Health- and Vision-Related Quality of Life in Children and Young People With Childhood Glaucoma, Childhood Cataract and Congenital Eye Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of babies requiring treatment for retinopathy of prematurity in the UK.
研究概览
简要总结
The management of childhood glaucoma (CG), childhood cataract (CC) and other birth defects affecting the eyes requires frequent hospital attendances and often multiple surgical and medical interventions, and are often associated with poor vision. Chronic medical conditions and vision impairment can affect quality of life (QoL). The QoL of children with the above conditions has not previously been evaluated.
详细描述
We wish to evaluate health related and vision related quality of life (HRQoL, VRQoL) in children age 2 to 16 years with childhood glaucoma (CG), childhood cataract (CC) and congenital eye defects microphthalmia, anophthalmia or coloboma (MAC).
We will recruit children who attend the children's eye clinics at Moorfields Eye Hospital at City Road. We will include the following subgroups:
A) children with primary or secondary glaucoma B) children with cataract or previously treated for cataract C) children with microphthalmia, anophthalmia or coloboma D) control group: agematched children without eye and vision problems. We will ask children and their carers to complete two age appropriate, validated questionnaires, the PedsQL (health related quality of life) and the Cardiff Visual Ability Questionnaire for Children. From the medical notes, we will record diagnosis and best corrected visual acuity with both eyes open. We will also record details of previous and current treatment, such as number of previous surgical interventions (sum of interventions right and left eye) and number of current topical medications (sum of eyedrop applications per day right and left eye).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A) children with primary or secondary glaucoma B) children with cataract or previously treated for cataract C) children with microphthalmia, anophthalmia or coloboma D) control group: age-matched children without eye and vision problems
排除标准
- •Ocular hypertension not requiring treatment; visually not significant cataract; inability to communicate in English; surgical intervention (incisional) within one month of potential date of completing questionnaire (before or after)
结局指标
主要结局
Incidence of babies requiring treatment for retinopathy of prematurity in the UK.
时间窗: 1 year
Captured in questionnaire
次要结局
- Demographic characteristics of babies that need treatment,(1 year)
- Outcome of the treatment at 1 year follow up: anatomical and functional(1 year)
- Type of treatment administered(1 year)