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Prospective clinical study using a new phaco system with intraocular system target pressure control

Poster Details

First Author: R.Lorente SPAIN

Co Author(s):    K. Solomon   R. Cionni   D. Fanney        

Abstract Details



Purpose:

To report final clinical study results comparing intraoperative metrics using a new phacoemulsifier aspirator (phaco) system with system target intraocular pressure control and new ultrasonic handpiece, tip, and sleeve to a standard Phaco system.

Setting:

R. Lorente1, K. Solomon2, R. Cionni3, D. Fanney4 1Complejo Hospitalario Universitario Orense, Orense, Spain; 2Carolina Eyecare Research Institute; 3Eye Institute of Utah; 4Alcon Research

Methods:

Prospective multicenter study using parallel, patient-masked, 2-arm, contralateral-comparison. Patients (n=98), aged ≥55 years with grade 2 to 3 cataracts undergoing bilateral cataract extraction and lens implant. Surgery performed using Centurion® Vision System, 0.9 mm Intrepid tip, and 0.9mm Intrepid sleeve (Centurion® Configuration) in 1 eye and Infiniti® Vision System, 0.9mm Mini Flared Tip, and 0.9mm Ultra Sleeve (Infiniti® Configuration) in the other eye; patients randomized for an equal first eye number. Clear cornea incisions: 2.2 to 2.4 mm. Surgeons had ≥1 month prior experience and ≥100 surgeries with both systems before study initiation. The co-primary and secondary endpoints were Cumulative Dissipated Energy (CDE) and Aspiration Fluid Used. The secondary endpoint was Aspiration Time

Results:

Final results are based on 98 patients (ITT): When compared to the Infiniti® Configuration, the Centurion® Configuration resulted in significant lower CDE (4.32 vs 7.11 percent-seconds; difference = -2.78 percent-seconds, 95%CI = -3.44, -2.13), lower Aspiration Fluid Used (46.6 vs 52.7 ml; difference = -6.12 ml, 95%CI = -9.82, -2.43), and lower Aspiration Time (151.8 vs 167.6 seconds; difference = -15.78 seconds, 95%CI = -26.49, -5.07).

Conclusions:

Both co-primary endpoints. (CDE, Aspiration Fluid Used) and the secondary endpoint (Aspiration Time) were significantly lower with the Centurion® Configuration vs the Infiniti® Configuration. This clinical study suggests the Centurion® configuration offers improved surgical efficiency over the Infiniti® configuration in phacoemulsification cataract extraction surgery. FINANCIAL INTEREST: One of more of the authors... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented

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