[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"amblyopia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:amblyopia":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,47,72,98,117,138,168,192,211,236,261,293,314,340,364,382,407,431,459,480,516,534,554,578,599],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"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?",[27,28],"Amblyopia","Amblyopia Unilateral",[27,30,31,32,33],"Dichopitc treatment","Binocular treatment","Patching","Occlusion","NOT_YET_RECRUITING","2026-05-28",{"date":37,"type":38},"2026-06-03","ACTUAL",{"date":40,"type":21},"2026-06-01",{"date":42,"type":21},"2027-05-31",{"name":44,"class":45},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":46},"100336091","binocular-visual-therapy-and-video-games-for-amblyopia-treatment-100336091","NCT03655912","Binocular Visual Therapy and Video Games for Amblyopia Treatment.","Inclusion Criteria:\n\n* Patients with anisometropic amblyopia, strabismic amblyopia or both\n* Patients with out previous amblyopia treatment\n* Patient with previous strabismus surgery or use of there best corrected visual acuity glasses for at least 1 month\n* Birth at term gestational age\n* Without any systemic or ophthalmic comorbidities\n* Previous patients parent verbal and fiscal assessment.\n\nExclusion Criteria:\n\n* Any other amblyopia diagnosis (deprivation)\n* Any previous amblyopia treatment\n* Any previous intraocular surgery\n* Any ocular condition\n* Any neurologic conditions or psychomotor development alterations\n* Patients not able to cooperate for visual acuity or stereopsis evaluation","4 Years","10 Years",{"count":20,"type":21},[24],"Amblyopia, or lazy eye, is best defined by the American Academy of Ophthalmology as a unilateral or bilateral reduction of the best corrected visual acuity that occurs in the setting of an otherwise normal eye, or a structural abnormality involving the eye or visual pathway with reduction in visual acuity that cannot be attributed only to the effect of the structural abnormality. Which causes an abnormal visual experience early in life, with consequences such as deficiencies in the ability to perceive contrast and\u002For movement, visual acuity, accommodation and stereopsis. The treatment of choice consists in patching of the fellow eye 2 hours per day. The disadvantage of this treatment modality is that patients end up not complying and when treatment is interrupted, lazy eye reappears. Amblyopia was thought to be a monocular disease, now a days there are reports of cortical visual paths changes in both eyes (the fellow and amblyopia eye), believing that it might be a monocular consequence of a binocular disease. Following that statement new treatment studies have arisen, stimulating both eyes not only to improve visual acuity in the lazy eye, but to restore binocular function as well. These treatments use videogames in celular phones, computers, or tablets where the fellow eye is exposed to reduced contrast and the lazy eye is exposed to full-contrast. Although the evidence is promising, more studies are needed to establish effectivity and security of this treatment modality.",[27],[27,60,61],"Binocular therapy","Videogames","RECRUITING","2026-05-04",{"date":65,"type":38},"2026-05-06",{"date":67,"type":38},"2018-10-09",{"date":69,"type":21},"2026-12",{"name":71,"class":45},"Universidad Autonoma de Nuevo Leon",{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":16,"minAge":53,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100635052","effectiveness-of-tdcs-in-paediatric-amblyopia-100635052","NCT07547670","Effectiveness of tDCS in Paediatric Amblyopia.","tDCS","Inclusion Criteria:\n\n* Children aged 4-14 years.\n* Strabismic amblyopia resistant to patching (PEDIG criteria).\n* Anisometropic amblyopia resistant to patching (PEDIG criteria).\n\nExclusion Criteria:\n\n* Ocular pathology.\n* Nystagmus.\n* Mental disability.\n* Cognitive delay.\n* Neurological problems incompatible with treatment.\n* Pacemakers.\n* Intracranial electrodes.\n* Implanted defibrillators.\n* Cranial pathologies.\n* Cranial lesions.\n* Withdrawal will occur upon adverse events, protocol deviation, refusal, or loss to follow-up.","14 Years",{"count":81,"type":21},100,[24],"The goal of this randomized, double-blind clinical trial is to determine whether transcranial direct current stimulation (tDCS) can effectively and safely improve vision in children aged 4-14 years with strabismic or anisometropic amblyopia that has not responded to conventional patching therapy.\n\nThe main questions it aims to answer are:\n\nDoes tDCS produce significant and sustained improvements in visual acuity, contrast sensitivity, and stereopsis in children with amblyopia?\n\nIs tDCS a safe, well-tolerated, and faster alternative or complementary treatment compared with standard occlusion therapy?\n\nDoes tDCS induce functional and structural changes in the visual cortex associated with increased neuroplasticity, including modulation of GABAergic activity?\n\nIf there is a comparison group:\n\nResearchers will compare active tDCS with sham (placebo) stimulation to see if active treatment leads to greater visual recovery and cortical changes than placebo.\n\nParticipants will:\n\nReceive several sessions of active or sham tDCS using low-intensity electrical stimulation applied to visual brain areas.\n\nUndergo standard visual assessments, including visual acuity, contrast sensitivity, and stereopsis.\n\nComplete neurophysiological and neuroimaging evaluations (EEG, pattern visual evoked potentials, and functional MRI).\n\nProvide biochemical measures related to GABA levels.\n\nThis study aims to validate tDCS as a non-invasive, child-friendly, and effective therapy that may overcome the limitations of patching and support its inclusion in paediatric clinical practice.",[27,85,86,87],"Amblyopia Strabismic","Visual Acuity","Stereoscopic Vision",[77,89],"Ambyopia","2026-04-23",{"date":92,"type":38},"2026-04-29",{"date":40,"type":21},{"date":95,"type":21},"2029-08-31",{"name":97,"class":45},"Universidad de Murcia",{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":16,"minAge":53,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":115,"locationsCount":4},"100629250","a-study-on-the-efficacy-and-user-experience-of-gamified-intervention-for-children-with-anisometropic-amblyopia-100629250","NCT07472231","A Study on the Efficacy and User Experience of Gamified Intervention for Children With Anisometropic Amblyopia","An Exploratory Study on the Short-Term Additive Efficacy and User Experience of Innovative Gamified Intervention as an Adjunctive Therapy for Children With Monocular Anisometropic Amblyopia","Inclusion Criteria:\n\n1. Clinically diagnosed with monocular anisometropic amblyopia.\n2. Aged 4 to 7 years.\n3. Able to cooperate with all examinations and comply with the amblyopia training regimen.\n4. Provided signed informed consent.\n\nExclusion Criteria:\n\n1. Severe developmental delay or cognitive impairment.\n2. Serious systemic diseases.\n3. Presence of organic ocular diseases (e.g., cataract, fundus diseases) or manifest strabismus.\n4. Participation in any other eye-related interventional trial within the past 4 weeks.","7 Years",{"count":107,"type":21},66,[24],"This project addresses the challenge of visual function intervention in children with monocular anisometropic amblyopia. It employs two innovatively designed digital games combined with occlusion therapy to conduct visual function training through parent-child interaction in home or multi-scenario environments. The study will compare this combined approach against traditional occlusion therapy alone, evaluating improvements in visual function, intrinsic motivation, and emotion regulation before and after the intervention. The research aims to promote the implementation and dissemination of personalized and engaging healthcare services. Ultimately, it seeks to establish a comprehensive visual function training product and service system suitable for daily use in home settings, with the goals of reducing medical anxiety in children and holistically enhancing treatment efficacy, training compliance, and overall clinical experience.",[27],{"date":92,"type":38},{"date":113,"type":21},"2026-05",{"date":69,"type":21},{"name":116,"class":45},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":16,"minAge":123,"maxAge":105,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":46},"100473000","video-treatment-for-amblyopia-100473000","NCT05439200","Video Treatment for Amblyopia","Inclusion Criteria:\n\n* aged 3-7 years\n* male and female\n* strabismic, anisometropic, or combined mechanism amblyopia (visual acuity 0.3-0.8 logMAR)\n* interocular visual acuity difference ≥0.3 logMAR\n* wearing glasses (if needed) for a minimum of 8 weeks with no change in visual acuity at 2 visits ≥4 weeks apart\n* child's ophthalmologist and family willing to forgo standard patching treatment during the study\n\nExclusion Criteria:\n\n* prematurity ≥8 wk\n* coexisting ocular or systemic disease\n* developmental delay\n* strabismus \\>5 pd\n* myopia \\> -3.00D","3 Years",{"count":125,"type":21},44,[24],"The purpose of this study is to determine whether viewing asynchronous movies leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive patch and whether this is associated with better adherence to treatment.",[27],"2026-04-01",{"date":131,"type":38},"2026-04-07",{"date":133,"type":38},"2023-08-23",{"date":135,"type":21},"2027-06-30",{"name":137,"class":45},"Retina Foundation of the Southwest",{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":146,"sex":16,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":165,"locationsCount":167},"100469605","optical-correction-and-visual-functions-of-adults-with-amblyopia-100469605","NCT05394987","Optical Correction and Visual Functions of Adults With Amblyopia","Spectacle Correction for the Treatment of Amblyopia","SPECTRA","Inclusion Criteria:\n\n* 18-39 (inclusive) years of age\n* Anisometropic amblyopia (difference of ≥0.50D spherical equivalent or ≥1.50D astigmatism between eyes) or mixed mechanism amblyopia (strabismus and anisometropia)\n* Best corrected visual acuity (BCVA) in the amblyopic eye of 0.3 logMAR to 1.0 logMAR (inclusive)\n* BCVA in the non-amblyopic eye of 0.1 logMAR or better, and an interocular VA difference of 2 logMAR lines or more\n* Difference of 1.00D or more between current refractive correction and study prescription\n* Good general health\n\nExclusion Criteria:\n\n* Other pathological ocular anomalies known to cause reduced visual acuity\n* Presbyopia (based on amplitude of accommodation)\n* Inability to tolerate prescribed refractive correction in spectacles (e.g., due to aniseikonia)\n* Contraindication to cycloplegic eye drops\n* Currently under amblyopia treatment\u002Ftherapy\n* Inability to comprehend test instructions and\u002For provide consent\n* Eccentric fixation\n* \\>-6.00DS of myopia in either eye with spectacles\n* Bilateral amblyopia\n* Presence of amblyopia that is not due to strabismus and\u002For anisometropia\n* Presence of (current or previous) psychiatric, visual, or neurological disorders",true,"18 Years","39 Years",{"count":150,"type":21},36,[24],"Amblyopia is a developmental anomaly resulting from abnormal visual experiences in early life. Amblyopia causes reduced visual acuity in the absence of a pathology. Adult sensory systems are believed to be structurally invariant beyond early, critical periods of development. However, recent evidence suggest that visual functions in adults with amblyopia can be improved with optical correction alone. This study aims to investigate whether improvements in best corrected visual acuity and other visual functions can result following appropriate optical correction in adults with amblyopia. Functional measures relating to vision, binocular vision, and eye movements will be used to assess the efficacy of refractive correction for improving vision. This study will help us better understand the improvements in visual functions following optical correction, as well as the mechanisms underlying neuroplasticity in adults with amblyopia.",[27],[27,155,156,157,158],"Binocular vision","Suppression","Plasticity","Optical correction","2026-03-16",{"date":161,"type":38},"2026-03-18",{"date":163,"type":38},"2022-06-13",{"date":42,"type":21},{"name":166,"class":45},"Centre for Eye and Vision Research",2,{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":16,"minAge":175,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":46},"100386323","visual-function-abnormalities-in-strabismus-and-amblyopia-and-response-to-therapy-100386323","NCT04310241","Visual Function Abnormalities in Strabismus and Amblyopia and Response to Therapy","Oculomotor Disorders: Experimental and Clinical Study","Inclusion Criteria:\n\n* History of amblyopia or presence of amblyogenic risk factors.\n\nExclusion Criteria:\n\n* History of neurologic disorders","6 Months","90 Years",{"count":178,"type":21},150,"OBSERVATIONAL","Amblyopia and strabismus are characterized by a reduction in visual acuity, contrast sensitivity, grating acuity, vernier acuity, reading difficulties and binocular visual function deficits. Treated patients have residual visual function deficits. The purpose of the current study is to quantify various visual functions in amblyopic and strabismic participants at baseline, during and at the completion of treatment.",[27,182],"Strabismus","2026-03-02",{"date":185,"type":38},"2026-03-04",{"date":187,"type":38},"2020-02-21",{"date":189,"type":21},"2027-03-12",{"name":191,"class":45},"The Cleveland Clinic",{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":46},"100307950","binocular-amblyopia-treatment-100307950","NCT03288948","Binocular Amblyopia Treatment","Inclusion Criteria:\n\n* age 4-10 y\n* male and female\n* strabismic, anisometropic, or combined mechanism amblyopia\n* amblyopic eye best-corrected visual acuity 0.3-0.8 logMAR\n* fellow eye best-corrected visual acuity ≤0.1 logMAR\n* interocular visual acuity difference ≥0.3 logMAR\n* wearing glasses (if needed) for 8 weeks or no change visual acuity with glasses at 2 visits\n\n  * 4 weeks apart.\n* child's ophthalmologist and family must be willing to forgo patching treatment during the 12-week study period\n* parent's informed consent\n* child must demonstrate understanding and ability to play binocular games\n\nExclusion Criteria:\n\n* prematurity ≥8 weeks\n* coexisting ocular or systemic disease\n* developmental delay\n* strabismus \\>5pd\n* any binocular amblyopia treatment in the past 3 months",{"count":199,"type":21},120,[24],"To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more complete and stable recovery.",[27],"2026-02-19",{"date":205,"type":38},"2026-02-23",{"date":207,"type":38},"2017-08-31",{"date":209,"type":21},"2026-12-31",{"name":137,"class":45},{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":234,"locationsCount":46},"100625008","possible-beneficial-effects-of-combined-fluoxetine-and-occlusion-therapy-in-improving-and-maintaining-vision-in-amblyopia-using-optical-coherence-tomography-angiography-octa-and-visual-evoked-potential-vep-the-aim-of-the-study-is-to-evaluate-possible-beneficial-effects-for-different-age-groups-100625008","NCT07417046","Possible Beneficial Effects Of Combined Fluoxetine And Occlusion Therapy In Improving And Maintaining Vision In Amblyopia Using Optical Coherence Tomography Angiography (OCTA) And Visual Evoked Potential (VEP). The Aim Of The Study Is To Evaluate Possible Beneficial Effects For Different Age Groups.","Possible Beneficial Effects Of Combined Fluoxetine And Occlusion Therapy In Improving And Maintaining Vision In Amblyopia Using Optical Coherence Tomography Angiography (OCTA) And Visual Evoked Potential (VEP)","VA; OCTA; VEP;","Inclusion Criteria:\n\n* Patients with unilateral amblyopia \\> 10 years old.\n\nExclusion Criteria:\n\n* Ocular pathology: media opacity, uveitis, glaucoma, retinal or optic nerve diseases, and history of ocular trauma.\n\n  * Poor fixation.\n  * Lack of cooperation.\n  * Any psychological disorder.",{"count":220,"type":21},50,[24],"Amblyopia is described as a limitation of the visual function of one or both eyes with no pathological cause, with a prevalence of about 1-5% of the total world population. This disorder is caused by early abnormal visual experience with a functional imbalance between the two eyes owing to anisometropia, strabismus, congenital cataract and ptosis, resulting in a dramatic loss of visual acuity (VA) in an apparently healthy eye.\n\nClinically, amblyopia can be defined as the presence in one or both eyes of a VA of 6\u002F12 or worse, with one or more lines of difference in VA between eyes in unilateral amblyopia which cannot be improved by refractive correction. This condition is an alteration of the visual cortex function which is due to suppression and deprivation of one eye leading to unilateral visual deterioration.\n\nOptical coherence tomography (OCT) is a noninvasive technique that can reveal morphology of the retinal layers in vivo. OCT determines structural changes in the macula that may be correlated with measures of subjective visual function such as visual acuity and visual field. OCT angiography (OCTA) can provide vascular system visualization of the posterior segment in amblyopic eyes.\n\nVisual evoked potentials (VEPs) are a non-invasive technique routinely used in clinical and preclinical practice. VEPs allow to quantify the functional integrity of the visual system from the retina via the optic nerves, optic tracts, to the thalamus, and form projections to the visual cortices.\n\nIn strabismic and anisometropic amblyopia, VEP responses are reduced. VEP may be used as an alternative objective method for diagnosis and monitoring of amblyopia.\n\nPassive treatments such as occlusion, optical and\u002For pharmacological penalization, and Bangerter foils have been demonstrated to be potentially useful treatments for amblyopia. Researches are being done on new pharmacological options to improve and maintain VA after occlusion treatment in amblyopia.\n\nAdults with amblyopia cannot be treated because their brains do not have enough plasticity. However, results obtained both in clinical trials and in animal models have challenged this traditional view, unmasking a previously unsuspected potential for promoting recovery after the end of the critical period for visual cortex plasticity. These studies point toward the intracortical inhibitory transmission as a crucial brake for therapeutic rehabilitation and recovery from amblyopia in the adult brain.\n\nSelective serotonin reuptake inhibitors (SSRIs) increase serotonin activity in the brain. While they are mostly known for their antidepressant properties, they have been shown to improve visual functions in amblyopia and impact cognitive functions ranging from attention to motivation and sensitivity to reward.",[27,224],"VEP",[226,224,227,27],"Flouxetine","OCTA","2026-02-10",{"date":230,"type":38},"2026-02-18",{"date":232,"type":38},"2024-12-01",{"date":129,"type":21},{"name":235,"class":45},"Minia University",{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":245,"conditions":246,"keywords":249,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":46},"100587464","ocular-characteristics-in-patients-with-craniosynostosis-100587464","NCT06928727","Ocular Characteristics in Patients With Craniosynostosis","COPACA","Inclusion Criteria:\n\n* Diagnosis of craniostenosis\n\nExclusion Criteria:\n\n* Posterior plagiocephalia",{"count":244,"type":21},65,"Craniosynostosis are cranial deformations due to the premature closure of one or more cranial sutures. These deformations affect approximately one in 2.500 births. In most cases, craniosynostoses are isolated with unknown (non syndrome). On the other hand, 20% of these deformations are associated with other concentration (syndrome).\n\nCraniosynostosis has morphological (associated dysmorphism) and functional (growth conflict between the skull and the brain) repercussions. Ophthalmological disorders are frequent: refractive disorders, oculomotor disorders, optic nerve damage, sensory damage.\n\nThis retrospective study aims to describe the ocular clinical characteristics associated with craniosynostosis in patients followed at the Amiens University Hospital.",[247,182,248,27],"Craniosynostosis","Intracranial Hypertension",[247,250,251,252],"strabismus","amblyopia","intracranial hypertension",{"date":254,"type":38},"2026-02-12",{"date":256,"type":38},"2025-04-04",{"date":258,"type":21},"2026-11",{"name":260,"class":45},"Centre Hospitalier Universitaire, Amiens",{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":16,"minAge":269,"maxAge":17,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":274,"conditions":275,"keywords":276,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":292},"100556421","phase-3-dichoptic-treatment-for-amblyopia-in-children-8-to-12-years-of-age-100556421","NCT06524882","Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age","A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age","ATS24","Inclusion Criteria:\n\n1. Age 8 to \\\u003C13 years.\n2. VA, measured in each eye without cycloplegia in current refractive correction (if applicable) using the E-ETDRS VA protocol on a study-approved device displaying single surrounded optotypes, as follows:\n\n   1. VA in the amblyopic eye 20\u002F40 to 20\u002F200 inclusive (33 to 72 letters with E-ETDRS).\n   2. VA in the fellow eye 20\u002F25 or better (≥ 78 letters with E-ETDRS).\n   3. Interocular difference ≥ 3 logMAR lines (≥ 15 letters) i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA).\n3. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).\n\n   1. Criteria for strabismic amblyopia: At least one of the following must be met:\n\n      * Presence of a heterotropia on examination at distance or near fixation (with optical correction), must be \\\u003C=5 prism diopters (∆) by SPCT at distance and near fixation.\n      * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia).\n   2. Criteria for anisometropia: At least one of the following criteria must be met:\n\n      * ≥1.00 D difference between eyes in spherical equivalent (SE).\n      * ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.\n   3. Criteria for combined-mechanism: Both of the following criteria must be met:\n\n      * A criterion for strabismus is met (see above).\n      * ≥1.00 D difference between eyes in SE OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.\n4. No more than 2 weeks (cumulative) of prior dichoptic treatment\n5. No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued.\n6. Refractive correction is required (single vision lenses or contact lenses) for any of the following refractive errors based on a cycloplegic refraction completed within the last 7 months:\n\n   * Hypermetropia of 2.50 D or more by SE\n   * Myopia of amblyopic eye of 0.50D or more SE\n   * Astigmatism of 1.00D or more\n   * Anisometropia of more than 0.50D SE\n\n   NOTE: Children with cycloplegic refractive errors that do not fall within the requirements above for refractive correction may be given refractive correction at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below.\n\n   NOTE: Monocular or binocular contact lens wear is allowed provided the contact lenses meet the refractive error correction requirements below. For each child, all testing must be performed using the same form of optical correction (i.e., no changing between contacts and spectacles).\n   1. Spectacles\u002Fcontact lens correction prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:\n\n      * SE must be within 0.50D of fully correcting the anisometropia (if new glasses are prescribed, reduction in plus sphere must be symmetric in the two eyes).\n      * SE must not be under corrected by more than 1.50D SE.\n      * Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism.\n      * Axis must be within +\u002F- 10 degrees if cylinder power is ≤1.00D, and within +\u002F- 5 degrees if cylinder power is \\>1.00D.\n      * Myopia must not be under corrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.\n   2. Spectacles\u002Fcontact lens correction (with or without other treatment such as patching) meeting the above criteria must be worn:\n\n      * For at least 18 weeks OR until VA stability is documented (defined as \\\u003C1-line change by the same testing method measured on 2 consecutive exams at least 9 weeks apart).\n      * For determining VA stability (non-improvement):\n\n        * The first of two measurements may be made 1) in current correction, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed),\n        * The second measurement must be made without cycloplegia in the correct spectacles\u002Fcontact lens correction that has been worn for at least 9 weeks.\n        * NOTE: Because this determination is a pre-randomization, the method of measuring VA is not mandated.\n7. Participant is willing to wear a headset.\n8. Participant is willing to continue full-time spectacles\u002Fcontact lens wear (if needed).\n9. Interpupillary distance of 52mm to 72mm inclusive.\n10. Investigator is willing to prescribe continued spectacles\u002Fcontact lens correction (if needed) or either dichoptic device per protocol.\n11. Participant is willing to accept assignment to either continued spectacles\u002F contact lens wear alone, dichoptic movies\u002Fshows (view 1 hour per day 6 days per week) OR dichoptic games (play approximately 25 minutes per day, 6 days per week) for 19 weeks.\n12. Parent understands the protocol and is willing to accept randomization.\n13. Parent has phone (or access to phone) and is willing to be contacted by JAEB Center staff.\n14. Relocation outside of area of an active PEDIG site for this study within the next 36 weeks is not anticipated.\n\nExclusion Criteria:\n\n1. Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)\n2. Prism greater than a total of 8 diopters horizontal and 1 diopter vertical in the refractive correction at time of enrollment.\n3. Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment).\n4. Myopia greater than -6.00D spherical equivalent in either eye.\n5. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met using patch occlusion. Fogging is not permitted).\n6. Diplopia more than once per week over the last week prior to enrollment by parental report.\n7. History of light-induced seizures.\n8. Known simulator sickness.\n9. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and\u002For learning disabilities are not excluded.\n10. Immediate family member (biological or legal guardian, child, sibling, parent) of investigative site personnel directly affiliated with this study or an employee of the JAEB center for Health Research.","8 Years",{"count":271,"type":21},252,[273],"PHASE3","Participants eligible for the study will be randomly allocated (1:1:1) to receive either Luminopia dichoptic treatment while wearing optical correction if needed, Vivid Vision dichoptic treatment while wearing optical correction if needed, or continued optical correction alone if needed, with clinical assessments at 9- and 18-weeks post-randomization.\n\nAt the 18-week primary outcome visit, participants who were randomly assigned to receive optical correction alone if needed with an IOD of 1 logMAR line (5 letters) or more, will be offered randomization to Luminopia or Vivid Vision dichoptic therapy and if they accept, followed forward with visits at 27- and 36-weeks post-randomization.\n\nThe study will end for all other participants at 18 weeks.",[27],[277,278,279,280,281,282],"Dichoptic","Luminopia","Vivid Vision","Game","movie","glasses","2026-02-09",{"date":285,"type":38},"2026-02-11",{"date":287,"type":38},"2024-10-22",{"date":289,"type":21},"2027-11-01",{"name":291,"class":45},"Jaeb Center for Health Research",58,{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":16,"minAge":53,"maxAge":105,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":303,"briefSummary":304,"conditions":305,"keywords":306,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":313},"100545331","phase-3-dichoptic-treatment-for-amblyopia-in-children-4-to-7-years-of-age-100545331","NCT06380517","Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age","A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age","ATS23","At the time of enrollment, individuals must meet all the following inclusion criteria to be eligible to participate in the study.\n\n1. Age 4 to 7 years.\n2. Visual acuity, measured in each eye without cycloplegia in current refractive correction (if applicable) using the ATS-HOTV VA protocol on a study-approved device displaying single surrounded optotypes, as follows:\n\n   1. VA in the amblyopic eye 20\u002F40 to 20\u002F200 inclusive.\n   2. Age-normal VA in the fellow eye:44,45\n\n      • 4 years: 20\u002F40 or better; 5-6 years: 20\u002F32 or better; 7 years: 20\u002F25 or better\n   3. Interocular difference ≥ 3 logMAR lines (i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA).\n3. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).\n\n   1. Criteria for strabismic amblyopia: At least one of the following must be met:\n\n      * Presence of a heterotropia on examination at distance or near fixation (with optical correction), must be \\\u003C=5 prism diopters (∆) by SPCT at distance and near fixation (see #7 below).\n      * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia).\n   2. Criteria for anisometropia: At least one of the following criteria must be met:\n\n      * ≥1.00 D difference between eyes in spherical equivalent (SE).\n      * ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.\n   3. Criteria for combined-mechanism: Both of the following criteria must be met:\n\n      * A criterion for strabismus is met (see above).\n      * ≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.\n4. No more than 2 weeks (cumulative) of prior dichoptic treatment.\n5. No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued.\n6. Refractive correction is required (single vision lenses or contact lenses) for any of the following refractive errors based on a cycloplegic refraction completed within the last 7 months:\n\n   * Hypermetropia of 2.50 D or more by SE\n   * Myopia of amblyopic eye of 0.50D or more SE\n   * Astigmatism of 1.00D or more\n   * Anisometropia of more than 0.50D SE\n\n   NOTE: Monocular or binocular contact lens wear is allowed provided the contact lenses meet the refractive error correction requirements below. For each child, all testing must be performed using the same form of optical correction (i.e., no changing between contacts and spectacles).\n   1. Spectacles\u002Fcontact lens correction prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:\n\n      * SE must be within 0.50D of fully correcting the anisometropia (if new glasses are prescribed, reduction in plus sphere must be symmetric in the two eyes).\n      * SE must not be under corrected by more than 1.50D SE.\n      * Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism.\n      * Axis must be within +\u002F- 10 degrees if cylinder power is ≤1.00D, and within +\u002F- 5 degrees if cylinder power is \\>1.00D.\n      * Myopia must not be under corrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.\n   2. Spectacles\u002Fcontact lens correction (with or without other treatment such as patching) meeting the above criteria must be worn:\n\n      * For at least 18 weeks OR until VA stability is documented (defined as \\\u003C0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 9 weeks apart).\n      * For determining VA stability (non-improvement):\n\n        * The first of two measurements may be made 1) in current correction, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed),\n        * The second measurement must be made without cycloplegia in the correct spectacles\u002Fcontact lens correction that has been worn for at least 9 weeks.\n        * NOTE: Because this determination is a pre-randomization, the method of measuring VA is not mandated.\n7. Participant is willing to wear the Luminopia headset.\n8. Participant is willing to continue full-time spectacles\u002Fcontact lens wear (if needed).\n9. Participant is willing to accept assignment to either dichoptic shows (view 1 hour per day 6 days per week) OR part-time patching (2 hours per day 7 days per week) for 26 weeks.\n10. Interpupillary distance of 52mm to 72mm inclusive.\n11. Investigator is willing to prescribe Luminopia or patching per protocol.\n12. Parent understands the protocol and is willing to accept randomization.\n13. Parent has phone (or access to phone) and is willing to be contacted by JAEB Center.\n14. Relocation outside area of active PEDIG site within the next 52 weeks is not anticipated.\n\nIndividuals meeting any of the following criteria will be excluded from study participation.\n\n1. Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)\n2. Prism lenses or need of a prism prescription at enrollment.\n3. Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment).\n4. Myopia greater than -6.00D spherical equivalent in either eye.\n5. Previous intraocular or refractive surgery.\n6. Known skin reactions to patch or bandage adhesives.\n7. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met using patch occlusion. Fogging is not permitted).\n8. Diplopia more than once per week over the last week prior to enrollment by parental report.\n9. History of light-induced seizures.\n10. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and\u002For learning disabilities are not excluded.\n11. Participation in a prior study involving patching for amblyopia\n12. Immediate family member (biological or legal guardian, child, sibling, parent) of investigative site personnel directly affiliated with this study or an employee of the JAEB center for Health Research.",{"count":302,"type":21},238,[273],"In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies\u002Fshows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks.",[27],[277,278,32,281],{"date":285,"type":38},{"date":309,"type":38},"2024-07-01",{"date":311,"type":21},"2028-01-01",{"name":291,"class":45},73,{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":16,"minAge":123,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":22,"phases":325,"briefSummary":326,"conditions":327,"keywords":328,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":339},"100391577","phase-3-a-randomized-trial-to-evaluate-sequential-vs-simultaneous-patching-100391577","NCT04378790","A Randomized Trial to Evaluate Sequential vs Simultaneous Patching","A Randomized Trial to Evaluate Sequential vs Simultaneous Spectacles Plus Patching for Amblyopia in Children 3 to \u003C13 Years Old","ATS22","Inclusion Criteria:\n\n1. Age 3 to \\\u003C13 years at the time of randomization\n2. Amblyopia associated with anisometropia, strabismus, or both\n\n   o Criteria for strabismic amblyopia: At least one of the following must be met:\n   * Presence of a heterotropia on examination at distance or near fixation (with or without optical correction)\n   * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)\n\n     * Criteria for anisometropia: At least one of the following criteria must be met:\n\n       * 1.00 D difference between eyes in spherical equivalent (SE)\n       * 1.50 D difference in astigmatism between corresponding meridians in the two eyes\n     * Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:\n   * Criteria for strabismus are met (see above)\n\n     * 1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes\n3. No previous treatment for amblyopia, including no more than 24 hours of spectacle wear.\n4. Investigator planning to initiate spectacle correction of refractive error meeting the following criteria based on a cycloplegic refraction that has been performed within 30 days:\n\n   1. Full correction of anisometropia\n   2. Full correction of astigmatism with the same axis found by the cycloplegic refraction\n   3. Full correction of any myopia\n   4. Hyperopia must not be under corrected by more than 1.50 D, and reduction in plus sphere must be symmetric in the two eyes.\n5. At enrollment, single VA measured in each eye assessed in trial frames with the spectacle correction the investigator plans to prescribe, using the investigator's routine method as follows:\n\n   * VA in the amblyopic eye 20\u002F40 to 20\u002F200 inclusive.\n   * Age-normal VA in the fellow eye:40,41\n\n     * 3 years: 0.4 logMAR (20\u002F50) or better\n     * 4 years: 0.3 logMAR (20\u002F40) or better\n     * 5-6 years: 0.2 logMAR (20\u002F32) or better\n     * 7-12 years: 0.12 logMAR (78 letters) or better\n   * Interocular difference ≥ 3 logMAR lines (0.3 logMAR) or ≥ 15 letters o When participants return for the Spectacle Baseline \u002F Randomization Visit with their new spectacles, they will need to meet the same criteria as above using the ATS-HOTV or E-ETDRS protocol after wearing the new spectacles for at least 10 minutes (based upon the mean of a test and retest of VA in those new spectacles).\n6. Investigator is willing to prescribe spectacle wear followed sequentially by patching or simultaneous spectacles and patching treatment per protocol.\n7. Parent understands the protocol and is willing to accept randomization.\n8. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff.\n9. Relocation outside of area of an active PEDIG site for this study within the next 56 weeks is not anticipated.\n\nExclusion Criteria:\n\n1. Myopia greater than -6.00 D spherical equivalent in either eye.\n2. Previous intraocular or refractive surgery.\n3. Planned strabismus surgery in the next 56 weeks.\n4. Any previous treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy, or binocular treatment).\n5. Previous spectacle or contact lens wear for more than 24 hours.\n6. Parent and participant willing to forego option of contact lens wear for the duration of the study.\n7. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above VA criteria are met).\n8. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and\u002For learning disabilities or attention deficit hyperactivity disorder (ADHD) are not excluded.\n9. Known allergy to adhesive patches.\n10. Known allergy to silicone.","13 Years",{"count":324,"type":21},544,[273],"A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to \\\u003C13 years of age.",[27],[329,282,330,331,332],"patching","spectacles","simultaneous","sequential",{"date":285,"type":38},{"date":335,"type":38},"2020-12-08",{"date":337,"type":21},"2028-05-01",{"name":291,"class":45},68,{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":16,"minAge":105,"maxAge":17,"enrollmentInfo":347,"targetDuration":4,"studyType":22,"phases":349,"briefSummary":350,"conditions":351,"keywords":352,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":46},"100617848","evaluation-of-amblyofix-for-the-treatment-of-unilateral-amblyopia-in-children-100617848","NCT07323953","Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia in Children","Prospective Clinical Trial Evaluating AmblyoFix for the Treatment of Unilateral Amblyopia in Children","Inclusion Criteria:\n\n* Age 7-12 years.\n* Unilateral amblyopia secondary to anisometropia and\u002For mild strabismus.\n* BCVA in amblyopic eye between 20\u002F40-20\u002F400 (0.3-1.3 logMAR); fellow eye ≥20\u002F32 (≤0.2 logMAR).\n* Interocular difference ≥2 lines (≥0.2 logMAR).\n* Stable refractive correction for ≥16 weeks or \\\u003C0.1 logMAR change across two visits ≥8 weeks apart.\n* Cycloplegic refraction within 7 months meeting anisometropia criteria (e.g., hyperopia ≥+2.50 D).\n* Access to a suitable home environment (laptop and internet).\n* Parent\u002Fguardian consent and child assent (7+ year olds).\n\nExclusion Criteria:\n\n* Atropine use within 2 weeks before starting treatment\n* Prior amblyopia treatment beyond refractive adaptation.\n* Myopia \\>-6.00 D SE, previous ocular surgery, or other ocular pathology.\n* Severe cognitive\u002Fdevelopmental delay impeding compliance.\n* History of light-induced seizures.\n* Inability\u002Funwillingness to comply with digital monitoring.\n* Any condition compromising safety or trial integrity.",{"count":348,"type":21},33,[24],"This is a prospective, single-arm, non-inferiority clinical trial designed to evaluate the efficacy, safety, and adherence of AmblyoFix binocular digital therapy for the treatment of unilateral amblyopia in children aged 7 to 12 years. Outcomes will be compared against a retrospective cohort of patients of the same age range previously treated with standard occlusion (patching) at the same clinic.\n\nA total of 33 participants will be enrolled, allowing for up to 15% attrition to ensure at least 28 evaluable completers at Week 24. Eligible participants must have unilateral amblyopia with amblyopic-eye best-corrected visual acuity (BCVA) between 0.3 and 1.3 logMAR and an interocular difference of at least 0.2 logMAR, with stable refractive correction for at least 16 weeks prior to enrollment.\n\nThe primary outcome is the change in amblyopic-eye BCVA (logMAR) from baseline to Week 24, assessed under standardized Snellen or ETDRS protocol by certified, masked outcome assessors. Secondary outcomes include adherence (captured via in-software usage logs), safety (BCVA worsening ≥2 lines and ocular adverse events), and patient-reported outcomes (acceptability, usability, satisfaction). An interim analysis will be conducted at Week 6 and at Week 12 to review early efficacy and safety, with the option to recommend early termination if robust evidence of non-inferiority is demonstrated.\n\nIn addition to the primary study population of unilateral amblyopia, an exploratory subgroup of 3 or more participants with bilateral amblyopia may be enrolled for observational evaluation. Treatment will initially target the eye with worse BCVA as selected in the AmblyoFix software. Upon sufficient improvement, as determined by the Principal Investigator, treatment may be switched to the other eye within the software settings. Data from the bilateral exploratory cohort will be analyzed descriptively and reported separately. These data will not contribute to the primary non-inferiority analysis.\n\nParticipants and caregivers cannot be blinded due to the nature of the intervention; however, outcome assessors and statisticians will remain masked to study objectives and comparator data to minimize bias. Follow-up assessments will occur at baseline, Week 6, Week 12, and Week 24, with no additional amblyopia treatment permitted during the study unless clinically required.\n\nThis trial is designed to rigorously determine whether AmblyoFix is a safe, effective, and non-inferior alternative to patching, with the potential to improve adherence, usability, and acceptability in real-world amblyopia therapy.",[27],[353],"Amblyopia Treatment","2026-01-16",{"date":356,"type":38},"2026-01-20",{"date":358,"type":21},"2025-12-25",{"date":360,"type":21},"2026-06-10",{"name":362,"class":363},"Eyesight Electronics","INDUSTRY",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":16,"minAge":123,"maxAge":17,"enrollmentInfo":370,"targetDuration":4,"studyType":22,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":46},"100473096","patch-free-occlusion-therapy-100473096","NCT05440448","Patch-free Occlusion Therapy","Inclusion Criteria:\n\n* 3-12 years\n* male and female\n* strabismic, anisometropic, or combined mechanism amblyopia (visual acuity: 0.3-0.8 logMAR)\n* interocular visual acuity difference ≥0.3 logMAR\n* wearing glasses (if needed) for a minimum of 8 weeks with no change in visual acuity at 2 visits ≥4 weeks apart\n* child's ophthalmologist and family willing to forgo standard patching treatment during the study\n\nExclusion Criteria:\n\n* Prematurity ≥8 wk\n* coexisting ocular or systemic disease\n* developmental delay\n* myopia \\> -3.00D",{"count":339,"type":21},[24],"The purpose of the study is to determine whether a patch-free occlusion therapy leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive patch and whether this is associated with better adherence to the treatment.",[27],"2026-01-05",{"date":376,"type":38},"2026-01-07",{"date":378,"type":38},"2024-04-22",{"date":380,"type":21},"2028-06-30",{"name":137,"class":45},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":16,"minAge":53,"maxAge":269,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":390,"briefSummary":391,"conditions":392,"keywords":393,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":4},"100615591","morning-versus-evening-patching-in-childhood-amblyopia-100615591","NCT07294599","Morning Versus Evening Patching in Childhood Amblyopia","Morning Versus Evening Patching in Childhood Amblyopia-A Randomized Clinical Trial","Inclusion Criteria:\n\n* Age: 4-8 years.\n* Unilateral amblyopia.\n* Amblyopic-eye BCVA decimal 0.17-0.67 (≈ 6\u002F36-6\u002F9).\n* Fellow-eye BCVA ≥ 0.80 decimal (≈ 6\u002F7.5 or better).\n* Amblyopia type: refractive-dominant or strabismic\u002Fmixed.\n* Parent\u002Fguardian consent obtained.\n\nExclusion Criteria:\n\n* Bilateral amblyopia.\n* Sensory-deprivation amblyopia (e.g., due to congenital cataract, ptosis, corneal opacity).\n* Ocular surgery within the past 6 months, or planned surgery during study.\n* Likely poor adherence (e.g., due to social, logistic, or family constraints).",{"count":81,"type":21},[24],"To determine whether the time of day at which daily occlusion (patching) is administered - morning (08:00-10:00) versus evening (17:00-19:00) - affects the amount of visual-acuity improvement in the amblyopic eye in children with unilateral amblyopia.\n\nRationale:\n\nWhile occlusion therapy remains the mainstay for treatment of childhood amblyopia, existing trials have focused on patching duration, not on the timing of occlusion. Diurnal or chronobiological factors - such as fluctuations in neuroplasticity, attention, compliance, or visual demand during the day - may influence the efficacy of patching. Understanding whether timing matters could help optimize occlusion therapy, improve outcomes, and reduce treatment burden.",[27],[394,395,27,396,397,182],"Morning patching","Evening patching","Clinical trial","Anisometriopia","2025-12-18",{"date":400,"type":38},"2025-12-26",{"date":402,"type":21},"2025-12-14",{"date":404,"type":21},"2026-06-14",{"name":406,"class":45},"Yarmouk University",{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":16,"minAge":53,"maxAge":79,"enrollmentInfo":415,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":420,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":4},"100616133","vision-3d-visual-skills-improvement-with-on-screen-3d-movies-100616133","NCT07301645","VISION-3D: Visual Skills Improvement With On-screen 3D Movies.","Efficacy of 3D Versus 2D Movie Viewing on Stereopsis and Visual Function in Children With Residual Ambliopia. A Randomized Controlled Trial.","VISION3D","Inclusion Criteria:\n\n* Children aged 4 to 12 years.\n* Previous diagnosis of unilateral amblyopia (anisometropic, strabismic, or mixed).\n* History of conventional treatment (optical correction, occlusion and\u002For penalization) with stable visual acuity for at least 6 months.\n* Interocular visual acuity difference ≥ 0.2 logMAR (≈ ≥2 Snellen lines).\n* Ability to understand and follow age-appropriate basic instructions.\n* Parent\u002Fguardian consent (and child assent when applicable)\n\nExclusion Criteria:\n\n* Ocular surgery within the last 6 months.\n* Manifest strabismus \\>15 prism diopters.\n* Concomitant ocular pathology that may affect vision (e.g., cataract, nystagmus, ptosis, corneal opacity, retinal disease, optic neuropathy).\n* Cognitive or neurological deficits preventing compliance with the protocol.\n* Prior intensive exposure to 3D cinema or VR\u002F3D videogames that could act as a confounder.\n* Family or child refusal to participate",{"count":416,"type":21},40,[24],"This clinical study investigates whether watching 3D films can help improve the vision of children with residual amblyopia (lazy eye), that is, those children who, despite having undergone usual treatments such as glasses or patching, still maintain some visual deficit. The main objective is to verify whether viewing in 3D is better than viewing in 2D in improving depth vision (stereopsis), visual acuity and ocular alignment. The hypothesis is that 3D films, by providing richer binocular stimuli, will produce greater improvements than the same 2D films.\n\nChildren between 4 and 14 years of age with residual, stable and previously treated unilateral amblyopia will be included. Participants will be recruited from the pediatric ophthalmology\u002Foptometry clinics of the Mútua University Hospital\n\nThe study will be conducted in two locations: the visual examinations will be performed at the Mútua University Hospital in Terrassa, and the film sessions at the Faculty of Optics and Optometry of Terrassa (FOOT, UPC), in rooms prepared with a projector and 3D glasses.\n\nThe design is randomized and controlled. In a first phase, the children will be randomly divided into two groups: one group will watch 3 films in 3D and the other will watch the same films in 2D. Then, in a second phase, all participants will watch 3 additional sessions in 3D. Four evaluation visits will be made: before starting, after phase 1, after phase 2 and a follow-up two months later. These visits will measure stereopsis, visual acuity, and ocular deviation with standard optometric tests.\n\nWatching 3D movies is a safe and non-invasive activity; therefore, no significant risks are expected beyond some possible mild and transient discomfort such as eye strain or headache, which will be recorded if it occurs. Potential benefits include improved depth perception and other visual functions, and the results could open the door to new, fun and motivating therapeutic options for other children with amblyopia in the future.",[27,182],[27,182,421],"Cinema 3D","2025-12-10",{"date":424,"type":38},"2025-12-24",{"date":426,"type":21},"2026-01-15",{"date":428,"type":21},"2026-07",{"name":430,"class":45},"Universitat Politècnica de Catalunya",{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":146,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":443,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":457,"locationsCount":46},"100479437","establishing-new-treatment-approaches-for-amblyopia-perceptual-learning-and-video-games-100479437","NCT05522972","Establishing New Treatment Approaches for Amblyopia: Perceptual Learning and Video Games","Improving Normal and Amblyopic Vision With Video Games and Perceptual Learning","Inclusion Criteria:\n\n* adults and children with normal vision or amblyopia\n* amblyopia: interocular VA difference of 0.1 logMAR or more\n\nExclusion Criteria:\n\n* any ocular pathological conditions, nystagmus",{"count":439,"type":21},180,[24],"Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. This study uses psychophysical measures to study neural plasticity in both adults and children with amblyopia.",[27],[444,445,446,447,448,449,450,250],"perceptual learning","video games","visual plasticity","amblyopia treatment","pathophysiology of amblyopia","vision training","stereoacuity","2025-12-08",{"date":453,"type":38},"2025-12-16",{"date":455,"type":38},"2022-09-13",{"date":95,"type":21},{"name":458,"class":45},"Nova Southeastern University",{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":146,"sex":16,"minAge":269,"maxAge":17,"enrollmentInfo":465,"targetDuration":4,"studyType":22,"phases":467,"briefSummary":468,"conditions":469,"keywords":470,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":479,"locationsCount":46},"100614603","amblyopia-treatment-for-children-aged-8-to-12-years-100614603","NCT07281742","Amblyopia Treatment for Children Aged 8 to 12 Years","Inclusion Criteria:\n\n* Female and male children with amblyopia age 8-12 years inclusive\n* Amblyopic eye visual acuity ≤ 1.0 logMar (20\u002F32-20\u002F200)\n* Interocular difference in visual acuity of 0.3 logMAR or more\n* Anisometropia or strabismus corrected to \\\u003C5 pd\n* Wearing glasses (if needed) ≥8 weeks\n* No longer using standard-of-care treatments for amblyopia\n* Informed consent\n\nExclusion Criteria:\n\n* Prematurity \\>8 weeks\n* Coexisting ocular or systemic disease\n* Developmental delay\n* History of light-induced epilepsy\n* Eye conditions that interfere with eye tracking (nystagmus, wearing RGP contact lenses, paralysis of the extra ocular muscles or any neurological condition that restricts eye movements, ptosis that covers the pupil)",{"count":466,"type":21},30,[24],"This study is being done to assess the effect of at-home amblyopia treatment with Curesight™ for children aged 8 to 12 years. Curesight™ allows you to stream any videos on a computer screen at home but the amblyopic eye will see the entire screen clearly while part of the image will be blurred for the other eye. There is already a pivotal clinical trial showing that this treatment is effective for young children and Curesight™ has been cleared for use as an amblyopia treatment by the FDA for children as young as 4 years.",[27],[251,471,472],"dichoptic","children","2025-12-04",{"date":475,"type":38},"2025-12-15",{"date":477,"type":38},"2025-01-07",{"date":380,"type":21},{"name":137,"class":45},{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":16,"minAge":269,"maxAge":487,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":489,"briefSummary":492,"conditions":493,"keywords":495,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":46},"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","17 Years",{"count":5,"type":21},[490,491],"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.",[27,28,494,85],"Amblyopia, Anisometropic",[27,496,497,498,499,500,501,329,502,503,504,505,472,506],"valproate","valproic acid","pediatric","lazy eye","Histone deacetylase Inhibitor","HDAC","eye patch","visual acuity","visual impairment","critical period","ophthalmology","2025-11-05",{"date":509,"type":38},"2025-11-10",{"date":511,"type":21},"2026-01-01",{"date":513,"type":21},"2027-09-30",{"name":515,"class":45},"Boston Children's Hospital",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":532,"locationsCount":533},"100549074","clinical-data-registry-of-amblyopia-patients-on-luminopia-treatment-100549074","NCT06429280","Clinical Data Registry of Amblyopia Patients on Luminopia Treatment","Inclusion Criteria:\n\n* Have a diagnosis of amblyopia\n* Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks\n\nExclusion Criteria:\n\n-Have participated in prior Luminopia clinical trials",{"count":523,"type":21},500,"Amblyopia is the most prevalent cause of reduced monocular visual acuity in children and young adults, with estimates of prevalence ranging from 1% to 5%. The most common associated amblyogenic risk factors are uncorrected anisometropia, strabismus, or a combination of these. In addition to reduced visual acuity, amblyopic patients may also have measurable dysfunction of accommodation, fixation, binocularity, vergence, reading fluency, depth perception, and contrast sensitivity.\n\nFor the first time since the incorporation of atropine penalization into amblyopia management, physicians can now offer Luminopia, an FDA-approved dual action dichoptic treatment, to patients with amblyopia. Since the product became commercially available in November 2022, the number of patients on Luminopia therapy continues to grow. This presents a unique opportunity to gather real world evidence from a large number of patients, representative of how ophthalmologists and optometrists are applying this novel treatment in the real world. A registry of the clinical data associated with Luminopia treatment, with IRB oversight, will provide answers to key scientific questions using a large dataset.",[27],"2025-09-05",{"date":528,"type":38},"2025-09-12",{"date":530,"type":38},"2023-09-01",{"date":209,"type":21},{"name":278,"class":363},13,{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":16,"minAge":147,"maxAge":540,"enrollmentInfo":541,"targetDuration":4,"studyType":22,"phases":543,"briefSummary":544,"conditions":545,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":550,"leadSponsor":552,"locationsCount":46},"100600898","interactive-binocular-treatment-i--bit-in-adult-patients-with-anisometropic-amblyopia-100600898","NCT07103473","Interactive Binocular Treatment (I- BiT) in Adult Patients With Anisometropic Amblyopia","1. Age range from 18 to 40 years\n2. Best corrected visual acuity of 0.3 log units or worse in one eye\n3. Cases of mild and moderate anisometropic amblyopia (BCVA≤0.3)","40 Years",{"count":542,"type":21},15,[24],"Amblyopia is one of the common, preventable and treatable causes of decreased acuity of one or both eyes without a specific organic cause. Common treatments include optical correction, patching (closing the healthy eye), perceptual learning, and drug treatments. The patient's low cooperation, reduction in effectiveness and long treatment period of common methods have led to the design of new treatments that eliminate these disadvantages, among which binocular vision treatments can be mentioned. The purpose of this study is to apply a new and innovative method under binocular conditions in the treatment of anisometropic amblyopia in adults. In this randomized clinical trial study, 30 people (15 patients in the case group and 15 patients in the control group) aged 18 to 40 years with amblyopia (decrease in best corrected vision worse than 0.3 logarithmic units in one of the eyes or the difference of the corrected minimum visual acuity of two lines between two eyes) in the form of two groups of 15 people (case and control) will be included in the study. Patients will be randomly divided into two groups: case and control. Interactive Binocular Treatment (I-BiT) is used in the case group and usual games without I-BiT system are used as placebo in the other group. For this purpose, the games will be presented in the control group in such a way that the two eyes will not be dissociated and the patient will see all the targets in the same way with his two eyes. I-BiT is a new method for the treatment of amblyopia in which a person plays age-appropriate games using special glasses in a 3D space. The stimuli are shown differently to the two eyes and both eyes are involved in the treatment process. The selection of people in two groups will be such that background variables such as age, sex, as well as the severity of amblyopia or vision loss in the two groups are the same and confounding factors are under control. First, all eye examinations such as measuring visual acuity, lateral vision, checking refractive errors with and without cycloplegic drops, checking the alignment of visual axes, and also checking the anterior and posterior segments of the eye are performed. After the definitive diagnosis of amblyopia, people in both groups will be asked to use the given virtual games in the same way for one month, 5 sessions per week, each session for 30 minutes. In order to control the amount of use of computer games by patients, the duration of time that people use games will be controlled and recorded online using software by design engineers. Patients will be examined before treatment, one month after treatment and also one month after stopping treatment.",[27],"2025-08-04",{"date":548,"type":38},"2025-08-05",{"date":422,"type":21},{"date":551,"type":21},"2025-12-29",{"name":553,"class":45},"Shahid Beheshti University of Medical Sciences",{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":146,"sex":16,"minAge":123,"maxAge":105,"enrollmentInfo":561,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":46},"100601597","early-detection-and-prevention-of-amblyopia-and-visual-impairment-through-systematic-pediatric-vision-screening-100601597","NCT07112560","Early Detection and Prevention of Amblyopia and Visual Impairment Through Systematic Pediatric Vision Screening","FALSSE","Inclusion criteria:\n\n* Patients aged 3 to 7 years at the time of consent signing.\n* Patients followed in the Ophthalmology Department of Strasbourg University Hospital (CHU Strasbourg).\n* Holders of parental authority must be affiliated with or beneficiaries of the health insurance system.\n* Holders of parental authority must be capable of understanding the objectives and risks related to the research, and able to provide dated and signed informed consent.\n* Amblyopic patients must have amblyopia diagnosed by the reference screening method.\n* Non-amblyopic patients must have undergone routine screening confirming the absence of amblyopia or any other ocular condition that could lead to amblyopia.\n* Screening must be performed in the Ophthalmology Department of CHU Strasbourg, unless a prior screening has been performed according to established guidelines and fully documented in a report by the patient's ophthalmologist (detailed results of the three standard screening tests).\n* The screening examination must have been performed within the three months prior to the signing of the informed consent form.\n\nExclusion criteria:\n\n* Amblyopic children currently undergoing treatment or having previously received treatment for amblyopia (optical correction, strabismus surgery, occlusion therapy, orthoptic rehabilitation).\n* Children presenting conditions or states that may cause side effects related to the use of the virtual reality headset (epilepsy, neurological or developmental disorders, autism spectrum disorders, dizziness, nausea, claustrophobia, etc.).\n* Inability to provide informed information to the patient or holders of parental authority (emergency situations, difficulties in patient comprehension, etc.).",{"count":416,"type":21},"Amblyopia, characterized by reduced visual acuity, develops in childhood due to insufficient sensory stimulation of the affected eye. It is the leading cause of low vision and loss of stereoscopic vision in both children and adults. Currently, 99 million people worldwide are affected, with recent projections indicating 222 million by 2040. Amblyopia can result from anisometropia (70%), strabismus (30%), or the presence of an ocular pathology (1%). Early management of these conditions (before the age of 7) can prevent the onset of amblyopia. Therefore, screening for these conditions is a major public health challenge to reduce the prevalence and associated costs of visual impairment.\n\nThe French-speaking Association of Strabology and Pediatric Ophthalmology (AFSOP) recommends systematic amblyopia screening for 3-year-old children. This screening involves measuring monocular visual acuity in both eyes (LEA chart at 3 meters), checking for strabismus (cover\u002Funcover test), and performing a stereoscopic vision test (e.g., Lang I test).\n\nAmblyopia is currently underdiagnosed for two main reasons: 1) it is often asymptomatic (75% of cases) and therefore cannot be detected without systematic screening; and 2) there is significant difficulty in accessing medical care in certain regions, and thus access to professionals capable of performing this screening (doctors, orthoptists). The difficulty in accessing healthcare professionals capable of screening for amblyopia in children aged 3 to 7 has already been raised.\n\nWe believe it would be beneficial to have an alternative screening method that is equivalent to the AFSOP-recommended method and accessible in areas with limited healthcare professionals. An eye-tracking system implemented in a virtual reality (VR) headset has recently been developed for monitoring eye movements. This system has shown effectiveness in rehabilitating visual field impairments in patients with traumatic brain injury. The system allows for remote monitoring of rehabilitation sessions, and data can be downloaded and viewed remotely via Wi-Fi.\n\nThe main objective of this study will be to estimate the sensitivity of the new VR-based eye-tracking screening method amblyopia screening method using an eye-tracking system implemented in a virtual reality headset compared to standard screening in children aged 3 to 7 years.",[27],[27,565,566,567,568],"Visual impairment","New method for amblyopia screening","Pediatric amblyopia screening","Eye Tracking system","2025-08-01",{"date":571,"type":38},"2025-08-08",{"date":573,"type":21},"2025-09",{"date":575,"type":21},"2026-09",{"name":577,"class":45},"University Hospital, Strasbourg, France",{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":16,"minAge":585,"maxAge":487,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":597,"locationsCount":46},"100519892","novel-amblyopia-treatment-with-virtual-reality-games-100519892","NCT06049459","Novel Amblyopia Treatment With Virtual Reality Games","Novel Amblyopia Treatment With Dichoptic, Disparity-guided, Hand-Eye Coordination Enhanced, Serious, Virtual Reality Games","Inclusion Criteria:\n\nPatients ages 5 to 17 years of age\n\n* Moderate to severe unilateral amblyopia (logMAR best corrected visual acuity 0.3 to 1.3) associated with anisometropia and\u002For strabismus of ≤5pd\n* Age normal VA in the nonamblyopic eye\n* Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (\\\u003C0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart)\n* Interocular difference of ≥ 3 lines\n* No amblyopia treatment in the past 2 weeks\n* An interpupillary distance of 52-72 mm (inclusive)\n\nExclusion Criteria:\n\n* Myopia greater than -6.00 diopters (D) spherical equivalent in either eye.\n* Previous intraocular or refractive surgery.\n* Previous dichoptic treatment \\> 2 weeks in duration\n* Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met).\n* Diplopia more than once per week over the last week prior to enrollment by parental report.\n* Down syndrome or cerebral palsy.\n* Light-induced seizures\n* Known simulator sickness\n* Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and\u002For learning disabilities are not excluded.","5 Years",{"count":587,"type":21},8,[24],"The goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is:\n\nIs a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. 25 min\u002Fday, 6 days\u002Fweek more effective for improvement in amblyopic-eye VA, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone?\n\nParticipants will each serve as their own control and complete:\n\nTreatment period 1: Continued optical correction (glasses) alone for 16 weeks; Treatment period 2: Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks (approx. 25min\u002Fday, 6 days\u002Fweek) plus continued optical correction",[27],"2025-07-17",{"date":593,"type":38},"2025-07-22",{"date":595,"type":38},"2024-03-14",{"date":209,"type":21},{"name":598,"class":45},"Marjean Kulp",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":16,"minAge":605,"maxAge":606,"enrollmentInfo":607,"targetDuration":4,"studyType":22,"phases":608,"briefSummary":609,"conditions":610,"keywords":611,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":46},"100469509","effect-of-transcranial-magnetic-stimulation-on-visual-functions-of-adult-amblyopia-a-preliminary-study-100469509","NCT05393739","Effect of Transcranial Magnetic Stimulation on Visual Functions of Adult Amblyopia: a Preliminary Study","Inclusion Criteria:\n\n1. Adult amblyopia participants, aged 20-50 years old.\n2. Based on inclusion criteria, there was a minimum of 2 lines difference in BCVA between the 2 eyes.\n3. An amblyogenic factor and history of amblyopia treatment was recorded\n\nExclusion Criteria:\n\n1. Unstable vital sign\n2. History of brain injury and\u002For head trauma\n3. Neurological and psychiatric disease\n4. Seizures or family history of seizure\n5. Pregnancy\n6. Uncontrolled migraine or the presence of metallic implants or shunt in the head or torso\n7. Wide region of ischemic cicatrix, multiple sclerosis, taking tricycle antidepressants,\n8. Analgesics or any drugs may decrease the threshold for inducing seizure\n9. Experienced sleep disorders during the rTMS treatment\n10. Severe alcoholism or taking seizure drugs\n11. Severe heart diseases or uncontrollable migraine caused by high intracranial pressure","20 Years","50 Years",{"count":466,"type":21},[24],"Amblyopia, with a prevalence rates of 3% in adult population, is a common cause of vision impairment. It is characterized by impaired vision in one or both eyes because of disruption of normal visual stimuli and underdevelopment of the visual cortex, leads to lifelong visual deficits affecting both monocular and binocular visual function. Common causes of amblyopia include refraction error, anisometropia, strabismus and visual deprivation arising from ptosis or congenital cataract. Our previous studies had shed light on the relationship between abnormal early visual experience, and development of later amblyopia and possible neural developmental disorders. Functional recovery is difficult when neuroplasticity slows down at the end of the critical period. To date, there is no established effective treatment for adult amblyopia.\n\nRepetitive transcranial magnetic stimulation (rTMS) is one of the non-invasive stimulations had been used widely as a research tool to understand the brain functions and an established treatment modality in neuropsychiatric diseases. Theta burst stimulation (TBS) is a newer form of rTMS protocol which have a major advantage over traditional rTMS in their reduced administration duration and allowing stimulation at significantly lower intensities to attain comparable effects. TBS had been demonstrated to able to improve functions in participants with visual disorders. However, studies of its use on adult amblyopia are scarce. Due to lack of efficient treatment at present, it is of scientific significance to conduct placebo-controlled experiments on this topic. Investigators will evaluate the effect of three regimens of TBS (intermittent, continuous and sham), after one session and accumulative sessions, on visual functions of amblyopia adults shortly after treatment and 2 weeks later (lasting effect), in order to evaluate its potential role in amblyopia and find out the best paradigm for amblyopia treatment.",[27],[612,27,613],"Transcranial magnetic stimulation","Neuroplasticity","2025-06-17",{"date":616,"type":38},"2025-06-22",{"date":618,"type":38},"2023-01-05",{"date":620,"type":21},"2025-12-31",{"name":622,"class":45},"National Taiwan University Hospital"]