An observational study in Uveitis, sponsored by Wroclaw Medical University. Recruiting at 1 site in Poland. Per ClinicalTrials.gov, last updated 2021-04-20.
Sponsored by Wroclaw Medical University · Observational
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.
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's planned enrollment of 300 is above the median of 107 across 104 observational studies indexed under Uveitis.
Browse Uveitis studies →Wroclaw Medical University is the lead sponsor of 99 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Any patient with a new diagnosis or a recurrence of uni or bilateral uveitis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: Surveillance card
Other: Surveillance card
Other: Surveillance card
Surveillance card and additional examination to find novel markers and better assess the existing ones
Treatment success
Total number of treatment success in each group
Time frame: 1 year
Recurrence time
Time to the next recurrence after the treatment regimen introduction
Time frame: 10 years
Severe visual loss
Time and cause of severe visual loss
Time frame: 10 years
ETDRS Visual Acuity
Visual Acuity will be performed with ETDRS charts different for right and left eye
Time frame: 10 years
The SUN working group grading system for anterior chamber cells
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.
Time frame: 10 years
The SUN working group grading system for anterior chamber flare
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.
Time frame: 10 years
AREDS 2008 Clinical Lens Opacity Grading Procedure
Using AREDS system for classifying cataracts from photographs: AREDS Report No. 4 the lens opacity will be graded.
Time frame: 10 years
NIH grading system for vitreous cells
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.
Time frame: 10 years
NIH grading system for vitreous haze
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.
Time frame: 10 years
Submacular choroidal thickness
OCT EDI recordings processed with developed by researchers methodology for image processing.
Time frame: 10 years
COVID-19 confirmed infection asymptomatic patient
PCR-positive result of COVID-19 specific testing, no treatment required
Time frame: 1 year
COVID-19 confirmed infection
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
Time frame: 1 year
COVID-19 related acute respiratory distress syndrome (ARDS)
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
Time frame: 1 year
Ocular Surface Disease Index
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
Time frame: 1 year
Dry Eye Questionnaire
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.
Time frame: 1 year
SANDE Questionnaire
SANDE Questionnaire that assess the frequency and severity of symptoms during the treatment.
Time frame: 1 year
LIKERT Questionnaire
LIKER Questionnaire that assess the frequency, severity of symptoms and infuence of symptoms on the patient day-to-day activities during the treatment.
Time frame: 1 year
LIPCOF scale
Assesment of conjunctival folds according to pre-defined scale.
Time frame: 1 year
OXFORD scale
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.
Time frame: 1 year
SICCA scale
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.
Time frame: 1 year
Plan to share: Undecided — 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.
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Wroclaw Medical University