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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-27

Study Completion Date

2017-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Cataracts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Centurion® Vision System, 45° Balanced Tip

Intervention Type DEVICE

INTREPID® Ultra infusion sleeve

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

Centurion® Vision System, 45° MFK Tip

Intervention Type DEVICE

INTREPID® Ultra infusion sleeve

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

lnfiniti® Vision System, 45° MFK Tip

Intervention Type DEVICE

Ultra infusion sleeve

Intervention Type DEVICE

Interventions

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Centurion® Vision System, 45° Balanced Tip

Intervention Type DEVICE

Centurion® Vision System, 45° MFK Tip

Intervention Type DEVICE

lnfiniti® Vision System, 45° MFK Tip

Intervention Type DEVICE

INTREPID® Ultra infusion sleeve

Intervention Type DEVICE

Ultra infusion sleeve

Intervention Type DEVICE

Other Intervention Names

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CVS with 45° Balanced Tip CVS with 45° MFK Tip IVS with 45° MFK Tip

Eligibility Criteria

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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;

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;

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No