Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-02-25 @ 8:27 PM
Study NCT ID:
NCT03265457
Status:
UNKNOWN
Last Update Posted:
2018-06-26
First Post:
2017-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Endothelial Count in Pxf
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017889', 'term': 'Exfoliation Syndrome'}], 'ancestors': [{'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-25', 'studyFirstSubmitDate': '2017-08-26', 'studyFirstSubmitQcDate': '2017-08-26', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between endothelial cell count in patients with Pseudoexfoliation syndrome and age matched controls.', 'timeFrame': 'One year', 'description': 'The corneal Endothelial cell count in patients with pseudoexfoliation syndrome will be measured by the specular microscopy \\& compared with the normal endothelial count in people at the same group'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pseudoexfoliation Syndrome']}, 'referencesModule': {'references': [{'pmid': '2750833', 'type': 'BACKGROUND', 'citation': 'Miyake K, Matsuda M, Inaba M. Corneal endothelial changes in pseudoexfoliation syndrome. Am J Ophthalmol. 1989 Jul 15;108(1):49-52. doi: 10.1016/s0002-9394(14)73259-3.'}]}, 'descriptionModule': {'briefSummary': 'Pseudoexfoliation Syndrome Is a common disorder in Egypt. IT is one of the common causes of coexisting cataract and glaucoma. It may be associated with a less than normal endothelial count.', 'detailedDescription': 'The corneal Endothelium is essential for the maintenance of normal corneal hydration, thickness, and transparency.\n\nIn patients with pseudoexfoliation syndrome , quantitative and qualitative morphological changes of the corneal endothelium have been demonstrated in specular and electron microscopic studies.\n\nSpecular microscopy is a non-invasive technique to access the structure and function of the corneal endothelium.\n\nOur research question is to study Endothelial cell count in patients with pseudoexfoliation syndrome \\& compare it to age matched group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pseudoexfoliation syndrome', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with pseudoexfoliation syndrome\n\nExclusion Criteria:\n\n* Patients with previous intra ocular surgeries.\n* Patients with uveitis\n* Patients with fuck's endothelial dystrophy"}, 'identificationModule': {'nctId': 'NCT03265457', 'briefTitle': 'The Endothelial Count in Pxf', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Corneal Endothelial Cell Count in Eyes With Pseudoexfoliation Syndrome', 'orgStudyIdInfo': {'id': 'PXF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patient with pseudoexfoliation syndrome', 'description': 'The corneal Endothelial cell count will be measured by specular microscopy', 'interventionNames': ['Other: Specular microscopy']}, {'label': 'Normal people at same age', 'interventionNames': ['Other: Specular microscopy']}], 'interventions': [{'name': 'Specular microscopy', 'type': 'OTHER', 'description': 'Comparison between corneal Endothelial count in patients with pseudoexfoliation syndrome and age matched group', 'armGroupLabels': ['Normal people at same age', 'patient with pseudoexfoliation syndrome']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Amira Asem', 'investigatorAffiliation': 'Assiut University'}}}}