[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kubota Vision Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100646807","a-controlled-evaluation-of-optical-defocus-parameters-on-transient-changes-in-axial-length-using-kubota-glass-100646807",false,"NCT07686289","A Controlled Evaluation of Optical Defocus Parameters on Transient Changes in Axial Length Using Kubota Glass","Inclusion Criteria:\n\n* Be of legal age or, if under legal age have written consent of their parent or guardian to participate.\n* Sign written Informed Consent (and the California Bill of Rights, if applicable).\n* Be between age 8-24 (inclusive) and able to understand and assent to participation.\n* Have a spherical component of spectacle prescription between -1.00 and -5.00 diopters (D) (inclusive) in each eye.\n* Have a refractive astigmatism of less than or equal to -1.00 D in each eye.\n* Have axial length between 23.00 and 25.99 millimeters (mm) in each eye.\n* Best Spectacle Corrected Visual Acuity (BSCVA) of 20\u002F25 or better in each eye.\n* Be willing and able to follow instructions and attend the schedule of follow-up visits.\n\nExclusion Criteria:\n\n* Unable or unwilling to provide informed consent and assent.\n* Eye injury or surgery within twelve weeks immediately prior to enrollment.\n* Currently enrolled in an ophthalmic clinical trial.\n* Pregnant or lactating or expect to become pregnant during the trial (by self-report).\n* Evidence of systemic or ocular abnormality, infection or disease.\n* Use of medications that may affect the eye (including, but not limited to, corticosteroids and antimetabolites).\n* Anisometropia ≥ 2.00.\n* Subjects who have undergone corneal refractive surgery.\n* Use atropine or other anticholinergic drug within the past month.\n* Employees or immediate family members of employees of study sites or sponsor.",true,"ALL","8 Years","24 Years",{"count":20,"type":21},35,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study will assess the optimal performance characteristics of optical defocus on transient changes in axial length with Kubota Glass, using a randomized, double-masked, 5-treatment, 5-period crossover design with contralateral eye control.",[27],"Myopia","NOT_YET_RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-07","ACTUAL",{"date":34,"type":21},"2026-07-06",{"date":36,"type":21},"2026-12-31",{"name":38,"class":39},"Kubota Vision Inc.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":15,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100518733","electronic-spectacles-versus-low-dose-atropine-in-young-myopes-100518733","NCT06034379","Electronic Spectacles Versus Low Dose Atropine in Young Myopes","Kubota Corrective Spectacles and Low Dose Atropine for Slowing Myopic Progression in Taiwanese Children","Inclusion Criteria:\n\n1. The subject must be between 6 and 13 years of age (inclusive).\n2. The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.\n3. The guardian of a minor under 18 years old must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form. The subject under 18 years old must be willing to assent to the STATEMENT OF INFORMED CONSENT.\n4. Spherical component of refraction in the range of -0.50 to -10.00 DS in each eye.\n5. Refractive cylinder less than or equal to 2.00 DC in each eye (minus cylinder format).\n6. Best corrected distance VA of at least 20\u002F25 in each eye.\n\nExclusion Criteria:\n\n1. Currently pregnant or lactating\n2. History of severe dry eye, strabismus, or amblyopia\n3. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., diabetes, rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with the participation in the study at the investigator's discretion.\n4. Use of systemic or ocular medications (e.g., chronic steroid use) that are known to interfere with vision and ocular accommodation at the investigator's discretion.\n5. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, strabismus surgery etc.) or orthokeratology\n6. Any active ocular infection.\n7. Any accommodative or binocular anomalies including amblyopia.\n8. Any physical or mental developmental delay.\n9. Any relevant ocular or systemic condition deemed unacceptable by the investigator that may negatively impact the subject's performance or ability to successfully complete the study (at the investigator's discretion)\n10. Anisometropia greater than 1.50D","6 Years","13 Years",{"count":50,"type":21},45,[24],"This is a bilateral, dispensing, masked, randomized clinical trial. Myopic children will be randomly assigned to one of the following: (1) Investigational clinical prototype (CP1) device without atropine, (2) Investigational CP1 device with daily instillation of 0.01% atropine, or (3) daily instillation of 0.01% atropine without use of the investigational CP1 device. Primary endpoint: Difference in the 12-month change of cycloplegic spherical refractive error and axial length between each of the three treatment groups.",[27],"RECRUITING","2024-12-08",{"date":57,"type":32},"2024-12-12",{"date":59,"type":32},"2023-10-01",{"date":61,"type":21},"2025-12",{"name":38,"class":39},1,""]