Phacoemulsification Systems for Cataract
(CDE Trial)
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cataract surgery using either the Unity VCS/CS with 4D Phaco or Centurion system with OZil technology
Follow-up
Participants are monitored for changes in ganglion cell and inner plexiform layer thickness, macular thickness, and anterior chamber inflammation
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
Patients are generally randomized to undergo surgery with Centurion system with OZil technology phacoemulsification on one of there eyes
Patients are generally randomized to undergo surgery with Unity VCS/CS system with 4D phacoemulsification on one of there eyes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nicole Fram M.D.
Lead Sponsor
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 ...
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 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. • ...
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