[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"amblyopia-unilateral\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:amblyopia-unilateral":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100640023","a-comparative-study-of-the-efficacy-of-ar-based-amblyopia-training-therapy-and-occlusion-therapy-in-older-children-and-adults-with-amblyopia-100640023",false,"NCT07622576","A Comparative Study of the Efficacy of AR Based Amblyopia Training Therapy and Occlusion Therapy in Older Children and Adults With Amblyopia","Inclusion Criteria:\n\n1. Individuals aged 12 to 55 years (12 ≤ age ≤ 55 years). Written informed consent shall be obtained from participants aged 18 years and above, or their legal guardians for those aged 12 to 17 years.\n2. Unilateral amblyopia with the following criteria: the best-corrected visual acuity (BCVA) of the dominant eye ≥ 0.8, and an interocular BCVA difference of two or more lines. Participants shall have confirmed amblyopia with relevant risk factors and no organic ocular diseases.\n3. For Individuals with refractive errors: the spherical equivalent (SE) measured via cycloplegic autorefraction or phoropter refraction ≤ -6.00 D. All participants shall have received optical refractive correction for more than 3 months, with stable visual acuity (acuity change \\\u003C 1 line) within the latest 2 months.\n4. Individuals with orthotropic eye position, including patients with strabismic amblyopia after strabismus correction. The distance manifest deviation measured at 6 m using the prism and alternate cover test shall be within 5 prism diopters (△).\n5. Individuals who are willing to enroll in this study and are able to complete the entire trial protocol.\n\nExclusion Criteria:\n\n1. Participants with other organic ocular disorders, including media opacities, nystagmus, eccentric fixation, acute inflammatory conditions such as keratitis, optic neuropathy, including glaucoma, retinal lesions, and cortical visual impairment.\n2. Individuals diagnosed with tumors, cardiac diseases, hypertension, or epilepsy.\n3. Individuals with implanted electronic devices such as cardiac pacemakers.\n4. Individuals presenting with severe ocular inflammation, photophobia, or lacrimation in either eye.\n5. Individuals with a history of ocular surgery that affects visual function, excluding congenital cataract extraction combined with intraocular lens implantation, strabismus correction and blepharoptosis repair.\n6. Individuals with severe mental disorders or poor treatment adherence.\n7. Individuals currently using or planning to use medications that may affect visual function (mydriatic eye drops for refraction examination such as atropine are excluded).\n8. Individuals with diplopia or inability to achieve binocular fusion during augmented reality-based amblyopia training.\n9. Individuals who received any amblyopia treatments except spectacle lenses within 2 weeks prior to screening.\n10. Individuals who enrolled in other clinical drug trials within 3 months or other medical device trials within 1 month before recruitment.\n11. Individuals who are unable to attend regular ophthalmological examinations.\n12. Individuals deemed ineligible by the investigators.","ALL","12 Years","55 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to investigate the efficacy and safety of dichoptic treatment based on Augmented Reality (AR) technology in treating monocular amblyopia aged 12 to 55 years, and compare dichoptic AR treatment with the standard patching therapy. The main questions it aims to answer are:\n\nDoes dichoptic AR treatment safely and effectively improve visual acuity and other monocular\u002Fbinocular visual functions in older children and adults with amblyopia? Is binocular therapy superior to occlusion therapy?",[26,27],"Amblyopia","Amblyopia Unilateral",[26,29,30,31,32],"Dichopitc treatment","Binocular treatment","Patching","Occlusion","NOT_YET_RECRUITING","2026-05-28",{"date":36,"type":37},"2026-06-03","ACTUAL",{"date":39,"type":20},"2026-06-01",{"date":41,"type":20},"2027-05-31",{"name":43,"class":44},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":45},"100610327","phase-1-valproate-for-the-treatment-of-residual-amblyopia-100610327","NCT07226141","Valproate for the Treatment of Residual Amblyopia","VARA","Inclusion Criteria:\n\n1. Age 8-17 years\n2. Amblyopia associated with strabismus and\u002For anisometropia\n\n   * Criteria for strabismus: must meet at least one of the following:\n\n     * Heterotropia at distance and\u002For near with or without spectacle correction\n     * History of strabismus surgery\n     * Documented history of strabismus that is no longer present and felt by the investigator could have caused the amblyopia\n   * Criteria for anisometropia: must meet at least one of the following:\n\n     * ≥ 0.50 D difference in spherical equivalent between eyes\n     * ≥ 1.50 D difference in astigmatism in any meridian between the eyes\n3. Visual acuity measured in each eye within 7 days prior to enrollment using ETDRS protocol on a study certified visual acuity tester as follows:\n\n   * Amblyopic eye visual acuity of 20\u002F40 - 20\u002F400\n   * Sound eye acuity of ≥ 20\u002F25.\n4. Current amblyopia treatment (other than spectacle correction)\n\n   * Subjects actively patching at the time of enrollment screening should continue patching through enrollment\n   * Visual acuity in amblyopic eye has not improved ≥ 1 line (5 letters) by the same testing method from a previous visit ≥ 8 weeks earlier while on treatment\n\n     * Since this determination is a pre-study examination, the method of visual acuity testing is not mandated\n   * Atropine treatment at any time during this pre-enrollment period is not allowed\n   * Any treatment prior to the current patching episode with stable acuity is allowed\n5. Spectacle correction for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction \\\u003C 6 months old:\n\n   • Requirement for spectacle correction:\n   * Spherical equivalent must be within 0.50 D of fully correcting anisometropia\n   * Hyperopia ≥ 3.00 D must be corrected\n   * Hyperopia may not be undercorrected by \\> 1.50 D spherical equivalent and must be symmetrically reduced in each eye\n   * Cylinder power must be within 0.50 D of fully correcting the astigmatism\n   * Cylinder axis must be within 6 degrees of the axis in the spectacles when the cylinder power is ≥ 1.00 D\n   * Myopia of the amblyopic eye \\> 0.50 D spherical equivalent must be corrected\n\n     ◊ Myopia may not be undercorrected by \\> 0.25 D or overcorrected by \\> 0.50D\n\n     • Spectacles meeting the above criteria must be worn:\n   * Until visual acuity in amblyopic eye has not improved ≥ 1 line (5 letters) by the same testing method during 2 consecutive visual acuity measurements at least 4 weeks apart (i.e. minimum of 8 weeks spectacle correction) ◊ Since this determination is a pre-study examination, the method of visual acuity testing is not mandated\n6. Eye examination within 6 months prior to enrollment\n7. Subject must be available for at least 6 months of follow-up, have access to a phone, and be willing to be contacted by clinical staff\n8. By investigator judgment, the subject is likely to comply with prescribed treatment (i.e. no prior history of poor compliance with patching) and unlikely to continue to improve with 2 hours of daily patching alone\n\n2.2.2 Exclusions\n\n1. Myopia \\> -6.00 D spherical equivalent\n2. Presence of associated findings that could cause reduced visual acuity\n\n   • Nystagmus does not exclude the subject if the above visual acuity criteria are met\n3. Previous intraocular or refractive surgery\n4. Strabismus surgery planned within 16 weeks\n5. Current vision therapy or orthoptics\n6. Known past or present liver or kidney disease\n7. Known past or present mitochondrial\u002Fmetabolic disorder\n8. Known past or present psychological problems\n9. Known allergies or contraindications to the use of valproate or anti-epileptic medication\n10. Current use of medication for the treatment of seizures, bipolar disorder, or migraine, or any medication on the appended list of medications that interact with valproate\u002Fvalproate acid and its derivatives which can be found here.\n11. Prior valproate use\n12. Known skin reaction to patch or bandage adhesives\n13. Treatment with topical atropine within the past 12 weeks\n14. Individuals capable of pregnancy who are pregnant, lactating, or may become pregnant within the next 6 months\n\n    * A negative urine pregnancy test will be required for all participants who have experienced menarche at the time of enrollment\n    * Individuals capable of pregnancy must convey an active suitable plan to avoid pregnancy that includes at least one of the following:\n    * Hormonal Contraceptives:\n\n      * Combined oral contraceptives (the pill)\n      * Contraceptive patch\n      * Vaginal contraceptive ring\n      * Progestin-only pills\n      * Hormonal injections (e.g., Depo-Provera)\n      * Hormonal implants (e.g., Nexplanon)\n    * Intrauterine Devices (IUDs):\n\n      * Copper IUD (e.g., ParaGard)\n      * Hormonal IUDs (e.g., Mirena, Skyla, Liletta)\n    * Barrier Methods with Spermicide (less commonly used alone but may be used in combination with other methods for added protection):\n\n      * Male condoms\n      * Female condoms\n      * Diaphragms with spermicide\n      * Cervical caps with spermicide\n    * Sterilization:\n\n      * Tubal ligation (for females)\n      * Vasectomy (Having a partner who has undergone a vasectomy, confirmed by semen analysis)\n    * Abstinence or True Sexual Abstinence:\n\n      o Refraining from heterosexual intercourse\n    * Requirements regarding the establishment of pregnancy status and monitoring for pregnancy over the course of the study may be further defined by the IRB","8 Years","17 Years",{"count":56,"type":20},28,[58,59],"PHASE1","PHASE2","The goal of this clinical trial is to determine the efficacy of valproate as an adjunct therapy to treat amblyopia beyond the critical period in children aged 8-17 years who have amblyopia of ≥3 lines of interocular best-corrected (with glasses) visual acuity difference.\n\nThe main questions it aims to answer are:\n\n* Does valproate enable clinically meaningful and durable visual recovery from amblyopia?\n* Do valproate-treated patients show a change in amblyopic eye visual acuity (lines)? Participants will undergo daily patching for 2 hours (standard of care) plus the addition of valproate or placebo for a total of 16 weeks.",[26,27,62,63],"Amblyopia, Anisometropic","Amblyopia Strabismic",[26,65,66,67,68,69,70,71,72,73,74,75,76,77],"valproate","valproic acid","pediatric","lazy eye","Histone deacetylase Inhibitor","HDAC","patching","eye patch","visual acuity","visual impairment","critical period","children","ophthalmology","2025-11-05",{"date":80,"type":37},"2025-11-10",{"date":82,"type":20},"2026-01-01",{"date":84,"type":20},"2027-09-30",{"name":86,"class":44},"Boston Children's Hospital",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":15,"minAge":94,"maxAge":17,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":45},"100554370","ar-training-versus-patching-in-unilateral-amblyopia-100554370","NCT06498206","AR Training Versus Patching in Unilateral Amblyopia","Dichoptic Augmented Reality (AR) Training Versus Patching for Unilateral Amblyopia in Children and Adults","Inclusion Criteria:\n\n1. Aged 5-55 years (including 5 years and 55 years);\n2. Best-corrected visual acuity worse than 20\u002F30 but no worse than 20\u002F200 in the amblyopic eye, interocular difference of 2 or more lines, with the better eye within the normal range;\n3. Patients have applied optical refractive correction for more than 3 months;\n4. Ability attend visits and complete the treatment;\n5. Normal binocular alignment including strabismic amblyopia with orthotropia after surgical correction, or intermittent exotropia within a range of -15 to 0 prism diopters measured by the prism cover test.\n\nExclusion Criteria:\n\n1. Organic eye diseases preventing the establishment of good vision (e.g. ptosis, media opacity, nystagmus, paracentral fixation, acute inflammation like keratitis, optic nerve diseases like glaucoma, retinal diseases);\n2. Lesions of the brain preventing the establishment of good vision (e.g. cortical visual impairment);\n3. Implantable electronic device;\n4. A history of ocular surgery (except strabismus surgery) affecting vision (e.g. retinal detachment repair);\n5. A history of ocular trauma affecting vision;\n6. Receiving amblyopia therapy (except wearing glasses) within 2 weeks prior to presentation;\n7. History of epilepsy or mental illness, or cognitive defects;\n8. Currently taking medications or needing to take medications during the study period that may affect vision;\n9. Inability to comply with the treatments or follow-up visits required;\n10. Participation in clinical trials on drugs within 3 months prior to presentation, or clinical trials on other medical devices within 30 days prior to presentation.","5 Years",{"count":96,"type":20},114,[23],"This is a multi-center, randomized controlled trial to compare the effectiveness of AR training with patching for the treatment of unilateral amblyopia.\n\nSpecific Aim 1 (Primary): To compare the improvement of visual acuity in the amblyopic eye between AR training and patching for the treatment of unilateral amblyopia.\n\nSpecific Aim 2 (Secondary): To compare the improvement of visual functions between AR training and patching for the treatment of unilateral amblyopia.",[27],[101,102,31],"Augmented reality training","Dichoptic therapy","RECRUITING","2025-04-08",{"date":106,"type":37},"2025-04-10",{"date":108,"type":37},"2024-08-31",{"date":110,"type":20},"2025-12",{"name":112,"class":44},"Eye & ENT Hospital of Fudan University"]