{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T05:10:29Z","timestamp":1789017029614,"version":"build-2803163510"},"reference-count":31,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T00:00:00Z","timestamp":1788998400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"\n Background<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Purpose<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Method and analysis<\/jats:title>\n \n 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\u201312 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 \u00b10.15\u2005mm. This study will enroll 120 myopic children, aged 6\u201312 years, with cycloplegic spherical equivalent (SE) ranging from \u22120.50 D to \u22126.00 D in both eyes. Eligible participants will be assigned to the DMMCL group (\n n<\/jats:italic>\n \u2009=\u200960) or the RCDL group (\n n<\/jats:italic>\n \u2009=\u200960) 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\u2005h 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.\n <\/jats:p>\n <\/jats:sec>\n \n Outcome<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n 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.<\/jats:p>\n \n Trial Registration<\/jats:bold>\n :\n https:\/\/www.chictr.org.cn\/<\/jats:ext-link>\n ,\n https:\/\/www.chictr.org.cn\/showproj.html?proj=301629<\/jats:ext-link>\n , identifier ChiCTR2600116438.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.3389\/fmed.2026.1931165","type":"journal-article","created":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T04:28:58Z","timestamp":1789014538000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Control effect of dual-mechanism myopia control lenses on myopia in children and adolescents: a prospective, 12-month, non-randomized, parallel-controlled, and single-center trial protocol"],"prefix":"10.3389","volume":"13","author":[{"given":"Ling","family":"Wang","sequence":"first","affiliation":[{"name":"Department of Optometry Engineering, Jinling Institute of Technology","place":["Nanjing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qing","family":"Zhang","sequence":"additional","affiliation":[{"name":"Ophthalmology Department, Nanjing Vision Jingling Eye Hospital","place":["Nanjing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shao-qi","family":"Zhou","sequence":"additional","affiliation":[{"name":"Ophthalmology Department, Fuyang Vision Zeming Eye Hospital","place":["Fuyang, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Huang","sequence":"additional","affiliation":[{"name":"Ophthalmology Department, Nanjing Vision Jingling Eye Hospital","place":["Nanjing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ting-Ting","family":"Zhou","sequence":"additional","affiliation":[{"name":"Ophthalmology Department, Nanjing Vision Jingling Eye Hospital","place":["Nanjing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yue-Si","family":"Gu","sequence":"additional","affiliation":[{"name":"Ophthalmology Department, Nanjing Vision Jingling Eye Hospital","place":["Nanjing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen-xin","family":"Wang","sequence":"additional","affiliation":[{"name":"Ophthalmology Department, Nanjing Vision Jingling Eye Hospital","place":["Nanjing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,9,10]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"Mi","DOI":"10.1167\/iovs.18-25983","article-title":"Myopia\u2014a 21st century public health 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