Uveitis in Childhood Prospective National Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 31
- 主要终点
- Incidence of ocular complications
研究概览
简要总结
Childhood uveitis (inflammation inside the eye) is an uncommon disorder that carries the risk of blindness. Inadequate treatment of active inflammation has been shown to be related to a poor outcome. There has been no population-based, prospective longitudinal study of all-cause childhood uveitis, with resultant limitations in the evidence base used to counsel affected families, balance treatment decisions, or plan further research. The aim of the study is to describe the characteristics of childhood-onset uveitis and describe outcomes. The investigators shall also aim to identify the socio-demographic, clinical, biological and treatment-related determinants of outcome. Early (1-2 years following diagnosis) outcomes will be described in the first instance: However, through the creation of a national inception cohort, the investigators shall enable longer-term studies of outcome for affected children and families. There will be no change to routine clinical care.
详细描述
Background:
Childhood uveitis descriptive term for a group of rare inflammatory eye disease, which are typically chronic, relapsing-remitting in nature, and of uncertain aetiology (idiopathic). Visual loss occurs due to structural damage caused by uncontrolled inflammation. Understanding of the determinants of long-term outcome is limited, particularly the predictors of therapeutic response or how to define disease control.
Aims:
To describe disease natural history and outcomes amongst a nationally representative group of children with non-infectious uveitis, describe the impact of disease course on quality of life for both child and family, and identify determinants of adverse visual, structural and developmental outcomes.
Methods:
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children newly diagnosed with uveitis (within previous 6 months)
- •Age < 18years
排除标准
- •Uveitis due to malignancy
- •Uveitis due to ocular trauma (including iatrogenic, ie intraocular surgery)
- •Uveitis due to confirmed ocular infection
- •Children with developmental disorders or impairments which prevent their self-report of their function level or quality of life
结局指标
主要结局
Incidence of ocular complications
时间窗: Up to 3 years
New incident of sight threatening ocular complications, including glaucoma, cataract and macular oedema
Pediatric Quality of Life Inventory Score
时间窗: Up to 3 years
Quality of life (patient reported outcomes) using Pediatric Quality of Life Inventory (PedsQL) in which items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life)
次要结局
- Change in Pediatric Quality of Life Inventory Score(Over one year from baseline to year one)
- Health Utility(Up to 3 years)
- Corticosteroid exposure(Up to 3 years)
- Attainment of disease control(Up to 3 years)