CataractNCT07222150
Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness
A study testing Cataract surgery with Unity VCS and Cataract surgery with Centurion with Ozil in people with Cataract, run by Metrolina Eye Associates, PLLC at 1 site in United States.
Trial summary
Phacoemulsification (cataract surgery) is usually performed while temporarily increasing the pressure inside the eye. The purpose of this study is to see if maintaining different pressure levels inside the eye during this procedure results in fewer side effects and better vision shortly after the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Cataract surgery with Unity VCS and Cataract surgery with Centurion with Ozil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Cataracts
Who cannot join
- Glaucoma, cornea disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Metrolina Eye Associates
Matthews, North Carolina, 28105
Megan Lee, 7042341930, mlee@metrolinaeye.com
Elisabeth Torres, 704234, etorres@metrolinaeye.com
About this study
Official title: Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness at Day 1 and Day 8 Post Op
Phacoemulsification (cataract surgery) is usually performed while temporarily increasing the pressure inside the eye. The purpose of this study is to see if maintaining different pressure levels inside the eye during this procedure results in fewer side effects and better vision shortly after the surgery. Cataract surgery will be performed using Unity VCS at a lower IOP in one eye compared to traditional IOP with Centurion Vision System with Ozil in the other eye. Both of which are approved by the United States Food and Drug Administration (FDA) and used per label.
Read the detailed description
Study patients will undergo sequential bilateral cataract surgery with the same cataract grade in both eyes. Both surgeries will be completed within one week of each other.
The first surgical eye will be randomly assigned (like the flip of a coin). Study patients will have surgery performed with the Alcon Unity VCS system using 4D. The second eye will undergo surgery a week later with Alcon Centurion Vision System (VCS) with Ozil. Surgery with the Unity VCS arm will be performed with a lower IOP setting (less than 40). Surgery with the Centurion with Ozil arm will be performed with a higher IOP setting (greater or equal 60).
Participation in the study is expected to take one month.
- Conditions
- Cataract
- Being tested
- Cataract surgery with Unity VCS, Cataract surgery with Centurion with Ozil
- Keywords
- Cataract Surgery, Phacoemulsification
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgery with Unity VCSDevice
Standard cataract surgery
Cataract surgery with Centurion with OzilDevice
Standard cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Unity VCS | Active comparator | Cataract surgery with Unity VCS Receives: Device: Cataract surgery with Unity VCS; Device: Cataract surgery with Centurion with Ozil |
| Centurion with Ozil | Active comparator | Cataract surgery with Centurion with Ozil Receives: Device: Cataract surgery with Unity VCS; Device: Cataract surgery with Centurion with Ozil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central corneal thickness (CCT)
Measurement of post-operative CCT pre and post-operatively with Pentacam
Measured: Pre-operative, Post-operative day #1, Post-operative day #8 for each arm of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start7 Oct 2025
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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
- Model description
- Prospective, two-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Unity VCS 4D phaco with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 65mmHg (high IOP) in the other eye usingCenturion Vision System with Ozil.
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metrolina Eye Associates, PLLC
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon, a Novartis Company
- Responsible party
- Sponsor
- Investigators
- Ivan Mac, MD, Principal investigator, Metrolina Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222150
- Sponsor's protocol ID
- IIT# 98711335
- Other IDs
- IM-25-02
- Status last verified
- Oct 2025
- First submitted
- 13 Oct 2025
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only summary data will be published comparing the two study arms.
Publications
Liu Y, Hong J, Chen X. Comparisons of the clinical outcomes of Centurion(R) active fluidics system with a low IOP setting and gravity fluidics system with a normal IOP setting for cataract patients with low corneal endothelial cell density. Front Med (Lausanne). 2023 Nov 23;10:1294808. doi: 10.3389/fmed.2023.1294808. eCollection 2023.
PubMed 38076276Spaulding J, Hall B. Efficiency of phacoemulsification handpieces with high and low intraocular pressure settings. J Cataract Refract Surg. 2025 Mar 1;51(3):218-221. doi: 10.1097/j.jcrs.0000000000001581.
PubMed 39602355Rauen MP, Joiner H, Kohler RA, O'Connor S. Phacoemulsification using an active fluidics system at physiologic vs high intraocular pressure: impact on anterior and posterior segment physiology. J Cataract Refract Surg. 2024 Aug 1;50(8):822-827. doi: 10.1097/j.jcrs.0000000000001457.
PubMed 38595209
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness at Day 1 and Day 8 Post Op
- ClinicalTrials.gov ID
- NCT07222150
- Acronym / sponsor ID
- IIT# 98711335
- Conditions
- Cataract
- Keywords
- Cataract Surgery, Phacoemulsification
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Metrolina Eye Associates, PLLCUniversity, hospital or other
- Collaborators
- Alcon, a Novartis Company
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Oct 2025 (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.
Phacoemulsification (cataract surgery) is usually performed while temporarily increasing the pressure inside the eye. The purpose of this study is to see if maintaining different pressure levels inside the eye during this procedure results in fewer side effects and better vision shortly after the surgery. Cataract surgery will be performed using Unity VCS at a lower IOP in one eye compared to traditional IOP with Centurion Vision System with Ozil in the other eye. Both of which are approved by the United States Food and Drug Administration (FDA) and used per label.
Detailed description
Study patients will undergo sequential bilateral cataract surgery with the same cataract grade in both eyes. Both surgeries will be completed within one week of each other.
The first surgical eye will be randomly assigned (like the flip of a coin). Study patients will have surgery performed with the Alcon Unity VCS system using 4D. The second eye will undergo surgery a week later with Alcon Centurion Vision System (VCS) with Ozil. Surgery with the Unity VCS arm will be performed with a lower IOP setting (less than 40). Surgery with the Centurion with Ozil arm will be performed with a higher IOP setting (greater or equal 60).
Participation in the study is expected to take one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, two-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Unity VCS 4D phaco with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 65mmHg (high IOP) in the other eye usingCenturion Vision System with Ozil.
| Arm | Type | Receives |
|---|---|---|
| Unity VCS | Active comparator | Device: Cataract surgery with Unity VCS, Device: Cataract surgery with Centurion with OzilCataract surgery with Unity VCS |
| Centurion with Ozil | Active comparator | Device: Cataract surgery with Unity VCS, Device: Cataract surgery with Centurion with OzilCataract surgery with Centurion with Ozil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cataracts
Key exclusion criteria (1 listed)
- Glaucoma, cornea disease
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 |
|---|---|---|
| Cataract surgery with Unity VCSStandard cataract surgery | Device | Centurion with Ozil, Unity VCS |
| Cataract surgery with Centurion with OzilStandard cataract surgery | Device | Centurion with Ozil, Unity VCS |
Primary outcome
Central corneal thickness (CCT)
Time frame: Pre-operative, Post-operative day #1, Post-operative day #8 for each arm of the study
Measurement of post-operative CCT pre and post-operatively with Pentacam
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Background: PubMed 38076276Liu Y, Hong J, Chen X. Comparisons of the clinical outcomes of Centurion(R) active fluidics system with a low IOP setting and gravity fluidics system with a normal IOP setting for cataract patients with low corneal endothelial cell density. Front Med (Lausanne). 2023 Nov 23;10:1294808. doi: 10.3389/fmed.2023.1294808. eCollection 2023.
- Background: PubMed 39602355Spaulding J, Hall B. Efficiency of phacoemulsification handpieces with high and low intraocular pressure settings. J Cataract Refract Surg. 2025 Mar 1;51(3):218-221. doi: 10.1097/j.jcrs.0000000000001581.
- Background: PubMed 38595209Rauen MP, Joiner H, Kohler RA, O'Connor S. Phacoemulsification using an active fluidics system at physiologic vs high intraocular pressure: impact on anterior and posterior segment physiology. J Cataract Refract Surg. 2024 Aug 1;50(8):822-827. doi: 10.1097/j.jcrs.0000000000001457.
- Individual participant dataSharing planned: No. Only summary data will be published comparing the two study arms.
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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.
Ivan Mac, MD principal investigator
Metrolina Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery with Unity VCS and Cataract surgery with Centurion with Ozil in people with Cataract, run by Metrolina Eye Associates, PLLC at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 29 Oct 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IVAN MAC, MD (7042341930, imac@metrolinaeye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central corneal thickness (CCT) (time frame: Pre-operative, Post-operative day #1, Post-operative day #8 for each arm of the study). 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 NCT07222150, which also lists 3 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 29 Oct 2025.