ImportanceControlling myopia progression is of interest worldwide. Low-dose atropine eye drops have slowed progression in children in East Asia.ObjectiveTo compare atropine, 0.01%, eye drops with placebo for slowing myopia progression in US children.Design, Setting, and ParticipantsThis 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]).InterventionEligible 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 MeasuresAutomated 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.ResultsA 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 RelevanceIn 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 RegistrationClinicalTrials.gov Identifier: NCT03334253
he Intermittent Exotropia Questionnaire (IXTQ) is a patientderived, intermittent exotropia-specific instrument designed to evaluate health-related quality of life (HRQOL) in children with intermittent exotropia and their parents. 1,2 The IXTQ consists of 3 parts: the 12-item child IXTQ (completed by the child to assess the child's HRQOL), the 12-item proxy IXTQ (completed by the parent to assess the child's HRQOL), and the 17-item parent IXTQ (completed by the parent regarding his or her own HRQOL). 1 The child and proxy questionnaires each have a single subscale. The parent questionnaire contains 3 subscales: psychosocial, function, and surgery. The IXTQ is reliable and valid for assessing HRQOL in children with intermittent exotropia. [1][2][3] It is available for download free of charge at http://pedig.jaeb.org/.The IXTQ was originally developed using classical test theory. Rasch analysis may be used to modify and improve existing HRQOL instruments. [4][5][6][7][8][9] In the present study, Rasch analysis was used to refine the existing IXTQ, removing items that do not contribute meaningful information to the instrument and ensuring that response options are properly interpreted. Methods Patient CohortParents gave written informed consent, and children gave written assent when required. The protocol was approved by the institutional review boards of the Mayo Clinic, Jaeb Center for Health Research, and other local sites involved in the study. Data were collected and analyzed in accordance with the Health Insurance Portability and Accountability Act guidelines. The IXTQ was completed by 575 parents of 575 children aged 1 through 16 years with intermittent exotropia at the time of their child's clinic examination, enrolled from May 15, 2008, through July 24, 2013. The 295 children aged 5 years or older completed the age-appropriate child IXTQ. Parents and children completed the IXTQ as part of routine care in the strabismus practice of one of the authors (J.M.H., n = 110) or at the enrollment examination for 1 of 2 ongoing randomized clinical trials being conducted by the Pediatric Eye Disease Investigator Group (NCT 01032603 [n = 69] and NCT 01032330 [n = 396]). Child questionnaires were administered to children aged 5 through 7 years by study personnel. All 8-to 17-year-old child, proxy, and parent questionnaires were self-administered. Patient demographics are reported in eTable 1 in the Supplement. Statistical AnalysisBefore Rasch analysis, items with floor and ceiling effects on the child, proxy, and parent IXTQs were eliminated as described in the eMethods in the Supplement. Rasch analysis was performed on each of the 4 IXTQs using the analytic methods that we have applied previously (eMethods in the Supplement). 9 The performance and structure of the Rasch-IMPORTANCE The Intermittent Exotropia Questionnaire (IXTQ) is a patient, proxy, and parental report of quality of life specific to children with intermittent exotropia. We refine the IXTQ using Rasch analysis to improve reliability and validity.OBSERVATI...
Most children were able to complete aniseikonia testing with AI3. Background aniseikonia was clinically insignificant (0.59%), and induced aniseikonia measurements were close to expected values using a 4% size lens. Aniseikonia Inspector Version 3 appears to be a useful means for measuring aniseikonia in a normal pediatric population. Further study in children with anisometropia is needed.
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