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

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ClinicalTrials.gov Identifier: NCT01848288
Recruitment Status : Completed
First Posted : May 7, 2013
Results First Posted : March 9, 2015
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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.

Condition or disease Intervention/treatment Phase
Cataract Device: CENTURION® Vision System (CVS) Device: INFINITI® Vision System (IVS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: Intra-Operative Metrics and Clinical Outcomes After Cataract Surgery With the CENTURION® Vision System and the INFINITI® Vision System
Study Start Date : July 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: CENTURION
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)
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.

Device: 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.

Active Comparator: INFINITI
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)
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.

Device: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848288


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Erin Hayes, MS Alcon Research

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01848288     History of Changes
Other Study ID Numbers: M-13-006
First Posted: May 7, 2013    Key Record Dates
Results First Posted: March 9, 2015
Last Update Posted: April 7, 2015
Last Verified: March 2015

Keywords provided by Alcon Research:
Cataract
Phacoemulsification
Cumulative Dissipated Energy (CDE)

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents