Retrospective and Prospective Observational Study on Non-infectious Chronic Uveitis in Pediatric Age
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 290
- 试验地点
- 5
- 主要终点
- Describe a population of paediatric patients with chronic non-infectious uveitis
研究概览
简要总结
Uveitis is an inflammatory disease of the uvea, one of the highly vascularized fundamental structures of the eye. It is a rare condition in children, with an incidence in the pediatric population ranging from 2% to 14% of all uveitis cases. The diagnosis and management of patients with uveitis rely on a multidisciplinary approach involving an ophthalmologist, a rheumatologist, and an infectious disease specialist to establish the correct diagnosis and assess the involvement of other organs. In Italy, there is no national or regional registry for non-infectious chronic uveitis as per the Prime Ministerial Decree (DPCM) of March 3, 2017 (Identification of surveillance systems and registries for mortality, tumors, and other diseases). However, many clinical centers adopt data recording systems to evaluate the quality of care and to study diseases and outcomes. The Universitary Hospital Meyer Institute Research Hospital (IRCCS) is a national referral center for managing these pediatric cases of non-infectious chronic uveitis, estimated to constitute 95% of all pediatric uveitis cases
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of non-infectious chronic uveitis before the age of 16;
- •signed informed consent form.
排除标准
- •Patients with a diagnosis of infectious uveitis
- •history of malignant pathology,
- •history of demyelinating pathology,
- •history of cerebral vasculitis
结局指标
主要结局
Describe a population of paediatric patients with chronic non-infectious uveitis
时间窗: 6 months, 12 months, 2 years and then every year
* Frequency of complications at onset, 6 months, 12 months, 2 years, then every year * Frequency of impaired visual acuity (LogMAR0.4-1) and blindness (LogMAR\>=1) at onset and at different time points (6 months, 12 months, 18 months, 2 years, then every year)
Identify any differences between the different forms of uveitis in terms of characteristics and outcomes
时间窗: thorugh the study and after 1 year
* Frequency of complications and impaired visual acuity * Description of laboratory characteristics
Identify risk factors for a more severe course
时间窗: thorugh the study and after 1 year
Percentages of children with impaired visual acuity * Percentages of children with ocular complications
Frequency achievement of response for each drug according to the definition of response
时间窗: thorugh the study and after 1 year
Frequency achievement of response for each drug according to the definition of response of the MIWGUC group
Time to archieve the response after drug initiation
时间窗: thorugh the study and after 1 year
Time to archieve the response after drug initiation
Time to the first flare on therapy
时间窗: thorugh the study and after 1 year
Time to the first flare on therapy
Achievement of inactive disease on therapy according to the definition of MIWGUC
时间窗: thorugh the study and after 1 year
Achievement of inactive disease on therapy according to the definition of MIWGUC
Presence and percentages of flares on therapy after achievement of remission on therapy
时间窗: thorugh the study and after 1 year
Presence and percentages of flares on therapy after achievement of remission on therapy
Time to achieve inactive disease on therapy according to the definition of MIWGUC
时间窗: thorugh the study and after 1 year
Time to achieve inactive disease on therapy according to the definition of MIWGUC
Time to flare after drug withdrawal
时间窗: 6, 12 and 18 months, 2 years then every year
Time to flare after drug withdrawal * Proportion of Flare after drug withdrawal in general at the last available follow-up * Proportion of children who flared after drug withdrawal at 6, 12 and 18 months, 2 years then every year
次要结局
未报告次要终点
研究者
Gabriele Simonini
Head of Rheumatology
Meyer Children's Hospital IRCCS