The Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) Study Design and Baseline Data

Abstract

The purpose of this study was to describe the baseline characteristics of subjects and methods for a multicenter, randomized clinical trial to compare the effects of contact lens wear and spectacle wear on children's self-perception. Eligible subjects are randomly assigned to wear glasses or contact lenses throughout the 3-year study. Self-perceptions are measured 1 month after randomization and every 6 months using the Self-Perception Profile for Children (SPPC). Children's satisfaction with spectacles and refractive error-related visual quality of life are also measured using surveys developed for the study. Visual acuity, cycloplegic autorefraction, corneal curvature, and axial dimensions are measured annually. Five clinical sites enrolled 484 subjects with a mean (+/- standard deviation [SD]) age of 10.4 +/- 1.1 years. Approximately three-fifths of the subjects are girls, 47.1% of the subjects are white, 21.5% are black, and 21.5% are Hispanic. The mean (+/- SD) cycloplegic spherical equivalent autorefraction of the right eye is -2.38 +/- 1.04 D, and the average (+/- SD) axial length of the right eye is 24.32 +/- 0.77 mm. The average (+/- SD) Global Self-Worth score on the SPPC is 3.20 +/- 0.62 on a scale from one (low perceived competence) to 4 (high perceived competence). The average (+/- SD) spectacle satisfaction is 59.1 +/- 26.6 on a scale from zero (no satisfaction) to 100 (perfect satisfaction). The average refractive error-related quality of life score is 63.5 +/- 12.8 on a scale from zero (poor quality of life) to 100 (excellent quality of life). Subjects enrolling in the ACHIEVE Study are an ethnically diverse group of young myopic children. Ocular characteristics of the sample are consistent with data presented in other randomized clinical trials evaluating treatments for myopic children. The data reported here represent the baseline data for a 3-year randomized clinical trial to investigate the effects of contact lens vs. spectacle wear on children's self-perceptions.