Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-29 @ 8:26 AM
Study NCT ID:
NCT04595357
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2020-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Iris Shelf" Technique for Intraocular Foreign Bodies Removal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005131', 'term': 'Eye Injuries'}], 'ancestors': [{'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-14', 'studyFirstSubmitDate': '2020-10-14', 'studyFirstSubmitQcDate': '2020-10-14', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'corrected distance visual acuity', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eye Injuries']}, 'descriptionModule': {'briefSummary': 'Intraocular foreign body (IOFB) injury is a common potentially serious form of ocular trauma. Metallic IOFB is the most common type of IOFB injury. Apart from the associated ocular tissue damage, Metallic IOFB may cause permanent visual impairment due to retinal toxicity and endophthalmitis.\n\nWhen presenting posteriorly, the approach of IOFB removal is challenging. Several techniques had been described for posterior IOFB removal. All of these techniques aimed to remove IOFB with the least possible collateral damage. This study aims to describe "Iris shelf" technique for posterior IOFB removal through a clear corneal incision combined with phaco-vitrectomy and report its outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with posterior segment metallic IOFB who underwent combined phacovitrectomy with IOFB removal through a clear corneal incision using "Iris shelf" technique at Assiut University hospitals and Al-Forsan eye center, Assiut; Egypt in the period between January 2016 and December 2019.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- posterior segment metallic IOFB who underwent combined phacovitrectomy with IOFB removal through a clear corneal incision using "Iris shelf" technique\n\nExclusion Criteria:\n\n* Any other surgical technique for posterior segment IOFB removal'}, 'identificationModule': {'nctId': 'NCT04595357', 'briefTitle': '"Iris Shelf" Technique for Intraocular Foreign Bodies Removal', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'orgStudyIdInfo': {'id': '17300500'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Iris shelf technique', 'type': 'PROCEDURE', 'description': 'Removal of posterior segment intraocular foreign bodies through corneal incision combined with phaco-vitrectomy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of Ophthalmology', 'investigatorFullName': 'Khaled Abdelazeem', 'investigatorAffiliation': 'Assiut University'}}}}