Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-08 @ 1:59 AM
Study NCT ID:
NCT02843594
Status:
UNKNOWN
Last Update Posted:
2016-08-24
First Post:
2016-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Clinical Outcomes of Surgical Phaco Segmentation Techniques in Patients Undergoing Cataract Surgery
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-22', 'studyFirstSubmitDate': '2016-07-20', 'studyFirstSubmitQcDate': '2016-07-21', 'lastUpdatePostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Dispersed Phaco energy', 'timeFrame': 'Intraoperative', 'description': 'Total phaco power and energy used as recorded by the phaco machine'}], 'secondaryOutcomes': [{'measure': 'Endothelial cell loss', 'timeFrame': '1 month', 'description': 'Change from baseline endothelial cell density as measured by specular microscopy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '29669780', 'type': 'DERIVED', 'citation': 'Ianchulev T, Chang DF, Koo E, MacDonald S, Calvo E, Tyson FT, Vasquez A, Ahmed IIK. Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study. Br J Ophthalmol. 2019 Feb;103(2):176-180. doi: 10.1136/bjophthalmol-2017-311766. Epub 2018 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to evaluate the clinical outcomes of different cataract surgical techniques for lens fragmentation in subjects undergoing routine cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits as confirmed by provision of written informed consent.\n2. Subjects with a visually significant cataract scheduled to undergo cataract surgery\n3. Subjects \\> 18 years of age\n4. BCVA at baseline not better than 20/40\n5. Grade 1+ cataracts\n\nExclusion Criteria:\n\n1. Subjects not able to complete the informed consent form\n2. Subjects \\< 18 years of age\n3. Polar cataracts\n4. Zonular instability'}, 'identificationModule': {'nctId': 'NCT02843594', 'briefTitle': 'A Study to Assess the Clinical Outcomes of Surgical Phaco Segmentation Techniques in Patients Undergoing Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Iantech, Inc'}, 'orgStudyIdInfo': {'id': 'LEEP103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LEEP Intervention C1', 'description': 'Cataract surgery with micro-interventional LEEP technology lens fragmentation (non-randomized cohort 1)', 'interventionNames': ['Procedure: LEEP intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LEEP Intervention C2', 'description': 'Cataract surgery with micro-interventional LEEP technology lens fragmentation (randomized cohort 2)', 'interventionNames': ['Procedure: LEEP intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Phaco C2', 'description': 'Cataract surgery with conventional phaco-assisted lens fragmentation (randomized cohort 2)', 'interventionNames': ['Procedure: Standard Phaco Control']}], 'interventions': [{'name': 'LEEP intervention', 'type': 'PROCEDURE', 'description': 'Low Energy Endosafe Phaco (LEEP) with micro-interventional lens fragmentation', 'armGroupLabels': ['LEEP Intervention C1', 'LEEP Intervention C2']}, {'name': 'Standard Phaco Control', 'type': 'PROCEDURE', 'armGroupLabels': ['Control Phaco C2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'status': 'RECRUITING', 'country': 'Panama', 'contacts': [{'name': 'Ernesto Calvo, MD', 'role': 'CONTACT', 'email': 'ecalvo86@mac.com', 'phone': '(305) 898-0472'}], 'facility': 'Clinica de Ojos Panama City', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'centralContacts': [{'name': 'Jennifer Gaines', 'role': 'CONTACT', 'email': 'admin@iantechmed.com', 'phone': '+1 (415) 295-4770'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iantech, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}