Bifocals reduce strabismus in children with Down syndrome: Evidence from a randomized controlled trial.

Purpose: Children with Down syndrome (DS) more often have strabismus, refractive errors, accommodative lags and reduced visual acuity (VA) than typically developing children. In this study, we compare the effects of bifocal glasses with those of unifocal glasses in children with DS. Changes in angle of strabismus, accommodation and refractive error were analysed in this paper.

Methods: In a multicentre randomized controlled trial, 119 children with DS, aged 2-16, were randomly allocated for bifocal or unifocal glasses (with full correction of refractive error in cycloplegia). The 15 centres, all in the Netherlands, followed the participants for 1 year. Changes in refractive error, accommodative accuracy, strabismus, binocularity and stereopsis were compared across 4 subsequent visits.

Results: Refractive errors and accommodative errors showed no significant change throughout the course of our study in either intervention group. The manifest angle of strabismus, however, reduced significantly in the bifocal group. This improvement was observed shortly after the children received their new correction (~6 weeks) (linear regression: t = 3.652, p < 0.001) and remained present in the final measurements after 1 year (linear regression: t = 3.604, p < 0.001). The percentage of children with positive binocularity and stereo tests showed no significant differences between the groups.

Conclusion: Bifocals with full correction of refractive error reduce the manifest angle of strabismus within a few weeks. No effects on accommodation, refractive error, stereopsis and binocularity occurred over the course of 1 year.