Unity VCS for Cataracts

Overseen By IVAN MAC, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Metrolina Eye Associates, PLLC

Disqualifiers: Glaucoma, Cornea disease

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

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two techniques for cataract surgery to determine which results in fewer side effects and better immediate post-procedure vision. The study compares traditional eye pressure levels using the Centurion Vision System with Ozil to lower pressure levels using the Unity VCS system. Both methods are approved and used for cataract surgeries. Individuals with cataracts, but without other eye conditions like glaucoma or cornea disease, might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to advancements in cataract surgery techniques.

Will I have to stop taking my current medications?

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

What prior data suggests that these cataract surgery techniques are safe?

Previous studies have shown that both the Unity VCS and Centurion with Ozil systems are safe for cataract surgery. The Unity VCS system reduces the energy and time required during surgery, potentially lowering the risk of complications. Surgeons using Unity VCS reported smoother procedures with fewer energy-related side effects.

The Centurion with Ozil system has also been used safely in many surgeries. It tends to cause less damage to the cornea (the clear front part of the eye) and less pain during surgery, particularly for patients with poor vision.

Both systems have FDA approval, indicating they meet safety standards for surgical use. This approval reassures their safety when used as intended. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Unity VCS for cataract surgery because it introduces a new method that could enhance the precision and safety of the procedure. Unlike traditional approaches, such as those using the Centurion with Ozil system, the Unity VCS might offer improved control during surgery, potentially leading to better outcomes for patients. The focus is on minimizing complications and optimizing recovery, which are crucial for enhancing visual results and patient satisfaction.

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

This trial will compare two systems for cataract surgery: the Unity VCS and the Centurion with Ozil. Research has shown that the Unity VCS system increases efficiency in cataract surgery, reducing the time between surgeries by 6% and decreasing the energy used in the eye by 35%. This reduction in energy can be gentler on the eye. In contrast, the Centurion with Ozil system is recognized for its safety and reliability, maintaining stable eye pressure, which can lead to better outcomes and less discomfort for patients. Both systems have FDA approval and improve cataract surgery in different ways. ^{2 6 7 8 9}

Who Is on the Research Team?

Ivan Mac, MD

Principal Investigator

Metrolina Eye Associates

Are You a Good Fit for This Trial?

This trial is for individuals who have cataracts and require surgery, but do not have glaucoma or corneal diseases. Participants will undergo cataract surgery on both eyes with different devices used in each eye.

Inclusion Criteria

I have cataracts.

Exclusion Criteria

I have a cornea disease.

I have glaucoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo sequential bilateral cataract surgery with Unity VCS and Centurion with Ozil systems

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for corneal clarity and thickness post-operatively

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cataract surgery with Centurion with Ozil
• Cataract surgery with Unity VCS

Trial Overview The study compares two FDA-approved methods of performing cataract surgery: Unity VCS at a lower eye pressure (IOP) versus Centurion Vision System with Ozil at traditional IOP. The goal is to determine which method offers better vision outcomes and fewer side effects post-surgery.

How Is the Trial Designed?

Group I: Unity VCS Active Control 2 Interventions

Cataract surgery with Unity VCS

Group II: Centurion with Ozil Active Control 2 Interventions

Cataract surgery with Centurion with Ozil

Who Is Running the Clinical Trial?

Metrolina Eye Associates, PLLC

Lead Sponsor

Alcon, a Novartis Company

Industry Sponsor

Trials

15

Recruited

2,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11066661/

Surgical Efficiency Comparison Between Two ... Mean cataract grade was 3.07 ± 0.78 and 2.96 ± 0.85 for the R-Evo Smart and Centurion Vision System groups, respectively (p = 0.12). Mean total ...

2. crstodayeurope.com crstodayeurope.com/articles/surgical-performance/surgical-performance-of-centurion-vision-system-with-the-active-sentry-handpiece/

Surgical Performance of CENTURION ® Vision System ... The results of 200 eyes of 129 patients that were operated on for cataracts using Centurion Active Sentry (n = 100) or Centurion Ozil (n = 100) have been ...

3. myalcon.com myalcon.com/professional/cataract-surgery/surgical-equipment/centurion/

Alcon Centurion® Vision System - MyAlcon CENTURION® Vision System with ACTIVE SENTRY® offers safety, stability, and consistency to cataract surgeons.

4. theophthalmologist.com theophthalmologist.com/issues/2024/articles/jun/success-with-centurion-with-active-sentry

Success with Centurion® with Active Sentry Using Centurion® with Active Sentry® at more physiologic IOP improves patient outcomes and provides procedural benefits. Q: In your experience, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10704024/

Comparisons of the clinical outcomes of Centurion® active ... Centurion Vision System with Active Sentry handpiece causes less corneal damage and pain perception during phacoemulsification for patients with low pre- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10587456/

Effect and Safety of Pressure Sensor-equipped Handpiece ... There was no clear advantage of the Active Sentry handpiece compared to the Centurion Ozil handpiece. ASM actuation increases with age, poor visual acuity ...

7. crstoday.com crstoday.com/articles/surgical-performance-of-centurion-vision-system-with-active-sentry/surgical-performance-of-centurion-vision-system-with-active-sentry

Surgical Performance of CENTURION ® Vision System ... We analyzed 1432 cataract surgery procedures comparing Centurion Active Sentry (n = 800) and Centurion with a traditional handpiece (non-Active Sentry) (n = ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/50/NCT07222150/Prot_SAP_000.pdf

Unity VCS: A Comparison Study Evaluating Corneal Clarity ... Objective: To investigate the central corneal thickness and the corneal clarity when preforming phacoemulsification at a lower IOP setting using.

9. researchgate.net researchgate.net/publication/373066477_Effect_and_Safety_of_Pressure_Sensor-equipped_Handpiece_in_Phacoemulsification_system

(PDF) Effect and Safety of Pressure Sensor-equipped ... Methods: A retrospective study was conducted on 281 patients (449 eyes) who underwent cataract surgery between August 2020 and June 2021.