CataractNCT07044674
A Cataract Surgery Clinical Trial
A study testing UNITY Vitreoretinal Cataract System, CENTURION Vision System with Active Sentry and Anterior segment ophthalmic surgery in people with Cataract, run by Alcon Research at 5 sites in United States.
Trial summary
The purpose of the study is to compare the efficiency and safety of UNITY™ Vitreoretinal Cataract System (UNITY VCS) to CENTURION® Vision System with Active Sentry (CAS) in adult subjects with grade 2 or greater nuclear sclerotic cataracts who require phacoemulsification in both eyes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- UNITY Vitreoretinal Cataract System, CENTURION Vision System with Active Sentry and Anterior segment ophthalmic surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2026to Jun 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
- Clinically documented diagnosis of age-related nuclear sclerotic cataract of grade 2 or greater in both eyes;
- Both eyes with similar nuclear sclerotic cataract severity and type (within 1 cataract grade);
- Both eyes able to be implanted with same intraocular lens material;
- Both eyes able to receive the same ophthalmic viscosurgical device (OVD).
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Planned intraoperative glaucoma surgery or expected postoperative procedures during the study in either study eye;
- Laser-assisted cataract surgery in either study eye;
- Any ocular disease and/or condition that, in the investigator's clinical judgement, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Eye Institute of Utah
Salt Lake City, Utah, 84107
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Whitsett Vision Group
Spring, Texas, 77388
Berkeley Eye Center
Sugar Land, Texas, 77478
Wolfe Eye Clinic
West Des Moines, Iowa, 50266
About this study
Official title: Cataract Surgery: Randomized Comparative Clinical Trial
The purpose of the study is to compare the efficiency and safety of UNITY™ Vitreoretinal Cataract System (UNITY VCS) to CENTURION® Vision System with Active Sentry (CAS) in adult subjects with grade 2 or greater nuclear sclerotic cataracts who require phacoemulsification in both eyes. Subjects will attend a total of 8 scheduled visits for an individual duration of participation of approximately 1 month.
Read the detailed description
In this contralateral eye clinical study, one eye will undergo surgery with UNITY VCS and the other eye will undergo surgery with CAS. The second eye surgery will occur 0 to 14 days after the first eye surgery.
- Conditions
- Cataract
- Being tested
- UNITY Vitreoretinal Cataract System, CENTURION Vision System with Active Sentry, Anterior segment ophthalmic surgery
- Keywords
- Phacoemulsification, Anterior segment
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNITY Vitreoretinal Cataract SystemDevice
Also called VCS
UNITY VCS is a commercially approved surgical system that facilitates the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during eye surgery. It consists of a console, remote control, foot controller, video overlay, and compatible anterior segment devices. In this study, it will be used for the removal of cataracts.
CENTURION Vision System with Active SentryDevice
Also called CAS
CAS is a commercially approved surgical system for use during anterior segment ophthalmic surgery. It consists of a console, foot controller, remote control, video overlay, and compatible anterior segment devices. The Active Sentry handpiece will be used.
Anterior segment ophthalmic surgeryProcedure or surgery
Cataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification)
| Study group | Role | What they receive |
|---|---|---|
| UNITY Vitreoretinal Cataract System (VCS) | Experimental | Anterior segment ophthalmic surgery in one eye using UNITY Vitreoretinal Cataract System (VCS) Receives: Device: UNITY Vitreoretinal Cataract System; Procedure: Anterior segment ophthalmic surgery |
| CENTURION Vision System with Active Sentry (CAS) | Active comparator | Anterior segment ophthalmic surgery in one eye using CENTURION Vision System with Active Sentry (CAS) Receives: Device: CENTURION Vision System with Active Sentry; Procedure: Anterior segment ophthalmic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Dissipated Energy (CDE)
Cumulative Dissipated Energy (CDE) is the measure of energy released at the level of the corneal incision during cataract surgery. CDE will be recorded by the system.
Measured: Day 0 surgery, each eye
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study startFeb 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: Sponsor's business decision based on strategic shifts
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044674
- Sponsor's protocol ID
- CTV678-P002
- Status last verified
- Dec 2025
- First submitted
- 24 Jun 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cataract Surgery: Randomized Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT07044674
- Acronym / sponsor ID
- CTV678-P002
- Conditions
- Cataract
- Keywords
- Phacoemulsification, Anterior segment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor's business decision based on strategic shifts
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 1 Jul 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.
The purpose of the study is to compare the efficiency and safety of UNITY™ Vitreoretinal Cataract System (UNITY VCS) to CENTURION® Vision System with Active Sentry (CAS) in adult subjects with grade 2 or greater nuclear sclerotic cataracts who require phacoemulsification in both eyes. Subjects will attend a total of 8 scheduled visits for an individual duration of participation of approximately 1 month.
Detailed description
In this contralateral eye clinical study, one eye will undergo surgery with UNITY VCS and the other eye will undergo surgery with CAS. The second eye surgery will occur 0 to 14 days after the first eye surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UNITY Vitreoretinal Cataract System (VCS) | Experimental | Device: UNITY Vitreoretinal Cataract System, Procedure: Anterior segment ophthalmic surgeryAnterior segment ophthalmic surgery in one eye using UNITY Vitreoretinal Cataract System (VCS) |
| CENTURION Vision System with Active Sentry (CAS) | Active comparator | Device: CENTURION Vision System with Active Sentry, Procedure: Anterior segment ophthalmic surgeryAnterior segment ophthalmic surgery in one eye using CENTURION Vision System with Active Sentry (CAS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinically documented diagnosis of age-related nuclear sclerotic cataract of grade 2 or greater in both eyes;
- Both eyes with similar nuclear sclerotic cataract severity and type (within 1 cataract grade);
- Both eyes able to be implanted with same intraocular lens material;
- Both eyes able to receive the same ophthalmic viscosurgical device (OVD).
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Planned intraoperative glaucoma surgery or expected postoperative procedures during the study in either study eye;
- Laser-assisted cataract surgery in either study eye;
- Any ocular disease and/or condition that, in the investigator's clinical judgement, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study.
- Other protocol-specified exclusion criteria may apply.
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 Vitreoretinal Cataract SystemAlso: VCSUNITY VCS is a commercially approved surgical system that facilitates the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during eye surgery. It consists of a console, remote control, foot controller, video overlay, and compatible anterior segment devices. In this study, it will be used for the removal of cataracts. | Device | UNITY Vitreoretinal Cataract System (VCS) |
| CENTURION Vision System with Active SentryAlso: CASCAS is a commercially approved surgical system for use during anterior segment ophthalmic surgery. It consists of a console, foot controller, remote control, video overlay, and compatible anterior segment devices. The Active Sentry handpiece will be used. | Device | CENTURION Vision System with Active Sentry (CAS) |
| Anterior segment ophthalmic surgeryCataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification) | Procedure or surgery | CENTURION Vision System with Active Sentry (CAS), UNITY Vitreoretinal Cataract System (VCS) |
Primary outcome
Cumulative Dissipated Energy (CDE)
Time frame: Day 0 surgery, each eye
Cumulative Dissipated Energy (CDE) is the measure of energy released at the level of the corneal incision during cataract surgery. CDE will be recorded by the system.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Clinical Trial Lead, Surgical study director
Alcon Research, LLC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UNITY Vitreoretinal Cataract System, CENTURION Vision System with Active Sentry and Anterior segment ophthalmic surgery in people with Cataract, run by Alcon Research at 5 sites 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Cumulative Dissipated Energy (CDE) (time frame: Day 0 surgery, each eye). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2025.