Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2025-12-26 @ 12:33 AM
Study NCT ID:
NCT01346566
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2011-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study of Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007906', 'term': 'Lens Subluxation'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-18', 'studyFirstSubmitDate': '2011-04-30', 'studyFirstSubmitQcDate': '2011-05-02', 'lastUpdatePostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOL Centration', 'timeFrame': '4 years follow-up'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': '4 years follow-up'}, {'measure': 'IOP', 'timeFrame': '4 years'}, {'measure': 'Posterior Capsule Opacification', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cionni Ring', 'In-the-bag IOL', 'Subluxated lenses', 'Intraoperative Performance', 'Postoperative Outcome'], 'conditions': ['Lens Subluxation']}, 'referencesModule': {'references': [{'pmid': '22317913', 'type': 'DERIVED', 'citation': 'Vasavada AR, Praveen MR, Vasavada VA, Yeh RY, Srivastava S, Koul A, Trivedi RH. Cionni ring and in-the-bag intraocular lens implantation for subluxated lenses: a prospective case series. Am J Ophthalmol. 2012 Jun;153(6):1144-53.e1. doi: 10.1016/j.ajo.2011.11.012. Epub 2012 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to report the intraoperative performance and postoperative outcomes of the Cionni-modified capsule tension ring implantation in eyes with subluxated lenses.', 'detailedDescription': 'The introduction of endocapsular stabilising devices have significantly improved the management of zonular weakness, allowing for in-the-bag IOL implantation. The Cionni modified capsule tension ring (M-CTR) has an anterior eyelet that provides for fixation of the capsular bag without violating its integrity. Adult and pediatric studies have shown the usefulness of the M-CTR to manage zonular weakness. However, there are very few prospective studies that show the outcomes following implantation of the M-CTR and in-the-bag IOL on a longterm basis. Therefore, the investigators decided to carry out this study to report the intraoperative performance and postoperative outcomes on a longterm basis following M-CTR and in-the-bag intraocular lens (IOL) implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subluxated Lenses\n* Traumatic or Non-traumatic etiology\n\nExclusion Criteria:\n\n* Dislocated Lenses'}, 'identificationModule': {'nctId': 'NCT01346566', 'briefTitle': 'Prospective Study of Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses', 'organization': {'class': 'OTHER', 'fullName': 'Iladevi Cataract and IOL Research Center'}, 'officialTitle': 'Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses: A Prospective Case Series', 'orgStudyIdInfo': {'id': 'ICIRCcionni'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cionni Modified Capsule Tension Ring', 'type': 'DEVICE', 'description': 'Cionni ring was used to fixate the capsular bag to the sclera and IOL was implanted in-the-bag'}]}, 'contactsLocationsModule': {'locations': [{'zip': '380052', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Iladevi Cataract & IOL Research Centre', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}], 'overallOfficials': [{'name': 'Abhay R Vasavada, MS, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Iladevi Cataract & IOL Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iladevi Cataract and IOL Research Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Abhay R. Vasavada', 'oldOrganization': 'Iladevi Cataract and IOL Research Centre'}}}}