Vitreoretinal vs Vision Systems for Cataracts

Not yet recruiting at 4 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Disqualifiers: Glaucoma, Laser surgery, Ocular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two different systems used in cataract surgery to determine which one is more efficient and safe. Participants will undergo surgery on both eyes, using a different system for each eye. The trial targets adults diagnosed with nuclear sclerotic cataracts, a common age-related cataract, in both eyes. Interested individuals should have cataracts of similar severity in both eyes and be eligible for the same type of lens and surgical device. Participants must attend eight visits over approximately one month. As an unphased trial, this study allows participants to contribute to advancements in cataract surgery techniques.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these systems are safe for cataract surgery?

A previous study compared the UNITY Vitreoretinal Cataract System (VCS) with other systems, focusing mainly on efficiency. Although these studies don't directly address safety, the UNITY VCS is often compared to systems already approved for cataract surgery, suggesting it meets certain safety expectations. This trial doesn't fit into the usual phases, so there might not be extensive previous safety data specifically for UNITY VCS in this setting.

In contrast, the CENTURION Vision System is widely used and known to be safe for cataract surgeries. Its long-term use has resulted in well-documented safety in medical settings.

Both systems aim to enhance the efficiency of cataract surgery and prioritize safety. However, prospective participants should consult a medical professional to discuss any concerns and understand potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for cataracts because they offer innovative surgical technology that could enhance outcomes for patients. The UNITY Vitreoretinal Cataract System (VCS) is distinctive for its advanced design aimed at improving precision and control during anterior segment ophthalmic surgery. On the other hand, the CENTURION Vision System with Active Sentry (CAS) stands out with its real-time adaptive fluidics, which optimizes intraocular pressure during surgery. These features have the potential to make cataract surgery safer and more efficient compared to traditional methods, which often include standard phacoemulsification techniques.

What evidence suggests that this trial's treatments could be effective for cataracts?

This trial will compare the UNITY Vitreoretinal Cataract System (UNITY VCS) with the CENTURION Vision System with Active Sentry (CAS) for cataract surgery. Research has shown that the UNITY VCS is highly effective, reducing setup and cleanup times by 33% and 38%, respectively. This efficiency allows surgeries to proceed more quickly, enhancing the flow of operations in the surgery room. In contrast, the CENTURION CAS is a well-known system praised for its accuracy and safety in cataract surgeries. While both systems perform effectively, the UNITY VCS may save time during the surgical process. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Trial Lead, Surgical

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

This trial is for adults with grade 2 or greater nuclear sclerotic cataracts needing phacoemulsification in both eyes. Participants will be involved for about a month and must attend 8 scheduled visits.

Inclusion Criteria

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

Exclusion Criteria

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

I am scheduled for glaucoma surgery or expect procedures after surgery in my study eye.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo cataract surgery using UNITY VCS in one eye and CAS in the other eye, with surgeries occurring 0 to 14 days apart

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after each eye surgery

2 weeks

6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Anterior segment ophthalmic surgery

Trial Overview The study compares the UNITY Vitreoretinal Cataract System to the CENTURION Vision System with Active Sentry, focusing on efficiency and safety during cataract surgery.

How Is the Trial Designed?

Group I: UNITY Vitreoretinal Cataract System (VCS) Experimental Treatment 2 Interventions

Anterior segment ophthalmic surgery in one eye using UNITY Vitreoretinal Cataract System (VCS)

Group II: CENTURION Vision System with Active Sentry (CAS) Active Control 2 Interventions

Anterior segment ophthalmic surgery in one eye using CENTURION Vision System with Active Sentry (CAS)

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Citations

1. investor.alcon.com investor.alcon.com/news-and-events/press-releases/news-details/2025/Alcon-Announces-New-Time-and-Motion-Study-Results-Supporting-Superior-Efficiency-for-Cataract-and-Vitreoretinal-Surgery-with-UNITY-VCS/default.aspx

Alcon Announces New Time and Motion Study Results ... UNITY VCS provides statistically significant set-up and tear-down efficiencies compared to CONSTELLATION Vision System or CENTURION Vision ...

2. myalcon.com myalcon.com/professional/surgical/unity-vcs-cs/

UNITY® VCS | CS – Vitreoretinal Cataract & Cataract Systems UNITY® VCS system setup and teardown time is significantly faster (25%) than CONSTELLATION® Vision System, reducing Operating Room turnover time by ~1.5 minutes ...

3. ophthalmologytimes.com ophthalmologytimes.com/view/time-and-motion-studies-demonstrate-workflow-efficiencies-of-alcon-s-unity-vcs-in-cataract-and-vitreoretinal-surgery

Time and motion studies demonstrate workflow efficiencies ... Unity VCS showed a 16% efficiency gain in vitreoretinal surgery workflow, with significant reductions in console setup (33%) and tear-down (38%) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07044674

Study Details | NCT07044674 | A Cataract Surgery Clinical ... 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 ...

5. finance.yahoo.com finance.yahoo.com/news/alcon-announces-time-motion-study-120000494.html

Alcon Announces New Time and Motion Study Results ... UNITY VCS provides statistically significant set-up and tear-down efficiencies compared to CONSTELLATION Vision System or CENTURION Vision ...

6. crstoday.com crstoday.com/articles/experience-extraordinary-with-unity-vitreoretinal-cataract-system/experience-extraordinary-with-unity-vitreoretinal-cataract-system

Experience Extraordinary With Unity Vitreoretinal Cataract ... A roundtable of world-class cataract surgeons discuss how the innovations packaged in UNITY VCS|CS have changed their ORs for the better.