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临床试验/NCT04193020
NCT04193020招募中不适用

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

Wroclaw Medical University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年1月1日最近更新:
适应症

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

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

发起方
Wroclaw Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanna Przeździecka-Dołyk

Principal Investigator

Wroclaw Medical University

研究点 (1)

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