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
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 12/16/2017 |
| Start Date: | July 27, 2015 |
| End Date: | November 2017 |
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 used with the
45° Balanced Tip will result in less Cumulative Dissipated Energy (CDE) than the lnfiniti®
Vision System 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)].
45° Balanced Tip will result in less Cumulative Dissipated Energy (CDE) than the lnfiniti®
Vision System 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)].
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.
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