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

NCT ID: NCT03479944

Last Updated: 2019-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-22

Study Completion Date

2019-05-17

Brief Summary

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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

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

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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FLACS

Femtosecond laser assisted cataract surgery (FLACS) in 1 eye, with manual conventional surgery in the fellow eye, as randomized

Group Type EXPERIMENTAL

FLACS

Intervention Type PROCEDURE

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

CENTURION® Vision System

Intervention Type DEVICE

Phacoemulsification aspiration platform for use during cataract surgery

LenSx®

Intervention Type DEVICE

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

Conventional

Manual conventional surgery in 1 eye, with FLACS in the fellow eye, as randomized

Group Type ACTIVE_COMPARATOR

Manual conventional surgery

Intervention Type PROCEDURE

Removal of cataractous lens by phacoemulsification

CENTURION® Vision System

Intervention Type DEVICE

Phacoemulsification aspiration platform for use during cataract surgery

Interventions

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FLACS

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

Intervention Type PROCEDURE

Manual conventional surgery

Removal of cataractous lens by phacoemulsification

Intervention Type PROCEDURE

CENTURION® Vision System

Phacoemulsification aspiration platform for use during cataract surgery

Intervention Type DEVICE

LenSx®

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

Intervention Type DEVICE

Eligibility Criteria

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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;

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;
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alcon, A Novartis Division

Role: STUDY_DIRECTOR

Alcon, A Novartis Division

Locations

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Alcon Investigative Site

Iizuka, Fukuoka, Japan

Site Status

Countries

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United States Japan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CTB258-P001

Identifier Type: -

Identifier Source: org_study_id