N/A
N=182
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
Cataracts
Bottom Line
View on ClinicalTrials.gov: NCT02502526 ↗Enrolled (actual)
182
Serious AEs
2.3%
Results posted
Apr 2018
Primary outcome: Primary: Cumulative Dissipated Energy (CDE) — 6.2; 11.4 percent-seconds — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Dissipated Energy (CDE) |
6.2; 11.6; 11.4 | <.001 sig |
| SECONDARY Cumulative Dissipated Energy (CDE) |
6.2; 11.6; 11.4 | <.001 sig |
| SECONDARY Balanced Salt Solution (BSS) Fluid Used |
95.8; 101.7; 94.1 | 0.520 |
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)].
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02502526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.