Skip to main content
OpenTrials
Completed

NCT Number: NCT03479944

Clinical Evaluation of FLACS 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site

Iizuka, Fukuoka, 820-0067, Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FLACS

Procedure

Femtosecond laser assisted cataract surgery consisting of LenSx® and Centurion® combination

Manual conventional surgery

Procedure

Removal of cataractous lens by phacoemulsification

CENTURION® Vision System

Device

Phacoemulsification aspiration platform for use during cataract surgery

LenSx®

Device

Femtosecond laser system used for continuous curvilinear capsulorhexis (CCC) and lens fragmentation during cataract surgery

Primary outcomes

  1. Cumulative Dissipated Energy (CDE)

    Time frame: 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 outcomes

  1. Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit

    Time frame: 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.

  2. Percentage of Average Torsional Amplitude

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 27, 2018
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.