Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-12 @ 3:21 AM
Study NCT ID:
NCT02311192
Status:
WITHDRAWN
Last Update Posted:
2023-08-15
First Post:
2014-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Grading Scale of Vitreous Haze in Patients With Uveitis Using Ultrasonography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Department chair choose not to participate', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2014-12-04', 'studyFirstSubmitQcDate': '2014-12-05', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inter-observer correlation for vitreous haze grading', 'timeFrame': '1 year', 'description': 'Inter-observer correlation for vitreous haze (VH) grading will be assessed using number of eyes as the unit of measure as well as standardized grading scheme for VH'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Vitreous Haze', 'Ocular ultrasound', 'B scan', 'Uveitis'], 'conditions': ['Uveitis']}, 'descriptionModule': {'briefSummary': 'This study is aimed at creation and validation of a vitreous haze scoring system using ultrasonography B-scan of the eye. Images will be obtained from patients with uveitis and quantification of inflammation will be done to create the scoring scale.', 'detailedDescription': 'Patients with uveitis may present with Vitreous Haze (VH) resulting in obscuration of fundus details. VH is composed of cells and protein exudation and results in decrease visual acuity.The degree of VH is an important indicator of disease activity, severity and response to therapy in patients with uveitis. Color fundus images are commonly used to objectively document VH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Ability to provide written informed consent and comply with study assessments for the full duration of the study\n\n * Age 18 -90 years\n * Diagnosis of uveitis\n\nExclusion Criteria:\n\n* • Patients with posterior segment complications including retinal detachment, choroidal detachment or hemorrhage\n\n * Patients with any intraocular foreign body or displaced intraocular lens\n * Patients with silicon oil filled eye or with gas tamponade.\n * Patients with vitreous hemorrhage\n * Patients with media opacity including visually significant cataract that precludes grading of VH based on fundus photography'}, 'identificationModule': {'nctId': 'NCT02311192', 'briefTitle': 'Grading Scale of Vitreous Haze in Patients With Uveitis Using Ultrasonography', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Grading Scale of Vitreous Haze in Patients With Uveitis Using Ultrasonography', 'orgStudyIdInfo': {'id': '0583-14-EP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasonography B-scan', 'description': 'Patients of uveitis who are included in the study will be imaged using ultrasound B-scan', 'interventionNames': ['Device: Ultrasonography B-scan']}], 'interventions': [{'name': 'Ultrasonography B-scan', 'type': 'DEVICE', 'description': "The patient's eye will be anesthetized. The ultrasound probe will then be used to obtain images by keeping the probe in light contact with the eye.", 'armGroupLabels': ['Ultrasonography B-scan']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Quan D Nguyen, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}, {'name': 'Giovanni Staurenghi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Luigi Sacco Hospital'}, {'name': 'Ramandeep Singh, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'collaborators': [{'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, {'name': 'Luigi Sacco University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}