 diopter (D) more (95% confidence interval [CI], -0.28 to 0.37 D) in the Nanodropper arm, which did not achieve noninferiority. Maximum pupil diameter after dilation was lower in the Nanodropper group (mean, -0.01 mm; 95% CI, -0.20 to -0.03), which did achieve noninferiority. Constriction percentage after dilation was 0.57 percentage points more (95% CI, -1.38 to 2.51 percentage points) in the Nanodropper group, which did not achieve noninferiority. CONCLUSIONS: Administration of eye drops using a small-volume adapter demonstrated similar efficacy to SOC in a pediatric population. Strict noninferiority was met only for pupillary dilation and not for cycloplegia or constriction percentage; however, the small differences in the effect of the Nanodropper versus SOC on all primary outcomes were not clinically significant. We conclude that small-volume eye drops have the potential to decrease unnecessary medical waste and medication toxicity while maintaining therapeutic effect. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Structural and refractive outcomes of intravitreal ranibizumab followed by laser photocoagulation for type 1 retinopathy of prematurity.

PURPOSE: To evaluate refractive and structural outcomes for patients treated for retinopathy of prematurity (ROP) with the anti-vascular endothelial growth factor (anti-VEGF) agent ranibizumab and "delayed laser," defined as any laser photocoagulation treatment administered at least 2 weeks and <1 year after the initial anti-VEGF injection. METHODS: The medical records of infants with type 1 ROP treated between 2015 and 2020 with intravitreal 0.25 mg ranibizumab followed by delayed laser photocoagulation, with a minimum of 6 months' follow-up, were reviewed retrospectively. Refractive and structural outcomes were extracted from the record. RESULTS: A total of 68 eyes of 34 neonates were included, with median gestational age of 24 weeks and birthweight of 657 g. Patients were aged 0.9 to 4.4 years at last follow-up; mean follow-up interval was 2.7 ± 1.02 years. There was no progression to stage 4 or 5 following treatment during the study period. At 2 years' follow-up (mean age, 2.41 ± 0.23 years), median spherical equivalent (SE) was -0.13 D (IQR, 4.20 D). At most recent examination (mean age, 2.70 ± 1.02 years), the most common ocular findings included strabismus (32%), optic atrophy (24%), amblyopia (21%), high myopia (7%), and nystagmus (4%). CONCLUSIONS: In our small cohort, neonates with type 1 ROP treated with intravitreal ranibizumab and delayed laser demonstrated good structural outcomes, with no progression to retinal detachment. We found lower rates of high myopia compared with previous reports of laser photocoagulation monotherapy.

Parental Keratoconus Literacy: A Socioeconomic Perspective.

Purpose: To assess the impact of parental socioeconomic status and keratoconus literacy on pediatric eye rubbing and keratoconus severity. Methods: In this mixed-methods study, pediatric keratoconus patients (age ≤ 18 years) were retrospectively identified. Sociodemographic and clinical characteristics were extracted from the electronic medical record (EMR). Telephone surveys were subsequently conducted to assess parental keratoconus literacy, receipt of counseling on keratoconus prevention, eye rubbing, and household socioeconomic factors not available in the EMR. Parents reporting poor keratoconus literacy were probed via semi-structured interview to explore barriers to their understanding. Results: Forty-eight patients met inclusion criteria, 22 (46%) of whom were reached by telephone. Most patients were insured by Medicaid (73%) and current eye rubbers (82%). Few parents reported good or excellent keratoconus literacy now (32%) or at the time of diagnosis (18%). Parents with a high-school education, limited English proficiency, lower income level, and Medicaid insurance tended to have lower keratoconus literacy, though this was not statistically significant. Parental keratoconus literacy was not correlated with disease severity. High-school education, limited English proficiency, lower income level, and Medicaid insurance were correlated with steeper keratometry readings, which was statistically significant for high-school education. In-depth interviews revealed parents felt unconfident with eye health in general and perceived a personal responsibility for learning more. Conclusion: This is the first study exploring keratoconus literacy from a socioeconomic perspective, demonstrating lower literacy among socioeconomically marginalized parents and a tendency toward more severe disease in their children.

Insurance Status and Biological and Psychosocial Determinants of Cardiometabolic Risk Among Mexican-Origin U.S. Hispanic/Latino Adults with Type 2 Diabetes.

Purpose: Hispanics/Latinos in the United States bear higher burden of type 2 diabetes (T2D) and associated complications compared with the general population. Health insurance coverage is also lower in this population. We examined the association of health insurance with biological and psychosocial determinants of cardiometabolic risk among U.S. Mexican-origin Hispanic/Latino adults with T2D. Methods: Participants were self-reported Hispanic/Latino adults with T2D diagnosis. Trained bilingual community health workers collected cross-sectional information on biological and psychosocial factors using clinical examinations, laboratory tests, validated questionnaires, and wearable activity monitors. Results: One hundred and seven Hispanic/Latino adults (54±12 years, 65% female, 36% prescribed insulin, 60% uninsured) with T2D were enrolled. While 93% had low language-based acculturation, 88% had high health literacy in Spanish. Forty percent were food insecure and 47% expressed at least one social need. Overall, 35% had an HbA1c <7.0% (indicating good control) and 31% had an HbA1c >9.0%. Sixty-three percent had blood pressure within target (<130/80 mmHg), and overall participants were moderately physically active. However, 53% were obese (body mass index ≥30 kg/m2) and 76% had a waist measurement defined as high risk (>88 cm for women and >102 cm for men). Participants without health insurance were younger (51.9±10.4 vs. 58.8±10.5 years mean±standard deviation, p=0.0008) but had higher HbA1c (8.4±2.2% vs. 7.6±1.6, p=0.031) and fasting glucose (184.9±86.5 vs. 148.6±61.2 mg/dl, p=0.008) levels. Conclusions: Health insurance status appears to influence achieved glycemic control for U.S. Hispanic/Latino adults with T2D. However, various psychosocial factors potentially influencing cardiometabolic risk independently of health insurance status may also be implicated in the inequitable burden of T2D. ClinicalTrials.gov Identifier: NCT03736486.

Self-reported and objectively measured physical activity levels among Hispanic/Latino adults with type 2 diabetes.

OBJECTIVE: In the USA, minority populations face a disproportionate burden from type 2 diabetes (T2D), in whom physical activity (PA) is recommended. The aim of this study was to determine levels of PA among a community of free-living Hispanic/Latino adults with T2D using a research accelerometer, a consumer device and a pictogram self-assessment questionnaire. RESEARCH DESIGN AND METHODS: This was a cross-sectional, observational study. Participants (57 women and 31 men, body mass index (kg/m2) 32.2±7.9 and 29.9±4.5, waist circumference 97.1±30.1 and 93.7±33.0 cm and hemoglobin A1c 8.0±2.0 and 8.1%±1.8%, respectively) wore an ActiGraph (AG) on the hip and a Fitbit (FB) on the wrist for 1 week to estimate daily steps and energy expenditure (EE). Participants reported type and intensity of PA using English-language or Spanish-language pictograms and a 10-point Likert scale (1='not active' to 10='very, very active'). RESULTS: Steps per day were not normally distributed; AG median steps/weekday (Monday-Friday) was 6990 (range 1091-25 884) compared with 9329 (288-31 669) using FB (p≤0.01). Both devices recorded significantly more steps on weekdays versus weekends (p≤0.05). EE was also higher during the week. AG and FB were highly correlated to each other (p<0.01). Men were more active than women and maintained their PA throughout the week, whereas women decreased theirs on weekends. Spanish-language pictograms were preferred and self-reported PA matched objective assessments by both devices. Participants perceived themselves to be active (7.1±2.0) due to work. CONCLUSIONS: Both objectively measured and self-reported levels of PA in Hispanic/Latino adults with T2D challenge the assumption that lack of PA may be commonplace for this group. AG and FB are different in their measurement of PA but are significantly correlated. New strategies, including use of pictograms, for interventions need to be considered if further increases or changes in PA are to be used as T2D therapy. TRIAL REGISTRATION NUMBER: NCT03736486.