Defocus Incorporated Multiple Segment lenses and 0.025% atropine for myopia control in a European population: 12-month results of a randomized clinical trial

Abstract

Purpose : Defocus Incorporated Multiple Segments (DIMS) spectacle lenses and atropine have proven standalone efficacy in controlling myopia progression in children. However, there is a scarcity of evidence of their efficacy when used in combination. This randomized controlled trial (RCT) aims to evaluate and compare the efficacy of combination treatment using 0.025% atropine and DIMS lenses compared to 0.025% atropine and single vision (SV) lenses in slowing myopia progression in European myopic children.

Methods : A 12-month RCT was carried out on European myopic children aged 4-16 years, with myopia between -1.00 and -6.00D and astigmatism ≤2.00D. Children were randomly assigned to the 0.025% atropine and SV lenses treatment group (group A) or 0.025% atropine and DIMS lenses treatment group (group B). Cycloplegic spherical equivalent refraction (SER) and axial length (AL) were measured at baseline and 12 months. Statistical analyses (Student's t-test or Mann-Whitney U-test) were performed to test for significance between the two groups.

Results : 56 patients completed the 12 month-follow-up: n=26 (46.4%) in group A, mean age 8.58 ±3.01 years and n=30 (53.6%) in the group B, mean age 9.67±2.25 years, p>0.05. Mean AL ±SD change over 12 months was 0.20±0.14 mm in group A and 0.07±0.14 mm in the group B. Mean SER ±SD progression was -0.21±0.29 D and -0.16±0.35 D, respectively. Group B had significantly less axial elongation than group A, mean difference -0.13±0.03 mm (95% CI -0.20 to -0.05, p<0.002). The SER mean difference was -0.05±0.09 D, 95% CI -0.12 to 0.23, p=0.781). 36.7% of the children in the Group B had no axial elongation over 12 months compared to 15.4% of the children in group A.

Conclusions : Combination treatment with 0.025% atropine and DIMS spectacle lenses is more effective in controlling axial elongation than 0.025% atropine with SV lenses in a European population. The differences in SER between the groups were not significant. The AL increase in group B was less than that previously reported with DIMS lenses alone in Asian and European children over 12 months. These findings suggest that other factors, such as pupil size, may enhance the efficacy of DIMS lenses in controlling axial elongation, supporting a possible synergistic effect of the two treatments.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.