Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT04230720
Status:
WITHDRAWN
Last Update Posted:
2021-06-22
First Post:
2020-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Artificial Tears on Biometry
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Stopped due to COVID-19.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-16', 'studyFirstSubmitDate': '2020-01-14', 'studyFirstSubmitQcDate': '2020-01-14', 'lastUpdatePostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Baseline in Keratometry Values (K1 and K2)', 'timeFrame': 'Baseline, Day 14', 'description': 'The change in keratometry (K) values (K1 and K2) in all subjects'}, {'measure': 'Change in Baseline in Axis of Astigmatism', 'timeFrame': 'Baseline, Day 14', 'description': 'The change in axis of astigmatism in all subjects'}], 'secondaryOutcomes': [{'measure': 'Change in Baseline Calculated Intraocular Lens Power', 'timeFrame': 'Baseline, Day 14', 'description': 'The change in intraocular lens power calculation in all subjects'}, {'measure': 'Change in Keratometry Values (K1 and K2) in Ocular Surface Disease Subjects', 'timeFrame': 'Baseline, Day 14', 'description': 'The change in keratometry (K) values (K1 and K2) in a subset of subjects that were positive for ocular surface disease on the American Society of Cataract and Refractive Surgery (ASCRS) modified Standardized Patient Evaluation of Eye Dryness (SPEED2) questionnaire'}, {'measure': 'Change in Axis of Astigmatism in Ocular Surface Disease Subjects', 'timeFrame': 'Baseline, Day 14', 'description': 'The change in axis of corneal astigmatism in a subset of subjects that were positive for ocular surface disease on the American Society of Cataract and Refractive Surgery (ASCRS) modified Standardized Patient Evaluation of Eye Dryness (SPEED2) questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biometry measurement', 'artificial tear', 'cataract surgery'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if measurements for cataract surgery are improved with use of additional lubrication with artificial tears. The research study is being done to optimize measurements and provide patients with the best visual outcomes after cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥ 18 years of age\n* Documentation of bilateral age-related senile cataracts diagnosis\n\nExclusion Criteria:\n\n* Patients currently using regularly scheduled artificial tears. Patients with infrequent or irregular use of artificial tears may not be excluded from the study.\n* Patients using contact lenses.\n* Patients with any other surface pathology affecting corneal biometric measurements determined with slit-lamp examination or medical history.'}, 'identificationModule': {'nctId': 'NCT04230720', 'briefTitle': 'Effect of Artificial Tears on Biometry', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Impact of Lubrication With Artificial Tears on Biometry Measurements for Cataract Surgery', 'orgStudyIdInfo': {'id': '19-11021101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Artificial Tears', 'description': 'One eye of each participant is randomized to receive Systane Complete artificial tears 4 times a day for 14 days', 'interventionNames': ['Drug: Systane Complete']}, {'type': 'NO_INTERVENTION', 'label': 'No Artificial Tears', 'description': 'One eye of each participant is randomized to receive no artificial tears for 14 days'}], 'interventions': [{'name': 'Systane Complete', 'type': 'DRUG', 'description': '1 drop 4 times a day for 14 days', 'armGroupLabels': ['Artificial Tears']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Ophthalmology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ashley Brissette, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}