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.

Feasibility of a clinical trial of vision therapy for treatment of amblyopia.

PURPOSE: We conducted a pilot randomized clinical trial of office-based active vision therapy for the treatment of childhood amblyopia to determine the feasibility of conducting a full-scale randomized clinical trial. METHODS: A training and certification program and manual of procedures were developed to certify therapists to administer a standardized vision therapy program in ophthalmology and optometry offices consisting of weekly visits for 16 weeks. Nineteen children, aged 7 to less than 13 years, with amblyopia (20/40-20/100) were randomly assigned to receive either 2 hours of daily patching with active vision therapy or 2 hours of daily patching with placebo vision therapy. RESULTS: Therapists in diverse practice settings were successfully trained and certified to perform standardized vision therapy in strict adherence with protocol. Subjects completed 85% of required weekly in-office vision therapy visits. Eligibility criteria based on age, visual acuity, and stereoacuity, designed to identify children able to complete a standardized vision therapy program and judged likely to benefit from this treatment, led to a high proportion of screened subjects being judged ineligible, resulting in insufficient recruitment. There were difficulties in retrieving adherence data for the computerized home therapy procedures. CONCLUSIONS: This study demonstrated that a 16-week treatment trial of vision therapy was feasible with respect to maintaining protocol adherence; however, recruitment under the proposed eligibility criteria, necessitated by the standardized approach to vision therapy, was not successful. A randomized clinical trial of in-office vision therapy for the treatment of amblyopia would require broadening of the eligibility criteria and improved methods to gather objective data regarding the home therapy. A more flexible approach that customizes vision therapy based on subject age, visual acuity, and stereopsis might be required to allow enrollment of a broader group of subjects.

Evaluating the burden of amblyopia treatment from the parent and child's perspective.

PURPOSE: To evaluate the psychometric properties of the original Parent and new Child Amblyopia Treatment Index (ATI), questionnaires that assess the burden of amblyopia treatment in children and families, and to compare scores between children treated with atropine or patching. METHODS: Parent ATI and Child ATI were administered to 233 children 7 to <13 years old and their parents as part of a randomized trial comparing patching and atropine for amblyopia treatment. For each ATI version, construct validity was assessed using factor analysis; internal consistency reliability was assessed using Cronbach's alpha. Data from the Parent ATI and Child ATI were correlated and scores for each version were compared between treatment groups. RESULTS: We analyzed the 3 subscales found in prior Parent ATI studies in younger children and confirmed subscales for adverse effects and treatment compliance, but not for social stigma, in both parent and child versions. Overall and subscale scores on the Parent ATI and Child ATI were moderately to well correlated except for the social stigma subscale. For both the Parent ATI and the Child ATI, children treated with atropine had better scores than those treated with patching, both overall and on treatment compliance and social stigma subscales (all p values ≤ 0.01). CONCLUSIONS: When used for children 7 to <13 years old, the Parent ATI and Child ATI have similar factor structures to each other and to the Parent ATI for children 3 to <7 years old. Atropine treatment was found to have less negative impact than patching.

Stability of visual acuity improvement following discontinuation of amblyopia treatment in children aged 7 to 12 years.

OBJECTIVE: To assess the stability of visual acuity improvement during the first year after cessation of amblyopia treatment other than spectacle wear in children aged 7 to 12 years. METHODS: At the completion of a multicenter randomized trial during which amblyopia treated with patching and atropine improved by at least 2 lines on the electronic Early Treatment of Diabetic Retinopathy Study testing protocol, 80 patients aged 7 to 12 years were followed up while not receiving treatment (other than spectacle wear) for 1 year. MAIN OUTCOME MEASURE: Ten letters or more (> or =2 lines) worsening of visual acuity (measured using the electronic Early Treatment of Diabetic Retinopathy Study testing protocol) during the year following treatment discontinuation. RESULTS: During the year following cessation of treatment, the cumulative probability of worsening visual acuity (> or =2 lines) was 7% (95% confidence interval, 3%-17%); 82% of patients maintained an increase in visual acuity of 10 letters or more compared with their visual acuity before starting treatment. CONCLUSION: Visual acuity improvement occurring during amblyopia treatment is sustained in most children aged 7 to 12 years for at least 1 year after discontinuing treatment other than spectacle wear. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00094692.

Reliability of the electronic early treatment diabetic retinopathy study testing protocol in children 7 to <13 years old.

PURPOSE: To assess the test-retest reliability of the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity algorithm using the computerized Electronic Visual Acuity (EVA) tester in children 7 to <13 years old. DESIGN: Test-retest reliability study. METHODS: This multicenter study involved 245 subjects at four clinical sites. As the main outcome measure, visual acuity was measured twice using the E-ETDRS testing protocol on the EVA system, which uses a programmed handheld device to communicate with a personal computer and a 17-inch monitor at a 3-m test distance. RESULTS: Test-retest reliability was high (r =.94 for right eyes and 0.96 for left eyes) and for both right and left eyes, 89% of retest scores were within 0.1 logarithm of the minimal angle of resolution (logMAR) (five letters) of the initial test score and 99% of retests were within 0.2 logMAR (10 letters). Reliability was high across the age range of 7 to <13 years. Based on 95% confidence level estimates, a change in visual acuity of 0.2 logMAR (10 letters) from a previous acuity measure is unlikely to result from measurement variability. CONCLUSIONS: The E-ETDRS protocol using the EVA has high test-retest reliability in children 7 to <13 years of age. Potential advantages include better standardization across multiple sites, the ability to directly capture data electronically with an automatic acuity score calculation, the reduction of potential bias by limiting the tester's role, and the requirement of only a single testing distance for measurements from 20/800 to 20/12. This computerized testing method should be considered when visual acuity is used as an outcome measure in eye research involving children 7 to <13 years old.