Visual Axis Obscuration and Postoperative Complications Following Pediatric Cataract Surgery With Introacular Lens Implantation In-the-bag Versus Posterior Optic Capture : A Randomized, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 主要终点
- Posterior capsule opacification requiring surgery
研究概览
简要总结
This prospective, randomized, clinical trial looks to compare children undergoing congenital cataract surgery with intraocular lens (IOL) implantation in terms of visual axis obscuration as well as postoperative complications such as glaucoma, inflammation and IOL centration when IOL fixation is performed using two different techniques : 1) conventional in the bag IOL implantation with anterior vitrectomy, and, 2) posterior optic capture of the IOL through the posterior capsulorhexis without any vitrectomy. 61 eyes of 61 children randomized to receiving IOL implantation using one of the two techniques will be followed up until 12 months postoperatively.
详细描述
This prospective, randomized, controlled, clinical trial compares visual axis obscuration as well as intra and postoperative complications in children undergoing cataract surgery with IOL implantation using one of two techniques :
- in the bag IOL with limbal anterior vitrectomy
- posterior optic capture of IOL optic through the posterior capsulorhexis without any vitrectomy.
The aim is to evaluate whether avoiding anterior vitrectomy is a feasible option, particularly younger children, where anterior vitrectomy has become an integral part of the routine surgical strategy.
All children will be evaluated at 1 month, 3 months, 6 months and 12 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Days 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •uncomplicated cataract,
- •unilateral or bilateral cataract,
- •corneal diameter >9.0mmHg
排除标准
- •pre-existing glaucoma,
- •ocular comorbidity,
- •microphthalmos,
- •microcornea,
- •parents not consenting to participate in study,
- •traumatic cataract
结局指标
主要结局
Posterior capsule opacification requiring surgery
时间窗: 12 months postoperatively
opacification of visual axis
次要结局
- intraocular pressure in mmHg(12 months postoperatively)
- inflammation on slitlamp examination(12 months postoperatively)
研究者
Abhay R. Vasavada
Director
Iladevi Cataract and IOL Research Center