Back to resultsClinical Evaluation of FLACS With Combination of LenSx® and Centurion®
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
FLACS
Manual conventional surgery
CENTURION® Vision System
LenSx®
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
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.
Sites / Locations
- Alcon Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FLACS
Conventional
Arm Description
Femtosecond laser assisted cataract surgery (FLACS) in 1 eye, with manual conventional surgery in the fellow eye, as randomized
Manual conventional surgery in 1 eye, with FLACS in the fellow eye, as randomized
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03479944
Brief Title
Clinical Evaluation of FLACS With Combination of LenSx® and Centurion®
Official Title
Clinical Evaluation of FLACS (Femtosecond Laser Assisted Cataract Surgery) With Combination of LenSx® and Centurion®
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 22, 2018 (Actual)
Primary Completion Date
November 19, 2018 (Actual)
Study Completion Date
May 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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 cataract surgery.
Detailed Description
Subjects will attend 7 scheduled visits: 1 pre-operative, 1 operative, and 5 post-operative.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FLACS
Arm Type
Experimental
Arm Description
Femtosecond laser assisted cataract surgery (FLACS) in 1 eye, with manual conventional surgery in the fellow eye, as randomized
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Manual conventional surgery in 1 eye, with FLACS in the fellow eye, as randomized
Intervention Type
Procedure
Intervention Name(s)
FLACS
Intervention Description
Femtosecond laser assisted cataract surgery consisting of LenSx® and Centurion® combination
Intervention Type
Procedure
Intervention Name(s)
Manual conventional surgery
Intervention Description
Removal of cataractous lens by phacoemulsification
Intervention Type
Device
Intervention Name(s)
CENTURION® Vision System
Intervention Description
Phacoemulsification aspiration platform for use during cataract surgery
Intervention Type
Device
Intervention Name(s)
LenSx®
Intervention Description
Femtosecond laser system used for continuous curvilinear capsulorhexis (CCC) and lens fragmentation during cataract surgery
Primary Outcome Measure Information:
Title
Cumulative Dissipated Energy (CDE)
Description
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.
Time Frame
Day 0 (operative day)
Secondary Outcome Measure Information:
Title
Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit
Description
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.
Time Frame
Preoperative, Day 150-210 (post-operative)
Title
Percentage of Average Torsional Amplitude
Description
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.
Time Frame
Day 0 (operative day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon, A Novartis Division
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Iizuka City
State/Province
Fukuoka
ZIP/Postal Code
820-0067
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of FLACS With Combination of LenSx® and Centurion®
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