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

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

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)].

Study Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Device: Centurion® Vision System, 45° Balanced Tip; Device: INTREPID® Ultra infusion sleeve; Device: Centurion® Vision System, 45° MFK Tip; Device: lnfiniti® Vision System, 45° MFK Tip; Device: Ultra infusion sleeve

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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: INTREPID® Ultra infusion sleeve; Device: Centurion® Vision System, 45° MFK Tip; Other Names: CVS with 45° MFK Tip
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 Names: IVS with 45° MFK Tip; Device: Ultra infusion sleeve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Dissipated Energy (CDE)	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.	Day 0 (operative day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Dissipated Energy (CDE)	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.	Day 0 (operative day)
Balanced Salt Solution (BSS) Fluid Used	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.	Day 0 (operative day)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Alcon, A Novartis Division, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2015
• Primary Completion (Actual): March 23, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: July 13, 2015
• First Submitted That Met QC Criteria: July 16, 2015
• First Posted (Estimate): July 20, 2015

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CTU424-P001