Efficacy of contact lenses for myopia control: Insights from a randomised, contralateral study design.

Abstract

To determine the efficacy of two myopia control contact lenses (CL) compared with a single-vision (SV) CL. Ninety-five Chinese children with myopia, aged 7-13 years in a 1-year prospective, randomised, contralateral, cross-over clinical trial with 3 groups; bilateral SVCL (Group I); randomised, contralateral wear of an extended depth of focus (EDOF) CL and SVCL (Group II) and MiSight® CL and SVCL (Group III). In Groups II and III, CL were crossed over at the 6-month point (Stage 1) and worn for a further 6months (Stage 2). Group I wore SVCL during both stages. At baseline and the end of each stage, cycloplegic spherical equivalent refractive error (SE) and axial length (AL) were measured. Six-monthly ΔSE/ΔAL across groups was analysed using a linear mixed model (CL type, stage, eye and eye* stage included as factors). Intra-group paired differences between eyes were determined. In Group I, mean (SD) ΔSE/ΔAL with SVCL was -0.41 (0.28)D/0.13 (0.09)mm and -0.25 (0.27)D/0.16 (0.09)mm for stages 1 and 2, with a mean paired difference between eyes of 0.01 D/0.01 mm and 0.05 D/-0.01 mm, respectively. ΔSE/ΔAL with SVCL was similar across Groups I to III (Stage 1: p=0.89/0.44, Stage 2: p=0.70/ 0.64). In Groups II and III, ΔSE/ΔAL was lower with the EDOF and MiSight® CL than the contralateral SVCL in 68% to 94% of participants, and adjusted 6-month ΔSE/ΔAL with EDOF was similar to MiSight® (p=0.49/0.56 for ΔSE/ΔAL, respectively). Discontinuations across the three groups were high, but not different between the groups (33.3%, 48.4% and 50% for Groups I to III, respectively [p=0.19]) and most discontinuations occurred immediately after baseline. Extended depth of focus and MiSight® CL demonstrated similar efficacy in slowing myopia. When switched from a myopia control CL to SVCL, myopia progression was similar to that observed with age-matched wearers in SVCL and not suggestive of rebound.