Cataract SurgeryCOMPASSNCT07756385
Comparison of Two Phacoemulsification Systems in Cataract Surgery (UNITY VCS vs. Centurion)
A study testing UNITY VCS SYSTEM ® and CENTURION VISION SYSTEM ® in people with Cataract Surgery, run by University Hospital Sveti Duh at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- UNITY VCS SYSTEM ® and CENTURION VISION SYSTEM ®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCroatia
- Study dates
- 6 Aug 2026to 16 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled for uncomplicated phacoemulsification with comparable cataract density between eyes (within one LOCS III grade)
Who cannot join
- Prior corneal or intraocular surgery
- Significant corneal pathology
- Significant asymmetry between eyes in: cataract density, astigmatism, or axial length
Trial locations and contacts
1 site in 1 country.
Croatia1 site
University Eye Department, University Hospital Sveti Duh
Zagreb, 10000
About this study
Official title: 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.
Read the 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.
- Conditions
- Cataract Surgery
- Being tested
- UNITY VCS SYSTEM ®, CENTURION VISION SYSTEM ®
- Keywords
- Phacoemulsification, UNITY VCS System 4D Phaco, Centurion Vision System with Active Sentry Handpiece, Contralateral eye study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNITY VCS SYSTEM ®Device
4D PHACO PROBE
CENTURION VISION SYSTEM ®Device
ACTIVE SENTRY PROBE
| Study group | Role | What they receive |
|---|---|---|
| UNITY VCS SYSTEM ® | Active comparator | Not described Receives: Device: UNITY VCS SYSTEM ® |
| CENTURION VISION SYSTEM ® | Active comparator | Not described Receives: Device: CENTURION VISION SYSTEM ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound efficiency evaluated through Cumulative Dissipated Energy (CDE) required to remove the cataract
Measured: Intraoperative
Secondary outcomes (6)
Ultrasound efficiency evaluated through Ultrasound (U/S) Total Time
Measured: Intraoperative
Ultrasound efficiency evaluated through Total Aspiration Time
Measured: Intraoperative
Ultrasound efficiency evaluated through Estimated Fluid Aspirated
Measured: Intraoperative
Ultrasound efficiency evaluated through Total Case Time
Measured: Intraoperative
Best-corrected visual acuity (BCVA)
Measured: Postoperative Day 1 and Day 7
Central corneal thickness (CCT)
Measured: Postoperative Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start6 Aug 2026
- Primary completion24 Sep 2026
- Study completion16 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Sveti Duh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biljana Kuzmanović Elabjer, University Hospital Sveti Duh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756385
- Sponsor's protocol ID
- 01-1788
- Acronym
- COMPASS
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 41739972Giglio 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.
PubMed 42079756
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07756385
- Acronym / sponsor ID
- COMPASS / 01-1788
- Conditions
- Cataract Surgery
- Keywords
- Phacoemulsification, UNITY VCS System 4D Phaco, Centurion Vision System with Active Sentry Handpiece, Contralateral eye study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital Sveti DuhUniversity, hospital or other
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 24 Sep 2026 (actual)
- Study completion
- 16 Oct 2026 (actual)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UNITY VCS SYSTEM ® | Active comparator | Device: UNITY VCS SYSTEM ® |
| CENTURION VISION SYSTEM ® | Active comparator | Device: CENTURION VISION SYSTEM ® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled for uncomplicated phacoemulsification with comparable cataract density between eyes (within one LOCS III grade)
Key exclusion criteria (3 listed)
- Prior corneal or intraocular surgery
- Significant corneal pathology
- Significant asymmetry between eyes in: cataract density, astigmatism, or axial length
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UNITY VCS SYSTEM ®4D PHACO PROBE | Device | UNITY VCS SYSTEM ® |
| CENTURION VISION SYSTEM ®ACTIVE SENTRY PROBE | Device | CENTURION VISION SYSTEM ® |
Primary outcome
Ultrasound efficiency evaluated through Cumulative Dissipated Energy (CDE) required to remove the cataract
Time frame: Intraoperative
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 41739972Braga-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.
- Background: PubMed 42079756Giglio 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UNITY VCS SYSTEM ® and CENTURION VISION SYSTEM ® in people with Cataract Surgery, run by University Hospital Sveti Duh at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound efficiency evaluated through Cumulative Dissipated Energy (CDE) required to remove the cataract (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07756385, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.