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OpenTrials
Completed

NCT Number: NCT02502526

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

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)].

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

21 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

  • 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.

Treatment and study plan

Centurion® Vision System, 45° Balanced Tip

Device

Other names: CVS with 45° Balanced Tip

Centurion® Vision System, 45° MFK Tip

Device

Other names: CVS with 45° MFK Tip

lnfiniti® Vision System, 45° MFK Tip

Device

Other names: IVS with 45° MFK Tip

INTREPID® Ultra infusion sleeve

Device

Ultra infusion sleeve

Device

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 20, 2015
Registry last updated
Jul 2, 2018

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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