Comparison of Two Phacoemulsification Systems in Cataract Surgery (UNITY VCS vs. Centurion) (COMPASS)

August 4, 2026 updated by: Biljana Kuzmanović Elabjer, University Hospital Sveti Duh

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Prof. Biljana Kuzmanović Elabjer, M.D., Ph.D.
  • Phone Number: +385912209555
  • Email: belabjer@kbsd.hr

Study Contact Backup

  • Name: Iva Ćubela, M.D.
  • Phone Number: +385912223220
  • Email: icubela@kbsd.hr

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • University Eye Department, University Hospital Sveti Duh
        • Contact:
          • Prof. Biljana Kuzmanović Elabjer, M.D., Ph.D.
          • Phone Number: +385912209555
          • Email: belabjer@kbsd.hr
        • Contact:
        • Principal Investigator:
          • Prof. Biljana Kuzmanović Elabjer, M.D., Ph.D
        • Sub-Investigator:
          • Iva Ćubela, M.D.
        • Sub-Investigator:
          • Prof. Mladen Bušić, M.D., Ph.D
        • Sub-Investigator:
          • Iva Bulat, M.D.
        • Sub-Investigator:
          • Prof. Mirjana Bjeloš, M.D., Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients scheduled for uncomplicated phacoemulsification with comparable cataract density between eyes (within one LOCS III grade)

Exclusion Criteria:

  • Prior corneal or intraocular surgery
  • Significant corneal pathology
  • Significant asymmetry between eyes in: cataract density, astigmatism, or axial length

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: UNITY VCS SYSTEM ®
Device: CENTURION VISION SYSTEM ®
ACTIVE SENTRY PROBE
Active Comparator: CENTURION VISION SYSTEM ®
Device: UNITY VCS SYSTEM ®
4D PHACO PROBE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ultrasound efficiency evaluated through Cumulative Dissipated Energy (CDE) required to remove the cataract
Time Frame: Intraoperative
Intraoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Ultrasound efficiency evaluated through Ultrasound (U/S) Total Time
Time Frame: Intraoperative
Intraoperative
Ultrasound efficiency evaluated through Total Aspiration Time
Time Frame: Intraoperative
Intraoperative
Ultrasound efficiency evaluated through Estimated Fluid Aspirated
Time Frame: Intraoperative
Intraoperative
Ultrasound efficiency evaluated through Total Case Time
Time Frame: Intraoperative
Intraoperative
Best-corrected visual acuity (BCVA)
Time Frame: Postoperative Day 1 and Day 7
Postoperative Day 1 and Day 7
Central corneal thickness (CCT)
Time Frame: Postoperative Day 1 and Day 7
Postoperative Day 1 and Day 7

Other Outcome Measures

Outcome Measure
Time Frame
Ultrasound efficiency evaluated through number of Actuations (iS vs ASM)
Time Frame: Intraoperative
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Sveti Duh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 6, 2026

Primary Completion (Estimated)

October 22, 2026

Study Completion (Estimated)

October 29, 2026

Study Registration Dates

First Submitted

August 4, 2026

First Submitted That Met QC Criteria

August 4, 2026

First Posted (Actual)

August 10, 2026

Study Record Updates

Last Update Posted (Actual)

August 10, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 01-1788

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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