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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Device: CENTURION® Vision System (CVS)
* Device: INFINITI® Vision System (IVS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CENTURION<br>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)<br>* 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.<br>Device: INFINITI® Vision System (IVS)<br>* 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.<br>|
| Active Comparator: INFINITI<br>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)<br>* 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.<br>Device: INFINITI® Vision System (IVS)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Phacoemulsification, Cumulative Dissipated Energy (CDE)