30 Participants NeededMy employer runs this trial

Phacoemulsification Systems for Cataract

(CDE Trial)

OS
Overseen ByOrly Shiler
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nicole Fram M.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two different phacoemulsification systems, which are devices used in cataract surgery, to determine their impact on the time required to remove cataracts. Researchers will use each system on different eyes of the same person to evaluate which one performs better. The trial seeks participants planning cataract surgery in both eyes, with cataracts that are not too complicated. Participants should have common cataracts, which are cloudy areas in the lens of the eye, requiring surgery in both eyes. As an unphased trial, this study allows participants to contribute to advancements in cataract surgery techniques.

Do I need to stop 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 trial team or your doctor.

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

Studies have shown that both the Centurion and Unity VCS/CS systems are generally safe for cataract surgery. The Centurion system employs a pressure sensor to maintain stability during the operation, quickly detecting and adjusting to changes to prevent issues. Research indicates that the Unity VCS/CS system uses less energy, which can be gentler on the eye and may lead to fewer side effects. It also stabilizes the eye, enhancing safety. Both systems represent advanced technologies designed to make cataract surgery safer and more effective.12345

Why are researchers excited about this trial?

Researchers are excited about these phacoemulsification systems for cataract surgery because they introduce advanced technologies that could improve surgical outcomes. The Centurion vision system with OZil Handpiece uses innovative OZil technology, which enhances the emulsification of the cataract, potentially offering more precision and less stress on the eye during surgery. On the other hand, the Unity VCS/CS with the 4D Phaco Handpiece brings a 4D technology approach, aiming for better fluidic management and more efficient cataract removal. These advancements could lead to quicker recovery times and improved vision results compared to existing phacoemulsification systems.

What evidence suggests that these phacoemulsification systems are effective for cataract surgery?

This trial will compare the Centurion vision system with the OZil Handpiece and the Unity VCS/CS system with 4D Phaco technology for cataract surgery. Studies have shown that the Centurion system increases efficiency in cataract surgery by using less energy, which helps maintain lower eye pressure and reduces complications during the procedure. In contrast, the Unity VCS/CS system effectively breaks up cataracts quickly while using 41% less energy, potentially leading to faster recovery times and fewer side effects. Both systems aim to improve surgical outcomes by enhancing precision and reducing the risk of eye damage.34678

Who Is on the Research Team?

NR

Nicole R Fram, M.D.

Principal Investigator

Advanced Vision Care

Are You a Good Fit for This Trial?

This trial is for adults 18 or older with cataracts in both eyes (nuclear sclerosis, grade 3 or above) who are healthy and scheduled for uncomplicated cataract surgery in both eyes by the same surgeon. People with complex eye conditions, prior recent eye surgeries, or certain other eye diseases cannot participate.

Inclusion Criteria

I am able to understand and agree to join the study.
I am 18 or older and having simple cataract surgery in both eyes.
Both eyes will be operated on by the same surgeon
See 2 more

Exclusion Criteria

I am under 18 years old.
Complex cataract cases involving zonulopathy (e.g., pseudoexfoliation syndrome, traumatic zonular weakness) that may require use of zonular support devices during surgery (e.g. capsular hooks) and/or implantation of capsular tension rings or other zonular support devices, and in the investigator's judgment, may interfere with the surgical procedure or study outcome measures
Require mechanical pupil expanding devices (e.g., iris hooks, Malyugin rings, etc.)
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cataract surgery using either the Unity VCS/CS with 4D Phaco or Centurion system with OZil technology

Intraoperative
1 visit (in-person)

Follow-up

Participants are monitored for changes in ganglion cell and inner plexiform layer thickness, macular thickness, and anterior chamber inflammation

1 week
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Phacoemulsification Systems

Trial Overview

The study compares two different phacoemulsification systems used to remove cataracts during surgery on both eyes. Each participant will have each system used on one of their eyes to see which works better based on energy use and ultrasound time.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Centurion vision system with OZil HandpieceActive Control1 Intervention
Group II: Unity VCS/CS with 4D Phaco HandpieceActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nicole Fram M.D.

Lead Sponsor

Trials
3
Recruited
110+

Citations

Surgical Efficiency Comparison Between Two ... - PMC

Results. One hundred and fifty-five eyes undergone cataract surgery with the R-Evo Smart and 146 eyes with the Centurion Vision System ...

Surgical Performance of CENTURION ® Vision System ...

The SASCA study results demonstrated that phacoemulsification with Active Sentry significantly reduced the amount of energy used during the procedures and ...

Centurion® Vision System with Active Sentry Handpiece

CENTURION Vision System with ACTIVE SENTRY Handpiece allows surgeons to maintain lower pressure in the eye thanks to best-in-class surge reduction.

Comparison of Phacoemulsification and Corneal Damage ...

The main goal of this study is to compare traditional cataract surgery with two new technologies: the femtosecond laser and the new Active Sentry handpiece.

Effect and Safety of Pressure Sensor-equipped Handpiece ...

This study aimed to compare the effects of using an Active Sentry handpiece in cataract surgery and analyze surgical outcomes according to cataract grade.

Effect and Safety of Pressure Sensor-equipped Handpiece in ...

It is expected that Centurion Vision System with Active Sentry handpiece improves the effectiveness and safety of cataract surgery by more sensitively ...

CENTURION ® Vision System with ACTIVE SENTRY

CENTURION® Vision System with ACTIVE SENTRY® offers safety, stability, and consistency to cataract surgeons1-4. CENTURION® Vision System with ACTIVE SENTRY ...

Discover the consistency and control of the first and only ...

Its innovative design and real-time surge reduction can help you offer a new baseline of safety, consistency and control to every cataract patient. • ...