This prospective, randomized, contralateral (crossover) study compares the ultrasound efficiency and early postoperative outcomes (Day 1 and Day 7) of two phacoemulsification platforms - the UNITY® VCS system with 4D Phaco and the Centurion® Vision System with ACTIVE SENTRY® Handpiece - used in the two eyes of the same patient undergoing cataract surgery.
Adult patients scheduled for uncomplicated phacoemulsification with comparable cataract density between eyes (within one LOCS III grade) will have one eye randomized to the UNITY VCS system and the contralateral eye to the Centurion Vision System, with the same surgeon and using the same low IOP fluidics parameters. The contralateral eye surgery will be performed two weeks after the first eye surgery. The study will evaluate ultrasound efficiency using machine-recorded parameters, best-corrected visual acuity (BCVA), and central corneal thickness (CCT) on postoperative Days 1 and 7.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
4D PHACO PROBE
ACTIVE SENTRY PROBE
University Eye Department, University Hospital Sveti Duh
Zagreb, Croatia
RECRUITINGUltrasound efficiency evaluated through Cumulative Dissipated Energy (CDE) required to remove the cataract
Time frame: Intraoperative
Ultrasound efficiency evaluated through Ultrasound (U/S) Total Time
Time frame: Intraoperative
Ultrasound efficiency evaluated through Total Aspiration Time
Time frame: Intraoperative
Ultrasound efficiency evaluated through Estimated Fluid Aspirated
Time frame: Intraoperative
Ultrasound efficiency evaluated through Total Case Time
Time frame: Intraoperative
Best-corrected visual acuity (BCVA)
Time frame: Postoperative Day 1 and Day 7
Central corneal thickness (CCT)
Time frame: Postoperative Day 1 and Day 7
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