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

Intra-Operative Metrics and Clinical Outcomes After Cataract Surgery With the CENTURION® Vision System and the INFINITI® Vision System

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: CENTURION® Vision System (CVS); Device: INFINITI® Vision System (IVS)

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CENTURION; 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.	Device: CENTURION® Vision System (CVS); Phacoemulsification aspiration platform, with configuration consisting of Centurion® Vision System Phaco Emulsifier Aspirator, 45° Balanced ultrasonic tip, and INTREPID Ultra Infusion Sleeve, for use during routine cataract extraction by phacoemulsification with intraocular lens implantation.; Device: INFINITI® Vision System (IVS); Phacoemulsification aspiration platform, with configuration consisting of Infiniti® Vision System Phaco Emulsifier Aspirator, 45° Mini Flared Kelman tip, and Ultra Infusion Sleeve, for use during routine cataract extraction by phacoemulsification with intraocular lens implantation.
Active Comparator: INFINITI; 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.	Device: CENTURION® Vision System (CVS); Phacoemulsification aspiration platform, with configuration consisting of Centurion® Vision System Phaco Emulsifier Aspirator, 45° Balanced ultrasonic tip, and INTREPID Ultra Infusion Sleeve, for use during routine cataract extraction by phacoemulsification with intraocular lens implantation.; Device: INFINITI® Vision System (IVS); Phacoemulsification aspiration platform, with configuration consisting of Infiniti® Vision System Phaco Emulsifier Aspirator, 45° Mini Flared Kelman tip, and Ultra Infusion Sleeve, for use during routine cataract extraction by phacoemulsification with intraocular lens implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Dissipated Energy	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.	Day 0 (operative day), each eye
Aspiration (ASP) Fluid Used	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.	Day 0 (operative day), each eye

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aspiration Time	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.	Day 0 (operative day), each eye

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Erin Hayes, MS, Alcon Research

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: May 1, 2013
• First Submitted That Met QC Criteria: May 3, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Estimate): April 7, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Cataract; Phacoemulsification; Cumulative Dissipated Energy (CDE)
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: M-13-006