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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Procedure: FLACS; Device: CENTURION® Vision System; Device: LenSx®; Procedure: Manual conventional surgery

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Iizuka City, Fukuoka, Japan, 820-0067
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Alcon, A Novartis Division, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2018
• Primary Completion (Actual): November 19, 2018
• Study Completion (Actual): May 17, 2019

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CTB258-P001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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