Clinical trial NCT04193020: Acute and Chronic Inflammatory Disease, Lifestyle and Treatment Response
Official title: Impact of Lifestyle and Treatment on the Recurrency and Severity of Acute and Chronic Inflamatory Eye Diseases: Protocol on Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uveitis
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
Collaborators: name: Wrocław University of Science and Technology
First posted: 2019-12-10
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with a new diagnosis or a recurrence of uni or bilateral uveitis.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment success
timeFrame: 1 year
measure: Recurrence time
timeFrame: 10 years
measure: Severe visual loss
timeFrame: 10 years
Secondary outcomes:
measure: ETDRS Visual Acuity
timeFrame: 10 years
measure: The SUN working group grading system for anterior chamber cells
timeFrame: 10 years
measure: The SUN working group grading system for anterior chamber flare
timeFrame: 10 years
measure: AREDS 2008 Clinical Lens Opacity Grading Procedure
timeFrame: 10 years
measure: NIH grading system for vitreous cells
timeFrame: 10 years
measure: NIH grading system for vitreous haze
timeFrame: 10 years
measure: Submacular choroidal thickness
timeFrame: 10 years
Other outcomes:
measure: COVID-19 confirmed infection asymptomatic patient
timeFrame: 1 year
measure: COVID-19 confirmed infection
timeFrame: 1 year
measure: COVID-19 related acute respiratory distress syndrome (ARDS)
timeFrame: 1 year
measure: Ocular Surface Disease Index
timeFrame: 1 year
measure: Dry Eye Questionnaire
timeFrame: 1 year
measure: SANDE Questionnaire
timeFrame: 1 year
measure: LIKERT Questionnaire
timeFrame: 1 year
measure: LIPCOF scale
timeFrame: 1 year
measure: OXFORD scale
timeFrame: 1 year
measure: SICCA scale
timeFrame: 1 year
Locations:
city: Wrocław
country: Poland
facility: Department of Ophthalmology
Study officials:
affiliation: Medical University of Wrocław
name: Marta Misiuk-Hojło, Professor
role: STUDY_CHAIR
References: