Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2026-06-08 @ 3:48 AM
Study NCT ID:
NCT03324295
Status:
UNKNOWN
Last Update Posted:
2018-01-11
First Post:
2017-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aqueous Urea Concentration May be Related to Cataract Development
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}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-09', 'studyFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood urea level', 'timeFrame': '1 Day', 'description': 'The relation between blood urea level and cataract'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract Cortical']}, 'descriptionModule': {'briefSummary': 'cataracts could be cured with eye drops. Some studies reported that in chronic renal failure, the occurrence of cataract is rare and the mechanism is unknown. The aim of this research is to describe correlation between urea concentration in the serum and aqueous humor and development of age related cataract.', 'detailedDescription': 'The study was conducted in the departments of Ophthalmology and internal medicine,\n\nAsyut University hospitals, Egypt. Three groups of subjects were included:\n\npatients with age related cortical cataracts who are otherwise healthy (cases) and two control groups; first systemically healthy subjects with ocular problems other than cataract and a second control group of patients with impaired renal functions and are not on dialysis treatment and thus have elevated serum urea levels. Slit lamp examination was performed to evaluate crystalline lens for opacities. Measurement of serum urea was done for all study subjects. Aqueous humor urea concentration was done only for the group of patients who are planned to have intraocular surgery. For that purpose, 0.1 ml of aqueous humor will be aspirated at the start of routine intraocular surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Assiut university hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Senile Cortical cataract.\n\nExclusion Criteria:\n\n* Senile Nuclear cataract.\n* Congenital cataract\n* Traumatic cataract'}, 'identificationModule': {'nctId': 'NCT03324295', 'briefTitle': 'Aqueous Urea Concentration May be Related to Cataract Development', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Aqueous Urea Concentration May be Related to Cataract Development', 'orgStudyIdInfo': {'id': 'IRB000078'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cortical cataract', 'description': 'patients with age related cortical cataracts who are otherwise healthy', 'interventionNames': ['Diagnostic Test: cortical cataract']}, {'label': 'ocular problems', 'description': 'systemically healthy subjects with ocular problems other than cataract', 'interventionNames': ['Diagnostic Test: cortical cataract']}, {'label': 'impaired renal functions', 'description': 'patients with impaired renal functions and are not on dialysis', 'interventionNames': ['Diagnostic Test: cortical cataract']}], 'interventions': [{'name': 'cortical cataract', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood urea', 'armGroupLabels': ['cortical cataract', 'impaired renal functions', 'ocular problems']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7111', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hassan Lotfy, prof.', 'role': 'CONTACT', 'email': 'hassaniron57@yahoo.com', 'phone': '01020833002'}], 'facility': 'Hassan Lotfy', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mohamed Gamal, Dr.', 'role': 'CONTACT', 'email': 'mgsaleh05@yahoo.com', 'phone': '01004530716'}], 'overallOfficials': [{'name': 'Hassan Fahmy, prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Hassan Lotfy Fahmy', 'investigatorAffiliation': 'Assiut University'}}}}