Abstract
Purpose :
Phase 1 of the Myopia Outcome Study of Atropine in Children found a modest myopia control effect of atropine 0.01% at 24 months. To explore the impact of (i) sudden versus gradual 0.01% atropine cessation on myopia progression (rebound) and (ii) the safety and efficacy of atropine 0.05% eye drops in a European population, a follow-on crossover phase was conducted over an additional 12-month period.
Methods :
Of the 204 subjects who completed Phase 1, 199 consented to participate in the crossover phase. Participants using atropine 0.01% eye drops in Phase 1 were re-randomized to receive placebo eye drops nightly, placebo eye drops in a tapering regimen, or atropine 0.01% eye drops in a tapering regimen (1:1:2 ratio). Participants originally allocated to placebo were re-randomized to 0.05% atropine treatment. Linear mixed models were used to model change in refraction and axial length from the 24- to 36-month visit.
Results :
No significant differences were present in key characteristics of the 0.01%, 0.05% atropine and placebo groups at the 24-month visit (p>0.05 for all). 182 participants completed the 36-month study visit [67 (36.8%) 0.01% atropine group, 61 (33.5%) 0.05% atropine, 54 (29.7%) placebo]. The atropine 0.05% group had significantly less myopia progression compared to placebo (difference=+0.13 D, p=0.01), and significantly less eye growth compared to both placebo (difference=-0.05mm, p=0.008) and atropine 0.01% (difference=-0.04, p=0.04) groups, after adjusting for age, sex and other variables. No obvious rebound effect was noted in either sudden or tapered cessation groups. Adverse events potentially related to the study treatment occurred in 1/60 (1.7%), 2/73 (2.7%) and 12/66 (18.2%) of placebo, atropine 0.01% and atropine 0.05% group participants, respectively (p=0.001), no serious adverse events were reported. Compliance was similar across all groups (p=0.81).
Conclusions :
This is the first RCT of 0.05% atropine eye drops for the management of myopia progression in a predominantly White, European population. While treatment-related adverse events were more common in this group, the higher concentration was well tolerated, with no participants discontinuing treatment due to adverse events and only 5% requiring varifocal lenses to manage symptoms. A dose-response effect was observed, with significantly greater myopia control achieved with the higher concentration atropine.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.