Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-04 @ 3:50 PM
Study NCT ID:
NCT07222150
Status:
RECRUITING
Last Update Posted:
2025-10-29
First Post:
2025-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-01', 'size': 240489, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-26T20:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective, two-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Unity VCS 4D phaco with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 65mmHg (high IOP) in the other eye usingCenturion Vision System with Ozil.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-26', 'studyFirstSubmitDate': '2025-10-13', 'studyFirstSubmitQcDate': '2025-10-26', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central corneal thickness (CCT)', 'timeFrame': 'Pre-operative, Post-operative day #1, Post-operative day #8 for each arm of the study', 'description': 'Measurement of post-operative CCT pre and post-operatively with Pentacam'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cataract Surgery', 'Phacoemulsification'], 'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '38076276', 'type': 'BACKGROUND', 'citation': '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/fmed.2023.1294808. eCollection 2023.'}, {'pmid': '39602355', 'type': 'BACKGROUND', 'citation': '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/j.jcrs.0000000000001581.'}, {'pmid': '38595209', 'type': 'BACKGROUND', 'citation': "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/j.jcrs.0000000000001457."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cataracts\n\nExclusion Criteria:\n\n* Glaucoma, cornea disease'}, 'identificationModule': {'nctId': 'NCT07222150', 'briefTitle': 'Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness', 'organization': {'class': 'OTHER', 'fullName': 'Metrolina Eye Associates, PLLC'}, 'officialTitle': 'Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness at Day 1 and Day 8 Post Op', 'orgStudyIdInfo': {'id': 'IIT# 98711335'}, 'secondaryIdInfos': [{'id': 'IM-25-02', 'type': 'OTHER', 'domain': 'Advarra IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Unity VCS', 'description': 'Cataract surgery with Unity VCS', 'interventionNames': ['Device: Cataract surgery with Unity VCS', 'Device: Cataract surgery with Centurion with Ozil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Centurion with Ozil', 'description': 'Cataract surgery with Centurion with Ozil', 'interventionNames': ['Device: Cataract surgery with Unity VCS', 'Device: Cataract surgery with Centurion with Ozil']}], 'interventions': [{'name': 'Cataract surgery with Unity VCS', 'type': 'DEVICE', 'description': 'Standard cataract surgery', 'armGroupLabels': ['Centurion with Ozil', 'Unity VCS']}, {'name': 'Cataract surgery with Centurion with Ozil', 'type': 'DEVICE', 'description': 'Standard cataract surgery', 'armGroupLabels': ['Centurion with Ozil', 'Unity VCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28105', 'city': 'Matthews', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Lee', 'role': 'CONTACT', 'email': 'mlee@metrolinaeye.com', 'phone': '7042341930'}, {'name': 'Elisabeth Torres', 'role': 'CONTACT', 'email': 'etorres@metrolinaeye.com', 'phone': '704234'}, {'name': 'Ivan Mac, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Charles A Blotnick, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Metrolina Eye Associates', 'geoPoint': {'lat': 35.11681, 'lon': -80.72368}}], 'centralContacts': [{'name': 'IVAN MAC, MD', 'role': 'CONTACT', 'email': 'imac@metrolinaeye.com', 'phone': '7042341930'}, {'name': 'Megan Lee', 'role': 'CONTACT', 'email': 'mlee@metrolinaeye.com', 'phone': '7042341930'}], 'overallOfficials': [{'name': 'Ivan Mac, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Metrolina Eye Associates'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only summary data will be published comparing the two study arms.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Metrolina Eye Associates, PLLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon, a Novartis Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}