Control effect of dual-mechanism myopia control lenses on myopia in children and adolescents: a prospective,...

Myopia has become an increasingly serious global issue. Preventing myopia and avoiding the risks of high myopia has become an important concern for children, adolescents and their parents. Dual-mechanism myopia control lenses (DMMCL) is a specialized design spectacle lens based on peripheral defocus theory and retinal contrast theory. Although the benefits of peripheral defocus lenses and retinal contrast-designed lenses (RCDL) in myopia prevention have been confirmed, whether the lenses integrating both two designs can effectively prevent further progression of myopia still requires further research.

To report the protocol of a clinical trial designed to evaluate the efficacy and safety of DMMCL vs. RCDL alone for slowing the progression of myopia among school-age children in China. The primary objective of this study is to evaluate whether DMMCL are equivalent to RCDL in controlling myopia progression.

This is a prospective, single-center, non-randomized, equivalence trial designed to compare the efficacy and safety of DMMCL vs. RCDL for controlling myopia progression in children aged 6-12 years over a 12-month period. The primary outcome is change in axial length (AL) from baseline to 12 months. We hypothesize that the two treatments are equivalent within a prespecified margin of ±0.15 mm. This study will enroll 120 myopic children, aged 6-12 years, with cycloplegic spherical equivalent (SE) ranging from -0.50 D to -6.00 D in both eyes. Eligible participants will be assigned to the DMMCL group (n = 60) or the RCDL group (n = 60) according to their own preferences, or those of their guardians. Participants will be advised to wear their assigned spectacles full-time throughout the trial. All participants will be advised to engage in at least 2 h outdoors per day and will be scheduled for regular follow-up visits. AL, cycloplegic SE, and binocular visual function will be assessed at baseline and throughout the 12-month study period. Both groups will complete questionnaires on adaptation and visual quality one week and one month after wearing the lenses. Participants from both groups will require a follow up visit every 3 months. The primary endpoint is the 12-month change from baseline in AL. Secondary outcomes include changes in cycloplegic SE and binocular vision. Adaption and vision quality questionnaire results are pre-specified outcomes.

Primary outcomes: Twelve-month changes in AL Secondary outcomes: Twelve-month changes in SE from baseline and binocular visual function parameters. Other pre-specified outcomes Adaption and vision quality questionnaire results.

The future findings of this trial are expected to provide valuable reference for optimizing myopia management strategies and may contribute to the evidence base that informs pediatric eye care policy.Trial Registration: https://www.chictr.org.cn/, https://www.chictr.org.cn/showproj.html?proj=301629, identifier ChiCTR2600116438.