Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-01-26 @ 5:42 PM
Study NCT ID:
NCT02058394
Status:
UNKNOWN
Last Update Posted:
2014-02-10
First Post:
2014-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retained Lens Fragments After Phacoemulsification
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': 'D018918', 'term': 'Phacoemulsification'}], 'ancestors': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-06', 'studyFirstSubmitDate': '2014-02-04', 'studyFirstSubmitQcDate': '2014-02-06', 'lastUpdatePostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Surgical Complications', 'timeFrame': 'Intraoperatively', 'description': 'Proportion of eyes with surgical adverse events.'}], 'primaryOutcomes': [{'measure': 'Macular edema', 'timeFrame': '1 month postoperatively', 'description': 'Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 1 month postoperatively'}], 'secondaryOutcomes': [{'measure': 'Intraocular inflammation', 'timeFrame': '1 month postoperativley', 'description': 'Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 1 month postoperatively'}, {'measure': 'Elevated intraocular pressure', 'timeFrame': '1 month postoperatively', 'description': 'Proportion of eyes with intraocular pressure increase requiring medical or surgery treatment at 1 month postoperatively'}, {'measure': 'Macular Edema', 'timeFrame': '1 week postoperatively', 'description': 'Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 1 week postoperatively'}, {'measure': 'Intraocular Inflammation', 'timeFrame': '1 week postoperatively', 'description': 'Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 1 week postoperatively'}, {'measure': 'Elevated Intraocular Pressure', 'timeFrame': '1 week postoperatively', 'description': 'Proportion of eyes with intraocular pressure increase requiring medical or surgery treatment at 1 week postoperatively'}, {'measure': 'Macular Edema', 'timeFrame': '3 months postoperatively', 'description': 'Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 3 months postoperatively'}, {'measure': 'Intraocular Inflammation', 'timeFrame': '3 months', 'description': 'Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 3 months postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Retained nuclear lens fragments', 'Phacoemulsification', 'Cataract Surgery'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate postoperative events in patients noted to have retained nuclear fragments in the anterior vitreous during routine phacoemulsification and in those who did not.', 'detailedDescription': 'In this study, we investigate whether presence of retained nuclear fragments in the anterior vitreous noted during uncomplicated cataract surgery is associated with higher incidence of postoperative adverse events. We will be assessing events including cystoid macular edema, iritis, elevated intraocular pressure, and retinal detachment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Routine cataract surgery with phacoemulsification\n\nExclusion Criteria:\n\n* Pre-existing macular edema\n* Active uveitis\n* Intraocular exclusion surgeries\n* Significant ocular trauma\n* Evidence of phacodonesis or zonular weakness .'}, 'identificationModule': {'nctId': 'NCT02058394', 'briefTitle': 'Retained Lens Fragments After Phacoemulsification', 'organization': {'class': 'OTHER', 'fullName': 'Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC'}, 'officialTitle': 'Postoperative Events in Patients With and Without Retained Nuclear Fragments in the Anterior Vitreous After Routine Phacoemulsification', 'orgStudyIdInfo': {'id': '12.08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cataract Phacoemulsification', 'description': 'Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.', 'interventionNames': ['Procedure: Phacoemulsification']}], 'interventions': [{'name': 'Phacoemulsification', 'type': 'PROCEDURE', 'description': 'Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.', 'armGroupLabels': ['Cataract Phacoemulsification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'David Ritterband, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic Consultants, Cornea and Refractive Surgery Assoicates, PC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'David Ritterband', 'investigatorAffiliation': 'Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC'}}}}