[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642322":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":20,"responsibleParty":31,"collaborators":20,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":20,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":20,"enrollmentInfo":42,"targetDuration":20,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":20,"overallStatus":51,"whyStopped":20,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":20},{"fullName":5,"class":6},"Kowa Research Institute, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"KI-362-US1","EXPERIMENTAL","Participants in this study receive an artificial lens (intraocular lens) implanted in the eye to replace the eye's natural lens that has been removed due to cataract surgery. The lens is delivered using a single-use, preloaded device that helps the surgeon place the lens safely and precisely into the natural lens capsule of the eye.",[13],"Device: KI-362-US1 (YP2.2VM)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","KI-362-US1 (YP2.2VM)","Injector and one-piece (1P) monofocal IOL",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Shona Pendse, MD, MMSc","STUDY_CHAIR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Director, Clinical Operations","CONTACT","919-433-1600","Clinical@KowaUS.com",{"type":32,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100642322","trial-to-investigate-the-safety-and-effectiveness-of-the-ki-362-us1-yp22vm-intraocular-lens-iol-in-adult-participants-for-correction-of-aphakia-following-cataract-extraction-100642322",false,"NCT07650201","Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction","A Prospective, Multicenter, Open-label, Single-arm Clinical Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) IOL for Correction of Aphakia Following Cataract Extraction","Inclusion Criteria:\n\n* Are able and willing to provide written informed consent, attend all scheduled visits, and comply with all trial procedures and follow-up\n* Have a study eye with visually significant cataract for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated\n* Meet all other inclusion criteria outlined in the clinical study protocol\n\nExclusion Criteria:\n\n* Have serious systemic disease that could increase operative risk or conditions that can confound the surgical outcome\n* Within 30 days of the Screening Visit, use of systemic medications with significant ocular side effects or any medications that could confound the outcome or increase participant risk\n* Meet any other exclusion criteria outlined in the clinical study protocol","ALL","22 Years",{"count":43,"type":44},340,"ESTIMATED","INTERVENTIONAL",[47],"NA","A study to learn how well an artificial lens, called an intraocular lens (IOL), works in adults who have cataract surgery. During this type of surgery, the eye's natural lens is removed and replaced with an artificial lens to help restore vision.\n\nThe main goal of the study is to evaluate vision after the lens is placed in the eye. About one year after surgery, participants' vision will be measured to understand how clearly they can see.\n\nThe study will also look at how the lens performs over time, including how well it remains in place in the eye.\n\nThe results of this study will help provide more information about how this lens performs in adults undergoing cataract surgery.",[50],"Aphakia, Postcataract","NOT_YET_RECRUITING","2026-06-10",{"date":54,"type":55},"2026-06-16","ACTUAL",{"date":57,"type":44},"2026-08",{"date":59,"type":44},"2028-11",{"name":5,"class":6}]