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

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Cataract

Intervention / Treatment
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* Procedure: FLACS
* Procedure: Manual conventional surgery
* Device: CENTURION® Vision System
* Device: LenSx®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLACS<br>Femtosecond laser assisted cataract surgery (FLACS) in 1 eye, with manual conventional surgery in the fellow eye, as randomized | Procedure: FLACS<br>* Femtosecond laser assisted cataract surgery consisting of LenSx® and Centurion® combination<br>Device: CENTURION® Vision System<br>* Phacoemulsification aspiration platform for use during cataract surgery<br>Device: LenSx®<br>* Femtosecond laser system used for continuous curvilinear capsulorhexis (CCC) and lens fragmentation during cataract surgery<br>|
| Active Comparator: Conventional<br>Manual conventional surgery in 1 eye, with FLACS in the fellow eye, as randomized | Procedure: Manual conventional surgery<br>* Removal of cataractous lens by phacoemulsification<br>Device: CENTURION® Vision System<br>* Phacoemulsification aspiration platform for use during cataract surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Dissipated Energy (CDE) | CDE is not expressed in standard units such as Watts or Joules and accounts for the power and time of longitudinal and torsional ultrasound delivery modes. CDE (the sum total of phacoemulsification energy dissipated at the incision point during the removal of cataractous lens with Centurion® Vision System footpedal in Position 3) was calculated by the Centurion® Vision System as follows: CDE = (Longitudinal time) x (Average longitudinal power) + (Torsional time x 0.4 x Average torsional amplitude). A lower CDE value indicates that less energy was expended in the eye. | Day 0 (operative day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit | Central endothelial cell counts were assessed using specular microscopy. ECD was measured in cells per square millimeter (mm2). The endothelium maintains corneal hydration, and positive percent change value indicates an improvement. In turn, a less negative percent change value is preferable over a more negative percent change value. | Preoperative, Day 150-210 (post-operative) | 
| Percentage of Average Torsional Amplitude | Torsional amplitude (the amplitude of the oscillations of the phacoemulsification tip) was reported on the Centurion® Vision System interface as a percentage from 0 to 100, where 100 represents maximum amplitude. A lower percentage value indicates greater efficiency in the phacoemulsification process. | Day 0 (operative day) |