[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628994":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":56,"collaborators":24,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":24,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Advanced Vision Care","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Unity VCS\u002FCS with 4D Phaco Handpiece","ACTIVE_COMPARATOR","Patients are generally randomized to undergo surgery with Unity VCS\u002FCS system with 4D phacoemulsification on one of there eyes",[13],"Device: Cataract extraction with phacoemulsification comparing two systems",{"label":15,"type":10,"description":16,"interventionNames":17},"Centurion vision system with OZil Handpiece","Patients are generally randomized to undergo surgery with Centurion system with OZil technology phacoemulsification on one of there eyes",[13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Cataract extraction with phacoemulsification comparing two systems","First arm: Phacoemulsification using UNITY VCS\u002FCS system with UNITY 4D phaco handpiece",[9],null,{"type":20,"name":21,"description":26,"armGroupLabels":27,"otherNames":24},"Second arm: Phacoemulsification using Centurion system with OZil technology",[15],[29],{"name":30,"affiliation":5,"role":31},"Nicole R Fram, M.D.","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"Orly Shiler","CONTACT","3102291220","orlyjr@inorbit.com",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Los Angeles","California","90067","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-118.24368,34.05223,{"lat":50,"lon":49},[53,55],{"name":34,"role":35,"phone":54,"phoneExt":24,"email":37},"8183919507",{"name":30,"role":31,"phone":24,"phoneExt":24,"email":24},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Nicole Fram M.D.","Principal investigator","100628994","this-clinical-trial-compares-two-phacoemulsification-systems-used-in-a-bilateral-cataract-surgery-subjects-in-order-to-study-cde-and-ultrasound-time-during-cataract-removal-100628994",false,"NCT07468877","This Clinical Trial Compares Two Phacoemulsification Systems Used in a Bilateral Cataract Surgery Subjects in Order to Study CDE and Ultrasound Time During Cataract Removal","Cumulative Dissipated Energy (CDE) and Total Phacoemulsification Energy (Joules) of Unity VCS\u002FCS With 4D Phaco Compared to Centurion System With OZil","CDE","Inclusion Criteria:\n\n* Healthy patients 18 years or older undergoing uncomplicated sequential bilateral cataract surgery with phacoemulsification and IOL implantation\n* Expected to undergo sequential cataract surgery in both eyes\n* Must have bilateral nuclear sclerosis cataracts classified using LOCS III as grade 3 or above (see appendix III)\n* Both eyes will be operated on by the same surgeon\n* Have the ability to consent for study and procedure planned\n\nExclusion Criteria:\n\n* Patients under 18 years of age.\n* Complex cataract cases involving zonulopathy (e.g., pseudoexfoliation syndrome, traumatic zonular weakness) that may require use of zonular support devices during surgery (e.g. capsular hooks) and\u002For implantation of capsular tension rings or other zonular support devices, and in the investigator's judgment, may interfere with the surgical procedure or study outcome measures.\n* Require mechanical pupil expanding devices (e.g., iris hooks, Malyugin rings, etc.)\n* Undergoing femtosecond laser-assisted lens fragmentation.\n* Surgical complications, in the opinion of the investigator, occurring either intraoperatively or postoperatively (including capsule tears, iris trauma, or decentered intraocular lens) and not attributable to the study device or study design.\n* Prior ocular surgery (including intraocular, oculoplastic, corneal or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment, if it interferes with the outcome measures of this study.\n* Presence of endothelial cell dystrophies and\u002For corneal comorbidities.\n* History of intraocular inflammation (e.g., uveitis, iritis).\n* History of retinal edema or presence of a clinically significant epiretinal membrane that, in the investigator's clinical judgment, may interfere with the outcome measures of this study.\n* History of retinal surgery (e.g.retinal detachment repair, membrane peel) involving vitrectomy.\n* Dense brunescent cataract that in the investigator's clinical judgment, may interfere with the outcome measures of this study.","ALL","18 Years",{"count":71,"type":72},30,"ESTIMATED","INTERVENTIONAL",[75],"NA","This clinical trial compares two phacoemulsification systems used in a bilateral cataract surgery subjects, in order to study CDE and Ultrasound time during cataract removal",[78,79,80],"Nuclear Sclerosis of the Lens","Phacoemulsification Cataract Surgery","Cataract Bilateral",[82,83,84,85,86],"Phacoemolsification","Unity VCS\u002FCS","Centurion","Nuclear Sclerosis of the lens","Cataract","2026-03-16",{"date":89,"type":90},"2026-03-18","ACTUAL",{"date":92,"type":90},"2026-02-13",{"date":94,"type":72},"2027-02-13",{"name":58,"class":6},1]