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First Author: R.Cionni USA
Co Author(s): D. Fanney K. Solomon H. Sandoval
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To report the design of a clinical study comparing the intraoperative metrics and clinical outcomes achieved with Centurion®, a new phacoemulsifier aspirator (phaco) system with intraocular pressure control and a new ultrasonic probe, tip, and sleeve configuration in comparison with Infiniti®, a standard Phaco system.
3 sites in USA and Spain
This study is a prospective, multicenter evaluation performed using a parallel, patient-masked, 2-arm, contralateral-comparison design. Patients (n=100), will be aged ?55 years with grade 2 or 3 cataracts undergoing bilateral cataract extraction and intraocular lens implantation. Surgery will be performed using the Centurion® Vision System in 1 eye and the Infiniti® Vision System in the other eye, with patients randomized for an equal number undergoing surgery in the first eye with each system. Clear cornea incisions will range from 2.2 to 2.4 mm. Patient exclusion criteria include diagnosis with severe degenerative visual disorders, previous corneal surgery, corneal or retinal disease, or plans for multiple corrective procedures during surgery or over the course of the study. All surgeons will have ?1 month experience and ?100 surgeries with both systems before study initiation. Surgery performed with the Centurion® Vision System will be coupled with a new handpiece, phacoemulsification tip, and irrigation sleeve. The co-primary endpoints will be cumulative dissipative energy (CDE) energy and aspiration fluid used. Secondary and supportive endpoints will include aspiration time, and central cornea thickness.
Results on primary end-points will be reported.
This multicenter clinical study will determine whether the Centurion® Vision System improves surgical efficacy and patient outcomes compared with the Infiniti® Vision System following phacoemulsification cataract surgery and intraocular lens implantation.
... receives consulting fees, retainer, or contract payments from a competing company, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented