Multifocal Contact Lenses and 0.01% Atropine Eye Drops for Myopia Control Study: Research Protocol for a 1-Year, Randomized, Four-Arm, Clinical Trial in Schoolchildren

Objectives: Previous studies have shown that combined use of orthokeratology and 0.01% atropine (AT) eye drops can strongly prevent axial elongation in myopic children. However, the efficacy of combined use with multifocal contact lens (MFCL) and 0.01% AT remains unclear. The aim of this trial is to clarify the efficacy of MFCL+0.01% AT combination therapy for myopia control and safety. Methods: This prospective study is a randomized, double-masked, placebo-controlled trial with four arms. A total of 240 children aged 6 to 12 years with myopia is recruited and randomly assigned to one of the four groups in a ratio of 1:1:1:1 as follows: group 1: MFCL+AT combination therapy, group 2: MFCL monotherapy, group 3: AT monotherapy, and group 4: placebo. The participants will continue the assigned treatment for 1 year. The primary and secondary outcomes are the comparisons of axial elongation and myopia progression in the four groups during the 1-year study period. Discussion: The present trial would determine whether the MFCL+AT combination therapy is more effective in slowing axial elongation and myopia progression in schoolchildren as compared with each monotherapy or placebo, and it also confirm acceptable safety of the combination therapy.