Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-29 @ 9:58 AM
Study NCT ID:
NCT01455168
Status:
UNKNOWN
Last Update Posted:
2011-10-20
First Post:
2011-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage After Cataract Surgery in Exfoliation Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017889', 'term': 'Exfoliation Syndrome'}], 'ancestors': [{'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-10-19', 'studyFirstSubmitDate': '2011-09-24', 'studyFirstSubmitQcDate': '2011-10-17', 'lastUpdatePostDateStruct': {'date': '2011-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage after Cataract Surgery in Exfoliation Syndrome', 'timeFrame': '3 years', 'description': 'The vertical diameters (A mm) and horizontal diameters (B mm) of the postoperative capsulorhexis opening were measured using the scale of a Haag-Strait slit lamp. The area of the rhexis is equal to πAB/4 mm2. The measurements are taken on day one (baseline), and thereafter at each weeks postoperatively. The statistical analyses are used for time-course changes in each group, and for the area among the three groups on the same postoperative period. For this study, the percent change is calculated based on the ratio of the area at each measurement in comparison to the initial value.'}, {'measure': 'Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage after Cataract Surgery in Exfoliation Syndrome', 'timeFrame': '3 years', 'description': 'The vertical diameters (A mm) and horizontal diameters (B mm) of the postoperative capsulorhexis opening are measured using the scale of a Haag-Strait slit lamp. The area of the rhexis is equal to πAB/4 mm2. The measurements are taken on day one (baseline), and thereafter at each weeks postoperatively. The statistical analyses are used for time-course changes in each group, and for the area among the three groups on the same postoperative period. For this study, the percent change is calculated based on the ratio of the area at each measurement in comparison to the initial value.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anterior capsule shrinkage', 'capsular tension ring', 'exfoliation syndrome', 'phacoemulsification and aspiration'], 'conditions': ['Cataract With Exfoliation Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the efficacy of a capsular tension ring (CTR) in preventing anterior capsule shrinkage after cataract surgery in exfoliation syndrome (XFS) with no zonular weakness. The eyes with XFS undergo phacoemulsification and aspiration (PEA) with an intraocular lens (IOL) implantation. All operations are performed by a single surgeon. No eyes with either ectopia lentis or phacodonesis are included. There are three groups; CTR is not used in group A, CTR is simply implanted in group B, and CTR is implanted and closed by tying both eyelets in group C. The areas of continuous curvilinear capsulorhexis (CCC) are calculated, and both the time-course change and the comparison among the 3 groups are tested.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients with cataract and exfoliation syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eyes with exfoliation syndrome are included.\n\nExclusion Criteria:\n\n* Eyes with either ectopia lentis or phacodonesis are excluded.'}, 'identificationModule': {'nctId': 'NCT01455168', 'acronym': 'Effect of CTR', 'briefTitle': 'Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage After Cataract Surgery in Exfoliation Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Occupational and Environmental Health'}, 'officialTitle': 'Prospective Study to Examine the Efficacy of a Capsular Tension Ring (CTR) in Preventing Anterior Capsule Shrinkage After Cataract Surgery in Exfoliation Syndrome (XFS) With no Zonular Weakness', 'orgStudyIdInfo': {'id': 'H23-75'}, 'secondaryIdInfos': [{'id': 'H23-75', 'type': 'OTHER', 'domain': 'Institutional Review Board of UOEH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'No treatment', 'description': 'Capsular tension ring is not used in the group.'}, {'label': 'CTR simply implanted', 'description': 'Capsular tension ring is simply implanted in the group.'}, {'label': 'CTR with the eyelets closed', 'description': 'Capsular tension ring is implanted and closed by tying both eyelets in the group.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '807-8555', 'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'University of Occupational and Environmental Health', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Occupational and Environmental Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yukinori Harada', 'investigatorAffiliation': 'University of Occupational and Environmental Health'}}}}