Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT01395069
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2011-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-12', 'studyFirstSubmitDate': '2011-07-11', 'studyFirstSubmitQcDate': '2011-07-13', 'lastUpdatePostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in macular volume (as quantified by OCT) at one month (compared to baseline)', 'timeFrame': 'baseline and one month after surgery'}], 'secondaryOutcomes': [{'measure': 'COMTOL health-related quality-of-life', 'timeFrame': 'one month after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post-cataract surgery', 'macular edema'], 'conditions': ['Macular Edema']}, 'descriptionModule': {'briefSummary': 'Assess prophylactic efficacy of topical non-steroidal anti-inflammatory drops in preventing macular edema. Patient undergoing uncomplicated cataract surgery will be enrolled and randomized to nepafenac, ketorolac, or placebo. Follow-up will occur at 1 month with ocular coherence tomography (OCT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to give informed consent\n* Age 18 years and older\n\nExclusion Criteria:\n\n* Any pre-existing retinal disease (e.g., diabetic retinopathy, vein occlusion, exudative macular degeneration, etc.)\n* Previous uveitis\n* Previous intraocular surgery\n* Allergy or hypersensitivity to NSAIDs\n* Complicated cataract surgery'}, 'identificationModule': {'nctId': 'NCT01395069', 'acronym': 'PNK', 'briefTitle': 'Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Randomized Clinical Trial Comparing Prophylactic Nepafenac 0.1% and Ketorolac 0.5% Versus Placebo in Preventing Postoperative Macular Edema After Uncomplicated Phacoemulsification Cataract Extraction (PNK)', 'orgStudyIdInfo': {'id': 'PNK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nepafenac 0.1%', 'interventionNames': ['Drug: Nepafenac 0.1%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketorolac 0.5%', 'interventionNames': ['Drug: Ketorolac 0.5%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo (sterile saline drops)']}], 'interventions': [{'name': 'Nepafenac 0.1%', 'type': 'DRUG', 'description': '1 drop QID for 1 month', 'armGroupLabels': ['Nepafenac 0.1%']}, {'name': 'Ketorolac 0.5%', 'type': 'DRUG', 'description': '1 drop QID for 1 month', 'armGroupLabels': ['Ketorolac 0.5%']}, {'name': 'Placebo (sterile saline drops)', 'type': 'OTHER', 'description': '1 drop QID for 1 month', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 3G2', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel Dieu Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Sherif El-Defrawy, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Sherif R El-Defrawy', 'investigatorAffiliation': "Queen's University"}}}}