Intra-Operative Metrics With CENTURION® and INFINITI® Vision Systems

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: CENTURION® Vision System (CVS); Device: INFINITI® Vision System (IVS)

• Registration Number: NCT01848288
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate intra-operative phacoemulsification machine metrics after phacoemulsification with the CENTURION® vision system configuration compared with the INFINITI® vision system configuration.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-07
• Study Start: 2013-07
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2015-02-27
• Results First Submitted QC: 2015-02-27
• Status Verified: 2015-03
• Results First Posted: 2015-03-09
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Eligible to undergo cataract extraction via phacoemulsification with primary ACRYSOF Intraocular Lens (IOL) implantation;
• Free of severe disease(s)/condition(s) listed in the "Warnings" and "Precautions" section of implanted ACRYSOF IOL;
• Willing to undergo second eye surgery within 14 days of first eye surgery;
• Willing and able to understand/sign a written Informed Consent Document;
• Willing and able to return for scheduled follow-up examinations;
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Planned multiple procedures at the time of surgery or during the course of the study (eg, LASIK, LRI, etc.);
• Previous intraocular or corneal surgery of any kind;
• Poorly dilating pupil;
• Severe retinal disorders (eg, macular degeneration, proliferative diabetic retinopathy);
• Corneal disease (eg, herpes simplex, herpes zoster, etc) or retinal detachment;
• Severe conditions that per Investigator's clinical judgment would increase the operative risk or confound the result of this investigation;
• Female patients who are pregnant, lactating, or planning to be pregnant during the course of the study;
• Currently participating in another drug or device clinical trial, or participated in another drug or device clinical trial within 30 days of enrollment into this trial;
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CENTURION	INFINITI® Vision System (IVS)	First surgical eye randomized to CENTURION® Vision System, with second surgical eye (fellow eye) assigned to INFINITI® Vision System. Second eye surgery conducted within 14 days of the first eye surgery. Duration of surgery less than 30 minutes each eye.
INFINITI	CENTURION® Vision System (CVS)	First surgical eye randomized to INFINITI® Vision System, with second surgical eye (fellow eye) assigned to CENTURION® Vision System. Second eye surgery conducted within 14 days of the first eye surgery. Duration of surgery less than 30 minutes each eye.
CENTURION	CENTURION® Vision System (CVS)	First surgical eye randomized to CENTURION® Vision System, with second surgical eye (fellow eye) assigned to INFINITI® Vision System. Second eye surgery conducted within 14 days of the first eye surgery. Duration of surgery less than 30 minutes each eye.
INFINITI	INFINITI® Vision System (IVS)	First surgical eye randomized to INFINITI® Vision System, with second surgical eye (fellow eye) assigned to CENTURION® Vision System. Second eye surgery conducted within 14 days of the first eye surgery. Duration of surgery less than 30 minutes each eye.

Primary Outcome Measures

Name	Time	Method
Cumulative Dissipated Energy	Day 0 (operative day), each eye	Cumulative Dissipated Energy (CDE) is an estimation of the energy at the incision site experienced during the removal of cataractous lens and is measured in %-secs. The incision is defined as 5.6mm back from the cutting edge of the tip. A lower CDE indicates that less energy was present at the incision site.
Aspiration (ASP) Fluid Used	Day 0 (operative day), each eye	Aspiration fluid used is the amount of aspiration fluid used during the removal of the cataractous lens. A lower value indicates that less fluid was removed from the eye.

Secondary Outcome Measures

Name	Time	Method
Aspiration Time	Day 0 (operative day), each eye	Aspiration Time indicated the amount of time the system was aspirating during the removal of the cataractous lens. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery.