Clinical Evaluation of FLACS with Combination of LenSx and Centurio
- Conditions
- Cataract
- Registration Number
- JPRN-jRCTs072180023
- Lead Sponsor
- Oka Yoshitaka
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 57
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method