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 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.

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.

Longitudinal changes in corneal curvature and its relationship to axial length in the Correction of Myopia Evaluation Trial (COMET) cohort.

PURPOSE: To describe longitudinal changes in corneal curvature (CC) and axial length (AL) over 14 years, and to explore the relationship between AL and CC, and the axial length/corneal radius (AL/CR) ratio. METHODS: In total 469, 6 to <12-year-old, children were enrolled in COMET. Measurements of refractive error, CC (D), CR (mm), and ocular component dimensions including AL were gathered annually. Linear mixed models were used to evaluate longitudinal changes adjusting for covariates (gender, ethnicity, lens type, baseline age and baseline refraction). The Pearson correlation coefficient between AL and CC was computed at each visit. RESULTS: There was a slight but significant (p<0.0001) flattening in CC over 14 years. At all visits females had significantly steeper CC than males (overall difference=0.53 D, p<0.0001). Caucasians had the steepest CC, and Hispanics the flattest (p=0.001). The correlation between AL and CC was -0.70 (p<0.0001) at baseline (mean age=9.3 years) and decreased to -0.53 (p<0.0001) at the 14-year visit (mean age=24.1 years). The average AL/CR ratio was 3.15 at baseline and increased to 3.31 at the 14-year visit. The correlation between the magnitude of myopia and AL/CR ratio was significantly higher (p<0.0001) at each visit than the correlation between myopia and AL alone. CONCLUSIONS: Differences in average corneal curvature by age, gender, and ethnicity observed in early childhood remain consistent as myopia progresses and stabilizes. This study also demonstrates increases in the AL/CR ratio as myopia progresses and then stabilizes, supporting observations from previous cross-sectional data.

Limited change in anisometropia and aniso-axial length over 13 years in myopic children enrolled in the Correction of Myopia Evaluation Trial.

PURPOSE: We investigated changes in anisometropia and aniso-axial length with myopia progression in the Correction of Myopia Evaluation Trial (COMET) cohort. METHODS: Of 469 myopic children, 6 to <12 years old, enrolled in COMET, 358 were followed for 13 years. Cycloplegic autorefraction and axial length (AL) in each eye were measured annually. The COMET eligibility required anisometropia (interocular difference in spherical equivalent refraction) of ≤ 1.00 diopter (D). For each child, a linear regression line was fit to anisometropia data by visit, and the regression slope b was used as the rate of change. Logistic regression was applied to identify factors for significant changes in anisometropia (b ≥ 0.05 D/y, or a cumulative increase in anisometropia ≥ 0.50 D over 10 years). Similar analyses were applied to aniso-AL. RESULTS: A total of 358/469 (76.3%) children had refractions at baseline and the 13-year visit. The mean (SD) amount of anisometropia increased from 0.24 D (0.22 D) at baseline to 0.49 D (0.46 D) at the 13-year visit. A total of 319/358 (89.1%) had slopes |b| < 0.05 D/y and 39 (10.9%) had slopes |b| ≥ 0.05 D/y, with only one negative slope. Similarly, 334/358 (93.3%) children had little change in aniso-AL over time. The correlation between changes in anisometropia and aniso-AL over 13 years was 0.39 (P < 0.001). The correlation between changes in anisometropia and myopia progression was significant (r = -0.36, P < 0.001). No correlation was found between baseline anisometropia and myopia progression (r = -0.02, P = 0.68). CONCLUSIONS: Myopia and axial length progressed at a similar rate in both eyes for most children in COMET during the period of fast progression and eventual stabilization. These results may be more generalizable to school-aged myopic children with limited anisometropia at baseline. (ClinicalTrials.gov number, NCT00000113.).

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.

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.

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.

Comparison of two drug combinations for dilating dark irides.

PURPOSE: Two combinations of dilation drops [1% tropicamide and 2.5% phenylephrine (TP) vs. 1% tropicamide and 1% cyclopentolate (TC)] were compared to determine time course and magnitude of dilation for patients with dark irides. METHODS: Forty-five subjects, aged 4 to 32 years, with dark irides were enrolled. Photographs were taken before dilation and at 5, 10, 15, 20, 40, and 60 min after instillation of drops. Subjects received TP in one eye and TC in the fellow eye, with eyes randomized to the combination received. An examiner masked to drug combination and time used digital analysis to calculate pupil diameter for each photograph. TP and TC were compared to determine the time to reach both 6- and 7-mm pupil diameter and the percentage of subjects reaching these diameters. RESULTS: Ninety-eight percent of pupils reached 6 mm with either combination; however, 80% reached 7 mm with TP and only 58% with TC (p = 0.0062, McNemars exact test). Time at which 50% of pupils reached 6 mm was not significantly different between drug combinations (TP 11 min vs. TC 12 min, Kaplan-Meier survival analysis). However, time at which 50% reached 7 mm was statistically and clinically significant (TP 32 min vs. TC 52 min, p = 0.0325). For subjects < or =10 years vs. >10 years, there was no significant difference in time at which 50% reached a 6- or 7-mm pupil with TP or TC; however, in every case, the younger group took longer. CONCLUSIONS: A 6-mm pupil dilation may be obtained with either TP or TC; however, more subjects achieved a 7-mm pupil with TP than TC and had a faster time course to attain that size.

The effect of strabismus on a young child's selection of a playmate.

PURPOSE: This study investigated the effect of strabismus on a child's playmate selection. METHODS: Photographs of orthotropic children aged 3-6 years were altered to simulate various magnitudes of strabismus. The pictures were arranged in pairs, one orthotropic child and one with strabismus. One hundred children aged 3-8 years viewed the photographs and were asked to select a playmate from each pair. RESULTS: Chi-squared analysis found 23 children showed evidence that strabismus influenced their choices (p < 0.07). Of these 23, 12 preferred playmates with strabismus and 11 preferred orthotropic playmates. Chi-squared analysis of all subjects combined found decisions were not based on the magnitude or direction of strabismus. CONCLUSIONS: As only 11% of the children consistently selected against playmates with strabismus, and about the same percentage preferred playmates with strabismus (12%), the presence of strabismus does not appear to be a significant factor in peer acceptance in this age group.

Evaluating the self-esteem of myopic children over a three-year period: The COMET Experience.

PURPOSE: The purposes of this study were to evaluate self-esteem over 3 years in the 469 myopic children participating in the Correction of Myopia Evaluation Trial (COMET), and to examine its relationship with lens assignment (progressive addition lenses [PALs] vs. single-vision lenses [SVLs]), myopia progression, and several other ocular and demographic characteristics. METHODS: Data collection included refractive error measurements, child-reported visual symptoms, attitude toward glasses, adherence, and self-esteem as measured by the Self-Perception Profile for Children (SPPC). A two-way analysis of variance (treatment group x time) was performed to examine whether PAL and SVL wearers differed in self-esteem over time. Multiple regression analyses were used to evaluate associations between self-esteem at follow-up and relevant factors identified by univariate analyses. RESULTS: Regardless of lens assignment or myopia progression, COMET children reported moderate to high levels of self-esteem at follow-up in the areas of scholastic and athletic competence, physical appearance, social acceptance, behavioral conduct, and global self-worth. Mean scores ranged from 2.87 (+/- 0.68) on athletic competence to 3.40 (+/- 0.56) on global self-worth. Self-esteem changed significantly (p < 0.05) over 3 years in the domains of scholastic competence, social acceptance, and physical appearance. Self-esteem at follow-up was associated with visual symptoms, attitude toward glasses, age, gender, and ethnicity. CONCLUSIONS: Lens assignment and myopia progression were not associated with self-esteem in the COMET cohort. These children had high levels of self-esteem, suggesting that having myopia does not negatively impact self-esteem. Follow-up reports will monitor self-esteem and related factors in this cohort of myopic children over the course of adolescence and early adulthood.

The intraexaminer and interexaminer repeatability of the alternate cover test using different prism neutralization endpoints.

PURPOSE: The alternate cover test (ACT) measures the magnitude of a deviation, but different prism endpoints may be used. This study investigated the intraexaminer and interexaminer repeatability of the ACT using two different prism neutralization endpoints. METHODS: To determine repeatability of two prism neutralization endpoints (first neutral and midpoint of reversal), two experienced examiners measured near point phoria on 72 subjects. Measurements were repeated with examiners masked to each other and the first results. Paired t-tests were used to assess interexaminer and intraexaminer repeatability and the agreement between different prism endpoints for each examiner within each session. Signed and absolute differences in phoria magnitude were calculated. RESULTS: For two different test sessions with the same examiner using the same prism neutralization endpoint (intraexaminer repeatability), none were significant except examiner 1 using first neutral (p = 0.038). Average signed differences (ASD's) between two test sessions for each comparison were <0.5 prism diopter (pd) with SD's of

The relationship between self-esteem of myopic children and ocular and demographic characteristics.

PURPOSE: To evaluate self-esteem and its relationship with various ocular and demographic characteristics in 469 myopic children participating in the Correction of Myopia Evaluation Trial (COMET), an ongoing, randomized, multicenter clinical trial designed to evaluate the effects of progressive addition lenses vs. single vision lenses on the progression of juvenile-onset myopia. METHODS: Baseline data collection included demographic information, refractive error measurements, parent-reported myopia history, child-reported visual symptoms, and self-esteem in several areas (scholastic/athletic competence, physical appearance, social acceptance, behavioral conduct, and global self-worth) as measured by the Self-Perception Profile for Children. Univariate and multiple regression analyses were used to identify factors associated with self-esteem. RESULTS: The Self-Perception Profile for Children is a reliable measure of self-esteem in COMET children as indicated by the high internal consistency reliabilities (0.74 to 0.81) obtained for the various domains. COMET children's mean self-esteem scores ranged from 2.72 +/- 0.69 for athletic competence to 3.36 +/- 0.56 for global self-worth and were similar to normative samples. Multiple regression analyses showed that less symptomatic children had higher self-esteem in all areas (p < 0.05), except athletic competence, after adjusting for other ocular and demographic characteristics. Self-esteem also varied significantly by age, gender, and ethnicity (p < 0.05). CONCLUSIONS: Baseline self-esteem is associated with visual symptoms, age, gender, and ethnicity, but not with magnitude of refractive error. Follow-up reports will assess whether there are changes in self-esteem associated with myopia progression and lens assignment.