Clinical Evaluation of FLACS With Combination of LenSx® and Centurion®



Status:Not yet recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:20 - Any
Updated:8/4/2018
Start Date:August 2018
End Date:May 2019
Contact:Alcon Call Center
Email:alcon.medinfo@alcon.com
Phone:1-888-451-3937

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Trial Summary
Trial Overview
Inclusion Criteria

Clinical Evaluation of FLACS (Femtosecond Laser Assisted Cataract Surgery) With Combination of LenSx® and Centurion®

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 cataract surgery.

Subjects will attend 7 scheduled visits: 1 pre-operative, 1 operative, and 5 post-operative.

Inclusion Criteria:

- 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 Criteria:

- 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.
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