Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT01078103
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2010-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes Mellitus Type II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-01', 'studyFirstSubmitDate': '2010-03-01', 'studyFirstSubmitQcDate': '2010-03-01', 'lastUpdatePostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'cornea endothelium', 'cell loss', 'cataract surgery'], 'conditions': ['Diabetes', 'Cataract']}, 'descriptionModule': {'briefSummary': 'Some studies indicated that the diabetic corneal endothelium is morphologically abnormal and may be at risk in any intraocular surgical procedure, while others showed no significant differences between diabetic and non-diabetic corneal endothelium.The purpose of this study is to investigate the differences in corneal endothelial cell density and morphology in diabetic patients and normal patients after phacoemulsification with intraocular lens implantation.To investigate if haemoglobin A1c can be used as a predictor of corneal endothelial cell changes after phacoemulsification.', 'detailedDescription': 'Some studies indicated that the diabetic corneal endothelium is morphologically abnormal and may be at risk in any intraocular surgical procedure, while others showed no significant differences between diabetic and non-diabetic corneal endothelium.The purpose of this study is to investigate the differences in corneal endothelial cell density and morphology in diabetic patients and normal patients after phacoemulsification with intraocular lens implantation.To investigate if haemoglobin A1c can be used as a predictor of corneal endothelial cell changes after phacoemulsification.\n\nSpecular microscopy photos will be taken pre-. and 3 month postoperatively. Cellular parameters will be compared between the two groups prior and post surgery. Clinical significant difference is defined as 1 SD (300 cell/mm2)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '30 typoe II diabetic and 30 non diabetic undergoing catarct surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cataract, diabetes\n\nExclusion Criteria:\n\n* Corneal disease\n* Uveitis\n* Previous intraocular surgery and diabetes type I'}, 'identificationModule': {'nctId': 'NCT01078103', 'briefTitle': 'Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes Mellitus Type II', 'organization': {'class': 'OTHER', 'fullName': 'Frederiksberg University Hospital'}, 'officialTitle': 'Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes', 'orgStudyIdInfo': {'id': 'J.nr.2005-41-4933'}}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Frederiksberg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Allan V Storr-Paulsen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Frederiksberg University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frederiksberg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Allan Storr-Paulsen', 'oldOrganization': 'Frederiksberg University Hospital'}}}}