Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-20 @ 8:25 PM
Study NCT ID:
NCT01897935
Status:
COMPLETED
Last Update Posted:
2014-05-01
First Post:
2013-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flare Photometry in Uveitis Patients
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-30', 'studyFirstSubmitDate': '2013-07-08', 'studyFirstSubmitQcDate': '2013-07-10', 'lastUpdatePostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establish OFAM algorithms for quantitation of ocular flare', 'timeFrame': '3 months', 'description': 'OFAM algorithms for quantitation of ocular flare will be established by comparing the output of the OFAM device to the flare measurements obtained during the standard slit lamp examination.'}], 'secondaryOutcomes': [{'measure': 'Determine the impact that various potential confounders such as age and sex have on OFAM Measurements', 'timeFrame': '3 months', 'description': 'OFAM data for various sub-groups (age and sex) will be compared in order to evaluate the degree to which each sub-group acts as a confounder for OFAM measurements.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Uveitis'], 'conditions': ['Uveitis']}, 'descriptionModule': {'briefSummary': 'This is a cross sectional study of a novel non-invasive optical flare photometer (OFAM). Patients meeting the inclusion/exclusion criteria will receive a standard eye examination including a slit lamp examination to collect ocular flare data. In addition to the standard eye examination, subjects will receive flare measurements using the OFAM device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with uveitis seen in the uveitis clinic at the UW Medicine Eye Institute would be eligible for participation in the uveitis arm of the study (n ≤ 50). Patients with other, non-inflammatory forms of eye disease will be eligible for the non-inflammatory arm of the study (n ≤ 50).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than 18 years\n* Ability to understand and willingness to sign a written informed consent document.\n* To be eligible for the uveitis arm of the study subjects must have active anterior chamber uveitis in one or both eyes as determined by a physician\n* To be eligible for the non-inflammatory arm of the study the study subjects must have no ocular inflammation in either eye as determined by a physician.\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Exclusion criteria for the uveitis arm: no active disease\n* Exclusion criteria for the non-inflammatory arm: Signs of uveitis'}, 'identificationModule': {'nctId': 'NCT01897935', 'briefTitle': 'Flare Photometry in Uveitis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'ChromoLogic, LLC'}, 'orgStudyIdInfo': {'id': 'OFAM_PRO_120417'}}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'UW Medicine Eye Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Deborah Lam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW Medicine Eye Institute'}, {'name': 'Russell Van Gelder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW Medicine Eye Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ChromoLogic, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'UW Medicine Eye Institute', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}