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Opt."],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Stage 2 of the Childhood Atropine for Myopia Progression (CHAMP) study was conducted to observe the safety, efficacy and rebound effects of low-dose atropine sulphate ophthalmic solutions (0.01% and 0.02%) for paediatric myopia in the year following cessation of 3 years of prior treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The study was a multicentre, randomised, double-masked, placebo-controlled Phase 3 clinical trial. Children aged 3 to &lt; 17 years with myopia (spherical equivalent refractive error (SER) from \u22120.50 to \u22126.00\u2009D) who entered and completed Stage 1 (3 years of treatment) participated in the fourth-year follow-up (Stage 2). Stage 1 participants who were treated with atropine 0.01% or 0.02% were re-randomised 1:1:1 to atropine 0.01%, atropine 0.02% or vehicle in Stage 2. Stage 1 vehicle-treated participants were re-randomised 1:1 to atropine 0.01% or atropine 0.02% in Stage 2. Outcomes included changes in cycloplegic SER, changes in axial length (AL), responder status continuity and progression to high myopia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Four hundred and twenty participants were randomised in Stage 2. Negligible rebound was observed among the participants who switched from 0.01% atropine to vehicle compared to those who continued on 0.01% atropine treatment (least square mean difference in SER change from Month 36 to Month 48 between continued treatment and switching to vehicle\u2009=\u20090.019\u2009D, 95% CI [\u22120.14, 0.18],\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.82 for the modified Intent to Treat set). Stage 1 responders remained responders in 83-90% of participants in various Stage 2 groups. Safety profiles were favourable, with mild, transient adverse events.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Atropine sulphate ophthalmic solution (0.01%) exhibited negligible rebound in myopia progression after treatment cessation following 3 years of continued treatment, highlighting its potential as a treatment option. The treatment maintained a favourable safety record, and the overall benefit and risk assessment support its potential use as a long-term myopia management option.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>The Childhood Atropine for Myopia Progression (CHAMP) study was registered in clinicaltrials.gov (NCT03350620, registration date November 17, 2017).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s44402-026-00064-w","type":"journal-article","created":{"date-parts":[[2026,4,8]],"date-time":"2026-04-08T09:20:23Z","timestamp":1775640023000},"page":"626-634","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Negligible Rebound in Myopia Progression Following Cessation of Treatment with 0.01% Atropine for 3 years: Year-4 Results from the CHAMP Phase 3 Clinical Trial"],"prefix":"10.1007","volume":"46","author":[{"given":"Karla","family":"Zadnik","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erica","family":"Schulman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian","family":"Flitcroft","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer S.","family":"Fogt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louis C.","family":"Blumenfeld","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tung M.","family":"Fong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Lang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon P.","family":"Chandler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Houman D.","family":"Hemmati","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the CHAMP trial Group Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,4,8]]},"reference":[{"key":"64_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, et al. 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Ian Flitcroft reported receiving consulting fees from Vyluma Inc., personal fees from CooperVision, EssilorLuxottica, Johnson & Johnson Vision, and Thea and contractual fees for analyses from Ocumetra. Jennifer S. Fogt reported receiving grants from Vyluma Inc., Bausch+Lomb, Eyenovia, Innovega, CooperVision and Interojo; personal fees from Alcon and financial support from Tearoptix outside the submitted work. Louis C. Blumenfeld reported receiving personal fees from Vyluma Inc. during the conduct of the study. Tung M. Fong, Simon P. Chandler, Eric Lang and Houman D. Hemmati reported being employees of Vyluma Inc. during the conduct of the study.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"This study was reviewed and approved by the concerned institutional review board (IRB) in the US or independent ethics committee (IEC) in Europe.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"All participants and\/or parents\/guardians consented to participate and were free to withdraw at any time. Multiple consent\/assent forms were used: informed consent form (ICF) for parents\/guardians, informed assent form for children (age ranges of the different assent forms varied by country) and an ICF for subjects 18 years of age.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Patient Consent Statement"}}]}}