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

NCT03479944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2019-12-16

Study results available
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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.

Conditions

  • Cataract

Interventions

PROCEDURE

FLACS

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

PROCEDURE

Manual conventional surgery

Removal of cataractous lens by phacoemulsification

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

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Alcon, A Novartis Division · Alcon, A Novartis Division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-22
Primary Completion
2018-11-19
Completion
2019-05-17
FDA Device
Yes

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03479944 on ClinicalTrials.gov