Eye Pressure Settings for Cataract Surgery

Overseen By Robyn Kohler, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Matthew Rauen

Must not be taking: Chronic pain meds, Benzodiazepines

Disqualifiers: Ocular surgery, Uncontrolled diabetes, others

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

Compensation: Varies

Number of Visits: 2

Duration: During cataract surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how different eye pressure settings during cataract surgery affect comfort for both the patient and the surgeon. It compares a higher pressure setting using the Centurion with Active Sentry to a lower pressure setting using the Unity VCS/CS. Individuals needing cataract surgery in both eyes with a similar cataract grade in each eye may be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative research that could improve surgical comfort and outcomes.

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

The trial does not specify if you need to stop taking your current medications, but it excludes those with a history of chronic pain medication or benzodiazepine use. It's best to discuss your specific medications with the trial team.

What prior data suggests that these intraocular pressure settings are safe for cataract surgery?

Research has shown that using the Centurion Vision System with Active Sentry during cataract surgery is very safe. Studies indicate it causes less damage to the eye and reduces pain during the procedure. This system aids surgeons by maintaining stable eye pressure, preventing sudden changes during surgery.

The Unity VCS/CS system with Intelligent Fluidics is also very safe. It operates at a lower eye pressure, similar to natural conditions, which can make the surgery more comfortable and controlled. This system enhances efficiency and provides smooth, predictable results.

Both systems have undergone thorough study and are reliable and safe for patients undergoing cataract surgery. The Centurion system, in particular, proves effective whether the eye pressure is set high or low, offering flexibility during surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different intraocular pressure (IOP) settings during cataract surgery can impact patient outcomes. Traditionally, higher IOP settings are used to stabilize the eye, but this trial is testing a lower IOP approach with new technology. The Centurion with Active Sentry maintains a traditionally high IOP of 65 mmHg, which is thought to provide stability during surgery. Meanwhile, the Unity VCS/CS with Intelligent Fluidics operates at a lower IOP of 25 mmHg, potentially reducing stress on the eye. By comparing these two settings, researchers hope to find out if a lower IOP can make the surgery safer or more effective, which could lead to improved surgical practices.

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

This trial will compare two methods used in cataract surgery. Participants in one arm will receive the Centurion with Active Sentry, set to a high eye pressure. This system has shown promising results in maintaining the health of the eye's tiny blood vessels after surgery. Studies have also found that it can make the cornea, the clear front part of the eye, clearer soon after the procedure. Meanwhile, participants in another arm will receive the Unity VCS/CS with Intelligent Fluidics, set to a low eye pressure. This system significantly reduces discomfort during surgery and is designed to provide better control and efficiency, leading to less pain and a smoother experience for patients. Both systems aim to improve comfort and outcomes in cataract surgery. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients at Wolfe Eye Clinic needing bilateral cataract surgery with a similar grade of visually significant cataract in both eyes and generally good eye health. It's not for those with small pupils, past eye surgeries, unstable zonules, inflammatory diseases, chronic pain or benzodiazepine use, liver/renal issues, or uncontrolled diabetes.

Inclusion Criteria

Evaluations will occur in the clinic of the Principal Investigator (PI) Matthew Rauen, MD at the Wolfe Eye Clinic

I need surgery for cataracts in both eyes.

I have moderate to severe cataracts in both eyes and am planning to have surgery.

Exclusion Criteria

I have small pupils.

I have had eye surgery, including vision correction procedures.

My eye's supporting fibers are weak or damaged.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cataract surgery with either high or low IOP settings using Unity VCS/CS or Centurion with Active Sentry

During cataract surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including a 1-day post-op patient survey

1 day post-op

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Physiologic Cataract Surgery

Trial Overview The study compares the effects of high vs low intraocular pressure (IOP) during cataract surgery on patient and surgeon comfort. It aims to see if operating at a higher IOP reduces the need for additional pain medication and results in lower discomfort scores.

How Is the Trial Designed?

Group I: Centurion with Active Sentry at a traditionally high IOP setting Active Control 1 Intervention

Centurion with Active Sentry at a traditionally high IOP setting, Eyes in this arm will maintain an Intraocular Pressure (IOP) of 65 millimeters of mercury (mmHg) throughout the cataract surgery.

Group II: Unity VCS/CS with Intelligent Fluidics at a low IOP setting Active Control 1 Intervention

Unity VCS/CS with Intelligent Fluidics at a low IOP setting. Eyes in this arm will maintain an Intraocular Pressure (IOP) of 25 millimeters of mercury (mmHg) throughout the cataract surgery.

Who Is Running the Clinical Trial?

Matthew Rauen

Lead Sponsor

Trials

2

Recruited

100+

Citations

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

Comparisons of the clinical outcomes of Centurion® active ... And owing to that lower IOP setting, Centurion® Vision System with Active Sentry handpiece causes less corneal damage and pain perception during ...

2. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1554832/full

Surgical outcomes of phacoemulsification with different ... Taken together, these results suggest that Centurion with Active Sentry provides better microvascular stability of the fundus after cataract surgery in high ...

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

Alcon Centurion® Vision System - MyAlcon Increase in corneal clarity in the early post-op period. · Evidence indicates that near physiological IOP results in less endothelial cell loss. · Supporting ...

4. alcon.com alcon.com/media-release/alcon-announces-new-cataract-surgery-outcomes-data-hosts-robust-educational-program/

Alcon Announces New Cataract Surgery Outcomes Data, ... Results support operating at a more physiologic intraocular pressure (IOP) in cataract surgery. Steel et al. finds that phacoemulsification with CENTURION® ...

5. ctv.veeva.com ctv.veeva.com/study/outcomes-of-high-vs-physiological-intraocular-pressure-during-cataract-surgery-using-active-sentry

Outcomes of High Vs Physiological Intraocular Pressure ... Most recent studies with Centurion Active Sentry show that there is similar efficiency between higher and lower IOP settings. Traditionally, ...

6. 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 ... The Active Sentry Handpiece allowed the surgeon to significantly reduce IOP and substantially eliminate post-occlusion waves.

7. bmcophthalmol.biomedcentral.com bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-024-03626-z

Safety and prognosis of phacoemulsification using active ... In this study, we compared safety and prognosis of phacoemulsification by using active sentry handpiece and AFS with high and low intraoperative IOP settings.