A randomized controlled clinical study of 0.01% and 0.02% atropine eye drops on myopia development in adolescents

Objective

To compare the clinical efficacy and safety of 0.01% and 0.02% atropine eye drops on myopia development in adolescents.

Methods

A randomized controlled double-blind study was carried out.Two hundred and eighty myopic adolescents (280 eyes) with spherical equivalent (SE) from -1.25 to -6.0 D were enrolled in The First Affiliated Hospital of Zhengzhou University from June 2016 to June 2017.All the subjects wore full-correction single vision spectacle lenses before topical administration of atropine eye drops.The subjects were randomly divided into 0.01% atropine group (142 eyes) and 0.02% atropine group (138 eyes) according to the random number table method.Atropine 0.01% or 0.02% eye drops was topically used in the test eye once per night according to grouping, and the related parameters of the right eyes were collected for data analysis.The subjects were followed up at the 1st, 4th, 8th and 12th month following administration.The SE was measured with an autorefractor to evaluate the refractive change.The anterior chamber depth, corneal curvature and axial length (AL) were measured with an IOLMaster.The adverse responses of atropine eye drops were investigated via a questionnaire.This study protocol adhered to the Declaration of Helsinki and was approved by an Ethics Committee of The First Affiliated Hospital of Zhengzhou University (No.2016-35). Written informed consent was obtained from subjects and their guardian prior to entering the cohort.

Results

The follow-up rate of 0.01% atropine group was 83.8%, and the follow-up rate of 0.02% atropine group was 84.8% at the end of following-up.SE and AL increased by (-0.47±0.32)D and (0.37±0.20)mm in 0.01% atropine group, and (-0.38±0.35)D and (0.30±0.17)mm in 0.02% atropine groups during the following-up, respectively, showing statistically significant differences between two groups (P=0.040, 0.004). After adjusting age, body mass index and baseline SE, the analysis by generalized additive mixed model showed that the increase rate of SE was -0.039 D/month and -0.032 D/month in 0.01% and 0.02% atropine group, respectively (P_interaction=0.041). After adjusting age, body mass index and baseline AL, the analysis of mixed effect model showed that the increase rate of AL was 0.031 mm/month and 0.025 mm/month in 0.01% and 0.02% atropine group, respectively (P_interaction=0.032). In 0.01% and 0.02% atropine groups, 32 cases (26.9%) and 33 cases (28.2%) occurred photophobia from 1st to 4th week during administration, and 7 cases (5.9%) and 7 cases (6.0%) appeared near-vision blur from 2nd to 4th week.Allergic response occurred in 0.01% atropine group at 1 month of treatment, and the symptom disappeared after interruption of the medication for two days.

Conclusions

The incidence of adverse resoponses of 0.01% and 0.02% atropine eye drops is similar.Atropine 0.02% eye drops is more effective in controlling myopia progression.