[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610152":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":25,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":25,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":25,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":25,"overallStatus":75,"whyStopped":25,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Wolfe Eye Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Centurion with Active Sentry at a traditionally high IOP setting","ACTIVE_COMPARATOR","Centurion with Active Sentry at a traditionally high IOP setting, Eyes in this arm will maintain an Intraocular Pressure (IOP) of 65 millimeters of mercury (mmHg) throughout the cataract surgery.",[13],"Device: High IOP Setting",{"label":15,"type":10,"description":16,"interventionNames":17},"Unity VCS\u002FCS with Intelligent Fluidics at a low IOP setting","Unity VCS\u002FCS with Intelligent Fluidics at a low IOP setting. Eyes in this arm will maintain an Intraocular Pressure (IOP) of 25 millimeters of mercury (mmHg) throughout the cataract surgery.",[18],"Device: Low IOP Setting",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","High IOP Setting","Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment",[9],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Low IOP Setting",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Robyn Kohler, RN","CONTACT","515-223-8685","rkohler@wolfeclinic.com",[36],{"facility":37,"status":25,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Wolfe Eye Clinic and Wolfe Surgery Center","West Des Moines","Iowa","50266","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-93.71133,41.57721,{"lat":47,"lon":46},[50],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Matthew Rauen","Principal Investigator","100610152","the-impact-of-physiologic-cataract-surgery-on-patient-comfort-and-medication-usage-100610152",false,"NCT07223866","The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage","Inclusion Criteria: Subjects who will require bilateral cataract surgery will be considered. Evaluations will occur in the clinic of the Principal Investigator (PI) Matthew Rauen, MD at the Wolfe Eye Clinic.\n\nInclusion Criteria:\n\n* Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery with similar cataract grade in both eyes\n* Unremarkable ocular health but inclusive of early AMD\n\nExclusion Criteria:\n\n* H\u002Fo ocular surgery including corneal refractive surgery\n* Compromised zonular integrity or stability\n* Uncontrolled diabetes and diabetic retinopathy\n* Small pupils\n* H\u002Fo systemic inflammatory disease\u002Fuveitis\n* H\u002Fo chronic pain medications (including narcotics) and benzodiazepine usage\n* Abnormal liver or renal function","ALL","60 Years",{"count":64,"type":65},85,"ESTIMATED","INTERVENTIONAL",[68],"NA","The study will pertain to investigating the impact of high vs low IOP on the intraoperative experience and comfort for the patient and surgeon. Our hypothesis is that operating at a more physiological IOP using Unity VCS\u002FCS and Centurion with Active Sentry at a higher, or more traditional IOP will result in significantly less discomfort\u002Fpain as assessed by the decreased need for rescue medication and lower VAS scores.",[71,72,73,74],"Cataract and IOL Surgery","Cataract Surgery Anesthesia","Cataract Surgery Experience","Nuclear Cataract","NOT_YET_RECRUITING","2025-11-05",{"date":78,"type":79},"2025-11-10","ACTUAL",{"date":81,"type":65},"2025-11-01",{"date":83,"type":65},"2027-01-01",{"name":53,"class":6},1]