Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-21 @ 4:56 PM
Study NCT ID:
NCT04187157
Status:
COMPLETED
Last Update Posted:
2019-12-05
First Post:
2019-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Light Spectrum and Survival After Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D021081', 'term': 'Chronobiology Disorders'}, {'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10192}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-03', 'studyFirstSubmitDate': '2019-11-26', 'studyFirstSubmitQcDate': '2019-12-03', 'lastUpdatePostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'From the date of the initial cataract surgery until the date of death or end of the study period (April 30, 2019), whichever occurred first, assessed up to 2,310 days.', 'description': 'The primary outcome was all-cause mortality. Mortality was identified based on the Social Security Death Master File and discharge status. Follow-up started from the day after the initial surgery until the end of the study period or death, whichever occurred first. Time to death was calculated as the number of days from the first cataract surgery to death. Participants who did not have a recorded death were censored on April 30, 2019.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['circadian', 'cataracts', 'blue light', 'survival'], 'conditions': ['Cataract', 'Age-related Cataract', 'Circadian Rhythm Disorders', 'Glaucoma', 'Age Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This study was a retrospective observational cohort analysis of subjects aged 65 years and older, who underwent bilateral cataract surgery within a single (15 hospital) healthcare system, to determine the association between type (conventional or blue-light filtering) of implanted intraocular lens and survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted of all adult patients (at least 65 years) who underwent bilateral cataract surgery between January 01, 2012 and January 01, 2018 within the University of Pittsburgh Medical Center (UPMC) healthcare system.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study population consisted of all adult patients (at least 65 years) who underwent bilateral cataract surgery between January 01, 2012 and January 01, 2018 within the University of Pittsburgh Medical Center (UPMC) healthcare system. To be considered bilateral and concomitant, cataract surgery had to be performed on both the left and the right eye within a 365-day period.\n\nExclusion Criteria:\n\n* We excluded patients undergoing unilateral cataract surgery, surgery to replace or repair a previously implanted IOL, or bilateral implantation with one Blue-IOL and one Natural-IOL (i.e., mixed IOL transmission properties).'}, 'identificationModule': {'nctId': 'NCT04187157', 'briefTitle': 'Association Between Light Spectrum and Survival After Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Association Between the Implantation of Conventional or Blue Light-filtering Intraocular Lens and Survival Among Patients Undergoing Bilateral Cataract Surgery: a Multi-center, Observational Cohort Study', 'orgStudyIdInfo': {'id': 'PRO18060034'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blue-light filtering intraocular lens (IOL)', 'description': 'Bilateral implantation of blue-filtering intraocular lens. Blue-IOL, in addition to ultraviolet, also impede the transmission of the lower visible blue spectrum between 400 and 500nm.', 'interventionNames': ['Device: Blue-light filtering intraocular lens']}, {'label': 'Conventional intraocular lens (IOL)', 'description': 'Bilateral implantation of conventional ultraviolet light-blocking intraocular lens', 'interventionNames': ['Device: Conventional intraocular lens']}], 'interventions': [{'name': 'Blue-light filtering intraocular lens', 'type': 'DEVICE', 'description': 'Bilateral implantation of blue light-blocking intraocular lens', 'armGroupLabels': ['Blue-light filtering intraocular lens (IOL)']}, {'name': 'Conventional intraocular lens', 'type': 'DEVICE', 'description': 'Bilateral implantation of conventional intraocular lens', 'armGroupLabels': ['Conventional intraocular lens (IOL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC-Presbyterian Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Matthew R Rosengart, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': 'Beginning12 months and ending 36 months after publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared.', 'accessCriteria': 'Data will be shared with researchers who provide a methodologically sound proposal.\n\nAnalyses are limited to those to achieve the aims listed in the approval proposal.\n\nProposals should be directed to mrr18@pitt.edu; to gain access, data requestors will need to sign a data access agreement.\n\nInformation regarding accessing data may be obtained after approval of the proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Matthew Rosengart', 'investigatorAffiliation': 'University of Pittsburgh'}}}}