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Clinical Trials
January 2010

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

Author Affiliations

ANNE S.LINDBLADPhDAuthor Affiliations: School of Optometry, Faculty of Health and Vision Improvement Domain, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia (Drs Cheng and Schmid); School of Optometry, Hong Kong Polytechnic University, Hong Kong, China (Dr Woo); and Essilor International, Research & Development Centre Singapore, Singapore (Dr Drobe). Dr Cheng is now with the School of Optometry, Hong Kong Polytechnic University, Hong Kong.

Arch Ophthalmol. 2010;128(1):12-19. doi:10.1001/archophthalmol.2009.332

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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