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OpenTrials
Completed

NCT Number: NCT01848288

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Cumulative Dissipated Energy

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

    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.

  2. Aspiration (ASP) Fluid Used

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

    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.

Secondary outcomes

  1. Aspiration Time

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

    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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 7, 2013
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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