NCT02502526

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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 \[Lens opacities classification system II (LOCSII)\].

Conditions

• Cataracts

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-07-27
• Primary completion: 2017-03-23
• Completion: 2017-11-30
• First posted: 2015-07-20
• Last updated: 2018-07-02
• Results posted: 2018-04-18