Prospective Clinical Study Using Novel Phaco System With Intraocular System Target Pressure Control and Existing Phaco System
Narrative Responses:
Purpose
To report clinical study results comparing intraoperative metrics using a novel phacoemulsifier aspirator (phaco) system with system target intraocular pressure control and new ultrasonic handpiece, tip, and sleeve to a standard Phaco system.
Methods
Prospective multicenter study using parallel, patient-masked, 2-arm, contralateral-comparison. Patients (n=100), aged ≥55 years with grade 2 to 3 cataracts undergoing bilateral cataract extraction and lens implant. Surgery performed using Centurion in 1 eye and Infiniti 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. Surgery performed with the Centurion included new handpiece, tip, and irrigation sleeve. The co-primary and secondary endpoints are aspiration fluid used, cumulative dissipated energy (CDE) and aspiration time respectively.
Results
Interim data lock based on 58 patients shows mean (Standard Deviation, SD) Aspiration Fluid used of 51.8 (15.1) ml and 56.2 (20.0) ml for the Centurion System and Infiniti System respectively. Respective mean (SD) CDE used for equivalent nuclear opacity cataract grades were 4.3(2.0) %-sec and 6.9 (3.2) %-sec. Mean (SD) Aspiration Time for the Centurion and Infiniti were 172.0 (54.7) sec and 189.5 (63.4) sec. respectively. Adverse Events were considered unrelated to the devices.
Conclusion
Improved intraoperative Aspiration Fluid usage, CDE, and ASP time with the Centurion System compared to the Infiniti System show tangible system improvements based on interim data. Final results to be presented at the meeting.