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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848288
• Other study ID #: M-13-006
• Status: Completed
• Phase: N/A
• First received: May 1, 2013
• Last updated: March 18, 2015
• Start date: July 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Cataract

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No