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Comparison of Centurion® Vision System With Balanced Tip and the Infiniti® Vision System With the Mini Flared Kelman (MFK) Tip During Cataract Extraction Surgery of Hard Lenses

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ClinicalTrials.gov Identifier: NCT02502526
Recruitment Status : Completed
First Posted : July 20, 2015
Results First Posted : April 18, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to demonstrate that the Centurion® Vision System (CVS) used with the 45° Balanced Tip will result in less Cumulative Dissipated Energy (CDE) than the lnfiniti® Vision System (IVS) used with the 45° Mini-Flared Kelman (MFK) tip during cataract extraction surgery via phacoemulsification of cataract grades NII- NIV [Lens opacities classification system II (LOCSII)].

Condition or disease Intervention/treatment Phase
Cataracts Device: Centurion® Vision System, 45° Balanced Tip Device: Centurion® Vision System, 45° MFK Tip Device: lnfiniti® Vision System, 45° MFK Tip Device: INTREPID® Ultra infusion sleeve Device: Ultra infusion sleeve Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Cumulative Dissipated Energy (CDE) and Balanced Salt Solution (BSS) Fluid Used With the Centurion® With the 45° Degree Balanced Ultrasound (U/S) Tip vs the Centurion® With Mini Flared Kelman U/S Tip vs the Infiniti® With Mini Flared Kelman U/S Tip on Hard Lenses
Actual Study Start Date : July 27, 2015
Actual Primary Completion Date : March 23, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: CVS with 45° Balanced Tip
Centurion® Vision System, 45° Balanced Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
Device: Centurion® Vision System, 45° Balanced Tip
Other Name: CVS with 45° Balanced Tip

Device: INTREPID® Ultra infusion sleeve
Active Comparator: CVS with 45° MFK Tip
Centurion® Vision System, 45° MFK Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
Device: Centurion® Vision System, 45° MFK Tip
Other Name: CVS with 45° MFK Tip

Device: INTREPID® Ultra infusion sleeve
Active Comparator: IVS with 45° MFK Tip
lnfiniti® Vision System, 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
Device: lnfiniti® Vision System, 45° MFK Tip
Other Name: IVS with 45° MFK Tip

Device: Ultra infusion sleeve



Primary Outcome Measures :
  1. Cumulative Dissipated Energy (CDE) [ Time Frame: Day 0 (operative day) ]
    Cumulative Dissipated Energy (CDE) represents the energy dissipated of the u/s tip and infusion sleeve at the incision point (5.6mm back from the cutting edge of the tip) during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was present at the incision site. Only one eye (study eye) contributed to the analysis. This outcome measure was pre-specified for CVS Bal and IVS MFK.


Secondary Outcome Measures :
  1. Cumulative Dissipated Energy (CDE) [ Time Frame: Day 0 (operative day) ]
    Cumulative Dissipated Energy (CDE) represents the energy dissipated of the u/s tip and infusion sleeve at the incision point (5.6mm back from the cutting edge of the tip) during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was present at the incision site. Only one eye (study eye) contributed to the analysis.

  2. Balanced Salt Solution (BSS) Fluid Used [ Time Frame: Day 0 (operative day) ]
    BSS Fluid was measured by weighing the BSS bag after priming. BSS Used is Incision Leakage Fluid plus Aspiration Fluid Used. A reduction in BSS fluid used implies less induced trauma to tissues. Only one eye (study eye) contributed to the analysis.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to consent for participation;
  • Willing and able to attend postoperative examinations per protocol schedule;
  • Cataract in at least one eye with a Nuclear Opalescence of II-IV (via LOCSII) followed by posterior chamber intraocular lens (IOL) implantation;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Planned multiple procedures, including Laser Phaco, LASIK, LRI's etc. during surgery or the course of this study;
  • Severe conditions of acute or chronic diseases or illnesses that would increase the operative risk or confound the result of this investigation;
  • Untreated or uncontrolled Glaucoma;
  • Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes;
  • Poorly dilating pupil or other pupil defect;
  • Current or previous use of an alpha-1-selective adrenoceptor blocking agent or antagonist of alpha 1A adrenoceptor (eg, Flomax®, Hyntrin®, or Cardura®);
  • Severe retinal disorders;
  • Corneal disease or retinal detachment;
  • Other protocol-specified 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): NCT02502526


Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Alcon, A Novartis Division Alcon, A Novartis Division
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] July 18, 2016
Statistical Analysis Plan  [PDF] August 29, 2017


Additional Information:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02502526     History of Changes
Other Study ID Numbers: CTU424-P001
First Posted: July 20, 2015    Key Record Dates
Results First Posted: April 18, 2018
Last Update Posted: July 2, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases