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Once myopia develops, appropriate clinical interventions need to be prescribed to slow its progression. Currently, several publications indicate that myopic defocus (MD) retards eye growth and myopia progression. However, no clinical trials have compared the outcomes of different MD spectacle lenses in the same observational group, especially in mainland China. The aim of the present study is to compare the myopia control efficiency of two different MD spectacle lenses: defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition lenses (PALs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The trial is designed as a 3-year, prospective, randomized, multicenter clinical trial of schoolchildren treated with DIMS lenses and PALs. A total of 600 Chinese primary school children aged 6\u201312\u2009years will be recruited, and each group is intended to include 300 subjects. The inclusion criteria are myopia between \u2212\u20091.00 and\u2009\u2212\u20095.00 diopters and astigmatism \u2264\u20091.50 diopters. The follow-up time points will be 1\u2009month (m), 3\u2009m, 6\u2009m, 12\u2009m, 18\u2009m, 24\u2009m, 30\u2009m, and 36\u2009m. The primary outcome will be determined by the difference between the two groups in cycloplegic spherical equivalent refraction between baseline and the last follow-up visit. The secondary outcome is the axial length, and the exploratory outcomes include ocular biometric measures, peripheral refraction, binocular vision, accommodation, compliance, and the results of questionnaires related to wearing experiences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The present study will be the first randomized controlled trial in myopic primary school children treated with DIMS lenses and PALs in China. The results will indicate whether and how much different MD mechanisms retard myopia progression and axial elongation. In addition, the comparison will provide information on the clinical efficacy and safety of DIMS lenses and PALs, including information related to wearing experiences and visual function.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      Chinese Clinical Trial Registry (ChiCTR), ChiCTR1900025645. Registered on 3 September 2019.\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.chictr.org.cn\/showproj.aspx?proj=42927\">http:\/\/www.chictr.org.cn\/showproj.aspx?proj=42927<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-020-4095-8","type":"journal-article","created":{"date-parts":[[2020,3,18]],"date-time":"2020-03-18T20:04:36Z","timestamp":1584561876000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":30,"title":["Evaluating the myopia progression control efficacy of defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition spectacle lenses (PALs) in 6- to 12-year-old children: study protocol for a prospective, multicenter, randomized controlled trial"],"prefix":"10.1186","volume":"21","author":[{"given":"Yan","family":"Li","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yafei","family":"Fu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kai","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiming","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoqing","family":"Shi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mingwei","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,3,19]]},"reference":[{"issue":"5","key":"4095_CR1","doi-asserted-by":"publisher","first-page":"1036","DOI":"10.1016\/j.ophtha.2016.01.006","volume":"123","author":"BA Holden","year":"2016","unstructured":"Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. 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Informed consent will be obtained from all participants and their parents\/guardians prior to their inclusion in the study. The children and their parents\/guardians should both sign the informed consent form. The children sign the signature at \u201cSignature of the subject,\u201d and their parents\/guardians sign the signature at \u201cLegal guardian signature.\u201d In addition, the parents\/guardians should write down their relationship at the \u201cRelationship with the subject\u201d in the informed consent form. In each procedure during the clinical trial, all of the participants and their parents\/guardians should be involved. Patient recruitment had not yet started at the time of manuscript submission. The study had not yet gained ethical approval at both the central and local levels at the time of manuscript submission. Central ethical approval has been confirmed from Peking University People\u2019s Hospital (approval no. 2019PHA049-001), and we will not begin recruiting at other centers in the trial until local ethical approval has been obtained.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"279"}}