Study will evaluate multifocal contact lens, atropine drop therapy for myopia in children
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Enrollment is underway for a study evaluating the combined use of multifocal contact lenses and 0.01% atropine eye drops in the management of myopia in children, according to a research protocol published in the Eye & Contact Lens.
“Combining myopia control treatments with different mechanisms of action has been receiving a great deal of attention recently because it could be more effective than monotherapies in slowing myopia progression,” Takahiro Hiraoka, MD, and colleagues from the University of Tsukuba in Japan wrote.
With limited data on the efficacy of multifocal contact lenses (MFCLs) and atropine for myopia control, researchers are conducting a 1-year, randomized controlled trial to determine whether the use of MFCLs and 0.01% atropine combination therapy “is more effective for myopia control in schoolchildren than monotherapy using either therapeutic option or a placebo.”
Hiraoka and colleagues aim to enroll 240 children aged 6 to 12 years with myopia in a prospective study, in which participants will be assigned to one of four groups: MFCL/atropine combination therapy, MFCL monotherapy, atropine monotherapy or placebo. Throughout the 1-year study period, researchers will compare axial elongation and myopia progression between the four groups.
Although the first patient was enrolled in August 2021, the pandemic delayed the trial, and recruitment has been extended to Dec. 31, 2023. Twenty-five participants are currently enrolled and undergoing follow-up visits, which are scheduled at 2 weeks and 3, 6, 9 and 12 months.
“We believe that our multi-arm trial, which includes a control arm, will clarify the efficacy, safety and limitations of MFCL and 0.01% [atropine] combination therapy and broaden the available therapeutic strategies for myopia control,” Hiraoka and colleagues wrote.
Perspective
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This protocol outlines the plans for a 1-year study evaluating the effects of MFCLs and atropine 0.01% to slow axial length in children 6 to 12 years old. Combination therapy is still a developing topic in myopia management, and the results of this study will impact clinical practice.
Previous studies with orthokeratology show the addition of atropine further slows axial elongation, whereas the addition of atropine to bifocal contact lens wear had no significant effect.
In this study, there will be four groups demonstrating the effects of MFCLs as monotherapy, atropine as monotherapy, combination therapy and placebo. Often a true placebo group is eliminated as it is deemed unethical to withhold treatment that has known efficacy. Additionally, the MFCL chosen for this study is a center near design. Most of the literature on multifocal contact lenses for myopia management support center distance design due to the induction of peripheral myopic defocus. Lastly, it has been recommended that myopia control clinical trials span at least 3 years to assess efficacy over time, as the extrapolation of 1-year results may lead to incorrect conclusions.
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