[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"progressive-myopia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:progressive-myopia":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100630986","efficacy-of-different-interventions-for-progressive-myopia-after-orthokeratology-lens-wear-100630986",false,"NCT07494799","Efficacy of Different Interventions for Progressive Myopia After Orthokeratology Lens Wear","A Prospective Study on the Efficacy of Different Interventions for Progressive Myopia in Children After Orthokeratology Lens Wear","Inclusion Criteria:\n\n1\\) The initial fitting age is between 8-12 years, irrespective of gender; 2) The spherical equivalent refraction (SE) of both eyes at the initial fitting falls within the manufacturer's approved range of -6.00D to -0.50D; 3) The best corrected visual acuity of both eyes is ≥1.0 (Snellen); 4) The ability to ensure overnight Ortho-K lens wear for a duration of 8 to 10 hours; 5) No prior history of ocular trauma or surgery; 6) No prior history of acute or chronic ocular inflammation, such as keratoconjunctivitis or abnormal tear film; 7) The ability to meticulously adhere to instructions for lens care and attend regular follow-up examinations; 8) The standard use of other myopia progression interventions, such as 0.01% atropine or red-light therapy as prescribed; 9) Comprehensive follow-up data; 10) At least one eye exhibits an annual axial length elongation of \\>0.30 mm during the first year of Ortho-K lens wear.\n\nExclusion Criteria:\n\n1\\) Axial length elongation less than 0.30 mm in both eyes during the first year of Ortho-K treatment; 2) Incidence of significant complications during the study period, such as recurrent corneal inflammation; 3) Incomplete data or cases lost to follow-up; 4) SE of either eye less than -6.00D, or astigmatism greater than -2.00D; 5) Unstable vision during Ortho-K treatment, characterized by multiple instances of vision below 0.2 (LogMAR); 6) Change in the brand of Ortho-K lens.\n\nThis study utilized a retrospective data collection approach. To prevent the influence of non-independent data from both eyes of a single participant on statistical analyses, data from only one eye per subject were included in the final analysis. The selection criterion prioritized data from the right eye; however, if the right eye did not satisfy the primary inclusion criterion of \"annual axial elongation \\>0.30 mm,\" data from the left eye were used instead. This study was conducted in accordance with the Declaration of Helsinki and received approval from the Ethics Committee of the Tianjin Medical University Eye Hospital. Informed consent was obtained from the guardians of all participating children.","ALL","8 Years","12 Years",{"count":20,"type":21},3890,"ESTIMATED","OBSERVATIONAL","Myopia has emerged as a significant concern impacting the visual health of children and adolescents on a global scale. According to research conducted by Holden BA et al., it is projected that by the year 2050, the worldwide prevalence of myopia and high myopia will experience a substantial increase, affecting approximately 5 billion and 1 billion individuals, respectively, with particularly high prevalence rates observed in East Asia\\[1\\]. The persistent rise in myopia incidence, coupled with the escalation of complications associated with high myopia, is anticipated to exert complex socio-economic repercussions \\[2\\]. Consequently, the prevention of myopia onset and the management of axial length elongation have become critically important \\[3\\].\n\nOrthokeratology (Ortho-K) is a procedure that involves the overnight application of specially designed reverse geometry rigid gas permeable contact lenses to achieve temporary corneal reshaping and reduce myopia during the day\\[4,5\\]. In children with mild to moderate myopia, Ortho-K has demonstrated visual correction efficacy ranging from 80% to 92%\\[6,7\\]. Nonetheless, its efficacy in controlling myopia progression may not match its corrective efficacy. The therapeutic effect of Ortho-K in decelerating axial elongation is reported to range from 43% to 63%. Despite the use of Ortho-K, approximately 15% of children continue to exhibit rapid axial elongation exceeding 0.36 mm per year.\\[8,9\\].\n\nIn recent years, adjunctive interventions such as low-concentration atropine eye drops, modification of the back optical zone diameter (BOZD) of orthokeratology (Ortho-K) lenses, and low-level red-light therapy (RLRL) have been proposed to augment the myopia control efficacy of Ortho-K. Zhao et al. \\[10\\] reported that after one year of treatment with either atropine orthokeratology (AOK) or Ortho-K lenses in children aged 5-14 years, the axial length (AL) increased by 0.14 mm and 0.29 mm, respectively. Another study involving children aged 8-12 years \\[11\\] demonstrated that after one year of treatment, the AOK group exhibited a 17% reduction in AL growth (0.20 mm vs. 0.24 mm). Research conducted by Xiong et al. \\[12\\] indicated that for children whose eyes elongated by at least 0.50 mm within one year of Ortho-K wear, the combination of RLRL therapy with Ortho-K significantly reduced axial elongation compared to Ortho-K alone. Additional studies have suggested that decreasing the BOZD can enhance the extent and degree of mid-peripheral corneal steepening, thereby decelerating axial elongation \\[13-15\\].\n\nMost existing studies primarily compare a single intervention against a control group, thereby lacking direct \"head-to-head\" comparisons. Traditional meta-analyses are limited to comparing two interventions at a time and often fail to assess multiple treatments concurrently. Consequently, most meta-analyses offer only statistical insights into the efficacy of individual interventions. Clinically, it is common to combine two or more interventions to treat myopia, particularly in cases of rapidly progressive myopia. Previous research has indicated that combined interventions may have additive effects in the prevention and control of myopia; however, these findings require further empirical validation.\n\nThis study employs a retrospective approach to evaluate the efficacy of various treatment strategies in managing axial elongation in children aged 8-12 years who experience rapid axial progression following Ortho-K lens wear. The objective is to provide a scientific foundation for the development of personalized myopia control plans.",[25,26,27],"Progressive Myopia","Pediatric Myopia","Orthokeratology-related Myopia Progression",[29,30,31,32],"Repeated low-level red-light therapy","Orthokeratology","Atropine","Small optical zone design","NOT_YET_RECRUITING","2026-03-26",{"date":36,"type":37},"2026-04-01","ACTUAL",{"date":36,"type":21},{"date":40,"type":21},"2027-04-01",{"name":42,"class":43},"Tianjin Medical University Eye Hospital","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100490540","phase-3-mad-trial-myopia-atropine-dose-100490540","NCT05667454","MAD Trial: Myopia Atropine Dose","Investigator Led, Double-masked, Multicenter, Randomized Clinical Trial for the Comparison of Atropine 0.5% Versus Atropine 0.05% Eye Drops for the Prevention of Myopia Progression in Dutch Children","MAD","Inclusion Criteria:\n\n* Children aged 6 to ≤ 11 years with bilateral myopia\n* Onset of myopia ≥ 4 years of age\n* History of progression\n* SER of at least -1.00D and no greater than -6.00D in each eye measured using cycloplegic auto refraction\n* Intraocular pressure \\\u003C 21 mm Hg in each eye\n* Distance vision correctable to at least 0.1 Log MAR (logarithm of the minimum angle of resolution) in each eye\n\nExclusion Criteria:\n\n* Allergy to atropine or other excipients of the eye drops\n* History of amblyopia or strabismus\n* History of retinal dystrophy or systemic disorder\n* Abnormal ocular biometry aside from axial length\n* History of glaucoma\n* Chronic use of topical or systemic antimuscarinic\u002Fanticholinergic medications in the 21 days prior to screening, and\u002For anticipated need for chronic use over the duration of the study (i.e., more than 7 consecutive days in 1 month or more than a total of 30 days in 1 year).\n* Chronic use (more than 3 days a week) of topical ophthalmological medication (prescribed or over the counter) other than the assigned study medication. The use of artificial tears is allowed but not in the 1 hour before or after the administration of the study medication.\n* The anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. (i.e., \\\u003C 2 weeks)\n* Prior myopia treatments.\n* Employees of the study center and their family members.","6 Years","11 Years",{"count":55,"type":21},550,"INTERVENTIONAL",[58],"PHASE3","The goal of this interventional study is to compare the efficacy of Atropine 0.05% to Atropine 0.5% treatment against progression of axial length in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse. Subjects will use Atropine eye drops for a period of 3 years, followed by a 2 year observational period.",[25],[62,31,63,64],"Myopia","Axial length","Child","RECRUITING","2025-04-24",{"date":68,"type":37},"2025-04-27",{"date":70,"type":37},"2022-12-19",{"date":72,"type":21},"2029-04-01",{"name":74,"class":43},"Erasmus Medical Center",20]