Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT01598428
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2012-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anterior Capsule Polishing Effect on Effective Lens Position
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pinkapples@126.com', 'phone': '0086-543-89268587', 'title': 'Dr.Yang Gao', 'organization': 'Shandong University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cataract', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effective Lens Position', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;'}, {'id': 'OG001', 'title': 'Anterior Capsule Polishing', 'description': 'During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher'}], 'classes': [{'title': 'ELP 1 day postoperative', 'categories': [{'measurements': [{'value': '3.97', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '4.02', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'ELP 1 week postoperative', 'categories': [{'measurements': [{'value': '3.93', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '3.99', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'ELP 1 month postoperative', 'categories': [{'measurements': [{'value': '3.97', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '3.99', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'ELP 3 months postoperative', 'categories': [{'measurements': [{'value': '3.98', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '3.97', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'ELP 6 months postoperative', 'categories': [{'measurements': [{'value': '3.92', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '3.97', 'spread': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'the root mean square of changes in the ELP(ELPrms)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day，1 week, 1 month，3 months and 6 months postoperatively', 'description': 'Effective lens position was measured with anterior chamber depth 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively using anterior segment Optical Coherence Tomograph. The anterior chamber depth defined as the distance between the posterior surface of the corneal and anterior surface of intraocular lens in the pupil center along the optical axis. The actual movement of intraocular lenses was defined as the root mean square of changes in the effective lens position at each visit.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Uncorrected Visual Acuity(UCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;'}, {'id': 'OG001', 'title': 'Anterior Capsule Polishing', 'description': 'During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher'}], 'classes': [{'title': 'UCVA 1 day postoperative', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'UCVA 1 week postoperative', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'UCVA 1 month postoperative', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'UCVA 3 months postoperative', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'UCVA 6 months postoperative', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day，1 week, 1 month as well as 3 months and 6 months postoperatively', 'description': 'The UCVA was recorded in logMAR units at each vist', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Refractive Error', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;'}, {'id': 'OG001', 'title': 'Anterior Capsule Polishing', 'description': 'During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher'}], 'classes': [{'title': 'the refractive error 1 day postoperative', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'the refractive error 1 week postoperative', 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'the refractive error 1 month postoperative', 'categories': [{'measurements': [{'value': '-0.37', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'the refractive error 3 month postoperative', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'the refractive error 6 months postoperative', 'categories': [{'measurements': [{'value': '-0.41', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day，1 week, 1 month as well as 3 months and 6 months postoperatively', 'description': 'auto refraction was performed at each visit. Spherical equivalent refraction (SER) (sphere +cylinder/2) was used in subsequent calculations.', 'unitOfMeasure': 'diopter(D)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cataract', 'description': 'During cataract surgery, the anterior capsule was unpolished intraoperatively in one eye; the anterior capsule and the equator of capsule was extensively polished intraoperatively in the other eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cataract'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'spread': '7.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-14', 'studyFirstSubmitDate': '2012-05-08', 'resultsFirstSubmitDate': '2014-06-17', 'studyFirstSubmitQcDate': '2012-05-14', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-14', 'studyFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective Lens Position', 'timeFrame': '1 day，1 week, 1 month，3 months and 6 months postoperatively', 'description': 'Effective lens position was measured with anterior chamber depth 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively using anterior segment Optical Coherence Tomograph. The anterior chamber depth defined as the distance between the posterior surface of the corneal and anterior surface of intraocular lens in the pupil center along the optical axis. The actual movement of intraocular lenses was defined as the root mean square of changes in the effective lens position at each visit.'}], 'secondaryOutcomes': [{'measure': 'Uncorrected Visual Acuity(UCVA)', 'timeFrame': '1 day，1 week, 1 month as well as 3 months and 6 months postoperatively', 'description': 'The UCVA was recorded in logMAR units at each vist'}, {'measure': 'Refractive Error', 'timeFrame': '1 day，1 week, 1 month as well as 3 months and 6 months postoperatively', 'description': 'auto refraction was performed at each visit. Spherical equivalent refraction (SER) (sphere +cylinder/2) was used in subsequent calculations.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['age related cataract', 'phacoemulsification', 'anterior capsule polishing', 'optical coherence tomography', 'anterior chamber depth'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': '* The purpose of this study is to evaluate effects of anterior capsule polishing on effective lens position (ELP) and actual axial movement of the intraocular lens (IOL) by measuring anterior chamber depth (ACD)\n* patients with bilateral age-related cataract undergo bilateral uneventful cataract surgeries with in-the- bag implantation of a single-piece hydrophobic acrylic foldable IOL (SN60WF). The anterior capsule was extensively polished using Whitman Shepherd Double-Ended Capsule Polisher in one eye randomly, and the other not. The ACD was measured 1day, 1 week, 1month, 3 months and 6 months with anterior segment Optical Coherence Tomograph (AS-OCT) postoperatively. The actual axial movement of IOL was defined as the root mean square (RMS) of the change in ELP at each visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bilateral age-related cataract\n* good overall physical constitution\n* uneventful surgeries of both eyes with in-the-bag IOL implantation\n\nExclusion Criteria:\n\n* history of intraocular surgery or laser therapy\n* history of ocular trauma or ocular disease\n* high myopia\n* diabetes\n* severe retinal pathology\n* patients who could not return on time'}, 'identificationModule': {'nctId': 'NCT01598428', 'briefTitle': 'Anterior Capsule Polishing Effect on Effective Lens Position', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Effect of Anterior Capsule Polishing on Effective Lens Position After Cataract Surgery', 'orgStudyIdInfo': {'id': 'YGao'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'cataract', 'interventionNames': ['Procedure: anterior capsule polishing']}], 'interventions': [{'name': 'anterior capsule polishing', 'type': 'PROCEDURE', 'description': 'polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher', 'armGroupLabels': ['cataract']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250013', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Department of Ophtalmology,Qianfoshan Hospital,Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yang Gao', 'investigatorAffiliation': 'Shandong University'}}}}