NCT07756385

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Aug 2026Oct 2026

First Submitted

Initial submission to the registry

August 4, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2026

Expected
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2026

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 4, 2026

Last Update Submit

August 4, 2026

Conditions

Cataract Surgery

Keywords

PhacoemulsificationUNITY VCS System 4D PhacoCenturion Vision System with Active Sentry HandpieceContralateral eye study

Outcome Measures

Primary Outcomes (1)

  • Ultrasound efficiency evaluated through Cumulative Dissipated Energy (CDE) required to remove the cataract

    Intraoperative

Secondary Outcomes (6)

  • Ultrasound efficiency evaluated through Ultrasound (U/S) Total Time

    Intraoperative

  • Ultrasound efficiency evaluated through Total Aspiration Time

    Intraoperative

  • Ultrasound efficiency evaluated through Estimated Fluid Aspirated

    Intraoperative

  • Ultrasound efficiency evaluated through Total Case Time

    Intraoperative

  • Best-corrected visual acuity (BCVA)

    Postoperative Day 1 and Day 7

  • +1 more secondary outcomes

Other Outcomes (1)

  • Ultrasound efficiency evaluated through number of Actuations (iS vs ASM)

    Intraoperative

Study Arms (2)

UNITY VCS SYSTEM ®

ACTIVE COMPARATOR
Device: CENTURION VISION SYSTEM ®

CENTURION VISION SYSTEM ®

ACTIVE COMPARATOR
Device: UNITY VCS SYSTEM ®

Interventions

UNITY VCS SYSTEM ®DEVICE

4D PHACO PROBE

CENTURION VISION SYSTEM ®
CENTURION VISION SYSTEM ®DEVICE

ACTIVE SENTRY PROBE

UNITY VCS SYSTEM ®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Department, University Hospital Sveti Duh

Zagreb, 10000, Croatia

RECRUITING

Related Publications (2)

  • Braga-Mele R, Yalamanchili S, Makari S, Jia G. Evolution of ultrasound in phacoemulsification: introduction of a novel ultrasound modality. J Cataract Refract Surg. 2026 Jul 1;52(7):703-708. doi: 10.1097/j.jcrs.0000000000001920.

    PMID: 41739972BACKGROUND

  • Giglio R, Tognetto D. Four-dimensional ultrasound versus torsional ultrasound phacoemulsification in cataracta nigra: a single-nucleus ex vivo bench pilot. Front Ophthalmol (Lausanne). 2026 Apr 16;6:1795898. doi: 10.3389/fopht.2026.1795898. eCollection 2026.

    PMID: 42079756BACKGROUND

Central Study Contacts

Prof. Biljana Kuzmanović Elabjer, M.D., Ph.D.

CONTACT

+385912209555belabjer@kbsd.hr

Iva Ćubela, M.D.

CONTACT

+385912223220icubela@kbsd.hr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 10, 2026

Study Start

August 6, 2026

Primary Completion (Estimated)

October 22, 2026

Study Completion (Estimated)

October 29, 2026

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Locations

CR(1)