Much effort is going into understanding the impact of combined treatments for myopia management, but little is known about the effect of multifocal contact lenses (MFCLs) with low dose atropine (AT).
However, that is about to change with Dr Takahiro Hiraoka and colleagues from the University of Tsukuba in Japan enrolling patients for a randomised, double-masked, placebo-controlled trial that will investigate the efficacy and safety of combined MFCLs and 0.01% AT.
They have published a research protocol in the Eye & Contact Lens journal.
“Previous studies have shown that combined use of orthokeratology and 0.01% AT eye drops can strongly prevent axial elongation in myopic children,” they wrote.
“However, the efficacy of combined use with 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.”
The study will comprise four arms. It will recruit 240 children aged 6 to 12 years with myopia who will be randomly assigned to one of the four groups in a ratio of 1:1:1:1.
Group 1 will include MFCL+AT combination therapy, group 2 will be prescribed MFCL monotherapy, group 3 will be given AT monotherapy, and group 4 will be the placebo control.
The participants will continue the assigned treatment for one year, with the primary and secondary outcomes being the comparison of axial elongation and myopia progression in the four groups during that duration.
“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,” the researchers concluded.
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