Effect of bifocal and prismatic bifocal spectacles on myopia progression in children: three-year results of a randomized clinical trial.

IMPORTANCE: Myopia is a significant public health problem, making it important to determine whether a bifocal spectacle treatment involving near prism slows myopia progression in children.

OBJECTIVE: To determine whether bifocal and prismatic bifocal spectacles control myopia in children with high rates of myopia progression and to assess whether the treatment effect is dependent on the lag of accommodation and/or near phoria status.

DESIGN, SETTING, AND PARTICIPANTS: This 3-year randomized clinical trial was conducted in a private practice. A total of 135 (73 female and 62 male) Chinese-Canadian children (aged 8-13 years; mean [SE] age, 10.29 [0.15] years; mean [SE] myopia, -3.08 [0.10] D) with myopia progression of at least 0.50 D in the preceding year were randomly assigned to 1 of 3 treatments. A total of 128 (94.8%) completed the trial.

INTERVENTIONS: Single-vision lenses (control, n = 41), +1.50-D executive bifocals (n = 48), and +1.50-D executive bifocals with 3-Δ base-in prism in the near segment of each lens (n = 46). MAIN OUTCOMES AND MEASURES Myopia progression (primary) measured using an automated refractor following cycloplegia and increase in axial length (secondary) measured using ultrasonography at intervals of 6 months for 36 months. RESULTS Myopia progression over 3 years was an average (SE) of -2.06 (0.13) D for the single-vision lens group, -1.25 (0.10) D for the bifocal group, and -1.01 (0.13) D for the prismatic bifocal group. Axial length increased an average (SE) of 0.82 (0.05) mm, 0.57 (0.07) mm, and 0.54 (0.06) mm, respectively. The treatment effect of bifocals (0.81 D) and prismatic bifocals (1.05 D) was significant (P < .001). Both bifocal groups had less axial elongation (0.25 mm and 0.28 mm, respectively) than the single-vision lens group (P < .001). For children with high lags of accommodation (≥ 1.01 D), the treatment effect of both bifocals and prismatic bifocals was similar (1.1 D) (P < .001). For children with low lags (<1.01 D), the treatment effect of prismatic bifocals (0.99 D) was greater than of bifocals (0.50 D) (P = .03). The treatment effect of both bifocals and prismatic bifocals was independent of the near phoria status.

CONCLUSIONS AND RELEVANCE: Bifocal spectacles can slow myopia progression in children with an annual progression rate of at least 0.50 D after 3 years. These results suggest that prismatic bifocals are more effective for myopic children with low lags of accommodation. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00787579.