Appropriate Capsulorhexis Size Results in Better Capsular Outcome When Treating Pediatric Cataract: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Mean area of anterior/posterior capsulorhexis opening
研究概览
简要总结
Different capsulorhexis size results in different capsular outcome when treating pediatric cataract, and there should be an appropriate capsulorhexis size for the best capsular outcome.
详细描述
Numerous studies have reported that ideal anterior capsulorhexis size is 4.5-5.0 mm with the capsulorhexis edges covering IOL optic surface because it can inhibit the proliferation and migration of remnant lens epithelial cells (LEC). But there are no reports investigating the relationship between the capsulorhexis size and the capsular outcome after pediatric cataract surgery. Therefore, the aim of the current study is to prospective evaluate the capsular outcomes of three controlled groups receiving different anterior capsulorhexis sizes (3.0-3.9, 4.0-5.0, 5.1-6.0 mm in diameter).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age< 2 years
- •performed cataract surgery without IOL implantation
- •without capsular fibrosis, glaucoma, ocular trauma, corneal disorders before surgery
- •No other corneal and systemic abnormalities
- •Written informed consents provided
排除标准
- •Patients with glaucoma, ocular trauma, corneal disorders, persistent hyperplastic primary vitreous, rubella, Lowe syndrome, capsular fibrosis
- •Cases with surgical complications
- •those who can't dilute pupil normally postoperation or can't complete the follow-up
结局指标
主要结局
Mean area of anterior/posterior capsulorhexis opening
时间窗: two years
次要结局
- the ratio of opacity accounting for posterior capsulorhexis opening at different visits(two years)
- The area change of anterior/posterior capsulorhexis opening(two years)
研究者
Haotian Lin
Ophthalmologist
Sun Yat-sen University