Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT00763360
Status:
COMPLETED
Last Update Posted:
2012-01-24
First Post:
2008-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Compare the Ability of DiscoVisc® OVD to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@alconlabs.com', 'phone': '888.451.3937; 817.568.6725', 'title': 'Director of Alcon Clinical', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 month', 'description': 'All adverse events were recorded by Principal Investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'DisCoVisc®', 'description': 'DisCoVisc® Ophthalmic Viscosurgical Device', 'otherNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healon', 'description': 'Healon', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Amvisc Plus', 'description': 'Amvisc Plus', 'otherNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Endothelial Cell Count Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DisCoVisc®', 'description': 'DisCoVisc® Ophthalmic Viscosurgical Device'}, {'id': 'OG001', 'title': 'Healon', 'description': 'Healon'}, {'id': 'OG002', 'title': 'Amvisc Plus', 'description': 'Amvisc Plus'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.91', 'spread': '16.49', 'groupId': 'OG000'}, {'value': '-5.11', 'spread': '19.41', 'groupId': 'OG001'}, {'value': '-4.92', 'spread': '13.89', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one month', 'description': 'Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.', 'unitOfMeasure': 'Percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those participants that had endothelial cell counts at both baseline and follow-up were included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Investigator Reported Space Maintenance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DisCoVisc®', 'description': 'DisCoVisc® Ophthalmic Viscosurgical Device'}, {'id': 'OG001', 'title': 'Healon', 'description': 'Healon'}, {'id': 'OG002', 'title': 'Amvisc Plus', 'description': 'Amvisc Plus'}], 'classes': [{'title': 'Capsulorhexis - full chamber maintained', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}, {'title': 'Capsulorhexis - working space maintained', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Capsulorhexis - shallow', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Capsulorhexis - flat', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hydrodissection - full chamber maintained', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'Hydrodissection - working space maintained', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Hydrodissection - shallow', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Hydrodissection - flat', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Phacoemulsification - full chamber maintained', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}, {'title': 'Phacoemulsification - working space maintained', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Phacoemulsification - shallow', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Phacoemulsification - flat', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'IOL insertion - full chamber maintained', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}, {'title': 'IOL insertion - working space maintained', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'IOL insertion - shallow', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'IOL insertion - flat', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During surgical procedure', 'description': 'Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: "Full Chamber Maintained", "Working Space Maintained", "Shallow", "Flat". Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Corneal Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DisCoVisc®', 'description': 'DisCoVisc® Ophthalmic Viscosurgical Device'}, {'id': 'OG001', 'title': 'Healon', 'description': 'Healon'}, {'id': 'OG002', 'title': 'Amvisc Plus', 'description': 'Amvisc Plus'}], 'classes': [{'categories': [{'measurements': [{'value': '0.53', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '0.53', 'spread': '0.04', 'groupId': 'OG002'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 month', 'description': 'Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects that did not have both baseline and 1 month values were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Corneal Clarity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DisCoVisc®', 'description': 'DisCoVisc® Ophthalmic Viscosurgical Device'}, {'id': 'OG001', 'title': 'Healon', 'description': 'Healon'}, {'id': 'OG002', 'title': 'Amvisc Plus', 'description': 'Amvisc Plus'}], 'classes': [{'title': 'Aqueous flare - no visible flare', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Aqueous flare - mild', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}, {'title': 'Aqueous flare - moderate', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Aqueous flare - severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Aqueous cells - no cells', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Aqueous cells - 1-10 cells', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Aqueous cells - 10-50 cells', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Aqueous cells - too many cells to count', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Aqueous cells - cells frozen', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen.', 'unitOfMeasure': 'units on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from subjects for whom this evaluation was not performed is not included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DisCoVisc®', 'description': 'DisCoVisc® Ophthalmic Viscosurgical Device'}, {'id': 'FG001', 'title': 'Healon', 'description': 'Healon'}, {'id': 'FG002', 'title': 'Amvisc Plus', 'description': 'Amvisc Plus'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were undergoing a cataract operation and were recruited from surgery during 2008 to 2010', 'preAssignmentDetails': 'Patients were screened prior to cataract operation'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'DisCoVisc®', 'description': 'DisCoVisc® Ophthalmic Viscosurgical Device'}, {'id': 'BG001', 'title': 'Healon', 'description': 'Healon'}, {'id': 'BG002', 'title': 'Amvisc Plus', 'description': 'Amvisc Plus'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.97', 'spread': '9.03', 'groupId': 'BG000'}, {'value': '75.56', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '75.51', 'spread': '8.49', 'groupId': 'BG002'}, {'value': '75.01', 'spread': '8.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'lastUpdateSubmitDate': '2011-12-20', 'studyFirstSubmitDate': '2008-09-26', 'resultsFirstSubmitDate': '2011-12-20', 'studyFirstSubmitQcDate': '2008-09-29', 'lastUpdatePostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-12-20', 'studyFirstPostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial Cell Count Change From Baseline', 'timeFrame': 'one month', 'description': 'Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.'}, {'measure': 'Investigator Reported Space Maintenance', 'timeFrame': 'During surgical procedure', 'description': 'Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: "Full Chamber Maintained", "Working Space Maintained", "Shallow", "Flat". Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion.'}], 'secondaryOutcomes': [{'measure': 'Change in Corneal Thickness', 'timeFrame': '1 month', 'description': 'Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.'}, {'measure': 'Corneal Clarity', 'timeFrame': '2 weeks', 'description': 'Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cataract'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to assess how DisCoVisc Ophthalmic Viscosurgical Device (OVD) compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the ability to maintain anterior chamber space, in routine cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '49 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients able to understand and sign a document of informed consent;\n* Patients aged ≥49 years with age-related cataract formation;\n* Patients planning to undergo surgical removal of cataract by phacoemulsification with implantation of a posterior chamber intraocular lens;\n* Patients that have healthy eyes excluding the formation of cataract.\n\nExclusion Criteria:\n\n* pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye;\n* A congenital ocular anomaly (e.g., aniridia, congenital cataract) in the operative eye;\n* Iris atrophy in the operative eye;\n* Glaucoma (including pseudoexfoliation or pigmentary) or any causes of compromised outflow in the operative eye;\n* Any abnormality which prevents reliable Goldmann applanation tonometry in the operative eye;\n* Ocular hypertension (lntraocular Pressure (IOP) \\> 21 mmHg) in the operative eye at the baseline exam;\n* Corneal abnormality that results in a poor endothelial cell photograph and prevents reliable endothelial cell density measurement;\n* Baseline endothelial cell density \\< 1500 cells/mm2, in the operative eye;\n* Planned multiple procedures during cataract/Intraocular Lens (IOL) implantation surgery (e.g., trabeculoplasty, corneal transplant). NOTE: A minor relaxing keratotomy\n* Patients 48 years of age or younger;\n* Proliferative diabetic retinopathy in the operative eye;\n* Uncontrolled diabetes mellitus;\n* Marfan's Syndrome;\n* An ocular disease and/or condition that may compromise results;\n* A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis) in the operative eye;\n* Lens for the correction of astigmatism may be performed;\n* Previous ocular trauma to the operative eye (this includes previous intraocular surgery and traumatic cataract). NOTE: history of non-invasive laser surgery (with the exception of laser treatment for PDR) is acceptable for inclusion;\n* A non-functional fellow eye;\n* Participation in any other clinical study within the 30 days before surgery"}, 'identificationModule': {'nctId': 'NCT00763360', 'briefTitle': 'To Compare the Ability of DiscoVisc® OVD to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'To Compare the Ability of DiscoVisc® Ophthalmic Viscosurgical Device (OVD) to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.', 'orgStudyIdInfo': {'id': 'AUS-S-07-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DisCoVisc®', 'description': 'DisCoVisc® Ophthalmic Viscosurgical Device', 'interventionNames': ['Device: DisCoVisc®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healon', 'description': 'Healon', 'interventionNames': ['Drug: Healon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amvisc Plus', 'description': 'Amvisc Plus', 'interventionNames': ['Drug: Amvisc Plus']}], 'interventions': [{'name': 'DisCoVisc®', 'type': 'DEVICE', 'description': 'Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure', 'armGroupLabels': ['DisCoVisc®']}, {'name': 'Healon', 'type': 'DRUG', 'description': 'Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure', 'armGroupLabels': ['Healon']}, {'name': 'Amvisc Plus', 'type': 'DRUG', 'description': 'Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure', 'armGroupLabels': ['Amvisc Plus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Alcon Call Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}