Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-03-08 @ 11:44 PM
Study NCT ID:
NCT02491918
Status:
COMPLETED
Last Update Posted:
2015-07-08
First Post:
2015-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial : Complications of in the Bag IOL Versus Optic Capture of IOL in Pediatric Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D019654', 'term': 'Lens Implantation, Intraocular'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-02', 'studyFirstSubmitDate': '2015-06-29', 'studyFirstSubmitQcDate': '2015-07-02', 'lastUpdatePostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Posterior capsule opacification requiring surgery', 'timeFrame': '12 months postoperatively', 'description': 'opacification of visual axis'}], 'secondaryOutcomes': [{'measure': 'inflammation on slitlamp examination', 'timeFrame': '12 months postoperatively', 'description': 'cell depostis'}, {'measure': 'inflammation on slitlamp examination', 'timeFrame': '12 months postoperatively', 'description': 'posterior synechiae'}, {'measure': 'intraocular pressure in mmHg', 'timeFrame': '12 months postoperatively', 'description': 'glaucoma'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Posterior Capsule Opacification', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'This prospective, randomized, clinical trial looks to compare children undergoing congenital cataract surgery with intraocular lens (IOL) implantation in terms of visual axis obscuration as well as postoperative complications such as glaucoma, inflammation and IOL centration when IOL fixation is performed using two different techniques : 1) conventional in the bag IOL implantation with anterior vitrectomy, and, 2) posterior optic capture of the IOL through the posterior capsulorhexis without any vitrectomy. 61 eyes of 61 children randomized to receiving IOL implantation using one of the two techniques will be followed up until 12 months postoperatively.', 'detailedDescription': 'This prospective, randomized, controlled, clinical trial compares visual axis obscuration as well as intra and postoperative complications in children undergoing cataract surgery with IOL implantation using one of two techniques :\n\n1. in the bag IOL with limbal anterior vitrectomy\n2. posterior optic capture of IOL optic through the posterior capsulorhexis without any vitrectomy.\n\nThe aim is to evaluate whether avoiding anterior vitrectomy is a feasible option, particularly younger children, where anterior vitrectomy has become an integral part of the routine surgical strategy.\n\nAll children will be evaluated at 1 month, 3 months, 6 months and 12 months postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '15 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* uncomplicated cataract,\n* unilateral or bilateral cataract,\n* corneal diameter \\>9.0mmHg\n\nExclusion Criteria:\n\n* pre-existing glaucoma,\n* uveitis,\n* ocular comorbidity,\n* microphthalmos,\n* microcornea,\n* parents not consenting to participate in study,\n* traumatic cataract'}, 'identificationModule': {'nctId': 'NCT02491918', 'briefTitle': 'Clinical Trial : Complications of in the Bag IOL Versus Optic Capture of IOL in Pediatric Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Iladevi Cataract and IOL Research Center'}, 'officialTitle': 'Visual Axis Obscuration and Postoperative Complications Following Pediatric Cataract Surgery With Introacular Lens Implantation In-the-bag Versus Posterior Optic Capture : A Randomized, Clinical Trial', 'orgStudyIdInfo': {'id': '13-009'}, 'secondaryIdInfos': [{'id': '2013 Research Foundation Grant', 'type': 'OTHER_GRANT', 'domain': 'ASCRS Foundation Research Grant'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'In the bag IOL', 'description': 'Cataract surgery with IOL implantation in the capsular bag', 'interventionNames': ['Procedure: cataract surgery', 'Procedure: Intraocular lens implantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Optic Capture of IOL', 'description': 'intraocular lens implantation in the capsular bag with posterior optic capture', 'interventionNames': ['Procedure: cataract surgery', 'Procedure: Intraocular lens implantation']}], 'interventions': [{'name': 'cataract surgery', 'type': 'PROCEDURE', 'description': 'cataract surgery in children', 'armGroupLabels': ['In the bag IOL', 'Optic Capture of IOL']}, {'name': 'Intraocular lens implantation', 'type': 'PROCEDURE', 'description': 'intraocular lens implantation in the capsular bag or optic capture', 'armGroupLabels': ['In the bag IOL', 'Optic Capture of IOL']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'abhay vasavada, MS,FRCS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Iladevi Cataract & IOL Research Centre, Ahmedabad, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iladevi Cataract and IOL Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Abhay R. Vasavada', 'investigatorAffiliation': 'Iladevi Cataract and IOL Research Center'}}}}