Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-27 @ 9:31 PM
Study NCT ID:
NCT01471561
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2011-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Cataract Surgery Induced Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-02', 'studyFirstSubmitDate': '2011-11-10', 'studyFirstSubmitQcDate': '2011-11-10', 'lastUpdatePostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post surgical tear osmolarity', 'timeFrame': '90-Day post-surgical', 'description': 'Correlation between pre-surgery value and development of dry eye disease post surgery\n\n1\\) Comparison of Osmolarity measurement pre to post-op, as well as over time, to determine change and statistical significance'}], 'secondaryOutcomes': [{'measure': 'Post-surgical dry eye symptoms', 'timeFrame': '90-Day post-surgical', 'description': 'Correlation between pre-surgery value and development of dry eye disease post surgery.\n\n1\\) Subjective patient reporting on dry eye symptoms from pre to postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osmolarity', 'Cataract', 'Dry Eye'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'This is a retrospective study to determine if rates of osmolarity and dry eye disease symptoms increase following cataract surgery.', 'detailedDescription': "The objective of this study is to determine if tear osmolarity is a good predictor for dry eye following cataract surgery.\n\nThe practice will retrospectively identify patients that have had cataract surgery from billing records. This will be cross referenced with patients that have had the diagnosis of dry eye and have had tear osmolarity testing, also from billing or electronic records analysis. The studies will be done at sites that have inclusion of a general statement about record review for research in the patient intake information at the practice. Information will be taken from the baseline visit at the final pre-operative examination prior to cataract surgery from these patients who have had tear osmolarity measured on each eye using the TearLab osmolarity device.\n\nBecause this is a retrospective study, patients will have followed each surgeon's typical pre-operative and post-operative protocol (i.e., lid cleansing, topical antibiotics, steroids, NSAIDS, etc.) without other peri-surgical complications, and followed at the normal post-operative follow-up appointments. Whenever tear osmolarity measurements had been taken and recorded in the patient's chart, this information will be collected from the patient's chart and recorded in a database. Information from visits up to and including the 3 month postoperative interval will be recorded. Additional information recorded will be demographic information such as age, corrected vision before and after the cataract surgery at the one month visit as well as at any time that tear osmolarity is measured. Additionally, any comments made in the history of present illness statement regarding dryness will be recorded in the database. Presence of other ocular surface disease present such as blepharitis, allergic disease, or anterior basement membrane dystrophy will be recorded. Systemic medications that the patient is taking will also be recorded. Presence or absence of diabetes mellitus will also be recorded. The database will be kept in a password protected computer in a locked office location, and every precaution will be taken to prevent identification of any patient specific identifiers. Information will be de-identified as soon as possible by using codes to identify the data rather than patient names or chart numbers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Male or female, eighteen years of age or older\n2. Confirmed diagnosis of cataract with cataract surgery performed in at least one eye', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, eighteen years of age or older\n2. Confirmed diagnosis of cataract with cataract surgery performed in at least one eye\n\nExclusion Criteria:\n\n1\\. Any complications of cataract surgery that have required a sclera incision rather than a clear corneal incision.'}, 'identificationModule': {'nctId': 'NCT01471561', 'briefTitle': 'Analysis of Cataract Surgery Induced Dry Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'TearLab Corporation'}, 'officialTitle': 'Retrospective Analysis of Cataract Surgery-induced Dry Eye Using Tear Osmolarity Testing', 'orgStudyIdInfo': {'id': 'TP00099'}}, 'contactsLocationsModule': {'locations': [{'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'William Trattler, MD', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'David Hardten, MD', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Chris Starr, MD', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11570', 'city': 'Rockville Centre', 'state': 'New York', 'country': 'United States', 'facility': 'Eric Donnenfeld, MD', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}], 'overallOfficials': [{'name': 'Gaston Lacayo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TearLab Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}