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

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Cataract surgery with Unity VCS; Device: Cataract surgery with Centurion with Ozil

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 Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: IVAN MAC, MD; Phone Number: 7042341930; Email: imac@metrolinaeye.com
• Study Contact Backup: Name: Megan Lee; Phone Number: 7042341930; Email: mlee@metrolinaeye.com

Study Locations

• United States
  • North Carolina
    • Matthews, North Carolina, United States, 28105
      • Recruiting
      • Metrolina Eye Associates
      • Contact: Megan Lee; Phone Number: 7042341930; Email: mlee@metrolinaeye.com
      • Contact: Elisabeth Torres; Phone Number: 704234; Email: etorres@metrolinaeye.com
      • Principal Investigator: Ivan Mac, MD
      • Sub-Investigator: Charles A Blotnick, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Cataracts

Exclusion Criteria:

• Glaucoma, cornea disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Unity VCS; Cataract surgery with Unity VCS	Device: Cataract surgery with Unity VCS; Standard cataract surgery; Device: Cataract surgery with Centurion with Ozil; Standard cataract surgery
Active Comparator: Centurion with Ozil; Cataract surgery with Centurion with Ozil	Device: Cataract surgery with Unity VCS; Standard cataract surgery; Device: Cataract surgery with Centurion with Ozil; Standard cataract surgery

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Metrolina Eye Associates, PLLC
• Collaborators: Alcon, a Novartis Company
• Investigators: Principal Investigator: Ivan Mac, MD, Metrolina Eye Associates

Publications and helpful links

General Publications

• Liu Y, Hong J, Chen X. Comparisons of the clinical outcomes of Centurion(R) active fluidics system with a low IOP setting and gravity fluidics system with a normal IOP setting for cataract patients with low corneal endothelial cell density. Front Med (Lausanne). 2023 Nov 23;10:1294808. doi: 10.3389/fmed.2023.1294808. eCollection 2023.
• Spaulding J, Hall B. Efficiency of phacoemulsification handpieces with high and low intraocular pressure settings. J Cataract Refract Surg. 2025 Mar 1;51(3):218-221. doi: 10.1097/j.jcrs.0000000000001581.
• Rauen MP, Joiner H, Kohler RA, O'Connor S. Phacoemulsification using an active fluidics system at physiologic vs high intraocular pressure: impact on anterior and posterior segment physiology. J Cataract Refract Surg. 2024 Aug 1;50(8):822-827. doi: 10.1097/j.jcrs.0000000000001457.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 13, 2025
• First Submitted That Met QC Criteria: October 26, 2025
• First Posted (Estimated): October 29, 2025

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 26, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Phacoemulsification; Cataract Surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Surgical Procedures, Operative; Ophthalmologic Surgical Procedures; Refractive Surgical Procedures; Cataract Extraction
• Other Study ID Numbers: IIT# 98711335; IM-25-02 (Other Identifier: Advarra IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only summary data will be published comparing the two study arms.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No