Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Incidence of DMD at postoperative day 1
研究概览
简要总结
This study is a single-center, parallel-group, randomized controlled trial with the following objectives: to compare the incidence of post-operative descemet membrane detachment (DMD) in phacoemulsification surgery between modified and conventional 2.2mm microincision.
详细描述
2.2mm incision is considered an ideal incision size in phacoemulsification. However, DMD is a common and serious complication in 2.2mm microincision phacoemulsification for hard nucleus age-related cataract. DMD is originated from the incision in the operation. How to construct the appropriate incision shape and size for reducing the occurrence of DMD is an important problem to be solved urgently in phacoemulsification surgery.
The investigators found that enlarging the internal incision could increase the range of motion of surgical instruments and reduce the friction of instruments to incision. Therefore，the incidence of DMD would be reduced. The investigators developed this technique, modified 2.2mm incision, to reduce the incidence of incision-site DMD and not to increase other incision related complications.
In this trial, the investigators aim to compare modified and conventional 2.2mm incision with regard to safety and efficacy in reducing the incidence of DMD.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged-related cataract patients between 65 and 90 years ;
- •Lens nuclear opalescence grade ≥4.0 on the Lens Opacities Classification System III (LOCS III);
- •Scheduled for phacoemulsification combined with intraocular lens implantation.
- •The number of corneal endothelial cells > 1500cells/mm
- •Dilated pupil diameter ≥6mm
排除标准
- •A history of ophthalmic trauma or surgery;
- •Other ophthalmic diseases such as glaucoma, uveitis, high myopia;
- •Ocular factors that would make surgery challenging or dangerous, including but not limited to small pupil, shallow anterior chamber, etc.
结局指标
主要结局
Incidence of DMD at postoperative day 1
时间窗: postoperative day 1
Incidence of incision-site descemet membrane detachment observed by anterior segment OCT at postoperative day 1
次要结局
- maximal incision thickness(postoperative day 1, day 7, month 1, month 3)
- the length of DMD(postoperative day 1, day 7, month 1, month 3)
- Best corrected visual acuity (BCVA)(postoperative day 1, day 7, month 1, month 3)
- modulation transfer function (MTF)-cut off(postoperative day 1, day 7, month 1, month 3)
- surgical induced-astigmatism(postoperative day 1, day 7, month 1, month 3)
- central cornea endothelial cell loss(postoperative day 1, day 7, month 1, month 3)