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

Not Applicable

Completed

• Conditions: Cataracts
• Interventions: 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

• Registration Number: NCT02502526
• Lead Sponsor: 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 \[Lens opacities classification system II (LOCSII)\].

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-20
• Study Start: 2015-07-27
• Primary Completion: 2017-03-23
• Study Completion: 2017-11-30
• Results First Submitted: 2018-03-23
• Results First Submitted QC: 2018-03-23
• Status Verified: 2018-04
• Results First Posted: 2018-04-18
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CVS with 45° MFK Tip	INTREPID® Ultra infusion sleeve	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
CVS with 45° Balanced Tip	Centurion® Vision System, 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
CVS with 45° Balanced Tip	INTREPID® Ultra infusion sleeve	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
IVS with 45° MFK Tip	Ultra infusion sleeve	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
CVS with 45° MFK Tip	Centurion® Vision System, 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
IVS with 45° MFK Tip	lnfiniti® Vision System, 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

Primary Outcome Measures

Name	Time	Method
Cumulative Dissipated Energy (CDE)	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

Name	Time	Method
Cumulative Dissipated Energy (CDE)	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.
Balanced Salt Solution (BSS) Fluid Used	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.