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

NCT ID: NCT01848288

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-02-28

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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

CENTURION® Vision System (CVS)

Intervention Type: DEVICE

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.

INFINITI® Vision System (IVS)

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

CENTURION® Vision System (CVS)

Intervention Type: DEVICE

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.

INFINITI® Vision System (IVS)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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;

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;

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Hayes, MS

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

M-13-006

Identifier Type: -

Identifier Source: org_study_id