Low-Dose Atropine for Treatment of Myopia

Summary

Study Objectives The objectives for this randomized trial are: 1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment). 2. To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment). Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.

Timeline

Start

2018-06-01

Primary completion

2022-04-15

Completion

2022-09-12

Publications

• Results Repka MX, Weise KK, Chandler DL, Wu R, Melia BM, Manny RE, Kehler LAF, Jordan CO, Raghuram A, Summers AI, Lee KA, Petersen DB, Erzurum SA, Pang Y, Lenhart PD, Ticho BH, Beck RW, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Aug 1;141(8):756-765. doi: 10.1001/jamaophthalmol.2023.2855.
• Weise KK, Repka MX, Zhu Y, Manny RE, Raghuram A, Chandler DL, Summers AI, Lee KA, Kehler LAF, Pang Y, Allen MS, Anderson HA, Erzurum SA, Golden RP, Koutnik CA, Kuo AF, Lenhart PD, Mokka PL, Petersen DB, Ticho BH, Wiecek EK, Yin H, Beaulieu WT, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Baseline factors associated with myopia progression and axial elongation over 30 months in children 5 to 12 years of age. Optom Vis Sci. 2024 Oct 1;101(10):619-626. doi: 10.1097/OPX.0000000000002187.

Drugs

Indications