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

Alcon Research112 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

112

Conditions

Cataract

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.

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.

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Day 0 (operative day), each eye

Secondary Outcomes

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.

Time frame: Day 0 (operative day), each eye

Data from ClinicalTrials.gov

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