NCT07222150

Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness

Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness at Day 1 and Day 8 Post Op

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Metrolina Eye Associates, PLLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phacoemulsification (cataract surgery) is usually performed while temporarily increasing the pressure inside the eye. The purpose of this study is to see if maintaining different pressure levels inside the eye during this procedure results in fewer side effects and better vision shortly after the surgery. Cataract surgery will be performed using Unity VCS at a lower IOP in one eye compared to traditional IOP with Centurion Vision System with Ozil in the other eye. Both of which are approved by the United States Food and Drug Administration (FDA) and used per label.

Detailed description

Study patients will undergo sequential bilateral cataract surgery with the same cataract grade in both eyes. Both surgeries will be completed within one week of each other. The first surgical eye will be randomly assigned (like the flip of a coin). Study patients will have surgery performed with the Alcon Unity VCS system using 4D. The second eye will undergo surgery a week later with Alcon Centurion Vision System (VCS) with Ozil. Surgery with the Unity VCS arm will be performed with a lower IOP setting (less than 40). Surgery with the Centurion with Ozil arm will be performed with a higher IOP setting (greater or equal 60). Participation in the study is expected to take one month.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Cataract surgery with Unity VCS	Standard cataract surgery
DEVICE	Cataract surgery with Centurion with Ozil	Standard cataract surgery

Timeline

• Start date: 2025-10-07
• Primary completion: 2026-04-01
• Completion: 2026-10-01
• First posted: 2025-10-29
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study