Acute and Chronic Inflammatory Disease, Lifestyle and Treatment Response (ACID LTR)
16 de abril de 2021 actualizado por: Joanna Przeździecka-Dołyk, Wroclaw Medical University
Impact of Lifestyle and Treatment on the Recurrency and Severity of Acute and Chronic Inflamatory Eye Diseases: Protocol on Prospective Cohort Study
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.
Each patient is treated in accordance to the best of medical knowledge and guidelines for each disease.
This 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).
At 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.
Descripción general del estudio
Tipo de estudio
De observación
Inscripción (Anticipado)
300
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Joanna Przeździecka-Dołyk, PhD
- Número de teléfono: +49605693022
- Correo electrónico: joanna.przezdziecka-dolyk@umed.wroc.pl
Ubicaciones de estudio
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Wrocław, Polonia, 54-622
- Reclutamiento
- Department of Ophthalmology
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Any patient with a new diagnosis or a recurrence of uni or bilateral uveitis.
Descripción
Inclusion Criteria:
- new diagnosis of uni or bilateral uveitis
- recurrence of the diagnosed previously uni or bilateral uveitis
Exclusion Criteria:
- not mentally able to reply the questionnaire
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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steroid only group (SG)
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Surveillance card and additional examination to find novel markers and better assess the existing ones
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combined (steroid and adjuvant drug) group (CG)
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Surveillance card and additional examination to find novel markers and better assess the existing ones
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bilogic therapy group (BTG)
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Surveillance card and additional examination to find novel markers and better assess the existing ones
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Treatment success
Periodo de tiempo: 1 year
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Total number of treatment success in each group
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1 year
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Recurrence time
Periodo de tiempo: 10 years
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Time to the next recurrence after the treatment regimen introduction
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10 years
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Severe visual loss
Periodo de tiempo: 10 years
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Time and cause of severe visual loss
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10 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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ETDRS Visual Acuity
Periodo de tiempo: 10 years
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Visual Acuity will be performed with ETDRS charts different for right and left eye
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10 years
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The SUN working group grading system for anterior chamber cells
Periodo de tiempo: 10 years
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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.
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10 years
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The SUN working group grading system for anterior chamber flare
Periodo de tiempo: 10 years
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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.
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10 years
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AREDS 2008 Clinical Lens Opacity Grading Procedure
Periodo de tiempo: 10 years
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Using AREDS system for classifying cataracts from photographs: AREDS Report No. 4 the lens opacity will be graded.
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10 years
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NIH grading system for vitreous cells
Periodo de tiempo: 10 years
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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.
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10 years
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NIH grading system for vitreous haze
Periodo de tiempo: 10 years
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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.
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10 years
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Submacular choroidal thickness
Periodo de tiempo: 10 years
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OCT EDI recordings processed with developed by researchers methodology for image processing.
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10 years
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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COVID-19 confirmed infection asymptomatic patient
Periodo de tiempo: 1 year
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PCR-positive result of COVID-19 specific testing, no treatment required
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1 year
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COVID-19 confirmed infection
Periodo de tiempo: 1 year
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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
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1 year
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COVID-19 related acute respiratory distress syndrome (ARDS)
Periodo de tiempo: 1 year
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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
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1 year
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Ocular Surface Disease Index
Periodo de tiempo: 1 year
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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
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1 year
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Dry Eye Questionnaire
Periodo de tiempo: 1 year
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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.
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1 year
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SANDE Questionnaire
Periodo de tiempo: 1 year
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SANDE Questionnaire that assess the frequency and severity of symptoms during the treatment.
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1 year
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LIKERT Questionnaire
Periodo de tiempo: 1 year
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LIKER Questionnaire that assess the frequency, severity of symptoms and infuence of symptoms on the patient day-to-day activities during the treatment.
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1 year
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LIPCOF scale
Periodo de tiempo: 1 year
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Assesment of conjunctival folds according to pre-defined scale.
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1 year
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OXFORD scale
Periodo de tiempo: 1 year
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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.
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1 year
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SICCA scale
Periodo de tiempo: 1 year
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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.
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1 year
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2020
Finalización primaria (Anticipado)
1 de enero de 2025
Finalización del estudio (Anticipado)
1 de enero de 2026
Fechas de registro del estudio
Enviado por primera vez
7 de diciembre de 2019
Primero enviado que cumplió con los criterios de control de calidad
7 de diciembre de 2019
Publicado por primera vez (Actual)
10 de diciembre de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de abril de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
16 de abril de 2021
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ST-859
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Indeciso
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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