NCT Number: NCT07756385
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Zagreb, 10000, Croatia
Location status: Recruiting
Iva Bulat, M.D.
SUB_INVESTIGATOR
Iva Ćubela, M.D.
CONTACT
Iva Ćubela, M.D.
SUB_INVESTIGATOR
Prof. Biljana Kuzmanović Elabjer, M.D., Ph.D
PRINCIPAL_INVESTIGATOR
Prof. Biljana Kuzmanović Elabjer, M.D., Ph.D.
CONTACT
Prof. Mirjana Bjeloš, M.D., Ph.D
SUB_INVESTIGATOR
Prof. Mladen Bušić, M.D., Ph.D
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4D PHACO PROBE
ACTIVE SENTRY PROBE
Time frame: Intraoperative
Time frame: Intraoperative
Time frame: Intraoperative
Time frame: Intraoperative
Time frame: Intraoperative
Time frame: Postoperative Day 1 and Day 7
Time frame: Postoperative Day 1 and Day 7
Time frame: Intraoperative
Contact information is provided by the study sponsor or research team.
Iva Ćubela, M.D.
CONTACT
Prof. Biljana Kuzmanović Elabjer, M.D., Ph.D.
CONTACT
University Hospital Sveti Duh
Other
Comparison of Ultrasound Efficiency and Early Postoperative Outcomes of Two Phacoemulsification Systems (UNITY VCS 4D Phaco and Centurion With Active Sentry Probe): A Randomized Contralateral Eye Study
Acronym: COMPASS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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