Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT06196333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Corneal Endothelium by Specular Microscope in Elderly Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-05-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-25', 'studyFirstSubmitDate': '2023-12-25', 'studyFirstSubmitQcDate': '2023-12-25', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial count', 'timeFrame': '15 months', 'description': 'Corneal endothelial cell count, coefficient of variation, percentage of hexagonal cells and central corneal thickness will be evaluated and correlated to known normal values in the same healthy individual age group'}], 'secondaryOutcomes': [{'measure': 'Correlated change', 'timeFrame': '15 months', 'description': 'Correlated change of corneal endotheliam to duration and control of DM'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Evaluation of Corneal Endothelium in Elderly Diabetic Patient']}, 'descriptionModule': {'briefSummary': 'A low endothelial count with endothelial pump dysfunction can contribute to corneal stromal hydration and loss of vision that can only be reversed by corneal transplantation,so this research proposed to detect any corneal endothelial changes related to DM , its duration and control of diabetes.', 'detailedDescription': '\\- To establish any correlation between endothelial changes , and the duration of diabetes, hemoglobin A1c (HbA1c) by using specular microscope to do morphological examination of corneal endothelial cells, makes the measurement of mean cell density (MCD), measurement of coefficient of variation (CV) in the cell size as well as hexagonal appearance of the cell. These parameters provide the functional status index of the corneal endothelial layer .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Not gender based from 40 years to 80 years diabetic patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Diabetic patient type 2\n* Elderly patients above 40 years old\n\nExclusion Criteria:\n\n* \\- Patients with any of the following conditions have been omitted from the study included a past medical history of ocular trauma, corneal or intraocular inflammation, the use of systemic drugs that could affect endothelial cells, evidence of endothelial disease during a slit-lamp examination, previous ocular surgery (including cataract surgery), increased intraocular pressure, corneal opacity, or retinal photocoagulation procedures.\n* non of the inclusion criteria patients'}, 'identificationModule': {'nctId': 'NCT06196333', 'briefTitle': 'Evaluation of Corneal Endothelium by Specular Microscope in Elderly Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluation of Corneal Endothelium by Specular Microscope in Elderly Diabetic Patients', 'orgStudyIdInfo': {'id': '04-2023-200228'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetes', 'description': 'Diabetes patients above 40 years', 'interventionNames': ['Device: Non-contact specular microscopy']}, {'label': 'Controls', 'description': 'Healthy controlled human beings have no medical histories', 'interventionNames': ['Device: Non-contact specular microscopy']}], 'interventions': [{'name': 'Non-contact specular microscopy', 'type': 'DEVICE', 'description': 'using specular microscope to do morphological examination of corneal endothelial cells', 'armGroupLabels': ['Controls', 'Diabetes']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Abanoub Hennis Mahrous', 'investigatorAffiliation': 'Assiut University'}}}}