Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-28 @ 5:19 PM
Study NCT ID:
NCT05984758
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014606', 'term': 'Uveitis, Anterior'}, {'id': 'D001171', 'term': 'Arthritis, Juvenile'}], 'ancestors': [{'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072776', 'term': 'Slit Lamp Microscopy'}], 'ancestors': [{'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'New diagnoses', 'timeFrame': '12months', 'description': 'Number of new diagnoses of uveitis / Number of new diagnosis of other visual/ocular problems'}], 'primaryOutcomes': [{'measure': 'Proportion of patients who meet the eligibility criteria', 'timeFrame': '18Months', 'description': 'Feasibility data for larger scale study'}, {'measure': 'Number of eligible patients recruited', 'timeFrame': '18Months', 'description': 'Feasibility data for larger scale study'}, {'measure': 'Proportion of patients that withdraw due to loss of consent or are lost to follow-up', 'timeFrame': '18Months', 'description': 'Feasibility data for larger scale study'}], 'secondaryOutcomes': [{'measure': 'Success', 'timeFrame': '12Months', 'description': 'Success rates (ie agreement with routine clinical examination, set at 100% for routine examination arm, and analysed at 6 months and 12 months milestones for OCT arm)'}, {'measure': 'Pediatric quality of life inventory (PedsQL) child self-report', 'timeFrame': '12Months', 'description': 'Health related quality of life, through child self-report, items linearly score on 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life)'}, {'measure': 'Visual analogue scoring (VAS) of examination procedures', 'timeFrame': '12Months', 'description': 'Scale running from 0 - 100, with higher score meaning better experience as reported by child'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Screening', 'Surveillance', 'Imaging', 'Optical coherence tomography'], 'conditions': ['Uveitis, Anterior', 'Juvenile Idiopathic Arthritis']}, 'referencesModule': {'references': [{'pmid': '39937818', 'type': 'DERIVED', 'citation': 'Dave S, Rahi JS, Petrushkin H, Testi I, Patel DE, Solebo AL. UVESCREEN1: A randomised feasibility study of imaging-based uveitis screening for children with juvenile idiopathic arthritis- Study Protocol. PLoS One. 2025 Feb 12;20(2):e0316410. doi: 10.1371/journal.pone.0316410. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'This study seeks to describe, for children undergoing uveitis surveillance following a new diagnosis of juvenile idiopathic arthritis, the feasibility metrics of undertaking a randomised comparative study of routine slit lamp examination (SLE) versus imaging based (anterior segment optical coherence tomography, OCT) surveillance in order to inform the development of a larger multi-centre trial.', 'detailedDescription': 'This study will compare imaging-based surveillance to routine clinical surveillance for uveitis in children with juvenile idiopathic arthritis (JIA) in order to support the design of a future study.\n\nChildhood uveitis is a rare inflammatory eye disease. Half of all children with uveitis also have a joint disorder: juvenile idiopathic arthritis (or JIA). Children with JIA must travel to a specialist centre every three months to have eye examinations in an attempt to pick uveitis up early enough to prevent visual loss.\n\nOptical coherence tomography (OCT) is a non-contact non-irradiating imaging modality. The investigators have recently demonstrated that novel application of OCT for uveitis detection in children is feasible, acceptable to families, repeatable, sensitive, and specific. The investigators have also found that families welcome the objectivity of imaging-based diagnosis. Standardised operating protocols for image acquisition and analysis have been developed across three imaging platforms (Optovue, Casia and Heidelberg OCT machines).\n\nThe investigators will be undertaking a feasibility study which compares routine clinical examination based uveitis surveillance to imaging based surveillance in order to provide the necessary information to address this issue in a larger scale clinical trial of clinical and cost-effectiveness, and explore issues around the impact of objective disease metrics on family perceptions of disease and treatment, as well as the perceptions of children, families and clinical staff on the use of automated diagnostic tools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients newly diagnosed (within preceding 12 months) with JIA who are eligible for uveitis surveillance\n* Aged 2-12 years\n\nExclusion Criteria:\n\n* A previous / existing diagnosis of uveitis\n* Any co-existing ocular or neurological abnormality which impacts on current corrected visual function, or could impact on future corrected visual function\n* Developmental/learning difficulties that preclude concordance with examination / informed assent'}, 'identificationModule': {'nctId': 'NCT05984758', 'acronym': 'UVESCREEN1', 'briefTitle': 'Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Child Health'}, 'officialTitle': 'A Randomised Feasibility Study of Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis', 'orgStudyIdInfo': {'id': '21PL04'}, 'secondaryIdInfos': [{'id': 'IRAS', 'type': 'OTHER', 'domain': '332422'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'Routine examination for uveitis with assessment of visual function followed by slit lamp examination', 'interventionNames': ['Diagnostic Test: Slit lamp examination']}, {'type': 'EXPERIMENTAL', 'label': 'ASOCT imaging', 'description': 'Assessment of visual function followed by image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines', 'interventionNames': ['Diagnostic Test: AS-OCT imaging']}], 'interventions': [{'name': 'AS-OCT imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines', 'armGroupLabels': ['ASOCT imaging']}, {'name': 'Slit lamp examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'SLE of anterior chamber', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1n 1DH', 'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Ameenat Lola Solebo, PhD FRCOphth', 'role': 'CONTACT', 'email': 'lola.solebo@gosh.nhs.uk', 'phone': '+44 20 3987 2162'}], 'facility': 'Great Ormond Street Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Ameenat Solebo', 'role': 'CONTACT', 'email': 'a.solebo@ucl.ac.uk', 'phone': '+44 20 3987 2162'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD shared only after dissemination of study findings and only on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Child Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Great Ormond Street Hospital for Children NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}