Purpose: To determine whether progressive-addition lenses (PALs) relative to single-vision lenses (SVLs) slow the progression of low myopia in children with high accommodative lag and near esophoria.
Methods: One hundred eighteen children 8 to <12 years of age with spherical equivalent refraction (SER) from -0.75 to -2.50 D and near esophoria ≥2 PD were enrolled in this double-masked multicenter randomized trial. A key additional eligibility criterion was high accommodative lag, initially defined as at least 0.50 D (accommodative response less than 2.50 D for a 3.00-D demand) and later restricted further to at least 1.00 D. One hundred four subjects had accommodative lag of at least 1.00 D, and 14 had lag between 0.50 and 0.99 D. The children were randomized to receive either PALs with a +2.00-D addition or standard SVLs. The clinicians performing the outcome testing, as well as the children and their families, were masked to treatment group. Follow-up visits occurred every 6 months for 3 years. At annual visits, refractive error was assessed in each eye by using cycloplegic autorefraction. The main outcome measure was change from baseline to 3 years in SER by cycloplegic autorefraction.
Results: The mean change in SER between baseline and the 3-year primary outcome visit was -0.87 D in the PAL group and -1.15 D in the SVL group, for a difference of 0.28 D (95% confidence interval [CI], 0.01-0.55D).
Conclusions: The PALs used in this study were found to have a statistically but not clinically significant effect of slowing myopia progression in children with high accommodative lag and near esophoria. (ClinicalTrials.gov number, NCT00320593.).