Acute and Chronic Inflammatory Disease, Lifestyle and Treatment Response

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Lifestyle and Treatment on the Recurrency and Severity of Acute and Chronic Inflamatory Eye Diseases: Protocol on Prospective Cohort Study

Conditions
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Uveitis

Intervention / Treatment
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* Other: Surveillance card


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| steroid only group (SG)<br> | Other: Surveillance card<br>* Surveillance card and additional examination to find novel markers and better assess the existing ones<br>|
| combined (steroid and adjuvant drug) group (CG)<br> | Other: Surveillance card<br>* Surveillance card and additional examination to find novel markers and better assess the existing ones<br>|
| bilogic therapy group (BTG)<br> | Other: Surveillance card<br>* Surveillance card and additional examination to find novel markers and better assess the existing ones<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success | Total number of treatment success in each group | 1 year | 
| Recurrence time | Time to the next recurrence after the treatment regimen introduction | 10 years | 
| Severe visual loss | Time and cause of severe visual loss | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ETDRS Visual Acuity | Visual Acuity will be performed with ETDRS charts different for right and left eye | 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. | 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. | 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. | 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. | 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. | 10 years | 
| Submacular choroidal thickness | OCT EDI recordings processed with developed by researchers methodology for image processing. | 10 years |