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

Alcon

Status: Completed

Conditions: Cataracts

Treatments: Device: lnfiniti® Vision System, 45° MFK Tip; Device: INTREPID® Ultra infusion sleeve; Device: Centurion® Vision System, 45° MFK Tip; Device: Ultra infusion sleeve; Device: Centurion® Vision System, 45° Balanced Tip

Study type: Interventional

Funder types: Industry

Identifiers

NCT02502526

CTU424-P001

Details and patient eligibility

About

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)].

Enrollment: 231 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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231 participants in 3 patient groups

CVS with 45° Balanced Tip

Experimental group

Description:

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

Treatment:

Device: Centurion® Vision System, 45° Balanced Tip

Device: INTREPID® Ultra infusion sleeve

CVS with 45° MFK Tip

Active Comparator group

Description:

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

Treatment:

Device: Centurion® Vision System, 45° MFK Tip

Device: INTREPID® Ultra infusion sleeve

IVS with 45° MFK Tip

Active Comparator group

Description:

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

Treatment:

Device: lnfiniti® Vision System, 45° MFK Tip

Device: Ultra infusion sleeve