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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Procedure: Manual conventional surgery; Procedure: FLACS; Device: CENTURION® Vision System; Device: LenSx®

• Registration Number: NCT03479944
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-27
• Study Start: 2018-08-22
• Primary Completion: 2018-11-19
• Study Completion: 2019-05-17
• Status Verified: 2019-11
• Results First Submitted: 2019-11-06
• Results First Submitted QC: 2019-11-27
• Last Update Submitted: 2019-11-27
• Results First Posted: 2019-12-16
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FLACS	LenSx®	Femtosecond laser assisted cataract surgery (FLACS) in 1 eye, with manual conventional surgery in the fellow eye, as randomized
Conventional	Manual conventional surgery	Manual conventional surgery in 1 eye, with FLACS in the fellow eye, as randomized
FLACS	FLACS	Femtosecond laser assisted cataract surgery (FLACS) in 1 eye, with manual conventional surgery in the fellow eye, as randomized
FLACS	CENTURION® Vision System	Femtosecond laser assisted cataract surgery (FLACS) in 1 eye, with manual conventional surgery in the fellow eye, as randomized
Conventional	CENTURION® Vision System	Manual conventional surgery in 1 eye, with FLACS in the fellow eye, as randomized

Primary Outcome Measures

Name	Time	Method
Cumulative Dissipated Energy (CDE)	Day 0 (operative day)	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

Name	Time	Method
Percentage of Average Torsional Amplitude	Day 0 (operative day)	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.
Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit	Preoperative, Day 150-210 (post-operative)	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.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇯🇵 Iizuka City, Fukuoka, Japan