[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tianjin Medical University Eye Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,71],{"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":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100627485","phase-1-protect-study-prospective-research-on-optimizing-atropine-concentration-escalation-for-childrens-myopia-prevention-100627485","NCT07449247","PROTECT-Study: Prospective Research on Optimizing Atropine Concentration Escalation for Children's Myopia Prevention","PROTECT","Inclusion criteria:\n\n1. A written informed consent form signed by the child and their legal guardian has been obtained.\n2. Children aged 6 to 9 years (inclusive).\n3. Equivalent spherical diopter of computerized refraction after bilateral ciliary muscle paralysis: 0D\\\u003CSE. The upper limit standards for SE are set as follows for different age groups: 6 years old: P25 = +1.13D,7 years old: P25 = +1.00D,8 years old: P25 = +0.88D,9 years old: P25 = +0.63D.\n4. After bilateral ciliary muscle paralysis, the astigmatism detected by computerized refraction is ≤1.00D.\n5. Anisometropia ≤1.5D.\n6. No other organic lesions affecting visual acuity in both eyes.\n7. Unaided visual acuity ≥0.8.\n8. Ocular intraocular pressure (IOP) ≤21 mmHg.\n\nExclusion criteria:\n\n1. Subjects who may have ocular diseases affecting vision or refractive errors (such as lens damage diseases like cataract, glaucoma, macular degeneration, corneal lesions, uveitis, retinal detachment, severe vitreous opacity, etc.).\n2. Systemic diseases: Immune system disorders, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary dysfunction, and a history of severe hepatic or renal dysfunction.\n3. Bilateral or unilateral ocular involvement with dominant strabismus or any other pathological ocular changes or acute inflammatory eye diseases.\n4. Patients who have undergone myopia control treatments, including pharmacological therapy (e.g., atropine or piperazine), orthokeratology, multifocal soft lenses, multifocal hard lenses, functional eyeglass frames, or red light therapy.\n5. Exclude patients who have used drugs affecting efficacy evaluation (e.g., anticholinergic agents: atropine, piperazine; cholinergic agents: pilocarpine) for systemic or local use within the preceding 3 months.\n6. Patients with hypersensitivity to atropine, cipretosil, or other drugs used in this study.\n7. Exclude participants who have participated in other drug clinical trials within the past 3 months.\n8. Other circumstances deemed unsuitable by the investigator.\n9. Individuals with chronic mental disorders or psychiatric abnormalities.\n10. Those with an adjustment range below 8D.",true,"6 Years","9 Years",{"count":55,"type":21},233,"INTERVENTIONAL",[58,59],"PHASE1","PHASE2","A prospective multicenter study design was adopted. Children aged 6-9 years with premyopia who met the criteria were screened and administered after completion of baseline assessment. Phase I: 0-24 weeks (0-6M). 0.01% atropine eye drops, once daily, at point in both eyes. Phase II: 24-48 weeks (6-12M). According to the rate of myopia progression at 0-24 weeks (6M), the atropine concentration was increased in steps; once daily, at point in both eyes. Group A: ( SE ≤ 0.25D), continued to maintain 0.01% atropine. Group B: (0.25D \\\u003C SE ≤ 0.375D), converted to 0.02% atropine. Group C: ( SE \\> 0.375D), converted to 0.04% atropine. Followed up 5 times (0, 3, 6, 9, 12 months), collected refractive, ocular axis, intraocular pressure and other data, and recorded adverse events and cost information synchronously. Statistical analysis was carried out by covariance analysis and multivariate model, and pharmacoeconomic evaluation and drug proportion analysis were carried out.",[62],"Pre-myopia","2026-02-26",{"date":65,"type":37},"2026-03-04",{"date":67,"type":21},"2026-03-30",{"date":69,"type":21},"2027-06-30",{"name":42,"class":43},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":56,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100495230","microinvasive-pars-plana-vitrectomy-combined-ilm-peeling-versus-anti-vegf-intravitreal-injection-for-treatment-nave-diabetic-macular-edema-100495230","NCT05728476","Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema","Inclusion Criteria:\n\n* ≥18 years of age\n* Patients and their families fully understand the research and sign the informed consent form\n* Diagnosed with type 1 or 2 diabetes mellitus\n* Hemoglobin A1c (HbA1c) of less than 10% within 3 months\n* Clear media for adequate OCT and optical coherence tomography angiography (OCTA) images\n* Treatment-naïve DME diagnosed clinically\n* Central subfield thickness (CST) of \\>300μm and intra- or subretinal fluid seen on (spectral-domain) SD-OCT\n* Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA between 24 and 73 letters on the day of randomization\n* Treatment within 12 months of DME diagnosis\n* No contraindication of vitrectomy or conbercept intravitreal injection\n\nExclusion Criteria:\n\n* Any previous DME treatment (i.e. anti-VEGF injections, intraocular corticosteroids, macular photocoagulation)\n* Macular edema caused by other disease (i.e. neovascular age-related macular degeneration, retinal vein occlusion, uveitis)\n* Any previous intraocular surgeries (cataract surgery performed at least 3 months before study entry will not be exclusionary)\n* Vision loss caused by other ocular disease (i.e. cataract, proliferative diabetic retinopathy, glaucoma, high myopia)\n* A follow-up duration of less than 12 months\n* Severe dysfunction of the heart, liver, kidney, lung and other organs","18 Years",{"count":79,"type":21},102,[81],"NA","Diabetic macular edema (DME) is the main cause of vision loss in patients with diabetes. At present, anti-vascular endothelial growth factor (VEGF) intravitreal injection is the first-line therapy for DME, nevertheless, some patients do not respond well to anti-VEGF agents and often require multiple injections, which increases the psychological and economic burden of patients. Microinvasive pars plana vitrectomy (PPV) has been proven to be safe and effective for refractory DME. However, there are few studies on treatment-naïve DME. The purpose of this study is to explore whether early PPV combined with internal limiting membrane (ILM) peeling can reduce the treatment burden of DME patients, prevent vision loss, and maintain long-term stabilization of diabetic retinopathy.",[84,85,86],"Diabetic Macular Edema","Pars Plana Vitrectomy","Conbercept","RECRUITING","2024-03-05",{"date":90,"type":37},"2024-03-06",{"date":88,"type":37},{"date":93,"type":21},"2026-09-05",{"name":42,"class":43},1,""]