Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery
2022年5月7日 更新者：Yune Zhao、Wenzhou Medical University
Study on The Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery
To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Zhejiang
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Wenzhou、Zhejiang、中国
- Eye Hospital of Wenzhou Medical College
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：cataract surgery performed by heads-up method
3D heads-up surgery was performed under the NGENUITY® 3D visualization system
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3D surgical video system, which includes Alcon NGENUITY 3D visualization system (Alcon, Fort Worth, TX) and Leica M822 and M844 microscopes (Leica Microsystems, Wetzlar, Germany),can be used to perform head-up phacoemulsification combined with intraocular lens implantation surgery.
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无干预：Traditional surgery
Traditional surgery was performed under a surgical microscope.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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change of corneal incision from 1day after surgery to 1 months
大体时间：up to 1day,1week,1 month
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the shape and length of the corneal incision ，if descemet's layer detachment happens
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up to 1day,1week,1 month
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corneal endothelial cell density
大体时间：up to 1 month
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the number of corneal endothelial cells per unit area
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up to 1 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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best corrected visual acuity
大体时间：up to 1 month
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best corrected visual acuity
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up to 1 month
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change from baseline central corneal thickness at 1 months
大体时间：up to 1 day,1 week,1 month
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thickness in micrometer
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up to 1 day,1 week,1 month
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change from baseline corneal incision thickness at 1 months
大体时间：up to 1 day,1 week,1 month
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Thickness of corneal incision
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up to 1 day,1 week,1 month
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年2月1日
初级完成 (实际的)
2021年10月31日
研究完成 (实际的)
2021年10月31日
研究注册日期
首次提交
2021年4月4日
首先提交符合 QC 标准的
2021年4月8日
首次发布 (实际的)
2021年4月9日
研究记录更新
最后更新发布 (实际的)
2022年5月12日
上次提交的符合 QC 标准的更新
2022年5月7日
最后验证
2022年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
heads-up method的临床试验
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Shannon E. Sauer-ZavalaNational Institute of Mental Health (NIMH)主动，不招人
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University of MichiganNational Institute on Drug Abuse (NIDA); Brown University; Pennington Biomedical Research Center; Oregon Research Institute 和其他合作者招聘中
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Mary LacyNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)主动，不招人
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Oregon Health and Science UniversityTexas A&M University; University of North Carolina, Greensboro主动，不招人
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Psychiatric Research Unit, Region Zealand, DenmarkAarhus University Hospital; University of Copenhagen; Mental Health Centre Copenhagen完全的
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Universidad Complutense de MadridUniversity of Alcala; Ministerio de Economía y Competitividad, Spain; Council of Madrid终止