Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT04193020
Status:
RECRUITING
Last Update Posted:
2021-04-20
First Post:
2019-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute and Chronic Inflammatory Disease, Lifestyle and Treatment Response
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-16', 'studyFirstSubmitDate': '2019-12-07', 'studyFirstSubmitQcDate': '2019-12-07', 'lastUpdatePostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'COVID-19 confirmed infection asymptomatic patient', 'timeFrame': '1 year', 'description': 'PCR-positive result of COVID-19 specific testing, no treatment required'}, {'measure': 'COVID-19 confirmed infection', 'timeFrame': '1 year', 'description': 'PCR-positive result of COVID-19 specific testing, patient require treatment. The mode of treatment will be recorded into several groups: 1) antibiotics, 2) antivirals, 3) biologic treatment, 4) immunoglobulins, 5) steroids'}, {'measure': 'COVID-19 related acute respiratory distress syndrome (ARDS)', 'timeFrame': '1 year', 'description': 'COVID-19 related acute respiratory distress syndrome (ARDS). Situation in which patients need any of described below: 1) supportive oxygen therapy, 2) non-invasive ventilation, 3) invasive/ mechanical ventilation, 4) use of ECMO, 5) admission to intensive care unit, 6) dialysis'}, {'measure': 'Ocular Surface Disease Index', 'timeFrame': '1 year', 'description': 'Ocular Surface Disease Index (OSDI) questionaire results are used to define if during the course of the disease the dry eye syndrom occurs. Used with subclasses describing the vision-related functions, ocular symptoms, environmental triggers'}, {'measure': 'Dry Eye Questionnaire', 'timeFrame': '1 year', 'description': 'Dry Eye Questionnaire (DEQ 5) questionaire results are used to define if during the course of the disease the dry eye syndrom occurs. Used with subscales describing the eye dyscomfort, eye dryness and watery eyes.'}, {'measure': 'SANDE Questionnaire', 'timeFrame': '1 year', 'description': 'SANDE Questionnaire that assess the frequency and severity of symptoms during the treatment.'}, {'measure': 'LIKERT Questionnaire', 'timeFrame': '1 year', 'description': 'LIKER Questionnaire that assess the frequency, severity of symptoms and infuence of symptoms on the patient day-to-day activities during the treatment.'}, {'measure': 'LIPCOF scale', 'timeFrame': '1 year', 'description': 'Assesment of conjunctival folds according to pre-defined scale.'}, {'measure': 'OXFORD scale', 'timeFrame': '1 year', 'description': 'OXFORD scale conducted with instalation of 2 microliters of 2% fluorescite into the conjunctival sac and assessment according to the pre-defined scale. The subscales for nasal, temporal and lower lid conjunctiva as well as for cornea was used. The scale has been conducted during the treatment period and if necessary during additional visits.'}, {'measure': 'SICCA scale', 'timeFrame': '1 year', 'description': 'SICCA scale conducted with instalation of 2 microliters of 2% fluorescite into the conjunctival sac and assessment of cornea according to the pre-defined scale. Different dye was used for conjunctica (lizamine green). The subscales for nasal and temporal conjunctiva as well as for cornea was used. The scale has been conducted during the treatment period and if necessary during additional visits.'}], 'primaryOutcomes': [{'measure': 'Treatment success', 'timeFrame': '1 year', 'description': 'Total number of treatment success in each group'}, {'measure': 'Recurrence time', 'timeFrame': '10 years', 'description': 'Time to the next recurrence after the treatment regimen introduction'}, {'measure': 'Severe visual loss', 'timeFrame': '10 years', 'description': 'Time and cause of severe visual loss'}], 'secondaryOutcomes': [{'measure': 'ETDRS Visual Acuity', 'timeFrame': '10 years', 'description': 'Visual Acuity will be performed with ETDRS charts different for right and left eye'}, {'measure': 'The SUN working group grading system for anterior chamber cells', 'timeFrame': '10 years', 'description': 'At each visit anterior chamber will be examined to assess anterior chamber cells (1mm x 1mm slit beam in height and width, when thrown at an angle of 45-60°). The recorded number of cells will be used to determine the grade according to the SUN criteria.'}, {'measure': 'The SUN working group grading system for anterior chamber flare', 'timeFrame': '10 years', 'description': 'At each visit anterior chamber will be examined to assess anterior chamber flare (1mm x 1mm slit beam in height and width, when thrown at an angle of 45-60°). The observed changes will be used to determine the grade according to the SUN criteria.'}, {'measure': 'AREDS 2008 Clinical Lens Opacity Grading Procedure', 'timeFrame': '10 years', 'description': 'Using AREDS system for classifying cataracts from photographs: AREDS Report No. 4 the lens opacity will be graded.'}, {'measure': 'NIH grading system for vitreous cells', 'timeFrame': '10 years', 'description': 'At each visit vitreous will be examined to assess vitreous cells (1mm x 3mm slit beam in anterior vitreous). The recorded number of cells will be used to determine the grade according to the NIH criteria.'}, {'measure': 'NIH grading system for vitreous haze', 'timeFrame': '10 years', 'description': 'At each visit vitreous will be examined to assess vitreous haze. The recorded of clarity of posterior pole funduscopy will be used to determine the grade according to the NIH criteria.'}, {'measure': 'Submacular choroidal thickness', 'timeFrame': '10 years', 'description': 'OCT EDI recordings processed with developed by researchers methodology for image processing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uveitis']}, 'descriptionModule': {'briefSummary': 'Acute and chronic inflammatory eye diseases are difficult to diagnose and maintain quiescent with therapy. Proposed study is aimed to find on the one hand, novel factors for recurrence of the disease or remission of inflammation and evaluation of the impact of lifestyle and known factors on the other.\n\nEach patient is treated in accordance to the best of medical knowledge and guidelines for each disease.\n\nThis prospective cohort study will enroll uveitic patients to the steroid only group (SG), combined (steroid and adjuvant drug) group (CG) or bilogic therapy group (BTG).\n\nAt baseline, patient data are recorded using patient-reported outcome measures and clinical assessments (ophthalomology) on disease activity (clinical scales), quality of life, and lifestyle together with registry data on comorbidity and medication. During follow-up evaluation of a successful treatment outcome response will be based on clinical scales and most frequently used primary endpoints; the major outcome of the analyses will be to detect differences in treatment outcome between patients in different treatment group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient with a new diagnosis or a recurrence of uni or bilateral uveitis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* new diagnosis of uni or bilateral uveitis\n* recurrence of the diagnosed previously uni or bilateral uveitis\n\nExclusion Criteria:\n\n* not mentally able to reply the questionnaire'}, 'identificationModule': {'nctId': 'NCT04193020', 'acronym': 'ACID LTR', 'briefTitle': 'Acute and Chronic Inflammatory Disease, Lifestyle and Treatment Response', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw Medical University'}, 'officialTitle': 'Impact of Lifestyle and Treatment on the Recurrency and Severity of Acute and Chronic Inflamatory Eye Diseases: Protocol on Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'ST-859'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'steroid only group (SG)', 'interventionNames': ['Other: Surveillance card']}, {'label': 'combined (steroid and adjuvant drug) group (CG)', 'interventionNames': ['Other: Surveillance card']}, {'label': 'bilogic therapy group (BTG)', 'interventionNames': ['Other: Surveillance card']}], 'interventions': [{'name': 'Surveillance card', 'type': 'OTHER', 'description': 'Surveillance card and additional examination to find novel markers and better assess the existing ones', 'armGroupLabels': ['bilogic therapy group (BTG)', 'combined (steroid and adjuvant drug) group (CG)', 'steroid only group (SG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54-622', 'city': 'Wroclaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Joanna Przeździecka-Dołyk, PhD', 'role': 'CONTACT'}], 'facility': 'Department of Ophthalmology', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'centralContacts': [{'name': 'Joanna Przeździecka-Dołyk, PhD', 'role': 'CONTACT', 'email': 'joanna.przezdziecka-dolyk@umed.wroc.pl', 'phone': '+49605693022'}], 'overallOfficials': [{'name': 'Marta Misiuk-Hojło, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Wrocław'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Sharing coded data such as BCVA, intraocular preassure, visual functioning questionaire responses, anterior chamber cells and flare scales records as well as lens opacity grading records.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wrocław University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joanna Przeździecka-Dołyk', 'investigatorAffiliation': 'Wroclaw Medical University'}}}}