Myopia control efficacy of topical Caffeine alone and in combination with Atropine – Results from a prospective, longitudinal clinical trial- Part I

Abstract

Purpose : To determine the role of topical Caffeine, a Xanthine derivative in slowing myopia either alone or in combination with Atropine.

Methods : In a prospective, randomized, dispensing clinical trial, 96 Vietnamese children with myopia (mean age 10.4 ± 2.0 years, -4.1±1.3D) were randomized to nightly use of either 2% Caffeine, 0.02% Atropine with 2% Caffeine, or 0.02% Atropine (Customcare Compounding Pharmacy, NSW, Australia). Additionally, 86 children with myopia (mean age 10.1 ± 2.1 years, -3.3±1.4D) were enrolled concurrently in a parallel group to wear single vision spectacles only. Cycloplegic autorefraction was conducted six monthly in addition to baseline using a Shin-Nippon NK5001 autorefractor. Axial length was assessed 3-monthly in addition to baseline using a Lenstar LS900. Comparison for change in cycloplegic spherical equivalent and axial length between groups was performed using a linear mixed model. Post-hoc multiple comparisons were conducted using Bonferroni corrections. Level of significance was set at 0.05%.

Results : All groups progressed in myopia. At twelve months, there was a significant difference in progression between the groups. Unadjusted change in spherical equivalent and axial length in the single vision spectacle lens group was -0.76D±0.51D/0.37±0.20mm. In comparison, change in spherical equivalent/axial length with 2% Caffeine, 0.02% Atropine with 2% Caffeine, or 0.02% Atropine was -0.70±0.55D/0.35 ±0.23mm, -0.47±0.38D/0.23 ±0.18mm and -0.46±0.50D/0.24 ±0.19mm, respectively. After adjusting for confounders, change in axial length was found to be significantly less with 0.02% Atropine (p <0.001), and 0.02% Atropine with 2% Caffeine (p=0.047) in comparison to single vision spectacles and change in spherical equivalent was significantly less with 0.02% Atropine compared to spectacle lens wearers (p=0.004). The 12-month progression was similar between those randomized to 2% Caffeine and single vision spectacle wearers (p=1.000). The change in progression between 0.02% Atropine versus 2% Caffeine with 0.02% Atropine was similar (p=1.000).

Conclusions : When used in isolation, topical caffeine did not have an impact on progression of myopia. When combined with Atropine, it had no impact on the efficacy of Atropine in slowing myopia.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.