Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT06746467
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-24
First Post:
2024-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Corneal Topography in Vernal Keratoconjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007637', 'term': 'Keratoconjunctivitis'}], 'ancestors': [{'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluate the corneal topographic changes in VKC patients using Pentacam', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'prevalence of KC development in VKC', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['corneal topography on vkc'], 'conditions': ['Keratoconjunctivitis']}, 'referencesModule': {'references': [{'pmid': '16322853', 'type': 'RESULT', 'citation': 'Dantas PE, Alves MR, Nishiwaki-Dantas MC. Topographic corneal changes in patients with vernal keratoconjunctivitis. Arq Bras Oftalmol. 2005 Sep-Oct;68(5):593-8. doi: 10.1590/s0004-27492005000500004. Epub 2005 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the corneal topographic changes in VKC patients using Pentacam and prevalence of KC development in VKC.', 'detailedDescription': 'Vernal keratoconjunctivitis (VKC) is a chronic allergic disease, with seasonal periods of exacerbation.VKC is characterized by itching, photophobia. white mucous discharge, lacrimation, foreign body sensation, and pain due to corneal involvement of shield ulcers. Corneal involvement in VKC involves injury to the superficial and basal epithelial layers and anterior stroma . Excessive eye rubbing and a slow release of matrix metalloproteinases penetrate the cornea in presence of chronic epithelial damage causing astigmatism and corneal ectasia . These changes may be undetected until advanced complications such as keratoconus(KC) with thinning and protrusion of cornea leading to myopia and astigmatism . These changes can be measured accurately by corneal topography, making it the gold standard in the screening of keratoconus and other corneal ectasias . Corneal topography is a method of computer-assisted examination of the cornea in which multiple concentric light rings are projected on cornea. Changes in corneal topography indices to be studied include changes in effective refeactivepower ,asphericity , corneal asymmetry index and visual performance . It is a non-invasive exploratory technique to analyse both qualitatively and quantitatively the morphology of the cornea . The Penta Cam is a cornea and anterior segment topography device, based on a rotating Scheimpflug camera. Its optical cross-sectional analysis that helps in imaging of anterior and posterior corneal surfaces which provides with fullpachymetric map and many other data such as corneal aberrometry and densitometry that allow early detection of ectasia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients will be selected from primary clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nclinical diagnosis of vernal keratoconjunctivitis -\n\nExclusion Criteria:\n\npatients with corneal disease as corneal opacity, corneal dystrophy or degenerative changes patients with previous corneal surgery patients with ocular trauma.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06746467', 'briefTitle': 'Corneal Topography in Vernal Keratoconjunctivitis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'the Effect of Vernal Keratoconjunctivitis on Corneal Topographic Profiles', 'orgStudyIdInfo': {'id': 'corneal topography in vkc'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pentacam', 'type': 'DEVICE', 'description': 'evaluate corneal changes by pentacam'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Assiut University', 'role': 'CONTACT', 'email': 'Monicabasem668@gmail.com', 'phone': '+201202961139'}], 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'monica basem fayez, doctor', 'role': 'CONTACT', 'email': 'Monicabasem668@gmail.com', 'phone': '+201202961139'}, {'name': 'dalia mohamed mohamed, professer', 'role': 'CONTACT', 'phone': '+201223212962'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecture', 'investigatorFullName': 'Monica Basem Fayez', 'investigatorAffiliation': 'Assiut University'}}}}