Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-30 @ 6:39 AM
Study NCT ID:
NCT04965168
Status:
COMPLETED
Last Update Posted:
2021-11-12
First Post:
2021-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corneal Endothelium Evaluation After Phacoemulsification in Diabetec and Non-diabetic Patients With Pseudoexfoliation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-11', 'studyFirstSubmitDate': '2021-07-07', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endothelial cell density', 'timeFrame': '6 months', 'description': 'number of endothelial cells'}, {'measure': 'Percentage of hexagonal cells', 'timeFrame': '6 months', 'description': 'indicator of healthy endothelial cells'}, {'measure': 'coefficient of variation (CV)', 'timeFrame': '6 months', 'description': 'indicator of the uniformity of the size of endothelial cells'}, {'measure': 'Central corneal thickness', 'timeFrame': '6 months', 'description': 'measurement of the distance between the epithelium and endothelium at the central cornea'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DM', 'phacoemulsification', 'endothelial cell density'], 'conditions': ['Pseudoexfoliation']}, 'referencesModule': {'references': [{'pmid': '23387877', 'type': 'BACKGROUND', 'citation': 'Storr-Paulsen A, Singh A, Jeppesen H, Norregaard JC, Thulesen J. Corneal endothelial morphology and central thickness in patients with type II diabetes mellitus. Acta Ophthalmol. 2014 Mar;92(2):158-60. doi: 10.1111/aos.12064. Epub 2013 Feb 7.'}, {'pmid': '30056522', 'type': 'BACKGROUND', 'citation': 'Fernandez-Munoz E, Zamora-Ortiz R, Gonzalez-Salinas R. Endothelial cell density changes in diabetic and nondiabetic eyes undergoing phacoemulsification employing phaco-chop technique. Int Ophthalmol. 2019 Aug;39(8):1735-1741. doi: 10.1007/s10792-018-0995-y. Epub 2018 Jul 28.'}, {'pmid': '26677035', 'type': 'BACKGROUND', 'citation': 'Oltulu R, Satirtav G, Kayitmazbatir ET, Bitirgen G, Ozkagnici A, Karaibrahimoglu A. Characteristics of the cornea in patients with pseudoexfoliation syndrome. Arq Bras Oftalmol. 2015 Nov-Dec;78(6):348-51. doi: 10.5935/0004-2749.20150092.'}, {'pmid': '32451432', 'type': 'BACKGROUND', 'citation': 'Aoki T, Kitazawa K, Inatomi T, Kusada N, Horiuchi N, Takeda K, Yokoi N, Kinoshita S, Sotozono C. Publisher Correction: Risk Factors for Corneal Endothelial Cell Loss in Patients with Pseudoexfoliation Syndrome. Sci Rep. 2020 May 26;10(1):8800. doi: 10.1038/s41598-020-66089-4.'}, {'pmid': '20456430', 'type': 'BACKGROUND', 'citation': 'Quiroga L, Lansingh VC, Samudio M, Pena FY, Carter MJ. Characteristics of the corneal endothelium and pseudoexfoliation syndrome in patients with senile cataract. Clin Exp Ophthalmol. 2010 Jul;38(5):449-55. doi: 10.1111/j.1442-9071.2010.02313.x. Epub 2010 Apr 28.'}, {'pmid': '37721703', 'type': 'DERIVED', 'citation': 'Mahmoud MSE, Omar IAN, AttaAllah HR. Evaluation of the corneal thickness and endothelial changes following uncomplicated phacoemulsification in diabetic and non-diabetic patients with pseudo-exfoliation syndrome by specular microscopy. Int Ophthalmol. 2023 Dec;43(12):4773-4780. doi: 10.1007/s10792-023-02877-x. Epub 2023 Sep 18.'}]}, 'descriptionModule': {'briefSummary': 'Our study is a comparative study, that was conducted to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation in normal controls, in non-diabetic and diabetic patients with PEX, and in patients with PEX only using specular microscopy.', 'detailedDescription': 'Our study is a comparative study that included 4 groups (controls, patients with PEX, non-diabetic patients with PEX, diabetic patients with PEX) to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation using specular microscopy, over a 6 months follow up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Senile cataract with age between 50 to 70 years\n* Clear cornea with no zonuler dehiscence\n* Lens opacity classification system III (LOCS III), with grade 2-3 nuclear cataract with any additional cortical (C) and posterior sub capsular (P)\n\nExclusion Criteria:\n\n* Uncontrolled DM in diabetic groups\n* Presence of autoimmune diseases\n* Patients with glaucoma\n* Corneal guttata\n* Zonular dehiscence\n* Rupture posterior capsule during cataract surgery'}, 'identificationModule': {'nctId': 'NCT04965168', 'briefTitle': 'Corneal Endothelium Evaluation After Phacoemulsification in Diabetec and Non-diabetic Patients With Pseudoexfoliation', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Evaluation of Corneal Endothelium Following Phacoemulsification in Diabetic and Non-diabetic Patients With Pseudoexfoliation Syndrome by Specular Microscopy', 'orgStudyIdInfo': {'id': '691:11/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'controls', 'description': 'phacoemulsification and IOL implantation', 'interventionNames': ['Procedure: phacoemulsification of the lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'diabetic without pseudoexfoliation', 'description': 'phacoemulsification and IOL implantation', 'interventionNames': ['Procedure: phacoemulsification of the lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non-diabetic with pseudoexfoliation', 'description': 'phacoemulsification and IOL implantation', 'interventionNames': ['Procedure: phacoemulsification of the lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'diabetic with pseudoexfoliation', 'description': 'phacoemulsification and IOL implantation', 'interventionNames': ['Procedure: phacoemulsification of the lens']}], 'interventions': [{'name': 'phacoemulsification of the lens', 'type': 'PROCEDURE', 'description': 'all patients underwent phacoemulsification and IOL implantation for immature cataract extraction', 'armGroupLabels': ['controls', 'diabetic with pseudoexfoliation', 'diabetic without pseudoexfoliation', 'non-diabetic with pseudoexfoliation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61111', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Ophthalmology department/ Minia University Hospital/Minia University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Heba R AttaAllah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Minia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Ophthalmology', 'investigatorFullName': 'Heba Radi AttaAllah', 'investigatorAffiliation': 'Minia University'}}}}