Myopia Progression in Children wearing Dual-Focus Contact Lenses: 6-year findings

Abstract

Purpose: To evaluate the myopia progression in children completing 6 years in dual-focus daily disposable contact lenses (MiSight1 day, omafilcon A, CooperVision, Inc.; M1D-6) contact lenses compared to a demographically matched group completing 3 years in the same product (M1D-3).

Methods: Following completion of a 3-year study (Part 1) to assess the efficacy of M1D (Chamberlain et al, OVS 2019), the control group, comprising wearers of single vision spherical daily disposable contact lenses (omafilcon A; Proclear 1 Day CooperVision Inc.), were refitted to M1D (M1D-3, 56) for a further 3 years of assessment (Part 2). The treatment group from that study continued with M1D (M1D-6, 52). The age range of both groups was 11-15 years at Part 2 baseline. Cycloplegic spherical equivalent autorefraction (SERE) and axial length (AL) were the primary endpoints measured at baseline and then subsequently at yearly intervals. Change in SERE and AL of Part 2 was compared between the groups.

Results: There was no significant difference (0.05) in fixed demographic factors between groups for Part 2 at baseline. However, the M1D-3 group commenced Part 2 with longer eyes (.02) and more myopia (0.001) due to the treatment effect previously reported in Part 1. 92 subjects (46 M1D-6 and 46 M1D-3) completed the study, 85 of those subjects (40 M1D-6 and 45 M1D-3) attended visits in range as per protocol and were eligible for analysis. The mean change in SERE from Part 2 Baseline to the 72-month visit was -0.44D (95%CI -0.31 to -0.58) for the M1D-6 group and -0.29D (95%CI -0.17 to -0.42) for the M1D-3 group, respectively (.10). Change in AL was 0.22mm (95%CI 0.16 to 0.28) and 0.18mm (95%CI 0.13 to 0.24), respectively (.40).

Conclusion: Older children (11-15 years of age) with greater myopia and longer axial lengths (M1D-3) progressed at a similar rate over 3 years to demographically matched group of children who were treated for 6 years (M1D-6). These findings suggest that while intervening with treatment at an early age is optimal for myopia management, commencing treatment at an older age could still be beneficial in slowing the rate of myopia progression.