Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT05271058
Status:
COMPLETED
Last Update Posted:
2022-03-08
First Post:
2022-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Intracameral Steroids During Phacoemulsification on the Cornea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-02-16', 'releaseDate': '2023-07-01'}], 'estimatedResultsFirstSubmitDate': '2023-07-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015715', 'term': 'Corneal Edema'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Purpose: Investigating the effect of intracameral steroids at the end of phacoemulsification on corneal edema and endothelial count.\n\nMethods: Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-27', 'studyFirstSubmitDate': '2022-02-16', 'studyFirstSubmitQcDate': '2022-02-27', 'lastUpdatePostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal edema', 'timeFrame': 'First day postoperative', 'description': 'Clinical grade of corneal edema on the first postoperative day'}, {'measure': 'Central corneal thickness (CCT)', 'timeFrame': 'Three months', 'description': 'Central corneal thickness in microns after phacoemulsification that was compared to preoperative values'}, {'measure': 'Endothelial cell loss', 'timeFrame': 'Three months', 'description': 'Corneal endothelial cell count (cell/ square mm) after phacoemulsification that was compared to preoperative values'}], 'secondaryOutcomes': [{'measure': 'IOP', 'timeFrame': 'Three months', 'description': 'Intraocular pressure in mmHg rise after after phacoemulsification'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Corneal Edema']}, 'descriptionModule': {'briefSummary': "Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.\n\nIntracameral steroids at the conclusion of phacoemulsification significantly improved corneal edema and spared corneal endothelium.", 'detailedDescription': "Purpose: Investigating the effect of intracameral steroids at the end of phacoemulsification on corneal edema and endothelial count.\n\nMethods: Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.\n\nOn the first postoperative day corneal edema in control compared to dexamethasone and TA groups respectively.\n\nOne month later, the mean increase of corneal thickness in control compared to intracameral dexamethasone and TA groups, respectively.\n\nmean endothelial cell loss in control compared to intracameral dexamethasone and TA groups respectively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Cataract grades 2 to 5 nuclear cataract (LOCS III scale)\n* uneventful phacoemulsification operation\n\nExclusion Criteria:\n\n* extremely hard cataract grade 6 nuclear cataract (LOCS III scale)\n* soft cataract\n* subluxated lenses or zonular dehiscence\n* associated ocular pathology such as glaucoma\n* any signs of uveitis\n* trauma\n* retinal detachment\n* vitrectomized or silicone filled eyes\n* corneal disease such as Fuch's dystrophy, corneal opacity\n* previous refractive corneal surgery\n* Cases that developed ruptured posterior capsule and vitreous loss\n* those lost to follow up were excluded and randomly replaced by the next chronological patient"}, 'identificationModule': {'nctId': 'NCT05271058', 'briefTitle': 'Effect of Intracameral Steroids During Phacoemulsification on the Cornea', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Intracameral Steroids Injection During Phacoemulsification on Postoperative Corneal Edema and Corneal Endothelium', 'orgStudyIdInfo': {'id': 'FMBSUREC/30042019/Mohamed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control group 1', 'description': '23 eyes that did not receive any intraoperative steroids', 'interventionNames': ['Other: Control group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone group 2', 'description': '23 eyes that received intracameral dexamethasone', 'interventionNames': ['Drug: Dexamethasone group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triamcinolone (TA) group 3', 'description': '23 eyes that received intracameral triamcinolone (TA)', 'interventionNames': ['Drug: Triamcinolone (TA) group']}], 'interventions': [{'name': 'Control group', 'type': 'OTHER', 'otherNames': ['No intraoperative steroids'], 'description': "23 eyes that didn't receive any intraoperative steroids", 'armGroupLabels': ['Control group 1']}, {'name': 'Dexamethasone group', 'type': 'DRUG', 'otherNames': ['Intracameral Dexamethasone'], 'description': '23 eyes each received intracameral dexamethasone at the conclusion of phacoemulsification Received intracameral 0.4 mg in / 0.1 ml dexamethasone (8mg/2ml®; Amriya or Epico) at the end of phacoemulsification.', 'armGroupLabels': ['Dexamethasone group 2']}, {'name': 'Triamcinolone (TA) group', 'type': 'DRUG', 'otherNames': ['Intracameral triamcinolone (TA)'], 'description': '23 eyes each received intracameral triamcinolone (TA) at the conclusion of phacoemulsification Received intracameral 2 mg/0.05 ml triamcinolone (TA) (Kenacort-A®; Bristol-Myers Squibb) at the end of phacoemulsification.', 'armGroupLabels': ['Triamcinolone (TA) group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12411', 'city': 'Giza', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Khaled G Abueleinen'}], 'overallOfficials': [{'name': 'Khaled G Abueleinen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmology department, Faculty of Medicine Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beni-Suef University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'khaled gamal abueleinen', 'investigatorAffiliation': 'Cairo University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-07-01', 'type': 'RELEASE'}, {'date': '2024-02-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'khaled gamal abueleinen, professor, Cairo University'}}}}