[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pre-myopia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pre-myopia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,69,94,115,139],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100652848","a-pilot-evaluation-of-refractive-error-progression-in-pre-myopic-children-in-singapore-with-and-without-myopia-control-spectacles-100652848",false,"NCT07779941","A Pilot Evaluation of Refractive Error Progression in Pre-Myopic Children in Singapore With and Without Myopia Control Spectacles","Inclusion Criteria\n\nParticipants enrolled in the trial must:\n\n1. be accompanied by a parent or guardian who is able to read and comprehend English and sign a record of informed consent\u002Fassent;\n2. be able to understand and participate in the Assent process;\n3. at baseline, be within the age range of 6 to 12 years old inclusive;\n4. No prior spectacle correction\n5. Cycloplegic spherical equivalent (SE) 0.00 to + 2.00 D\n6. Astigmatism of less than -1.50D\n7. Anisometropia of not more than 1.50D\n8. At least 1 parent or more with myopia\n\nExclusion Criteria\n\nParticipants enrolled in the trial must NOT have:\n\n* Any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error;\n* Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus.\n* Use of or a need for any systemic medication or topical medications which may alter normal ocular findings \u002F are known to affect a participant's ocular health \u002F physiology in an adverse or beneficial manner at enrolment and\u002For during the study. NB: Systemic antihistamines are allowed on an \"as needed basis\", provided they are not used prophylactically during the trial and at least 24 hours before the study product is used.\n* History of eye trauma\n* Amblyopia\n* Strabismus\n* History of any form of optical correction\n* Any concomitant myopia control treatment including atropine eyedrops, contact lenses or other myopia control glasses.\n\nThe Investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the study requirements or it is believed to be in the participant's best interests.",true,"ALL","6 Years","12 Years",{"count":20,"type":21},124,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to find out whether ZEISS MyoActive lenses can help prevent short-sightedness from developing in children. We aim to recruit at least 50 children in total for this study.\n\nMyopia (short-sightedness) is becoming increasingly common in children worldwide. Early onset of myopia often leads to faster progression and a higher chance of developing high myopia, which increases the risk of serious eye conditions that can affect vision in adulthood, such as retinal detachment, glaucoma, and cataracts. Current treatments can slow the worsening of short-sightedness once children become myopic, but there is limited evidence on whether early intervention can delay myopia from developing in the first place.\n\nThis study will compare two types of commonly used spectacle lenses:\n\nZEISS MyoActive lenses, which are designed to provide a type of optical signal that may reduce the worsening of short-sightedness; and Standard single-vision lenses, which are the usual lenses prescribed for clear vision.\n\nChildren who join the study will be randomly assigned to wear one of these two lens types for 12 months. They will attend regular check-ups during this time so we can monitor their eye health and vision.\n\nBy randomly assigning children to one of these two lens types and following them over 12 months, we aim to determine whether ZEISS MyoActive lenses:\n\nreduce the likelihood of developing short-sightedness, slow changes in how short-sighted a child's eyes are becoming and eye growth, and are safe, comfortable, and well-tolerated for everyday use. The findings from this study may help improve early myopia prevention strategies and potentially reduce future risks of high myopia and its associated eye conditions.",[27,28],"Myopia","Pre-myopia",[30,31],"myopia","pre-myopia","NOT_YET_RECRUITING","2026-08-18",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":21},"2026-08",{"date":40,"type":21},"2029-02",{"name":42,"class":43},"Singapore National Eye Centre","OTHER_GOV",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":17,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":44},"100651827","myopia-prevention-in-young-premyopic-children-using-defocus-incorporated-multiple-segments-spectacle-lenses-100651827","NCT07765550","Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Age between 3 and 6 years (inclusive), regardless of gender or ethnicity.\n* Cycloplegic spherical equivalent refraction (SER) of the worse eye \\> -0.50 D and ≤ +0.75 D, absolute cylindrical power ≤ 1.0 D, anisometropia ≤ 1.5 D.\n* Best corrected monocular distance high contrast VA ≥ 0.5 for ages 3-5; ≥ 0.7 for age 6.\n* At least one parent with SER ≤-3.00D\n\nExclusion Criteria:\n\n* Individuals with any ocular or systemic diseases that may affect vision and refractive development (e.g., keratoconus, abnormalities in lens shape or position, Marfan syndrome, retinopathy of prematurity, etc.).\n* Individuals with known allergies or contraindications to cycloplegic agents.\n* Previous use of myopia management treatment (spectacles, atropine; CLs).\n* Individuals with binocular vision abnormalities: manifest strabismus, monocular suppression, abnormal fusion function, or impaired stereopsis.\n* Individuals unable to cooperate with examinations or communicate.\n* Any other conditions deemed by the investigator as unsuitable for participation in the study.","3 Years",{"count":53,"type":21},128,[24],"Pre-myopia refers to a condition in which children have not yet developed myopia but exhibit insufficient hyperopic reserve (≤ +0.75 D). This is particularly relevant for young children aged 6 years and under; if their hyperopic reserve is depleted prematurely and they progress into the pre-myopia stage, the likelihood of developing myopia or even high myopia in the future becomes extremely high. Therefore, this study plans to conduct a parallel-design, open-label, single-center randomized controlled clinical trial to evaluate the efficacy and safety of artificial intelligence-assisted defocus incorporated multiple segments (DIMS) based spectacle lens in preventing and controlling myopia in pre-myopic children aged 3 to 6 years.",[28,27],[31,58,59],"young children","AI-assisted DIMS-based spectacle lens","2026-08-17",{"date":33,"type":36},{"date":63,"type":21},"2026-09-12",{"date":65,"type":21},"2028-08-31",{"name":67,"class":68},"Shanghai Eye Disease Prevention and Treatment Center","OTHER",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":44},"100636480","evaluation-of-contact-lenses-and-myopia-100636480","NCT07566234","Evaluation of Contact Lenses and Myopia.","Myopia Prevention Study in Chinese Population With Dual Focus Myopia Control Lenses.","Inclusion Criteria:\n\n1. Male and female children aged between 8-10 years inclusive.\n2. Cycloplegic SER from -0.25 (non-inclusive) to +0.75 D (inclusive) in both eyes.\n3. Astigmatism ≤ -1.00D in both eyes.\n4. Un-corrected visual acuity (UCVA) ≤ 0.1 LogMAR.\n5. As applicable (dependent on local requirements), the subject and parent\u002Flegal guardian will have read the Informed Assent\u002FConsent, been given an explanation of the study, indicated an understanding and signed the forms.\n6. Along with their parent or guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to the instructions set forth in this protocol.\n7. Along with their parent or guardian, agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study.\n8. Agree and able to wear the assigned contact lenses successfully for a minimum of 10 hours per day, at least 6 days per week, for the duration of the study and to inform the study investigator if this schedule is interrupted. (Wearing time may be modified by the study staff for health reasons.)\n9. Be in good general health, based on his\u002Fher and parent's\u002Fguardian's knowledge.\n10. Any history of myopia control interventions with in 1 month must complete a 4-weeks of washout period.\n\nExclusion Criteria:\n\n1. History of myopia control intervention (e.g., atropine, orthokeratology, soft myopia control contact lenses, red light therapy, etc. over more than 1 month)\n2. Currently wears rigid gas permeable contact lenses, including orthokeratology lenses.\n3. Current use of systemic or ocular or medications which may affect contact lens wear, tear film production, pupil size, accommodation or refractive state.\n4. Ocular or systemic disease that contraindicates contact lens wear.\n5. Active allergic conjunctivitis.\n6. Any ocular, systemic or neuro-developmental conditions that could influence refractive development.\n7. Keratoconus or an irregular cornea.\n8. History of clinically significant binocular vision abnormality or strabismus.\n9. Any active anterior segment finding that would contraindicate contact lens wear.\n10. The investigator for any reason considers that it is not in the best interest of the subject to participate in the study.","8 Years","10 Years",{"count":79,"type":21},110,[24],"This study will evaluate the effect of dual focus contact lenses on Myopia prevention.",[28],"RECRUITING","2026-07-15",{"date":86,"type":36},"2026-07-16",{"date":88,"type":36},"2026-06-06",{"date":90,"type":21},"2029-05",{"name":92,"class":93},"CooperVision International Limited (CVIL)","INDUSTRY",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":44},"100592629","virtual-far-sight-reading-device-for-myopia-intervention-among-pre-myopic-children-100592629","NCT06995911","Virtual Far-sight Reading Device for Myopia Intervention Among Pre-myopic Children","A Randomized Controlled Clinical Trial on the Efficacy and Safety of the Virtual Far-sight Reading Device for Myopia Intervention in Pre-myopic Children","Inclusion Criteria:\n\n* Age: 6-12 years (inclusive), gender unrestricted.\n\n  * Worse eye cycloplegic spherical equivalent refraction (SER): -0.5 D \\\u003C SER ≤ +0.75 D; Cylinder ≤ -1.5 D in both eyes; Interocular anisometropia ≤ 1.5 D ③ Visual acuity: Best-corrected visual acuity (BCVA) ≤ 0.1 logMAR in both eyes. ④ Family history: At least one parent with myopia.\n\n    * Intraocular pressure (IOP): 10-21 mmHg in both eyes; Interocular IOP difference ≤ 5 mmHg\n\n      ⑥ Compliance: Commitment to daily home use of the Far-Image Light Field Desk per protocol, immediate notification to investigators if unable to comply, and completion of scheduled follow-ups.\n\n      ⑦ Informed consent: Signed assent form (minor) and written informed consent from legal guardian.\n\nExclusion Criteria:\n\n* Ocular comorbidities affecting vision\u002Frefractive development: Marfan syndrome; Lens pathologies (e.g., cataracts); Glaucoma; retinal detachment; retinopathy of prematurity\n\n  * Systemic diseases: Immune\u002FCNS disorders; Down syndrome; Severe cardiopulmonary\u002Fhepatic\u002Frenal dysfunction; Uncontrolled asthma\n\n    * Ocular abnormalities: Manifest strabismus; Binocular vision dysfunction; Pathological ocular changes or active ocular inflammation ④ Recent myopia interventions (within 3 months prior to screening): Orthokeratology; multifocal contact lenses; Functional spectacles, red-light therapy\n\n      ⑤ Medications affecting efficacy evaluation (within 3 months): Anticholinergics (e.g., atropine, pirenzepine); Cholinergics (e.g., pilocarpine)\n\n      ⑥ Participation in other clinical trials within 3 months.\n\n      ⑦ Contraindications\u002Fallergies to cycloplegics or study-related medications.\n\n      ⑧ Chronic psychiatric disorders or cognitive impairment.\n\n      ⑨ Other conditions deemed unsuitable by investigators.",{"count":102,"type":21},80,[24],"This clinical trial wants to find out if the Virtual Far-sight Reading Device can help prevent or slow down myopia progression in children and teenagers with pre-myopia. We also want to know what makes this treatment work better for some participants and check for any eye or body-related side effects over time.\n\nMain questions:\n\nCan using the Virtual Far-sight Reading Device reduce the risk of myopia? Is the device safe to use every day for up to 6 months?\n\nWhat we'll do:\n\nResearchers will compare two groups of children:\n\nGroup A: Uses the device for reading\u002Fwriting (at least 1 hour daily) Group B: Does regular reading\u002Fwriting without the device After 90 days, the groups will switch to see if the results stay the same.\n\nParticipants will:\n\n* Have free eye checkups 3 times over 6 months\n* Use the device during homework time (if in the desk group)\n* Report any eye discomfort or problems",[27,28],[27,28],"2026-05-21",{"date":109,"type":36},"2026-05-26",{"date":111,"type":36},"2025-06-01",{"date":113,"type":21},"2026-05-31",{"name":67,"class":68},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"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.","9 Years",{"count":124,"type":21},233,[126,127],"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.",[28],"2026-02-26",{"date":132,"type":36},"2026-03-04",{"date":134,"type":21},"2026-03-30",{"date":136,"type":21},"2027-06-30",{"name":138,"class":68},"Tianjin Medical University Eye Hospital",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":17,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":156,"leadSponsor":158,"locationsCount":44},"100606545","early-onset-myopia-intervention-project-100606545","NCT07176949","Early-Onset Myopia Intervention Project","Project on Myopia Surveillance and Intervention Services for Preschool Children in Shanghai","EOM","Inclusion Criteria:\n\n* Age 3-6 years, gender unrestricted;\n* Bilateral cycloplegic spherical equivalent (SE) ≤ +0.75 D, astigmatism ≤-2.5 D, anisometropia ≤2.5 D;\n* Best corrected visual acuity: ≥0.5 for ages 3-5, ≥0.7 for age 6;\n* Accept regular follow-up, written informed consent from guardians, verbal informed consent from children;\n* Possess normal thinking and language communication skills, and can actively cooperate to wear spectacles as required.\n\nExclusion Criteria:\n\n* Existence of strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and history of eye surgery;\n* Any ocular or systemic disease that may affect vision and refractive development (e.g., Keratoconus, Marfan syndrome, retinopathy of prematurity, etc.);\n* Current or previous use of other treatments for myopia intervention, such as pharmacological (atropine) and optical (orthokeratology lenses or DIMS spectacle lenses) approaches, interrupt use for at least 4 weeks;\n* Allergy or contraindication to cycloplegic drugs;\n* Epilepsy or other mental disorders unable to expressing consent;\n* Other conditions deemed unsuitable for participation by the researcher.",{"count":148,"type":21},508,[24],"The prevalence of myopia among children has been increasing year by year, which has become a globle public health issue. Studies have shown that defocusing lenses and atroping eyedrops can control the progression of myopia, but there is little evidence of its efficacy in myopia intervention of young pre-schoolers who will face a greater risk of progression to high myopia later in life. Therefore, this study aims to evaluate the effectiveness and safety of spectacle lenses with highly aspherical lenslets (Essilor's Stellest) , as well as 0.01% and 0.05% low concentration atropine eyedrops in myopia intervention among young children aged 3-6.",[27,28],"2025-09-10",{"date":154,"type":36},"2025-09-16",{"date":111,"type":36},{"date":157,"type":21},"2028-05-31",{"name":67,"class":68}]