Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-01-29 @ 12:33 AM
Study NCT ID:
NCT00494494
Status:
COMPLETED
Last Update Posted:
2011-07-12
First Post:
2007-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Nepafenac on Post-operative Macular Swelling Following Uncomplicated Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'C414203', 'term': 'nepafenac'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'klc@med.unc.edu', 'phone': '919 843-0292', 'title': 'Kennth L. Cohen, MD', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Although the peak incidence of CME is said to be at 4-12 weeks after surgery, we may have missed the time course for detecting the maximum increased OCT measured macular thickness.'}}, 'adverseEventsModule': {'description': 'Serious and/or other adverse Events were not collected for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Treatment', 'description': 'These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nepafenac', 'description': '1 drop per study eye three times per day for 30 days plus standard care', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment', 'description': 'These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.'}, {'id': 'OG001', 'title': 'Nepafenac', 'description': '1 drop per study eye three times per day for 30 days plus standard care'}], 'classes': [{'categories': [{'measurements': [{'value': '2.78', 'groupId': 'OG000', 'lowerLimit': '-10.12', 'upperLimit': '15.68'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '-8.2', 'upperLimit': '19.4'}]}]}], 'analyses': [{'pValue': '0.7029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.82', 'ciLowerLimit': '-3.27', 'ciUpperLimit': '8.91', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '13.8', 'groupDescription': 'The null hypothesis is that there is no correlation between the 2 groups. Standard methods were used for power calculation to determine the sample size needed to have 0.90 power for the comparison between two groups at the two-sided significance of 0.05.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Our estimate of a clinically relevant increase is 25 microns. With these specifications, the sample size that is required to have 0.90 power for the comparison between two groups at the two-sided 0.05 significance level is about 10 per group.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 8 weeks', 'description': 'The endpoints of the study were change in macular thickness measured by OCT in the central 1mm diameter centred on the fovea (central macular thickness)', 'unitOfMeasure': 'microns', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Three subjects in the treatment group and two subjects in the control group had unreliable preoperative OCT scans because of dense posterior subcapsular cataracts. These subjects were excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Pre-operative Best Corrected Visual Acuity (BCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment', 'description': 'These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.'}, {'id': 'OG001', 'title': 'Nepafenac', 'description': '1 drop per study eye three times per day for 30 days plus standard care'}], 'classes': [{'categories': [{'measurements': [{'value': '38.48', 'spread': '9.83', 'groupId': 'OG000'}, {'value': '40.49', 'spread': '9.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1937', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.01', 'ciLowerLimit': '-2.41', 'ciUpperLimit': '6.43', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '9.56', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Patients were instructed to read letters on the EDTRS visual acuity chart. The mean and standard deviation for each group was measured. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was per protocol. At baseline, everybody was given a Best Corrected Visual Acuity Assessment (BCVA).'}, {'type': 'PRIMARY', 'title': 'Foveal Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment', 'description': 'These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.'}, {'id': 'OG001', 'title': 'Nepafenac', 'description': '1 drop per study eye three times per day for 30 days plus standard care'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-25.4', 'upperLimit': '21.4'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '-14.9', 'upperLimit': '24.3'}]}]}], 'analyses': [{'pValue': '0.5066', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.70', 'ciLowerLimit': '-3.12', 'ciUpperLimit': '16.52', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '19.6', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 8 weeks', 'description': 'difference in mean pre-post changes by the two treatment groups', 'unitOfMeasure': 'microns', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment', 'description': 'These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.'}, {'id': 'OG001', 'title': 'Nepafenac', 'description': '1 drop per study eye three times per day for 30 days plus standard care'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '-0.46', 'upperLimit': '0.56'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '-0.11', 'upperLimit': '0.31'}]}]}], 'analyses': [{'pValue': '0.5099', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.227', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.21', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 8 weeks', 'unitOfMeasure': 'microns', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-operative Best Corrected Visual Acuity (BCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment', 'description': 'These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.'}, {'id': 'OG001', 'title': 'Nepafenac', 'description': '1 drop per study eye three times per day for 30 days plus standard care'}], 'classes': [{'categories': [{'measurements': [{'value': '54.46', 'groupId': 'OG000', 'lowerLimit': '39', 'upperLimit': '67'}, {'value': '55.49', 'groupId': 'OG001', 'lowerLimit': '44', 'upperLimit': '65'}]}]}], 'analyses': [{'pValue': '0.5005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '-1.49', 'ciUpperLimit': '3.55', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.64', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 8 weeks', 'description': 'The patients were again instructed to read letters on the ETDRS chart 8 weeks post-surgery. The mean and standard deviation for each group was recorded. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.', 'unitOfMeasure': 'letters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Treatment', 'description': 'These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.'}, {'id': 'FG001', 'title': 'Nepafenac', 'description': '1 drop per study eye three times per day for 30 days plus standard care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Treatment', 'description': 'These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.'}, {'id': 'BG001', 'title': 'Nepafenac', 'description': '1 drop per study eye three times per day for 30 days plus standard care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.33', 'spread': '8.04', 'groupId': 'BG000'}, {'value': '73.95', 'spread': '8.99', 'groupId': 'BG001'}, {'value': '72.14', 'spread': '8.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-13', 'studyFirstSubmitDate': '2007-06-28', 'resultsFirstSubmitDate': '2011-04-11', 'studyFirstSubmitQcDate': '2007-06-28', 'lastUpdatePostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-13', 'studyFirstPostDateStruct': {'date': '2007-06-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)', 'timeFrame': 'baseline and 8 weeks', 'description': 'The endpoints of the study were change in macular thickness measured by OCT in the central 1mm diameter centred on the fovea (central macular thickness)'}, {'measure': 'Pre-operative Best Corrected Visual Acuity (BCVA)', 'timeFrame': 'baseline', 'description': 'Patients were instructed to read letters on the EDTRS visual acuity chart. The mean and standard deviation for each group was measured. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.'}, {'measure': 'Foveal Thickness', 'timeFrame': 'baseline and 8 weeks', 'description': 'difference in mean pre-post changes by the two treatment groups'}, {'measure': 'Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)', 'timeFrame': 'baseline and 8 weeks'}, {'measure': 'Post-operative Best Corrected Visual Acuity (BCVA)', 'timeFrame': 'baseline and 8 weeks', 'description': 'The patients were again instructed to read letters on the ETDRS chart 8 weeks post-surgery. The mean and standard deviation for each group was recorded. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cystoid macular edema', 'cataract', 'nonsteroidal antiinflammatory drugs', 'optical coherence tomography'], 'conditions': ['Cystoid Macular Edema']}, 'descriptionModule': {'briefSummary': 'Purpose: Study the effect of nepafenac ophthalmic suspension 0.1% to prevent post-operative cystoid macular edema following uncomplicated cataract surgery\n\nParticipants: Patients having cataract surgery at UNC who meet eligibility criteria\n\nProcedures (methods): Patients will have pre and post-operative vision measured and optical coherence tomography (OCT) testing, also cataract density and intraoperative phacoemulsification parameters including ultrasound power and ultrasound time will be measured. Patients will be randomized into two groups. Group 1 will be treated with standard post-operative cataract management. Group 2 will be treated with standard post-operative cataract management plus topical nepafenac for one month. Post-operative macular thickness will be studied by analyzing the visual acuity and OCT measurements at two months post surgery.', 'detailedDescription': 'We plan to enroll 80 patients in this prospective randomized clinical trial. Eligible patients will be randomized into two groups. All patients will have pre-operative Early Treatment of Diabetic Retinopathy Study (ETDRS) vision measured and pre-operative OCT (Humphrey-Zeiss Medical Systems, San Leandro, CA) in both eyes. OCT measurements will include total macular volume, central foveal thickness, and average macular thickness. Pre-operatively, all cataracts will be graded using the LOCS III classification system.10 Group 1 will receive pre-operative topical nepafenac to maintain intra-operative pupillary dilation which is standard care for cataract surgery. Following surgery Group 1 will be treated with standard post operative cataract treatment, including a topical antibiotic and a topical corticosteroid. Group 2 will also receive pre-operative topical nepafenac to maintain intra-operative pupillary dilation. Following surgery patients in Group 2 will be treated with topical nepafenac, a topical antibiotic, and a topical corticosteroid. Group 2 will be given the 3ml bottle of nepafenac to take home and instructed to use it three times per day for one month. Intra-operative surgical parameters including ultrasound time and average percent phacoemulsification power will be recorded for all surgeries. All patients will be seen on post-operative day one, one week, one month, and two months. At the two month visit, best corrected ETDRS vision and OCT will be repeated in both eyes. The two month visual acuity and post-operative OCT will be analyzed to evaluate the effect of nepafenac on CME following cataract surgery. Wilcoxon signed rank test will be used to compare pre-operative and post-operative differences between visual acuity and OCT measurements. The Spearman correlation will be used to compare the variables in the study including cataract density, ultrasound time, average percent phacoemulsification power, and OCT measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over age 50\n* having cataract surgery at UNC\n\nExclusion Criteria:\n\n* medically controlled diabetes\n* history of intraocular surgery\n* abnormal pre-op optical coherence tomography scan\n* history of ocular inflammation\n* have age related macular degeneration'}, 'identificationModule': {'nctId': 'NCT00494494', 'briefTitle': 'Effect of Nepafenac on Post-operative Macular Swelling Following Uncomplicated Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Effect of Nepafenac on Post-operative Cystoid Macular Edema Following Uncomplicated Cataract Surgery', 'orgStudyIdInfo': {'id': '05-3115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Treatment', 'description': 'topical antibiotic for 10 days and a topical corticosteroid for 1 month', 'interventionNames': ['Drug: Standard Care']}, {'type': 'EXPERIMENTAL', 'label': 'Nepafenac', 'description': '1 drop per study eye three times per day for 30 days in addition to standard care', 'interventionNames': ['Drug: nepafenac']}], 'interventions': [{'name': 'Standard Care', 'type': 'DRUG', 'description': 'topical antibiotic for 10 days plus topical corticosteroids for 1 month', 'armGroupLabels': ['Standard Treatment']}, {'name': 'nepafenac', 'type': 'DRUG', 'description': 'liquid drops, administered three times per day for 1 month in addition to standard care use of topical antibiotic and topical corticosteroid', 'armGroupLabels': ['Nepafenac']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27517', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Kenneth C Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research to Prevent Blindness', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Kenneth Cohen, MD', 'oldOrganization': 'UNC Chapel Hill'}}}}