Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Corneal clarity on postoperative day 1
研究概览
简要总结
Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by providing endothelial protection, maintaining space, as well as facilitating surgical maneuvers, including IOL implantation. Equally important is the ease of use, good visualisation and easy removal of the OVD from the eye. Currently, 3 popularly used OVDs as a single injection sufficing for surgery are: Healon 5, DiscoVisc, and Celoftal (2% hydroxypropylmethylcellulose). Whereas, there are studies showing efficacy of each of these in clinical scenarios, there is no randomized trial comparing intraoperative performance and postoperative outcomes. The aim of this study was to compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification when using one of the three OVDs
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age related, uncomplicated senile cataracts
排除标准
- •presence of glaucoma,
- •shallow anterior chamber (ACD < 2.1mm),
- •pupillary dilatation < 6mm,
- •extremely dense cataracts,
- •posterior polar cataract,
- •subluxated cataract,
- •white mature cataract,
- •diabetic retinopathy,
- •high myopia (defined as AL > 25mm),
- •uveitis, or
- •previous ocular trauma/surgery.
结局指标
主要结局
Corneal clarity on postoperative day 1
时间窗: postoperative day 1
次要结局
- Central corneal thickness on postoperative day 1 and week 1(day 1 and week 1)