Study on The Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change of corneal incision from 1day after surgery to 1 months
研究概览
简要总结
To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery
详细描述
To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery.Prospective research.One eligible eye from patients having cataract surgery performed using the 3-D head-up technique were included in the study as an experimental group,in the meanwhile eyes performed cataract surgery by traditional microsurgery included as a control group.All eyes in the study are operated by the same doctor. Corneal incision form,corneal endothelial cell density and best corrected visual acuity are included to evaluate the results of cataract surgery.
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnose age-related cataract;
- •Plan to perform phacoemulsification of cataract with intraocular lens implantation;
- •Willing to cooperate with the re-examination of 1 day, 1 week, and 1 month after surgery;
- •Able to understand and independently fill in the informed consent form and postoperative follow-up plan.
排除标准
- •Cataract caused by other reasons;
- •Fundus diseases such as severe diabetic retinopathy, high myopic retinopathy or macular degeneration;
- •Corneal diseases, corneal endothelial cells <1800/mm2;
- •Small palpebral fissure;
- •Those with a history of glaucoma, uveitis, eye trauma or eye surgery;
- •Those who cannot cooperate with the inspection and have not completed the one-month follow-up
研究组 & 干预措施
cataract surgery performed by heads-up method
3D heads-up surgery was performed under the NGENUITY® 3D visualization system
干预措施: heads-up method (Procedure)
Traditional surgery
Traditional surgery was performed under a surgical microscope.
结局指标
主要结局
change of corneal incision from 1day after surgery to 1 months
时间窗: up to 1day,1week,1 month
the shape and length of the corneal incision ，if descemet's layer detachment happens
corneal endothelial cell density
时间窗: up to 1 month
the number of corneal endothelial cells per unit area
次要结局
- best corrected visual acuity(up to 1 month)
- change from baseline central corneal thickness at 1 months(up to 1 day,1 week,1 month)
- change from baseline corneal incision thickness at 1 months(up to 1 day,1 week,1 month)
研究者
Yune Zhao
Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
Wenzhou Medical University