Acute and Chronic Inflammatory Disease, Lifestyle and Treatment Response
- Conditions
- Uveitis
- Interventions
- Other: Surveillance card
- Registration Number
- NCT04193020
- Lead Sponsor
- Wroclaw Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- new diagnosis of uni or bilateral uveitis
- recurrence of the diagnosed previously uni or bilateral uveitis
- not mentally able to reply the questionnaire
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description steroid only group (SG) Surveillance card - combined (steroid and adjuvant drug) group (CG) Surveillance card - bilogic therapy group (BTG) Surveillance card -
- Primary Outcome Measures
Name Time Method Recurrence time 10 years Time to the next recurrence after the treatment regimen introduction
Severe visual loss 10 years Time and cause of severe visual loss
Treatment success 1 year Total number of treatment success in each group
- Secondary Outcome Measures
Name Time Method 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.
ETDRS Visual Acuity 10 years Visual Acuity will be performed with ETDRS charts different for right and left eye
Submacular choroidal thickness 10 years OCT EDI recordings processed with developed by researchers methodology for image processing.
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.
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.
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.
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.
Trial Locations
- Locations (1)
Department of Ophthalmology
🇵🇱Wrocław, Poland