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Clinical Trials |

Randomized Trial of Effect of Bifocal and Prismatic Bifocal Spectacles on Myopic Progression:  Two-Year Results

Desmond Cheng, OD, MSc, PhD; Katrina L. Schmid, PhD; George C. Woo, OD, MSc, PhD; Bjorn Drobe, MSc, PhD
Arch Ophthalmol. 2010;128(1):12-19. doi:10.1001/archophthalmol.2009.332.
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Objective  To determine whether bifocal and prismatic bifocal spectacles could control myopia in children with high rates of myopic progression.

Methods  This was a randomized controlled clinical trial. One hundred thirty-five (73 girls and 62 boys) myopic Chinese Canadian children (myopia of ≥1.00 diopters [D]) with myopic progression of at least 0.50 D in the preceding year were randomly assigned to 1 of 3 treatments: (1) single-vision lenses (n = 41), (2) +1.50-D executive bifocals (n = 48), or (3) +1.50-D executive bifocals with a 3–prism diopters base-in prism in the near segment of each lens (n = 46).

Main Outcome Measures  Myopic progression measured by an automated refractor under cycloplegia and increase in axial length (secondary) measured by ultrasonography at 6-month intervals for 24 months. Only the data of the right eye were used.

Results  Of the 135 children (mean age, 10.29 years [SE, 0.15 years]; mean visual acuity, −3.08 D [SE, 0.10 D]), 131 (97%) completed the trial after 24 months. Myopic progression averaged −1.55 D (SE, 0.12 D) for those who wore single-vision lenses, −0.96 D (SE, 0.09 D) for those who wore bifocals, and −0.70 D (SE, 0.10 D) for those who wore prismatic bifocals. Axial length increased an average of 0.62 mm (SE, 0.04 mm), 0.41 mm (SE, 0.04 mm), and 0.41 mm (SE, 0.05 mm), respectively. The treatment effect of bifocals (0.59 D) and prismatic bifocals (0.85 D) was significant (P < .001) and both bifocal groups had less axial elongation (0.21 mm) than the single-vision lens group (P < .001).

Conclusions  Bifocal lenses can moderately slow myopic progression in children with high rates of progression after 24 months.

Applications to Clinical Practice  Bifocal spectacles may be considered for slowing myopic progression in children with an annual progression rate of at least 0.50 D.

Trial Registration  clinicaltrials.gov Identifier: NCT00787579

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Figures

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Figure 1.

Flowchart of randomization, assignment, follow-up, and analysis of participants.

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Figure 2.

Model-adjusted mean change of refraction from baseline to 24 months.

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Figure 3.

Model-adjusted mean change of axial length from baseline to 24 months.

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Figure 4.

Rate of myopia progression in children with high and low lags of accommodation. Both bifocal groups had significantly reduced myopia progression in children with high lags compared with single-vision lenses (P < .001). For children with low lags, those wearing prismatic bifocal lenses had a lower rate of myopia progression compared with those wearing single-vision lenses (P = .001) and bifocal lenses (P = .02). Bifocal lenses did not significantly reduce myopia progression compared with single-vision lenses (P = .18).

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Figure 5.

Rate of myopia progression based on near phoria status. Neither bifocal nor prismatic bifocal lenses were significant at reducing myopia progression in esophoric children (P = .27). For those with orthophoria, bifocal (P = .01) and prismatic bifocal (P < .001) lenses significantly inhibited myopic progression compared with single-vision lenses, but there was no difference between the 2 bifocal groups (P = .08). For those with exophoria, bifocal (P = .007) and prismatic bifocal (P = .002) lenses significantly inhibited myopic progression compared with single-vision lenses, but there was no difference between the 2 bifocal groups (P = .64). Δ Indicates prism diopters.

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