Status:
COMPLETED
Clinical Evaluation of FLACS With Combination of LenSx® and Centurion®
Lead Sponsor:
Alcon Research
Conditions:
Cataract
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate cumulative dissipated energy (CDE), endothelial cell loss, and average torsional amplitude with combination of LenSx® and Centurion® compared to conventional c...
Detailed Description
Subjects will attend 7 scheduled visits: 1 pre-operative, 1 operative, and 5 post-operative.
Eligibility Criteria
Inclusion
- Cataracts (Grade 2-4 of Emery-Little Classification) with planned cataract removal by phacoemulsification in both eyes;
- Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
- Calculated lens power within the available range;
- Other protocol-specified inclusion criteria may apply.
Exclusion
- Any pathology that could reduce visual potential;
- Hypotony or the presence of a corneal implant;
- Residual, recurrent, active ocular or eyelid disease;
- Poorly dilating pupil;
- Any contraindication to cataract;
- Eyes with two different levels of cataract grade;
- Pregnant, or planned pregnancy during the study;
- Expected to require an ocular surgical treatment at any time during the study;
- Other protocol-specified exclusion criteria may apply.
Key Trial Info
Start Date :
August 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2019
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03479944
Start Date
August 22 2018
End Date
May 17 2019
Last Update
December 16 2019
Active Locations (1)
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1
Alcon Investigative Site
Iizuka, Fukuoka, Japan, 820-0067