JPRN-jRCTs072180023已完成未知
Clinical Evaluation of FLACS (Femtosecond Laser Assisted Cataract Surgery) with Combination of LenSx and Centurion - Clinical Evaluation of FLACS (Femtosecond Laser Assisted Cataract Surgery) with Combination of LenSx and Centurion
Oka Yoshitaka0 个研究点目标入组 57 人开始时间: 2019年2月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 57
研究概览
简要总结
The superiority of LenSx to Conventional was demonstrated in the primary efficacy endpoint of CDE. The superiority of LenSx to Conventional was not shown in the secondary efficacy endpoints of percent change of ECD at Visit 5 (150 to 210 days after surgery) from Pre-Operative Visit and average torsional amplitude. No AEs related to the study medical device were reported. No subjects discontinued the study due to AEs, and there were no safety concerns of the study medical device.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20age 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Cataracts (Grade 2-4 of Emery-Little Classification) with planned cataract removal by phacoemulsification in both eyes
- •2.Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures
- •3.Calculated lens power within the available range
- •4.Other protocol-specified inclusion criteria may apply.
排除标准
- •1.Any pathology that could reduce visual potential
- •2.Hypotony or the presence of a corneal implant
- •3.Residual, recurrent, active ocular or eyelid disease
- •4.Poorly dilating pupil
- •5.Any contraindication to cataract
- •6.Eyes with two different levels of cataract grade
- •7.Pregnant, or planned pregnancy during the study
- •8.Expected to require an ocular surgical treatment at any time during the study
- •9.Other protocol-specified exclusion criteria may apply
研究者
相似试验
已完成
不适用
Clinical Evaluation of FLACS (Femtosecond Laser Assisted Cataract Surgery) With Combination of LenSx and CenturiocataractJPRN-UMIN000031996Alcon Japan Ltd.57
已完成
不适用
Clinical Evaluation of FLACS With Combination of LenSx® and Centurion®CataractNCT03479944Alcon Research57
已完成
不适用
Efficacy and Safety of ReLEx Smile for Laser Correction of MyopiaMyopiaNCT01481792University of Aarhus125
已完成
不适用
Correction of Myopia Wtih or Without Astigmatism Using the VisuMax™ Femtosecond LaserMyopiaAstigmatismNCT02430428Carl Zeiss Meditec, Inc.357
已完成
1 期
Use of the VisuMax™ Femtosecond LaserMyopiaNCT01638390Carl Zeiss Meditec, Inc.357