Uveitis
Conditions
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.
Interventions
OTHERSurveillance card
Surveillance card and additional examination to find novel markers and better assess the existing ones
Sponsors
Wrocław University of Science and Technology
Wroclaw Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success | 1 year | Total number of treatment success in each group |
| Severe visual loss | 10 years | Time and cause of severe visual loss |
| Recurrence time | 10 years | Time to the next recurrence after the treatment regimen introduction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ETDRS Visual Acuity | 10 years | Visual Acuity will be performed with ETDRS charts different for right and left eye |
| The SUN working group grading system for anterior chamber cells | 10 years | 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. |
| The SUN working group grading system for anterior chamber flare | 10 years | 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. |
| AREDS 2008 Clinical Lens Opacity Grading Procedure | 10 years | Using AREDS system for classifying cataracts from photographs: AREDS Report No. 4 the lens opacity will be graded. |
| NIH grading system for vitreous cells | 10 years | 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. |
| NIH grading system for vitreous haze | 10 years | 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. |
| Submacular choroidal thickness | 10 years | OCT EDI recordings processed with developed by researchers methodology for image processing. |
Other
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 confirmed infection asymptomatic patient | 1 year | PCR-positive result of COVID-19 specific testing, no treatment required |
| Ocular Surface Disease Index | 1 year | 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 |
| COVID-19 related acute respiratory distress syndrome (ARDS) | 1 year | 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 |
| COVID-19 confirmed infection | 1 year | 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 |
| Dry Eye Questionnaire | 1 year | 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. |
| SANDE Questionnaire | 1 year | SANDE Questionnaire that assess the frequency and severity of symptoms during the treatment. |
| LIKERT Questionnaire | 1 year | LIKER Questionnaire that assess the frequency, severity of symptoms and infuence of symptoms on the patient day-to-day activities during the treatment. |
| LIPCOF scale | 1 year | Assesment of conjunctival folds according to pre-defined scale. |
| OXFORD scale | 1 year | 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. |
| SICCA scale | 1 year | 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. |
Countries
Poland
Contacts
Primary ContactJoanna Przeździecka-Dołyk, PhD
Outcome results
None listed