Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness

Not Applicable

Recruiting

• Conditions: Cataract

• Registration Number: NCT07222150
• Lead Sponsor: Metrolina Eye Associates, PLLC

Brief 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.

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-10-07
• Study First Submitted: 2025-10-13
• Study First Submitted QC: 2025-10-26
• Last Update Submitted: 2025-10-26
• Study First Posted: 2025-10-29
• Last Update Posted: 2025-10-29
• Primary Completion: 2026-04
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Cataracts

Exclusion Criteria

• Glaucoma, cornea disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Central corneal thickness (CCT)	Pre-operative, Post-operative day #1, Post-operative day #8 for each arm of the study	Measurement of post-operative CCT pre and post-operatively with Pentacam

Trial Locations

Locations (1)

Metrolina Eye Associates; 🇺🇸 Matthews, North Carolina, United States