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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479944
• Other study ID #: CTB258-P001
• Status: Completed
• Phase: N/A
• Start date: August 22, 2018
• Est. completion date: May 17, 2019

Study information

• Verified date: November 2019
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 17, 2019
• Est. primary completion date: November 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• FLACS
Femtosecond laser assisted cataract surgery consisting of LenSx® and Centurion® combination
• Manual conventional surgery
Removal of cataractous lens by phacoemulsification

Device:
• CENTURION® Vision System
Phacoemulsification aspiration platform for use during cataract surgery
• LenSx®
Femtosecond laser system used for continuous curvilinear capsulorhexis (CCC) and lens fragmentation during cataract surgery

Locations

Country	Name	City	State
Japan	Alcon Investigative Site	Iizuka City	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)