Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT01016405
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2009-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Health Assessment of Cataract Patients' Ocular Surface
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-31', 'studyFirstSubmitDate': '2009-07-13', 'studyFirstSubmitQcDate': '2009-11-18', 'lastUpdatePostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dry eye as evaluated by grade on ITF (International Task Force) level.', 'timeFrame': 'One study visit'}], 'secondaryOutcomes': [{'measure': "TBUT (tear break-up time), OSDI (Ocular surface disease index), corneal staining with fluorescein, conjunctival staining with lissamine, Schirmer's, and a patient questionnaire. These are all standard operations of care.", 'timeFrame': 'One study visit'}]}, 'conditionsModule': {'keywords': ['Dry eye', 'incidence and severity', 'cataract surgery'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'This study will determine the incidence and severity of dry eye in patients undergoing cataract surgery as determined by grade on the International Task Force (ITF) scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients should be at least 55 years old.\n* Patients must be scheduled to undergo cataract surgery.\n\nExclusion Criteria:\n\n* No previous intraocular surgery in the previous 3 months in either eye.\n* No previous Corneal laser vision correction in either eye within the last one year.\n* No previous lid surgery within the past 3 months.\n* Patients may not have used topical antibiotics, topical NSAIDs or topical steroid in either eye in the past month.\n* Patients are not eligible if they have recently been started on Restasis solely as a perioperative treatment regimen.\n* Patients presently using Restasis in either eye will not undergo any of the study testing but a questionnaire should be completed for these patients regarding use of these medications.'}, 'identificationModule': {'nctId': 'NCT01016405', 'briefTitle': "Prospective Health Assessment of Cataract Patients' Ocular Surface", 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovative Medical'}, 'officialTitle': "Cataract and Dry Eye The PHACO Study (Prospective Health Assessment of Cataract Patients' Ocular Surface)", 'orgStudyIdInfo': {'id': '0167'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Severity of dry eye in patients undergoing cataract surgery'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'The Center for Excellence in Eye Care', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'William Trattler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Center for Excellence in Eye Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovative Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'William Trattler, M.D', 'oldOrganization': 'The Center for Excellence in Eye Care'}}}}