Abstract
PURPOSE: Children with Down syndrome (DS) typically have reduced visual acuity (VA) and accommodation lag, but it is unclear whether prescribed glasses should correct both distance VA (DVA) and near VA (NVA) due to the lack of RCTs. We therefore conducted a multicentre RCT to compare the effects of bifocals designed to correct both DVA and NVA with distance-correcting unifocal glasses in children with DS. METHODS: A total of 119 children with DS, aged 2-16, were randomly allocated for bifocal or unifocal glasses (with full correction of refraction error in cycloplegia) in 14 Dutch hospitals and followed during 1 year. VA data were analysed in relation to baseline VA with ancova. RESULTS: Treatment groups showed no differences at baseline. Shortly after receiving new corrections (~6 weeks), uncrowded NVA (bifocals 0.18 ± 0.33 LogMar; unifocals 0.09 ± 0.19 LogMar) and crowded NVA with bifocals (bifocals 0.13 ± 0.36 LogMar; unifocals 0.08 ± 0.33 LogMar) were significantly better than at baseline, but these short-term improvements in NVA were not significantly different between the two treatments (p > 0.151). The 1-year treatment differences were as follows: significantly larger improvement for bifocals compared to unifocals in both uncrowded NVA (bifocals 0.23 ± 0.29 LogMar, unifocals 0.12 ± 0.30 LogMar, p = 0.045) and crowded NVA (bifocals 0.31 ± 0.28 LogMar; unifocals 0.16 ± 0.30 LogMar, p = 0.017). Improvements in DVA were comparable (bifocals 0.07 ± 0.21 LogMar, unifocals 0.08 ± 0.22 LogMar, p = 0.565). Children with poor baseline VA improved more. Accommodation lag stayed unchanged. CONCLUSION: After one year, bifocals with full correction of ametropia led to significantly larger improvement of both uncrowded NVA and crowded NVA in children with DS with accommodation lag compared to unifocals.