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

Alcon

Status: Completed

Conditions: Cataract

Treatments: Device: CENTURION® Vision System (CVS); Device: INFINITI® Vision System (IVS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01848288

M-13-006

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

112 participants in 2 patient groups

CENTURION

Experimental group

Description:

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.

Treatment:

Device: CENTURION® Vision System (CVS)

Device: INFINITI® Vision System (IVS)

INFINITI

Active Comparator group

Description:

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.

Treatment:

Device: CENTURION® Vision System (CVS)

Device: INFINITI® Vision System (IVS)