Predicting the onset of myopia in children by age, sex, and ethnicity: Results from the CLEERE Study.

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 (J0), age, sex, and race/ethnicity. Onset of myopia was more likely with lower amounts of hyperopia and less positive/more negative values of J0. 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.

Dioptric differences between clinically determined and metric-optimised refractions for adults with Down syndrome.

PURPOSE: Refractions based on the optimisation of single-value wavefront-derived metrics may help determine appropriate corrections for individuals with Down syndrome where clinical techniques fall short. This study compared dioptric differences between refractions obtained using standard clinical techniques and two metric-optimised methods: visual Strehl ratio (VSX) and pupil fraction tessellated (PFSt), and investigated characteristics that may contribute to the differences between refraction types. METHODS: Thirty adults with Down syndrome (age = 29 ± 10 years) participated. Three refractive corrections (VSX, PFSt and clinical) were determined and converted to vector notation (M, J0 , J45 ) to calculate the dioptric difference between pairings of each type using a mixed model repeated measures approach. Linear correlations and multivariable regression were performed to examine the relationship between dioptric differences and the following participant characteristics: higher order root mean square (RMS) for a 4 mm pupil diameter, spherical equivalent refractive error and Vineland Adaptive Behavior Scales (a measure of developmental ability). RESULTS: The least squares mean estimates (standard error) of the dioptric differences for each pairing were as follows: VSX versus PFSt = 0.51 D (0.11); VSX versus clinical = 1.19 D (0.11) and PFSt versus clinical = 1.04 D (0.11). There was a statistically significant difference in the dioptric differences between the clinical refraction and each of the metric-optimised refractions (p < 0.001). Increased dioptric differences in refraction were correlated with increased higher order RMS (R = 0.64, p < 0.001 [VSX vs. clinical] and R = 0.47, p < 0.001 [PFSt vs. clinical]) as well as increased myopic spherical equivalent refractive error (R = 0.37, p = 0.004 [VSX vs. clinical] and R = 0.51, p < 0.001 [PFSt vs. clinical]). CONCLUSIONS: The observed differences in refraction demonstrate that a significant portion of the refractive uncertainty is related to increased higher order aberrations and myopic refractive error. Methodology surrounding clinical techniques and metric-optimisation based on wavefront aberrometry may explain the difference in refractive endpoints.

Visual Acuity Outcomes in a Randomized Trial of Wavefront Metric-optimized Refractions in Adults with Down Syndrome.

SIGNIFICANCE: This study reports visual acuity outcomes from a clinical trial investigating an objective refraction strategy that may provide a useful tool for practitioners needing additional strategies to identify refractive corrections for adults with intellectual disability. PURPOSE: Determining refractions for individuals with Down syndrome is challenging because of the presence of elevated refractive error, optical aberrations, and cognitive impairment. This randomized clinical trial evaluated the performance of spectacle corrections determined using clinical techniques and objective refractions derived from wavefront aberration measures. METHODS: Thirty adults with Down syndrome had a clinical refraction determined by a single expert examiner using pre-dilation and post-dilation techniques appropriate for this population. Objective refractions were determined from dilated wavefront aberration measures that were processed post-visit to identify refractions that optimized each of two image quality metrics: pupil fraction tessellated and visual Strehl ratio in the spatial domain. The three refractions were dispensed in random order and worn for 2 months each. The primary outcome measure, binocular visual acuity, was obtained by a masked examiner administering a distance logMAR acuity test. To compare treatment types, mean acuity was compared using a two-sided type 3 F test of the treatment effect in a linear mixed-effects regression model, where the final model included fixed effects for treatment, period (1, 2, or 3), and first-order carryover effects. RESULTS: The 2-month estimated least square means in binocular visual acuity (logMAR) were 0.34 (95% confidence interval [CI], 0.25 to 0.39) for clinical refractions, 0.31 (95% CI, 0.25 to 0.36) for pupil fraction tesselated refractions, and 0.33 (95% CI, 0.27 to 0.38) for visual Strehl ratio refractions. No statistically significant treatment effect was observed (F = 1.10, P = .34). CONCLUSIONS: Objective refractions derived from dilated wavefront aberration measures resulted in acuity similar to expert clinician-derived refractions, suggesting that the objective method may be a suitable alternative for patients with Down syndrome.

A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 4 to 6 Years.

SIGNIFICANCE: Binocular treatment for unilateral amblyopia is an emerging treatment that requires evaluation through a randomized clinical trial. PURPOSE: This study aimed to compare change in amblyopic-eye visual acuity (VA) in children aged 4 to 6 years treated with the dichoptic binocular iPad (Apple, Cupertino, CA) game, Dig Rush (not yet commercially available; Ubisoft, Montreal, Canada), plus continued spectacle correction versus continued spectacle correction alone. METHODS: Children (mean age, 5.7 years) were randomly assigned to home treatment for 8 weeks with the iPad game (prescribed 1 h/d, 5 d/wk [n = 92], or continued spectacle correction alone [n = 90]) in a multicenter randomized clinical trial. Before enrollment, children wearing spectacles were required to have at least 16 weeks of wear or no improvement in amblyopic-eye VA (<0.1 logMAR) for at least 8 weeks. Outcome was change in amblyopic-eye VA from baseline to 4 weeks (primary) and 8 weeks (secondary) assessed by masked examiner. RESULTS: A total of 182 children with anisometropic (63%), strabismic (16%; <5∆ near, simultaneous prism and cover test), or combined-mechanism (20%) amblyopia (20/40 to 20/200; mean, 20/63) were enrolled. After 4 weeks, mean amblyopic VA improved by 1.1 logMAR lines with binocular treatment and 0.6 logMAR lines with spectacles alone (adjusted difference, 0.5 lines; 95.1% confidence interval [CI], 0.1 to 0.9). After 8 weeks, results (binocular treatment: mean amblyopic-eye VA improvement, 1.3 vs. 1.0 logMAR lines with spectacles alone; adjusted difference, 0.3 lines; 98.4% CI, -0.2 to 0.8 lines) were inconclusive because the CI included both zero and the pre-defined difference in mean VA change of 0.75 logMAR lines. CONCLUSIONS: In 4- to 6-year-old children with amblyopia, binocular Dig Rush treatment resulted in greater improvement in amblyopic-eye VA for 4 weeks but not 8 weeks. Future work is required to determine if modifications to the contrast increment algorithm or other aspects of the game or its implementation could enhance the treatment effect.

Ciliary muscle thickness in adults with Down syndrome.

PURPOSE: The relationship between ciliary muscle thickness (CMT), age and refractive error was investigated to determine if CMT, like other anterior ocular anatomy, differs in adults with Down syndrome (DS). METHODS: The CMT of 33 adults with DS was imaged using anterior segment optical coherence tomography. Images from the right eye obtained 45 minutes after cycloplegia (1% tropicamide, 2.5% phenylephrine) were analysed to calculate thickness at 1, 2 and 3 mm posterior to the scleral spur (CMT1, CMT2, CMT3), maximum thickness (CMTMAX) and apical thickness (AT = CMT1 - CMT2). Spherical equivalent refractive error was determined by clinical refraction using both non-dilated and dilated measures. Multivariate regression analysis evaluated the relationship between CMT and refractive error while controlling for subject age. RESULTS: Images were analysed from 26 subjects (mean age (SD) 29 years; mean refractive error (SD): -0.90 (5.03) D, range: -15.75 to +5.13D). Mean (SD) CMT decreased with posterior position (CMT1: 804 (83) µm; CMT2: 543 (131) µm; CMT3: 312 (100) µm). Mean (SD) CMTMAX and AT was 869 (57) µm and 260 (84) µm, respectively. There was a significant linear correlation indicating thinning CMT with increasing age for CMT1 and CMT2 (p ≤0.05). CMT2 and CMT3 had a significant negative correlation (thicker muscle with increasing myopic refractive error) (p ≤0.01). AT had a significant positive correlation (thicker muscle with increasing hyperopic refractive error) (p <0.01). CONCLUSIONS: Ciliary muscle thickness in participants with DS was found to be in a similar range with similar refractive error trends to previous reports of individuals without DS. However, it is important to note that the refractive error trends were driven by individuals with moderate to high levels of myopia.

A Randomized Trial of Objective Spectacle Prescriptions for Adults with Down Syndrome: Baseline Data and Methods.

SIGNIFICANCE: It is difficult to determine the most efficacious refractive correction for individuals with Down syndrome using routine clinical techniques. New objective methods that optimize spectacle corrections for this population may reduce limitations on daily living by improving visual quality. PURPOSE: This article describes the methods and baseline characteristics of study participants in a National Eye Institute-sponsored clinical trial to evaluate objectively derived spectacle corrections in adults with Down syndrome. Intersession repeatability of the primary outcome measure (distance visual acuity) is also reported. METHODS: Adults with Down syndrome were enrolled into a nine-visit study to compare clinically derived spectacle corrections and two different objective spectacle corrections derived from wavefront aberration data. Spectacle corrections were randomized and dispensed for 2 months each. Distance visual acuity was measured with a Bailey-Lovie-style chart. Intersession repeatability of acuity was established by performing difference versus mean analysis from binocular acuity measures obtained through habitual corrections at visits 1 and 2. RESULTS: Thirty adults (mean ± standard deviation age, 29 ± 10 years) with a large range of refractive errors were enrolled. Presenting visual acuity at visit 1 was reduced (right eye, 0.47 ± 0.20 logMAR; left eye, 0.42 ± 0.17 logMAR). The mean difference between visits 1 and 2 was 0.02 ± 0.06 logMAR, with a coefficient of repeatability (1.96 × within-subject standard deviation) of 0.12 logMAR. CONCLUSIONS: This study seeks to investigate new strategies to determine optical corrections that may reduce commonly observed visual deficits in individuals with Down syndrome. The good intersession repeatability of acuity found in this study (six letters) indicates that, despite the presence of reduced acuity, adults with Down syndrome performed the outcome measure for this clinical trial reliably.

Uncorrected Refractive Error and Distance Visual Acuity in Children Aged 6 to 14 Years.

SIGNIFICANCE: This study presents the relationship between distance visual acuity and a range of uncorrected refractive errors, a complex association that is fundamental to clinical eye care and the identification of children needing refractive correction. PURPOSE: This study aimed to analyze data from the Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error Study to describe the relationship between distance uncorrected refractive error and visual acuity in children. METHODS: Subjects were 2212 children (51.2% female) 6 to 14 years of age (mean ± standard deviation, 10.2 ± 2.1 years) participating in the Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error Study between 2000 and 2010. Uncorrected distance visual acuity was measured using a high-contrast projected logMAR chart. Cycloplegic refractive error was measured using the Grand Seiko WR-5100K autorefractor. The ability of logMAR acuity to detect various categories of refractive error was examined using receiver operating characteristic curves. RESULTS: Isoacuity curves show that increasing myopic spherical refractive errors, increasing astigmatic refractive errors, or a combination of both reduces distance visual acuity. Visual acuity was reduced by approximately 0.5 minutes of MAR per 0.30 to 0.40 D of spherical refractive error and by approximately 0.5 minutes of MAR per 0.60 to 0.90 D of astigmatism. Higher uncorrected hyperopic refractive error had little effect on distance visual acuity. Receiver operating characteristic curve analysis suggests that a logMAR distance acuity of 0.20 to 0.32 provides the best balance between sensitivity and specificity for detecting refractive errors other than hyperopia. Distance acuity alone was ineffective for detecting hyperopic refractive errors. CONCLUSIONS: Higher myopic and/or astigmatic refractive errors were associated with predictable reductions in uncorrected distance visual acuity. The reduction in acuity per diopter of cylindrical error was about half that for spherical myopic error. Although distance acuity may be a useful adjunct to the detection of myopic spherocylindrical refractive errors, accommodation presumably prevents acuity from assisting in the detection of hyperopia. Alternate procedures need to be used to detect hyperopia.

A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years.

PURPOSE: To compare visual acuity (VA) improvement in children aged 7 to 12 years with amblyopia treated with a binocular iPad game plus continued spectacle correction vs. continued spectacle correction alone. DESIGN: Multicenter randomized clinical trial. PARTICIPANTS: One hundred thirty-eight participants aged 7 to 12 years with amblyopia (33-72 letters, i.e., approximately 20/200 to 20/40) resulting from strabismus, anisometropia, or both. Participants were required to have at least 16 weeks of optical treatment in spectacles if needed or demonstrate no improvement in amblyopic-eye visual acuity (VA) for at least 8 weeks prior to enrollment. METHODS: Eligible participants (mean age 9.6 years, mean baseline VA of 59.6 letters, history of prior amblyopia treatment other than spectacles in 96%) were randomly assigned to treatment for 8 weeks with the dichoptic binocular Dig Rush iPad game (prescribed for 1 hour per day 5 days per week) plus spectacle wear if needed (n = 69) or continued spectacle correction alone if needed (n = 69). MAIN OUTCOME MEASURES: Change in amblyopic-eye VA from baseline to 4 weeks, assessed by a masked examiner. RESULTS: At 4 weeks, mean amblyopic-eye VA letter score improved from baseline by 1.3 (2-sided 95% confidence interval [CI]: 0.1-2.6; 0.026 logMAR) with binocular treatment and by 1.7 (2-sided 95% CI: 0.4-3.0; 0.034 logMAR) with continued spectacle correction alone. After adjusment for baseline VA, the letter score difference between groups (binocular minus control) was -0.3 (95% CI: -2.2 to 1.5, P = 0.71, difference of -0.006 logMAR). No difference in letter scores was observed between groups when the analysis was repeated after 8 weeks of treatment (adjusted mean: -0.1, 98.3% CI: -2.4 to 2.1). For the binocular group, adherence data from the iPad indicated that slightly more than half of the participants (58% and 56%) completed >75% of prescribed treatment by the 4- and 8-week visits, respectively. CONCLUSIONS: In children aged 7 to 12 years who have received previous treatment for amblyopia other than spectacles, there was no benefit to VA or stereoacuity from 4 or 8 weeks of treatment with the dichoptic binocular Dig Rush iPad game.

A Randomized Clinical Trial of Immediate versus Delayed Glasses for Moderate Hyperopia in 1- and 2-Year-Olds.

PURPOSE: Two strategies were compared for managing moderate hyperopia without manifest strabismus among 1- and 2-year-old children: (1) immediate prescription of glasses versus (2) observation without glasses unless reduced distance visual acuity (VA), reduced stereoacuity, or manifest strabismus. DESIGN: Prospective randomized clinical trial. PARTICIPANTS: A total of 130 children aged 1 to 2 years with hyperopia between +3.00 diopters (D) and +6.00 D spherical equivalent (SE) in at least 1 eye, anisometropia ≤1.50 D SE, and astigmatism ≤1.50 D based on cycloplegic refraction and no manifest strabismus. METHODS: Participants were randomly assigned to glasses (1.00 D less than full cycloplegic hyperopia) versus observation and followed every 6 months for 3 years. Glasses were prescribed to those assigned to observation if they met prespecified deterioration criteria of distance VA or near stereoacuity below age norms, or development of manifest strabismus. MAIN OUTCOME MEASURES: At the 3-year primary outcome examination, participants were classified as failing the randomized management regimen if distance VA or stereoacuity was below age norms or manifest strabismus was observed (each with and without correction in trial frames, confirmed by masked retest, irrespective of whether deterioration had occurred previously), or if strabismus surgery had been performed. RESULTS: Of the 106 participants (82%) completing the 3-year primary outcome examination, failure occurred in 11 (21%) of 53 in the glasses group and 18 (34%) of 53 in the observation group (difference = -13%; 95% confidence interval [CI], -31 to 4; P = 0.14). Sixty-two percent (95% CI, 49-74) in the observation group and 34% (95% CI, 23-48) in the glasses group met deterioration criteria (requiring glasses if not wearing). CONCLUSIONS: For 1- and 2-year-olds with uncorrected moderate hyperopia (+3.00 D to +6.00 D SE), our estimates of failure, after 3 years of 6-month follow-ups, are inconclusive and consistent with a small to moderate benefit or no benefit of immediate prescription of glasses compared with careful observation (with glasses only if deteriorated).

Impact of Cognitive Demand during Sustained Near Tasks in Children and Adults.

SIGNIFICANCE: These results demonstrate that accommodation in children is more accurate and less variable when performing a sustained near task with increased cognitive demand. In addition, children with increased uncorrected hyperopia have less stable accommodative responses, which may have visual implications during sustained near tasks. PURPOSE: This study investigated accommodative accuracy (lag) and variability during sustained viewing for passive and active tasks in children and adults with emmetropia and uncorrected hyperopia. METHODS: Lag and variability (root mean square [RMS] and low-frequency component) were measured in 54 children aged 3 to younger than 10 years with mean spherical equivalent of +1.31 ± 1.05 diopters (D) (range, -0.37 to +4.58 D) and 8 adults aged 22 to 32 years with mean spherical equivalent +0.65 ± 0.62 D (range, -0.13 to +1.15 D). Subjects viewed 20/50 stimuli at 33 cm during both a 10-minute passive and active task. Group 1 (<6 years or nonreaders) viewed shapes; group 2 (≥6 years and reading) and adults read passages. RESULTS: Groups 1 and 2 had larger lags, RMS, and low-frequency component for passive versus active tasks (P < .001). Lag and RMS did not differ between tasks in adults (P > .05), but low-frequency component was larger during passive viewing (P = .04). Group 1 had significantly higher RMS and low-frequency component than group 2 and the adults in the passive condition had greater low-frequency component in the active condition. In children, hyperopia was independently associated with RMS and low-frequency component under passive (RMS 95% confidence interval [CI], 0.04 to 0.15; low-frequency component 95% CI, 0.00011 to 0.00065) and active (RMS 95% CI, 0.001 to 0.06; 95% CI, 0.000014 to 0.00023) viewing. CONCLUSIONS: Accommodation is more accurate and less variable when children are engaged in the task. Children also have more variable accommodation than adults. In addition, children with greater hyperopia have more variable accommodation during sustained near tasks.

Blur Detection, Depth of Field, and Accommodation in Emmetropic and Hyperopic Children.

SIGNIFICANCE: Our results demonstrate that blur detection thresholds are elevated in young children compared with adults, and poorer blur detection thresholds are significantly correlated with the magnitude of accommodative microfluctuations. Given that accommodative microfluctuations are greater with greater accommodative responses, these findings may have implications for young uncorrected hyperopes. PURPOSE: This study investigated the association between subjective blur detection thresholds and accommodative microfluctuations in children 3 years to younger than 10 years old and adults. METHODS: Blur detection thresholds were determined in 49 children with habitually uncorrected refractive error (+0.06 to +4.91 diopters [D] spherical equivalent) and 10 habitually uncorrected adults (+0.08 to +1.51 D spherical equivalent) using a custom blur chart with 1° sized optotypes at 33 cm. Letters were blurred by convolution using a Gaussian kernel (SDs of 0.71 to 11.31 arc minutes in √2 steps). Subjective depth of field was determined in subjects 6 years or older and adults. Accommodative microfluctuations, pupils, and lag were measured using infrared photorefraction (25 Hz). RESULTS: Children had greater blur detection thresholds (P < .001), accommodative microfluctuations (P = .001), and depth of field (P < .001) than adults. In children, increased blur detection thresholds were associated with increased accommodative microfluctuations (P < .001), increased uncorrected hyperopia (P = .01), decreased age (P < .001), and decreased pupil size (P = .01). In a multiple linear regression analysis, blur detection thresholds were associated with accommodative microfluctuations (P < .001) and age (P < .001). Increased accommodative microfluctuations were associated with increased uncorrected hyperopia (P = .004) and decreased pupil size (P = .003) and independently associated with uncorrected hyperopia (P = .001) and pupil size (P = .003) when controlling for age and lag. CONCLUSIONS: Children did not have adult-like blur detection thresholds or depth of field. Increased accommodative microfluctuations and decreased age were independently associated with greater blur detection thresholds in children 3 years to younger than 10 years. Larger amounts of uncorrected hyperopia in children appear to increase blur detection thresholds because the greater accommodative demand and resulting response increase accommodative microfluctuations.

Internal Astigmatism in Myopes and Non-myopes: Compensation or Constant?

PURPOSE: To examine internal astigmatism (IA) in myopes and non-myopes using a new method to assess compensation of corneal astigmatism (CA) by IA, to look for predictors of high IA in young adult myopes, and to determine if as CA changes IA changes to reduce refractive astigmatism (RA) in an active compensatory process in myopes. METHODS: Right eye keratometry and cycloplegic autorefraction were measured annually over 14 years in 367 myopes and once in 204 non-myopes age- (mean 21.91 ± 1.47 years), gender-, and ethnicity-matched to myopes at year 12. CA and RA at the corneal plane were expressed as J0, J45. IA = RA - CA. Inverse power transformation provided cylinder power and axis of IA for the compensation factor (IA/CA). Analyses included (1) paired and unpaired t-tests (refractive data), (2) chi-square tests (distributions of compensation factor), (3) logistic regression analysis (predictors of high IA), and (4) linear mixed models (time effect on RA, CA, and IA). RESULTS: The magnitude of IAJ0 varied by refractive error (myopes -0.25 ± 0.24 vs. non-myopes -0.32 ± 0.21, p < 0.001). Compensation of CA by IA was poorer in myopes than non-myopes (χ p < 0.001). When matched by CA, compensation remained poorer in myopes than non-myopes (χ all p ≤ 0.04). Within each refractive group, compensation was better when CA was low than high (χ p < 0.001). When CA was low in myopes, high IA (≥1.00D) was less likely (p = 0.01). Longitudinal follow-up of myopes found no evidence for an active compensatory role for IA as CA increased over time. There were differences in IAJ0 by ethnicity over time (p < 0.0001). CONCLUSIONS: In myopic and non-myopic eyes with low amounts of CA, IA may reduce CA's contribution to RA, but IA is not a constant. However, there is no evidence for an active compensatory role for IA reducing CA in myopes.

Myopia, contact lens use and self-esteem.

PURPOSE: To evaluate whether contact lens (CL) use was associated with self-esteem in myopic children originally enrolled in the Correction of Myopia Evaluation Trial (COMET), that after 5 years continued as an observational study of myopia progression with CL use permitted. METHODS: Usable data at the 6-year visit, one year after CL use was allowed (n = 423/469, age 12-17 years), included questions on CL use, refractive error measurements and self-reported self-esteem in several areas (scholastic/athletic competence, physical appearance, social acceptance, behavioural conduct and global self-worth). Self-esteem, scored from 1 (low) to 4 (high), was measured by the Self-Perception Profile for Children in participants under 14 years or the Self-Perception Profile for Adolescents, in those 14 years and older. Multiple regression analyses were used to evaluate associations between self-esteem and relevant factors identified by univariate analyses (e.g., CL use, gender, ethnicity), while adjusting for baseline self-esteem prior to CL use. RESULTS: Mean (±S.D.) self-esteem scores at the 6-year visit (mean age = 15.3 ± 1.3 years; mean refractive error = -4.6 ± 1.5 D) ranged from 2.74 (± 0.76) on athletic competence to 3.33 (± 0.53) on global self-worth. CL wearers (n = 224) compared to eyeglass wearers (n = 199) were more likely to be female (p < 0.0001). Those who chose to wear CLs had higher social acceptance, athletic competence and behavioural conduct scores (p < 0.05) at baseline compared to eyeglass users. CL users continued to report higher social acceptance scores at the 6-year visit (p = 0.03), after adjusting for baseline scores and other covariates. Ethnicity was also independently associated with social acceptance in the multivariable analyses (p = 0.011); African-Americans had higher scores than Asians, Whites and Hispanics. Age and refractive error were not associated with self-esteem or CL use. CONCLUSIONS: COMET participants who chose to wear CLs after 5 years of eyeglass use had higher self-esteem compared to those who remained in glasses both preceding and following CL use. This suggests that self-esteem may influence the decision to wear CLs and that CLs in turn are associated with higher self-esteem in individuals most likely to wear them.

Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control: A Randomized Clinical Trial.

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 and 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.

Intraocular pressure and central corneal thickness in the COMET cohort.

PURPOSE: To describe intraocular pressure (IOP) and central corneal thickness (CCT) in ethnically diverse, myopic young adults enrolled in COMET (the Correction of Myopia Evaluation Trial) and their association with ocular and demographic factors. METHODS: IOP (Goldmann tonometry), CCT (handheld pachymetry), refractive error (cycloplegic autorefraction), and ocular components (A-scan ultrasonography) were measured in 385 of the original 469 subjects (mean age = 20.3 ± 1.3 years). Summary statistics for descriptive analysis, Pearson correlation coefficients, and linear regression models to formally test the association of IOP and CCT with other covariates were used. RESULTS: Mean IOP was 15.1 ± 0.1 mm Hg and differed by ethnicity and CCT but did not vary by gender, magnitude of myopia, or vitreous chamber depth (VCD). Adjusting for CCT, IOP in black participants was 1.8 mm Hg higher than in Hispanics (p = 0.0001) and 0.8 mm Hg higher than in whites (p = 0.03). Mean CCT was 562.4 ± 1.8 µm and differed by ethnicity, VCD, and IOP after adjusting for covariates. Blacks had thinner corneas than Asians, whites, and Hispanics, with adjusted differences of 15.4, 11.8, and 15.3 µm (p = 0.03, < 0.01 and < 0.01), respectively. Eyes with shorter VCD (<17.8 mm) had 8.0-µm thinner CCT (p = 0.03). CCT did not vary by gender or magnitude of myopia. Overall, a modest positive correlation (r = 0.25, P < 0.0001) was found between IOP and CCT, which varied by ethnicity in Asians (r = 0.47; p = 0.008), blacks (r = 0.29; p = 0.002), and whites (r = 0.24; p = 0.002). CONCLUSIONS: Myopic, black young adults had higher IOP and thinner corneas relative to other ethnic groups, suggesting that evaluation of these parameters during routine examination of these individuals should begin at a young age. Their thinner CCT should also be considered in evaluations for refractive surgery.

Predictors of adequate correction following vision screening failure.

PURPOSE: To determine whether compliance with referral 1 year after vision screening failure was associated with care model, demographic, or ocular factors. METHODS: Data were analyzed from 798 children in the Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error Study with habitual logMAR visual acuity (VA) ≥0.26 (20/40 + 2 or worse) in either eye due to uncorrected or undercorrected refractive error and who returned the following year. The parents of 492 children failing in TX and CA were sent letters indicating the need for a complete vision examination (screening model), while 306 children seen primarily in AZ and AL received a free complete examination and eyeglasses if needed (complete care model). Presenting to follow-up with adequate correction (logMAR <0.26) in each eye was considered compliant. Logistic regression models for compliance were fit to assess whether care model, ethnicity, sex, age, uncorrected logMAR in the better eye, or parental income, education, or myopia were predictors. RESULTS: Overall compliance was 28%. Age [p = 0.01, odds ratio (OR) = 1.12] and uncorrected logMAR (p < 0.001, OR = 1.13) were associated with compliance but care model, ethnicity, and sex were not. Among the 447 children for whom data on parental factors were available, 27% were compliant. In this model, age, ethnicity, sex, parental income, parental education, and parental myopia were not associated with compliance, but uncorrected logMAR (p = 0.005; OR = 1.13) was predictive. An interaction between unaided VA and care model predicted improved compliance with poorer unaided VA in the complete care model. CONCLUSIONS: Expensive complete care screening programs may not improve compliance over typical notification and referral screening protocols in school-aged children, unless unaided VA is worse than the common 20/40 referral criteria. Unaided VA had less impact on predicted compliance in the screening-only protocol.

Corneal and crystalline lens dimensions before and after myopia onset.

PURPOSE: To describe corneal and crystalline lens dimensions before, during, and after myopia onset compared with age-matched emmetropic values. METHODS: Subjects were 732 children aged 6 to 14 years who became myopic and 596 emmetropic children participating between 1989 and 2007 in the Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error Study. Refractive error was measured using cycloplegic autorefraction, corneal power using a hand-held autokeratometer, crystalline lens parameters using video-based phakometry, and vitreous chamber depth (VCD) using A-scan ultrasonography. Corneal and crystalline lens parameters in children who became myopic were compared with age-, gender-, and ethnicity-matched model estimates of emmetrope values annually from 5 years before through 5 years after the onset of myopia. The comparison was made without and then with statistical adjustment of emmetrope component values to compensate for the effects of longer VCDs in children who became myopic. RESULTS: Before myopia onset, the crystalline lens thinned, flattened, and lost power at similar rates for emmetropes and children who became myopic. The crystalline lens stopped thinning, flattening, and losing power within ±1 year of onset in children who became myopic compared with emmetropes statistically adjusted to match the longer VCDs of children who became myopic. In contrast, the cornea was only slightly steeper in children who became myopic compared with emmetropes (<0.25 D) and underwent little change across visits. CONCLUSIONS: Myopia onset is characterized by an abrupt loss of compensatory changes in the crystalline lens that continue in emmetropes throughout childhood axial elongation. The mechanism responsible for this decoupling remains speculative but might include restricted equatorial growth from internal mechanical factors.

Ten-year changes in fusional vergence, phoria, and nearpoint of convergence in myopic children.

PURPOSE: To identify longitudinal changes in fusional vergence ranges and their relationship to other clinical measures in young myopic subjects. METHODS: Measurements were collected annually for 10 years on 114 subjects from the University of Houston Correction of Myopia Evaluation Trial cohort. Subject age was 7 to 13 years at year 1 of follow-up. Measurements included refractive error, distance and near phoria, interpupillary distance (IPD), prism bar fusional vergence ranges, and nearpoint of convergence (NPC). Multilevel modeling was used to determine baseline and rate of change for fusional vergence ranges and the impact of phoria, IPD, and NPC on these measures. RESULTS: Year 1 mean distance base-out (BO) break was 20 prism diopters (pd) and decreased 5.6 pd over 10 years (p < 0.001). Mean near BO break was 30 pd at year 1 and decreased 9.4 pd over 10 years (p < 0.001). Greater esophoria was significantly related to greater BO break (p < 0.02) and receded NPC was significantly related to lower magnitude BO break at near (p < 0.001). Distance IPD increased 3 mm over 10 years (p < 0.001) but was unrelated to the magnitude of the BO ranges (p > 0.2). Mean distance base-in (BI) break was 7 pd at year 1 and increased 0.5 pd in 10 years (p = 0.04). Mean near BI break was 13 pd at year 1 and did not significantly change. Mean distance phoria was 0.1 pd exophoria at year 1 and did not change, whereas near phoria was 2.4 pd esophoria at year 1 and became more exophoric (4 pd in 10 years, p < 0.001). CONCLUSIONS: These results suggest that for myopic children convergence ranges decrease for both distance and near viewing during the school years as near phoria becomes more exophoric. These findings could have clinical implications given that compensating convergence ranges decrease as near phoria becomes more divergent.

Intraocular pressure, ethnicity, and refractive error.

PURPOSE: The ethnically diverse Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study cohort provides a unique opportunity to explore associations among intraocular pressure (IOP), ethnicity, and refractive error while adjusting for potential confounding variables. METHODS: Mixed linear models were used to examine the effect of age, refractive error (cycloplegic auto-refraction), ethnicity, sex, and measurement protocol on IOP (Tono-pen) in 3777 children, aged 6 to 14 years at their first CLEERE visit (1995-2009). Children who became myopic during follow-up were used to examine the relationship between time since myopia onset and IOP. Clinically meaningful differences in IOP were preset at >2 mm Hg. RESULTS: IOP differed among refractive error categories with higher IOP in children with low/moderate myopia than those with high hyperopia (differences <1 mm Hg). There was a statistically significant relationship between age and IOP that depended on ethnicity (interaction p < 0.0001) and measurement protocol (interaction p < 0.0001). The relationship between sex and IOP depended on measurement protocol (interaction p = 0.0004). For children who became myopic during follow-up, the adjusted mean IOP showed a significant decline for only Asian (p = 0.024) and white children (p = 0.004). As with other statistically significant results, these changes in mean adjusted IOPs from 2 years before to 2 years after myopia onset were <2 mm Hg. CONCLUSIONS: Small but significant differences in IOP by refractive error category were found in this ethnically diverse cohort of children. Relationships between IOP and age, ethnicity, sex, and measurement protocol were complicated by significant interactions between these parameters. Longitudinal analysis of children before and after myopia onset showed changes in IOP over time that varied by ethnicity. Higher IOPs before and at myopia onset were not present in all ethnic groups, with differences before and after onset too small to suggest a role for IOP in the onset of myopia.

Myopia Progression as a Function of Sex, Age, and Ethnicity.

Purpose: To model juvenile-onset myopia progression as a function of race/ethnicity, age, sex, parental history of myopia, and time spent reading or in outdoor/sports activity. Methods: Subjects were 594 children in the Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study with at least three study visits: one visit with a spherical equivalent (SPHEQ) less myopic/more hyperopic than -0.75 diopter (D), the first visit with a SPHEQ of -0.75 D or more myopia (onset visit), and another after myopia onset. Myopia progression from the time of onset was modeled using cubic models as a function of age, race/ethnicity, and other covariates. Results: Younger children had faster progression of myopia; for example, the model-estimated 3-year progression in an Asian American child was -1.93 D when onset was at age 7 years compared with -1.43 D when onset was at age 10 years. Annual progression for girls was 0.093 D faster than for boys. Asian American children experienced statistically significantly faster myopia progression compared with Hispanic (estimated 3-year difference of -0.46 D), Black children (-0.88 D), and Native American children (-0.48 D), but with similar progression compared with White children (-0.19 D). Parental history of myopia, time spent reading, and time spent in outdoor/sports activity were not statistically significant factors in multivariate models. Conclusions: Younger age, female sex, and racial/ethnic group were the factors associated with faster myopic progression. This multivariate model can facilitate the planning of clinical trials for myopia control interventions by informing the prediction of myopia progression rates.