A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision
试验速览
- 阶段
- 不适用
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- descemet membrane detachment(DMD)
研究概览
简要总结
Objective and Principle: To evaluate whether enlarging the incision can reduce corneal complications associated with phacoemulsification with regular 2.2 mm incision.
The aim of this study: To evaluate whether the technique of enlarging internal incision could reduce the incidence of descemet membrane detachment after 2.2 mm incision phacoemulsification.
Secondary outcome: To evaluate whether the technique of enlarged internal incision can reduce other corneal complications such as corneal edema and astigmatism after 2.2 mm incision phacoemulsification.
Study Design: A prospective randomized controlled study
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
- •Age-related cataract patients
- •Age from 65 to 90
- •The diameter of pupil after mydriasis is more than 6 mm
- •LOCS III nuclear grade ≥4
- •Corneal endothelial cell count > 1500 cells/mm2
- •Phacoemulsification and intraocular lens implantation are planned
- •Agree to participate in this study and sign informed consent
排除标准
- •History of ocular trauma
- •Anterior segment lesions (exfoliation syndrome, suspension ligament injury or relaxation, corneal and iris lesions, glaucoma)
- •Other ocular diseases that impair visual function, such as optic neuropathy, uveitis and ocular tumors
- •History of Ophthalmic Surgery
- •Intraoperative and Postoperative Complications
研究组 & 干预措施
Enlarged internal incision
enlarged the internal incision about 0.4mm
干预措施: enlarged internal incision (Procedure)
Regular 2.2mm incision
regular 2.2mm corneal incision for microincision coaxial phacoemulsification
干预措施: regular 2.2mm incision (Procedure)
结局指标
主要结局
descemet membrane detachment(DMD)
时间窗: postoperative 1 week
DMD at the incision observed by anterior segment optical coherence tomography
次要结局
未报告次要终点