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.

Peripheral Defocus, Pupil Size, and Axial Eye Growth in Children Wearing Soft Multifocal Contact Lenses in the BLINK Study.

Purpose: The purpose of this study was to evaluate the relationship between peripheral defocus and pupil size on axial growth in children randomly assigned to wear either single vision contact lenses, +1.50 diopter (D), or +2.50 D addition multifocal contact lenses (MFCLs). Methods: Children 7 to 11 years old with myopia (-0.75 to -5.00 D; spherical component) and ≤1.00 D astigmatism were enrolled. Autorefraction (horizontal meridian; right eye) was measured annually wearing contact lenses centrally and ±20 degrees, ±30 degrees, and ±40 degrees from the line of sight at near and distance. Photopic and mesopic pupil size were measured. The effects of peripheral defocus, treatment group, and pupil size on the 3-year change in axial length were modeled using multiple variables that evaluated defocus across the retina. Results: Although several peripheral defocus variables were associated with slower axial growth with MFCLs, they were either no longer significant or not meaningfully associated with eye growth after the treatment group was included in the model. The treatment group assignment better explained the slower eye growth with +2.50 MFCLs than peripheral defocus. Photopic and mesopic pupil size did not modify eye growth with the +2.50 MFCL (all P ≥ 0.37). Conclusions: The optical signal causing slower axial elongation with +2.50 MFCLs is better explained by the lens type worn than by peripheral defocus. The signal might be something other than peripheral defocus, or there is not a linear dose-response relationship within treatment groups. We found no evidence to support pupil size as a criterion when deciding which myopic children to treat with MFCLs.

Quality of life after wearing multifocal contact lenses for myopia control for 2 weeks in the BLINK Study.

PURPOSE: To validate Pediatric Refractive Error Profile 2 (PREP2) subscales that can be used to evaluate contact lens wearers and compare vision-specific quality of life measurements between children wearing multifocal and single vision contact lenses for 2 weeks. METHODS: Two hundred and ninety-four myopic children aged 7-11 years (inclusive) were enrolled in the 3-year, double-masked Bifocal Lenses In Nearsighted Kids (BLINK) Study. Participants completed the PREP2 survey after having worn contact lenses for 2 weeks. The Vision, Symptoms, Activities and Overall PREP2 subscales were used to compare participants' subjective assessment while wearing +1.50 or +2.50 D add multifocal or single vision contact lenses. Rasch analysis was used to validate each subscale and to compare participants' subjective assessment of contact lens wear. RESULTS: Item fit to the Rasch model was good for all scales, with no individual items having infit mean square statistics outside the recommended range (0.7-1.3). Response category function was acceptable for all subscales, with ordered category thresholds. Measurement precision, assessed by the Rasch person reliability statistic, was less than ideal (≥0.8) for three of the subscales, but met the minimum acceptable standard of 0.5. Scores for the Vision subscale differed by treatment assignment (p = 0.03), indicating that participants with the highest add power reported statistically worse quality of vision, although the difference was only 3.9 units on a scale of 1-100. Girls reported fewer symptoms than boys (p = 0.006), but there were no other differences between boys and girls. CONCLUSIONS: Rasch analysis demonstrates that the PREP2 survey is a valid instrument for assessing refractive error-specific quality of life. These results suggest that vision-related quality of life is not meaningfully affected by 2 weeks of soft multifocal contact lens wear for myopia control.

Vergence/accommodative therapy for symptomatic convergence insufficiency in children: Time course of improvements in convergence function.

PURPOSE: To evaluate the time course of improvements in clinical convergence measures for children with symptomatic convergence insufficiency treated with office-based vergence/accommodative therapy. METHODS: We evaluated convergence measures from 205, 9- to 14-year-old children with symptomatic convergence insufficiency randomised to office-based vergence/accommodative therapy in the Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART). Near-point of convergence (NPC) and near-positive fusional vergence (PFV) were measured at baseline and after 4, 8, 12 and 16 weeks of therapy; mean change in NPC and PFV between these time points were compared using repeated measures analysis of variance. Rates of change in NPC and PFV from: (1) baseline to 4 weeks and (2) 4-16 weeks were calculated. For each time point, the proportion of participants to first meet the normal criterion for NPC (<6 cm), PFV blur (break if no blur; >15Δ and >2 times the exodeviation) and convergence composite (NPC and PFV both normal) were calculated. RESULTS: The greatest change in NPC and PFV (7.6 cm and 12.7 Δ) and the fastest rate of improvement in NPC and PFV (1.9 cm/week and 3.2 Δ/week, respectively) were both found during the first 4 weeks of therapy, with both slowing over the subsequent 12 weeks. After 12 weeks of therapy, the NPC, PFV and convergence composite were normal in 93.2%, 91.7% and 87.8% of participants, respectively, and normalised with another 4 weeks of therapy in 4.4%, 2.0% and 4.4% of participants, respectively. CONCLUSION: Although the greatest improvements in NPC and PFV occurred in the first 4 weeks of therapy, most participants had weekly improvements over the subsequent 12 weeks of treatment. While most children with convergence insufficiency obtained normal convergence following 12 weeks of therapy, an additional 4 weeks of vergence/accommodative therapy may be beneficial for some participants.

The Effect of Multifocal Soft Contact Lens Wear on Axial and Peripheral Eye Elongation in the BLINK Study.

Purpose: The purpose of this study was to compare axial and peripheral eye elongation during myopia therapy with multifocal soft contact lenses. Methods: Participants were 294 children (177 [60.2%] girls) age 7 to 11 years old with between -0.75 diopters (D) and -5.00 D of myopia (spherical component) and less than 1.00 D astigmatism at baseline. Children were randomly assigned to Biofinity soft contact lenses for 3 years: D-designs with a +2.50 D addition, +1.50 D addition, or single vision. Five measurements of eye length were averaged at the fovea, ±20°, and ±30° in the horizontal and vertical meridians of the right eye using the Haag-Streit Lenstar LS 900. Results: Axial elongation over 3 years with single vision contact lenses was greater than peripheral elongation in the superior and temporal retinal qeuadrants by 0.07 mm (95% confidence interval [CI] = 0.05 to 0.09 mm) and 0.06 mm (95% CI = 0.03 to 0.09 mm) and similar in the inferior and nasal quadrants. Axial elongation with +2.50 D addition multifocal contact lenses was similar to peripheral elongation in the superior retinal quadrant and less than peripheral elongation in the inferior and nasal quadrants by -0.04 mm (95% CI = -0.06 to -0.01 mm) and -0.06 mm (95% CI = -0.09 to -0.02 mm). Conclusions: Wearing +2.50 D addition multifocal contact lenses neutralized or reversed the increase in retinal steepness with single vision lenses. The mismatch between greater inhibition of elongation at the fovea than peripherally despite greater peripheral myopic defocus suggests that optical myopia therapy may operate through extensive spatial integration or mechanisms other than local defocus.

Effect of Combining 0.01% Atropine with Soft Multifocal Contact Lenses on Myopia Progression in Children.

SIGNIFICANCE: Combining 0.01% atropine with soft multifocal contact lenses (SMCLs) failed to demonstrate better myopia control than SMCLs alone. PURPOSE: The Bifocal & Atropine in Myopia (BAM) Study investigated whether combining 0.01% atropine and SMCLs with +2.50-D add power leads to greater slowing of myopia progression and axial elongation than SMCLs alone. METHODS: Participants of the BAM Study wore SMCLs with +2.50-D add power daily and administered 0.01% atropine eye drops nightly (n = 46). The BAM subjects (bifocal-atropine) were age-matched to 46 participants in the Bifocal Lenses in Nearsighted Kids Study who wore SMCLs with +2.50-D add power (bifocal) and 46 Bifocal Lenses in Nearsighted Kids participants who wore single-vision contact lenses (single vision). The primary outcome was the 3-year change in spherical equivalent refractive error determined by cycloplegic autorefraction, and the 3-year change in axial elongation was also evaluated. RESULTS: Of the total 138 subjects, the mean ± standard deviation age was 10.1 ± 1.2 years, and the mean ± standard deviation spherical equivalent was -2.28 ± 0.89 D. The 3-year adjusted mean myopia progression was -0.52 D for bifocal-atropine, -0.55 D for bifocal, and -1.09 D for single vision. The difference in myopia progression was 0.03 D (95% confidence interval [CI], -0.14 to 0.21 D) for bifocal-atropine versus bifocal and 0.57 D (95% CI, 0.38 to 0.77 D) for bifocal-atropine versus single vision. The 3-year adjusted axial elongation was 0.31 mm for bifocal-atropine, 0.39 mm for bifocal, and 0.68 mm for single vision. The difference in axial elongation was -0.08 mm (95% CI, -0.16 to 0.002 mm) for bifocal-atropine versus bifocal and -0.37 mm (95% CI, -0.46 to -0.28 mm) for bifocal-atropine versus single vision. CONCLUSIONS: Adding 0.01% atropine to SMCLs with +2.50-D add power failed to demonstrate better myopia control than SMCLs alone.

Ocular and Nonocular Adverse Events during 3 Years of Soft Contact Lens Wear in Children.

SIGNIFICANCE: Children are being fitted at younger ages with soft contact lenses for myopia control. This 3-year investigation of adverse events related to contact lens wear in 7- to 11-year-old participants helps optometrists understand what to expect when fitting children with soft contact lenses. PURPOSE: The purpose of this article is to report the frequency and type of ocular and nonocular adverse events related to soft contact lens wear in children. METHODS: Seven- to 11-year-old children wore soft contact lenses for 3 years. Adverse events were defined by a slit-lamp examination finding of grade 3 or worse; parental report of a clinically meaningful change (determined by the examiner) in eyes, vision, or health; or a clinically meaningful response (determined by examiner) to a symptom checklist. Adverse events were categorized and reported by examiners and finalized by the Executive Committee. The presence or absence of an infiltrate and a list of diagnoses was determined at the conclusion of the study. RESULTS: The 294 participants wore their contact lenses 73.0 ± 26.5 hours per week, and 220 (74.8%) encountered at least 1 adverse event. Of the 432 adverse events, 75.2% were ocular, and 24.8% were nonocular. Contact lens wear was probably or definitely related to 60.6% of the ocular and 2.8% of the nonocular adverse events. None of the ocular adverse events were serious or severe or caused permanent contact lens discontinuation. The corneal infiltrate incidence was 185 cases per 10,000 patient-years of wear (95% confidence interval, 110 to 294). The incidence of moderate ocular adverse events that were definitely or probably related to contact lens wear was 405 cases per 10,000 patient-years of wear (95% confidence interval, 286 to 557). CONCLUSIONS: The adverse events experienced by 7- to 11-year-old myopic children rarely required meaningful treatment and never led to permanent discontinuation of contact lens wear or loss of best-corrected vision.

Morphological characteristics of Meibomian Glands and their Influence on Dry Eye disease in contact lens wearers.

PURPOSE: Meibomian glands (MG) are now easily imaged via clinical meibography machines. The purpose of this work was to explore the utility of the known MG morphology metrics for predicting dry eye disease (DED) in contact lens (CL) wearers. METHODS: Successful and previous CL wearers were recruited. DED was diagnosed if the participant's worst eye had a reduced tear meniscus height (TMH) of <0.2 mm or non-invasive tear break-up time (NITBUT) of <10 s and a Standardized Patient Evaluation of Eye Dryness (SPEED) score >5.0. Meibography was performed and images were subjectively graded by two examiners for the following MG characteristics: distorted, tortuous, hooked, abnormal gap, overlapping, fluffy areas, tadpoling, thinned, thickened, ghost, no extension to lid margin, shortened and dropout (atrophy). DED diagnostic ability of each metric was determined with receiver operating characteristic (ROC) analysis. RESULTS: A total of 112 participants were recruited, with 18.8% having DED and 60.7% being female. The only MG morphology metrics that were marginally predictive of DED were thickened upper eyelid MGs (p = 0.046), thickened mean upper plus lower eyelid MGs (p = 0.007), and atrophy of upper eyelid MGs (p = 0.043); however, none of these metrics reached a meaningful area under the curve in ROC analysis (all <0.70). CONCLUSION: While abnormal MG morphology is likely suggestive of DED in CL wearers, none of the MG morphology metrics evaluated alone in this study had clinically meaningful predictive value for detecting DED in this group of current and previous CL wearers.

Does coexisting accommodative dysfunction impact clinical convergence measures, symptoms and treatment success for symptomatic convergence insufficiency in children?

PURPOSE: To determine whether coexisting accommodative dysfunction in children with symptomatic convergence insufficiency (CI) impacts presenting clinical convergence measures, symptoms and treatment success for CI. METHODS: Secondary data analyses of monocular accommodative amplitude (AA; push-up method), monocular accommodative facility (AF; ±2.00 D lens flippers) and symptoms (CI Symptom Survey [CISS]) in children with symptomatic CI from the Convergence Insufficiency Treatment Trial (N = 218) and CITT-Attention and Reading Trial (N = 302) were conducted. Decreased AA was defined as more than 2D below the minimum expected amplitude for age (15 - » age); those with AA < 5 D were excluded. Decreased AF was defined as <6 cycles per minute. Mean near point of convergence (NPC), near positive fusional vergence (PFV) and symptoms (CISS) were compared between those with and without accommodative dysfunction using analysis of variance and independent samples t-testing. Logistic regression was used to compare the effect of baseline accommodative function on treatment success [defined using a composite of improvements in: (1) clinical convergence measures and symptoms (NPC, PFV and CISS scores) or (2) solely convergence measures (NPC and PFV)]. RESULTS: Accommodative dysfunction was common in children with symptomatic CI (55% had decreased AA; 34% had decreased AF). NPC was significantly worse in those with decreased AA (mean difference = 6.1 cm; p < 0.001). Mean baseline CISS scores were slightly worse in children with coexisting accommodative dysfunction (decreased AA or AF) (30.2 points) than those with normal accommodation (26.9 points) (mean difference = 3.3 points; p < 0.001). Neither baseline accommodative function (p ≥ 0.12 for all) nor interaction of baseline accommodative function and treatment (p ≥ 0.50) were related to treatment success based on the two composite outcomes. CONCLUSIONS: A coexisting accommodative dysfunction in children with symptomatic CI is associated with worse NPC, but it does not impact the severity of symptoms in a clinically meaningful way. Concurrent accommodative dysfunction does not impact treatment response for CI.

Association between Vision Impairment and Physical Quality of Life Assessed Using National Surveillance Data.

SIGNIFICANCE: Physically unhealthy days assessments in national health surveillance datasets represent a useful metric for quantifying quality-of-life differences in those with and without vision impairment. Disproportionately poorer physical health in the visually impaired population provides further rationale for the inclusion of vision care in multidisciplinary approaches to chronic disease management. PURPOSE: This study aimed to assess the association between vision impairment and health-related quality of life using data from the Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System. METHODS: Data from each of the 50 states were extracted from the 2017 Behavioral Risk Factor Surveillance System data set. Self-report of difficulty seeing was used to categorize visually impaired versus nonvisually impaired populations. Self-report number of physically unhealthy days in the previous 30 days was used to quantify quality of life. The number of unhealthy days was calculated for the visually impaired and nonvisually impaired cohorts for each state. The ratio of the number of physically unhealthy days in the visually impaired versus nonvisually impaired population was calculated for each state and for different age cohorts. RESULTS: Mean numbers of physically unhealthy days among persons with and without severe vision impairment across all states were 10.63 and 3.68 days, respectively, and demonstrated considerable geographic variability. Mean ratios of physically unhealthy healthy days in the visually impaired versus the nonvisually impaired population were 2.91 in the 18- to 39-year-old cohort, 2.87 in the 40- to 64-year-old cohort, and 2.16 in the ≥65-year-old cohort. CONCLUSIONS: National surveillance data demonstrate a greater number of physically unhealthy days in the visually impaired population, indicating a need to improve our understanding of causes that lead to reduced physical health among those with vision impairment. Additional research is needed to better understand how individuals perceive vision as part of their overall health.

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.

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.

Effectiveness of vergence/accommodative therapy for accommodative dysfunction in children with convergence insufficiency.

PURPOSE: To determine the effectiveness of office-based vergence/accommodative therapy for improving accommodative amplitude and accommodative facility in children with symptomatic convergence insufficiency and accommodative dysfunction. METHODS: We report changes in accommodative function following therapy among participants in the Convergence Insufficiency Treatment Trial - Attention and Reading Trial with decreased accommodative amplitude (115 participants in vergence/accommodative therapy; 65 in placebo therapy) or decreased accommodative facility (71 participants in vergence/accommodative therapy; 37 in placebo therapy) at baseline. The primary analysis compared mean change in amplitude and facility between the vergence/accommodative and placebo therapy groups using analyses of variance models after 4, 8, 12 and 16 weeks of treatment. The proportions of participants with normal amplitude and facility at each time point were calculated. The average rate of change in amplitude and facility from baseline to week 4, and from weeks 4 to 16, were determined in the vergence/accommodative therapy group. RESULTS: From baseline to 16 weeks, the mean improvement in amplitude was 8.6 dioptres (D) and 5.2 D in the vergence/accommodative and placebo therapy groups, respectively (mean difference = 3.5 D, 95% confidence interval (CI): 1.5 to 5.5 D; p = 0.01). The mean improvement in facility was 13.5 cycles per minute (cpm) and 7.6 cpm in the vergence/accommodative and placebo therapy groups, respectively (mean difference = 5.8 cpm, 95% CI: 3.8 to 7.9 cpm; p < 0.0001). Significantly greater proportions of participants treated with vergence/accommodative therapy achieved a normal amplitude (69% vs. 32%, difference = 37%, 95% CI: 22 to 51%; p < 0.0001) and facility (85% vs. 49%, difference = 36%, 95% CI: 18 to 55%; p < 0.0001) than those who received placebo therapy. In the vergence/accommodative therapy group, amplitude increased at an average rate of 1.5 D per week during the first 4 weeks (p < 0.0001), then slowed to 0.2 D per week (p = 0.002) from weeks 4 to 16. Similarly, facility increased at an average rate of 1.5 cpm per week during the first 4 weeks (p < 0.0001), then slowed to 0.6 cpm per week from weeks 4 to 16 (p < 0.0001). CONCLUSION: Office-based vergence/accommodative therapy is effective for improving accommodative function in children with symptomatic convergence insufficiency and coexisting accommodative dysfunction.

A randomised clinical trial of multifocal contact lenses and contact lens discomfort.

PURPOSE: To determine how multifocal contact lenses affect contact lens discomfort. METHODS: This randomised, participant-masked, crossover clinical trial fitted 84 uncomfortable soft contact lens wearers (30-40 years old) with single vision and multifocal contact lenses. Contact lens discomfort was assessed using the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). RESULTS: There was no difference between multifocal and single vision survey scores (p = 0.08). There was an interaction between lens type and age group (p = 0.05). CLDEQ-8 scores with the single vision lens were less symptomatic than multifocal scores in participants <35 years old (p = 0.01). Single vision and multifocal scores for the older age group were not different. Subjectively, those in the <35 year-old age group preferred the single vision lens for intermediate (p = 0.02), distance (p = 0.003), and overall vision (p = 0.002). In the ≥35 year-old age group, no lens was significantly preferred for vision. CONCLUSIONS: Participants in the younger age group had more favourable wearing experiences with the single vision lens compared to the multifocal lens. The older age group, however, had similar wearing experiences with both lens types. While younger contact lens wearers may prefer the wearing experience with single vision lenses, some uncomfortable contact lens wearers approaching 40 years old may benefit from wearing a multifocal contact lens sooner in life than is typically practised.

Effect of High Add Power, Medium Add Power, or Single-Vision Contact Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial.

Importance: Slowing myopia progression could decrease the risk of sight-threatening complications. Objective: To determine whether soft multifocal contact lenses slow myopia progression in children, and whether high add power (+2.50 D) slows myopia progression more than medium (+1.50 D) add power lenses. Design, Setting, and Participants: A double-masked randomized clinical trial that took place at 2 optometry schools located in Columbus, Ohio, and Houston, Texas. A total of 294 consecutive eligible children aged 7 to 11 years with -0.75 D to -5.00 D of spherical component myopia and less than 1.00 D astigmatism were enrolled between September 22, 2014, and June 20, 2016. Follow-up was completed June 24, 2019. Interventions: Participants were randomly assigned to wear high add power (n = 98), medium add power (n = 98), or single-vision (n = 98) contact lenses. Main Outcomes and Measures: The primary outcome was the 3-year change in cycloplegic spherical equivalent autorefraction, as measured by the mean of 10 autorefraction readings. There were 11 secondary end points, 4 of which were analyzed for this study, including 3-year eye growth. Results: Among 294 randomized participants, 292 (99%) were included in the analyses (mean [SD] age, 10.3 [1.2] years; 177 [60.2%] were female; mean [SD] spherical equivalent refractive error, -2.39 [1.00] D). Adjusted 3-year myopia progression was -0.60 D for high add power, -0.89 D for medium add power, and -1.05 D for single-vision contact lenses. The difference in progression was 0.46 D (95% CI, 0.29-0.63) for high add power vs single vision, 0.30 D (95% CI, 0.13-0.47) for high add vs medium add power, and 0.16 D (95% CI, -0.01 to 0.33) for medium add power vs single vision. Of the 4 secondary end points, there were no statistically significant differences between the groups for 3 of the end points. Adjusted mean eye growth was 0.42 mm for high add power, 0.58 mm for medium add power, and 0.66 mm for single vision. The difference in eye growth was -0.23 mm (95% CI, -0.30 to -0.17) for high add power vs single vision, -0.16 mm (95% CI, -0.23 to -0.09) for high add vs medium add power, and -0.07 mm (95% CI, -0.14 to -0.01) for medium add power vs single vision. Conclusions and Relevance: Among children with myopia, treatment with high add power multifocal contact lenses significantly reduced the rate of myopia progression over 3 years compared with medium add power multifocal and single-vision contact lenses. However, further research is needed to understand the clinical importance of the observed differences. Trial Registration: ClinicalTrials.gov Identifier: NCT02255474.

Spectacle correction versus no spectacles for prevention of strabismus in hyperopic children.

BACKGROUND: Hyperopia in infancy requires accommodative effort to bring images into focus. Prolonged accommodative effort has been associated with an increased risk of strabismus. Strabismus may result in asthenopia and intermittent diplopia, and makes near work tasks difficult to complete. Spectacles to correct hyperopic refractive error is believed to prevent the development of strabismus. OBJECTIVES: To assess the effectiveness of prescription spectacles compared with no intervention for the prevention of strabismus in infants and children with hyperopia. SEARCH METHODS: We searched CENTRAL (2018, Issue 12; which contains the Cochrane Eyes and Vision Trials Register); Ovid MEDLINE; Embase.com; three other databases; and two trial registries. We used no date or language restrictions in the electronic search for trials. We last searched the electronic databases on 4 December 2018. SELECTION CRITERIA: We included randomized controlled trials and quasi-randomized trials investigating spectacle intervention or no treatment for children with hyperopia. We required hyperopia to be at least greater than +2.00 diopters (D). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. The primary outcome was the proportion of children with manifest strabismus, as defined by study investigators. Other outcomes included the amblyopia, stereoacuity, and the effect of spectacle use of strabismus and visual acuity. We also collected information on change in refractive error as a measurement of the interference of emmetropization. MAIN RESULTS: We identified four randomized controlled trials (985 children enrolled who were aged six months to less than 36 months) in this review. Three trials were in the UK with follow-up periods ranging from one to 3.5 years and one in the US with three years' follow-up. Investigators reported both incidence and final status regarding strabismus. Evidence of the incidence of strabismus, measured in 804 children over three to four years in four trials was uncertain although suggestive of a benefit with spectacle use (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.41 to 1.02). We have very low confidence in these results due to high risk of bias, inconsistency, and imprecision. When assessed as the proportion of children with strabismus at the end of three years' follow-up, we found a similar level of evidence for an effect of spectacles on strabismus as reported in one study (RR 1.00, 95% CI 0.31 to 3.25; 106 children). We have very low confidence in these results because of low sample size and risk of bias. One trial reported on the risk for developing amblyopia and inadequate stereoacuity after three years in 106 children. There was unclear evidence for a decreased risk of developing amblyopia (RR 0.78, 95% CI 0.31 to 1.93), and limited evidence for a benefit of spectacles for prevention of inadequate stereoacuity (RR 0.38, 95% CI 0.16 to 0.88). We have very low confidence in these findings due to imprecision and risk of bias. The risk of not developing emmetropization is unclear. One trial reported on the proportion of children not achieving emmetropization at three years' follow-up (RR 0.75, 95% CI 0.18 to 3.19). One trial suggested spectacles impede emmetropization, and one trial reported no difference. These two trials could not be combined because the methods for assessing emmetropization were different. With the high risk of bias and inconsistency, the certainty of evidence for a risk for impeding or benefiting emmetropization is very low. Based on a meta-analysis of four trials (770 children), the risk of having visual acuity worse than 20/30 measured up to three years of age or at the end of three years of follow-up was uncertain for children with spectacle correction compared with those without correction (RR 0.87, 95% CI 0.64 to 1.18; very low confidence due to risk of bias and imprecision). AUTHORS' CONCLUSIONS: The effect of spectacle correction for prevention of strabismus is still unclear. In addition, the use of spectacle on the risk of visual acuity worse than 20/30, amblyopia, and inadequate emmetropization is also unclear. There may be a benefit on prevention of inadequate stereoacuity. However, these effects may have been chance findings or due to bias.

Impact of meibomian gland width on successful contact lens use.

PURPOSE: To evaluate meibomian gland (MG) width and determine its impact on successful contact lens (CL) use and ocular health. METHODS: A five-site study was conducted by recruiting 18- to 45-year-old subjects who had dropped out of CLs because of discomfort. CL dropouts were compared to age- and sex-matched successful CL wearers. Right eyes were evaluated for tear break-up time, tear meniscus height, MG expressibility, meibum quality, and meibography. Central MG widths were evaluated with a custom MATLAB program. RESULTS: CL dropouts (n = 56) and successful CL (n = 56) wearers had similar grades for upper (p = 1.0) and lower (p = 0.22) MG atrophy, upper (p = 0.07) and lower (p = 0.89) MG tortuosity, and upper (p = 0.92) and lower (p = 0.97) MG widths. Upper eyelid MG widths were narrower than lower eyelid MG widths (p = 0.03). Upper and lower MG tortuosity (p < 0.001) and widths (p = 0.03) were associated, but not atrophy (p = 0.42). Lower eyelid MG widths were associated with MG expressibility (p = 0.01), but MG widths were not with any other factors. CONCLUSIONS: Successful CL wear does not appear to be clinically influenced by MG width or other measures of MG structural integrity. Lower eyelid MGs were wider than upper eyelid MGs and narrower lower eyelid MGs were associated with worse MG expressibility, suggesting that narrower MGs may produce abnormal meibum. Data also suggests that MG factors of both eyelids should be evaluated in practice.

Bifocal & Atropine in Myopia Study: Baseline Data and Methods.

SIGNIFICANCE: The Bifocal & Atropine in Myopia (BAM) study aims to determine whether combining 0.01% atropine and +2.50-diopter add center-distance soft bifocal contact lenses (SBCL) slows myopia progression more than SBCL alone. The results could provide significant information on the myopia control effect of combining optical and pharmacological treatments. PURPOSE: This article describes the subject characteristics at baseline, the study methods, and the short-term effects of this combination treatment on visual acuity (VA) and vision-related outcomes. METHODS: Subjects from the BAM study who met the baseline eligibility criteria were dispensed the combination treatment for 2 weeks to determine final eligibility. Outcome measures included VA at near and distance (Bailey-Lovie logMAR charts), near phoria (modified Thorington), accommodative lag (Grand Seiko WAM-5500), and pupil size (NeurOptics VIP-200 Pupillometer). Compliance was monitored using surveys. Two subgroups in the Bifocal Lenses In Nearsighted Kids study, single-vision contact lens wearers and those who wore +2.50-diopter add SBCL, will serve as the age-matched historical controls for BAM study. RESULTS: Forty-nine BAM subjects (9.6 ± 1.4 years) were enrolled; mean spherical equivalent cycloplegic autorefraction was -2.33 ± 1.03 diopters. After 2 weeks of treatment, the best-corrected low-contrast (10% Michelson) distance VA was reduced (pre-treatment, +0.09 ± 0.07; post-treatment, +0.16 ± 0.08; P < .0001), but the high-contrast VA at near or distance was unaffected. Near phoria increased by approximately 2 in the exo direction (P = .01), but the accommodative lag was unchanged. The pupil size was not significantly different between pre-treatment and post-treatment of either the photopic or mesopic condition. Surveys indicated that the subjects wore SBCL 77 ± 22% of waking hours and used atropine 6.4 ± 0.7 days per week. CONCLUSIONS: Two weeks of combination treatment reduced low-contrast distance VA and increased near exophoria slightly, but the subjects were compliant and tolerated the treatment well.

Peripheral Refraction and Eye Lengths in Myopic Children in the Bifocal Lenses In Nearsighted Kids (BLINK) Study.

PURPOSE: Provide a detailed assessment of peripheral refractive error and peripheral eye length in myopic children. METHODS: Subjects were 294 children aged 7 to 11 years with -0.75 to -5.00 diopter (D) of myopia by cycloplegic autorefraction. Peripheral refraction and eye length were measured at ±20° and ±30° horizontally and vertically, with peripheral refraction also measured at ±40° horizontally. RESULTS: Relative peripheral refraction became more hyperopic in the horizontal meridian and more myopic in the vertical meridian with increasing field angle. Peripheral eye length became shorter in both meridians with increasing field angle, more so horizontally than vertically with correlations between refraction and eye length ranging from -0.40 to -0.57 (all P < 0.001). Greater foveal myopia was related to more peripheral hyperopia (or less peripheral myopia), shorter peripheral eye lengths, and a consistent average asymmetry between meridians. CONCLUSIONS: Peripheral refractive errors in children do not appear to exert strong local control of peripheral eye length given that their correlation is consistently negative and the degree of meridional asymmetry is similar across the range of refractive errors. The BLINK study will provide longitudinal data to determine whether peripheral myopia and additional peripheral myopic defocus from multifocal contact lenses affect the progression of myopia in children. TRANSLATIONAL RELEVANCE: Local retinal control of ocular growth has been demonstrated numerous times in animal experimental myopia models but has not been explored in detail in human myopia development. These BLINK baseline results suggest that children's native peripheral optical signals may not be a strong stimulus for local growth responses.