Ignite Creation Date:
2025-12-24 @ 3:46 PM
Ignite Modification Date:
2025-12-24 @ 3:46 PM
Study NCT ID:
NCT04346992
Status:
COMPLETED
Last Update Posted:
2022-09-08
First Post:
2020-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence Of Keratoconus Among Patients With Thyroid Gland Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'description': 'blood sample to measure thyroid profile'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-02', 'studyFirstSubmitDate': '2020-04-12', 'studyFirstSubmitQcDate': '2020-04-12', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of keratoconus in thyroid gland dysfunction', 'timeFrame': 'we will recruit patients who meer the inclusion criteria during the study period April-August 2020', 'description': 'Our Screening for KC will include evaluation of the demographic data and complete ophthalmological examination of the patients using:\n\nVA Refraction K reading Slit lamp examination Pentacam'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Keratoconus in Thyroid Gland Dysfunction']}, 'descriptionModule': {'briefSummary': 'Hormonal imbalances are likely to affect the corneal metabolism and may be also associated with Keratoconus. Among the various endocrinologic dysfunctions assumed so far, thyroid gland dysfunction (TGD) (hypo- or hyperthyroidism; comprised as TGD) is frequently associated with eye diseases such as Graves disease', 'detailedDescription': 'Aim of the work\n\nWe aim to examine the prevalence of KC among patients already diagnosed by endocrinologist with TGD.\n\nMaterials and methods\n\nOur Screening for KC will include evaluation of the demographic data and complete ophthalmological examination of the patients using:\n\nVA Refraction K reading Slit lamp examination Pentacam Study design Epidemiological study\n\nInclusion citeria All patients diagnosed as thyroid gland dysfunction Control group\n\nExclusion criteria Uncooperative patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'we will enroll all patients who meet the inclusion criteria and signed a written informed consent form', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients diagnosed as thyroid gland dysfunction\n\nExclusion Criteria:\n\n* Uncooperative patients'}, 'identificationModule': {'nctId': 'NCT04346992', 'briefTitle': 'Prevalence Of Keratoconus Among Patients With Thyroid Gland Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': 'Prevalence Of Keratoconus Among Patients With Thyroid Gland Dysfunction', 'orgStudyIdInfo': {'id': 'R109'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63514', 'city': 'Al Fayyum', 'country': 'Egypt', 'facility': 'Fayoum University', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Omar Said', 'investigatorAffiliation': 'Fayoum University'}}}}