Impact of Lifestyle and Treatment on the Recurrency and Severity of Acute and Chronic Inflamatory Eye Diseases: Protocol on Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Recurrence time
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •new diagnosis of uni or bilateral uveitis
- •recurrence of the diagnosed previously uni or bilateral uveitis
排除标准
- •not mentally able to reply the questionnaire
结局指标
主要结局
Recurrence time
时间窗: 10 years
Time to the next recurrence after the treatment regimen introduction
Severe visual loss
时间窗: 10 years
Time and cause of severe visual loss
Treatment success
时间窗: 1 year
Total number of treatment success in each group
次要结局
- The SUN working group grading system for anterior chamber flare(10 years)
- ETDRS Visual Acuity(10 years)
- Submacular choroidal thickness(10 years)
- NIH grading system for vitreous cells(10 years)
- The SUN working group grading system for anterior chamber cells(10 years)
- AREDS 2008 Clinical Lens Opacity Grading Procedure(10 years)
- NIH grading system for vitreous haze(10 years)
研究者
Joanna Przeździecka-Dołyk
Principal Investigator
Wroclaw Medical University
