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NCT Number: NCT07222150

Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness

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.

Recruiting

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metrolina Eye Associates

Matthews, North Carolina, 28105, United States

Location status: Recruiting

Location contact

Charles A Blotnick, MD

SUB_INVESTIGATOR

Elisabeth Torres

CONTACT

[email protected]

704234

Ivan Mac, MD

PRINCIPAL_INVESTIGATOR

Megan Lee

CONTACT

[email protected]

7042341930

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cataracts

Exclusion criteria

  • Glaucoma, cornea disease

Treatment and study plan

Cataract surgery with Unity VCS

Device

Standard cataract surgery

Cataract surgery with Centurion with Ozil

Device

Standard cataract surgery

Primary outcomes

  1. Central corneal thickness (CCT)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

IVAN MAC, MD

CONTACT

[email protected]

7042341930

Megan Lee

CONTACT

[email protected]

7042341930

Sponsors and collaborators

Lead sponsor

Metrolina Eye Associates, PLLC

Other

Collaborators

  • Alcon, a Novartis Company

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2025
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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