Congenital Cataract Morphological Classifications and Monitoring Using Slit-Lamp-Adapted Photography in CCPMOH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,050
- 试验地点
- 1
- 主要终点
- Congenital Cataract Morphological Classifications and Monitoring using Slit-Lamp-Adapted Photography
研究概览
简要总结
Photography is considered as one of the most important means to promote evidence-based medical practice in pediatric ophthalmology.This study is to investigate the feasibility of congenital cataract morphological classifications and monitoring using slit-lamp-adapted anterior segmental photography in a large cohort that included uncooperative children.
详细描述
Lens opacities in congenital cataracts have a wide range of presentations.Therefore, it is important to find a method of recording, classifying and monitoring cataract morphologies that is feasible and safe in a large cohort of children with congenital cataracts, including uncooperative children. Photography is considered as one of the most important means to promote evidence-based medical practice in pediatric ophthalmology.
In this study, the investigators studied congenital cataract morphological classifications and monitoring using slit-lamp-adapted anterior segmental photography and evaluated its safety and feasibility in pediatric cataract patients registered in the Childhood Cataract Program of the Chinese Ministry of Health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with pediatric unilateral/bilateral cataracts
- •Children who were younger than 10 years of age
排除标准
- •Premature birth
- •Microphthalmia
- •Micro-or Megalocornea
- •Keratoconus
- •Traumatic or complicated cataracts
- •Vitreous and retinal diseases
- •Any previous surgeries, and contraindication for pupil dilation and sedation
结局指标
主要结局
Congenital Cataract Morphological Classifications and Monitoring using Slit-Lamp-Adapted Photography
时间窗: baseline
All eligible pediatric patients underwent pupil dilation with compound tropicamide eye drops 3 times (1 time every 10 minutes) before the examination or administration of sleep aid medicine. Then, the children underwent slit-lamp-adapted anterior segmental photography (BX900, Haag-Streit AG, Köniz, Switzerland) for each cataractous lens, including one diffuse light photo, one slit-light photo across the cataract and one retro-illumination photo. All photos of the included patients were screened and morphologically classified separately by two pediatric ophthalmologists; a third ophthalmologist was masked and required to make a decision if the first two physicians had different opinions.
次要结局
未报告次要终点
研究者
Erping Long
Principal Investigator，Home for Cataract Children, Zhongshan Ophthalmic Center
Sun Yat-sen University