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

NCT01848288 | Completed Results

• 1 other identifier: M-13-006
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

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

Keywords

Cataract; Phacoemulsification; Cumulative Dissipated Energy (CDE)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Aspiration Time

  Day 0 (operative day), each eye

Study Arms (2)

CENTURION

EXPERIMENTAL

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); Device: INFINITI® Vision System (IVS)

INFINITI

ACTIVE COMPARATOR

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); Device: INFINITI® Vision System (IVS)

Interventions

CENTURION® Vision System (CVS) 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.

CENTURION; INFINITI

INFINITI® Vision System (IVS) 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.

CENTURION; INFINITI

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Doug Fanney, Director, Global Medical Affairs, Cataract Instrumentation
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Erin Hayes, MS

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 7, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 7, 2015
• Results First Posted: March 9, 2015

Record last verified: 2015-03