[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100404988":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":261,"collaborators":21,"id":263,"slug":264,"hasResults":265,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":265,"sex":271,"minAge":272,"maxAge":21,"enrollmentInfo":273,"targetDuration":21,"studyType":276,"phases":277,"briefSummary":279,"conditions":280,"keywords":21,"overallStatus":58,"whyStopped":21,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":291},{"fullName":5,"class":6},"Alcon Research","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Hydrus Microstent","EXPERIMENTAL","Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL)",[13,14,15],"Device: Hydrus Microstent","Procedure: Cataract surgery","Device: Monofocal IOL",[17,22,27],{"type":18,"name":9,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","Crescent-shaped nitinol device intended as a permanent implant to provide an outflow pathway for aqueous humor. The device is placed through the trabecular meshwork into Schlemm's canal immediately following placement of a monofocal IOL.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"PROCEDURE","Cataract surgery","Cataract surgery performed using standard anesthesia and phacoemulsification techniques",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":21},"Monofocal IOL","Commercially available monofocal intraocular lens as determined by the investigator",[9],[32],{"name":33,"affiliation":5,"role":34},"Clinical Project Lead, CDMA Surgical","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":21,"email":40},"Alcon Call Center","CONTACT","1-888-451-3937","alcon.medinfo@alcon.com",[42,56,66,76,86,97,107,117,127,137,146,156,166,176,185,194,204,214,223,232,241,251],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":21},"Coastal 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Township","Pennsylvania","16066",{"type":51,"coordinates":200},[201,202],-80.10714,40.68496,{"lat":202,"lon":201},{"facility":205,"status":58,"city":206,"state":207,"zip":208,"country":48,"countryCode":49,"cosmosGeoPoint":209,"geoPoint":213,"contacts":21},"Texan Eye \u002F Keystone Research","Austin","Texas","78731",{"type":51,"coordinates":210},[211,212],-97.74306,30.26715,{"lat":212,"lon":211},{"facility":215,"status":88,"city":216,"state":207,"zip":217,"country":48,"countryCode":49,"cosmosGeoPoint":218,"geoPoint":222,"contacts":21},"Glaucoma Associates Of Texas","Dallas","75231",{"type":51,"coordinates":219},[220,221],-96.80667,32.78306,{"lat":221,"lon":220},{"facility":224,"status":58,"city":225,"state":207,"zip":226,"country":48,"countryCode":49,"cosmosGeoPoint":227,"geoPoint":231,"contacts":21},"El Paso Eye Surgeons","El 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Kenosha","Kenosha","Wisconsin","53142",{"type":51,"coordinates":257},[258,259],-87.82119,42.58474,{"lat":259,"lon":258},{"type":262,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100404988","hydrus-microstent-new-enrollment-post-approval-study-100404988",false,"NCT04553523","Hydrus® Microstent New Enrollment Post-Approval Study","The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial","CONFIRM","Inclusion Criteria:\n\n* An operable, age-related cataract with best corrected visual acuity (BCVA) of 20\u002F40 or worse;\n* Diagnosis of primary open angle glaucoma treated with no more than 4 topical hypotensive medications;\n* Optic nerve appearance characteristic of glaucoma;\n* Medicated IOP less than or equal to 31 millimeters mercury (mmHg); Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Closed angle forms of glaucoma;\n* Congenital or developmental glaucoma;\n* Secondary glaucoma;\n* Use of more than 4 ocular hypotensive medications;\n* Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative surgery;\n* Prior surgery with implanted device or other surgery involving the trabecular meshwork or Schlemm's canal;\n* Other protocol-defined exclusion criteria may apply.","ALL","45 Years",{"count":274,"type":275},545,"ESTIMATED","INTERVENTIONAL",[278],"NA","The purpose of this post-approval study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.",[281],"Primary Open Angle Glaucoma","2026-06-08",{"date":284,"type":285},"2026-06-10","ACTUAL",{"date":287,"type":285},"2020-08-25",{"date":289,"type":275},"2028-06",{"name":5,"class":6},22]