[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07222150":3,"trial-entities:NCT07222150":104,"trial-summary:NCT07222150":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":41,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":56,"locations":59,"central_contacts":85,"overall_officials":90,"references":92,"see_also_links":103},"NCT07222150","IIT# 98711335","Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness","Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness at Day 1 and Day 8 Post Op","RECRUITING","2026-10","2025-10","2025-10-29","2025-10-07","Metrolina Eye Associates, PLLC","OTHER",false,"Phacoemulsification (cataract surgery) is usually performed while temporarily increasing the pressure inside the eye. The purpose of this study is to see if maintaining different pressure levels inside the eye during this procedure results in fewer side effects and better vision shortly after the surgery. Cataract surgery will be performed using Unity VCS at a lower IOP in one eye compared to traditional IOP with Centurion Vision System with Ozil in the other eye. Both of which are approved by the United States Food and Drug Administration (FDA) and used per label.","Study patients will undergo sequential bilateral cataract surgery with the same cataract grade in both eyes. Both surgeries will be completed within one week of each other.\n\nThe first surgical eye will be randomly assigned (like the flip of a coin). Study patients will have surgery performed with the Alcon Unity VCS system using 4D. The second eye will undergo surgery a week later with Alcon Centurion Vision System (VCS) with Ozil. Surgery with the Unity VCS arm will be performed with a lower IOP setting (less than 40). Surgery with the Centurion with Ozil arm will be performed with a higher IOP setting (greater or equal 60).\n\nParticipation in the study is expected to take one month.",[19],"Cataract",[21,22],"Cataract Surgery","Phacoemulsification","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},105,"ESTIMATED",[31,38],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Cataract surgery with Unity VCS","Standard cataract surgery",[36,37],"Centurion with Ozil","Unity VCS",{"type":32,"name":39,"description":34,"armGroupLabels":40},"Cataract surgery with Centurion with Ozil",[36,37],[42],{"measure":43,"description":44,"timeFrame":45},"Central corneal thickness (CCT)","Measurement of post-operative CCT pre and post-operatively with Pentacam","Pre-operative, Post-operative day #1, Post-operative day #8 for each arm of the study",[],"ALL","18 Years",null,{"inclusion":51,"exclusion":53,"raw_text":55},[52],"Cataracts",[54],"Glaucoma, cornea disease","Inclusion Criteria:\n\n* Cataracts\n\nExclusion Criteria:\n\n* Glaucoma, cornea disease",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":61,"status":8,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":82},"Metrolina Eye Associates","Matthews","North Carolina","28105","United States",[67,72,76,79],{"name":68,"role":69,"phone":70,"email":71},"Megan Lee","CONTACT","7042341930","mlee@metrolinaeye.com",{"name":73,"role":69,"phone":74,"email":75},"Elisabeth Torres","704234","etorres@metrolinaeye.com",{"name":77,"role":78},"Ivan Mac, MD","PRINCIPAL_INVESTIGATOR",{"name":80,"role":81},"Charles A Blotnick, MD","SUB_INVESTIGATOR",{"lat":83,"lon":84},35.11681,-80.72368,[86,89],{"name":87,"role":69,"phone":70,"email":88},"IVAN MAC, MD","imac@metrolinaeye.com",{"name":68,"role":69,"phone":70,"email":71},[91],{"name":77,"affiliation":61,"role":78},[93,97,100],{"pmid":94,"type":95,"citation":96},"38076276","BACKGROUND","Liu Y, Hong J, Chen X. Comparisons of the clinical outcomes of Centurion(R) active fluidics system with a low IOP setting and gravity fluidics system with a normal IOP setting for cataract patients with low corneal endothelial cell density. Front Med (Lausanne). 2023 Nov 23;10:1294808. doi: 10.3389\u002Ffmed.2023.1294808. eCollection 2023.",{"pmid":98,"type":95,"citation":99},"39602355","Spaulding J, Hall B. Efficiency of phacoemulsification handpieces with high and low intraocular pressure settings. J Cataract Refract Surg. 2025 Mar 1;51(3):218-221. doi: 10.1097\u002Fj.jcrs.0000000000001581.",{"pmid":101,"type":95,"citation":102},"38595209","Rauen MP, Joiner H, Kohler RA, O'Connor S. Phacoemulsification using an active fluidics system at physiologic vs high intraocular pressure: impact on anterior and posterior segment physiology. J Cataract Refract Surg. 2024 Aug 1;50(8):822-827. doi: 10.1097\u002Fj.jcrs.0000000000001457.",[],{"nct_id":4,"conditions":105,"biomarkers":106},[19],[],{"nct_id":4,"found":108,"summary":109,"prompt_version":119},true,{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This interventional study plans to enroll 105 participants. You would have surgery on both eyes, with the order of the two different surgical methods decided randomly.","completed","Unity VCS: A Comparison Study for Cataract Surgery","This study is comparing two methods of cataract surgery to see if maintaining different pressure levels inside the eye during the procedure leads to fewer side effects and better vision soon after. You would have standard cataract surgery using the Unity VCS system in one eye and the Centurion with Ozil system in the other eye. Researchers will measure the thickness and clarity of your cornea (the clear front part of your eye) before and after surgery to see which method is more effective. This study is for people aged 18 and older who have cataracts, but not glaucoma or other corneal diseases. The current recruitment status is unclear.","Your central corneal thickness will be measured up to 8 days after each surgery.",109,"You would undergo two cataract surgeries, one week apart. Your participation in the study is expected to last one month, with measurements taken before surgery and on day 1 and day 8 after each surgery.","Not stated in the trial record.",[],"v2"]