Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness

NCT07222150 | Recruiting FDA Device

• 2 other identifiers: IIT# 98711335IM-25-02
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Cataract Surgery; Phacoemulsification

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Unity VCS

ACTIVE COMPARATOR

Cataract surgery with Unity VCS

Device: Cataract surgery with Unity VCS; Device: Cataract surgery with Centurion with Ozil

Centurion with Ozil

ACTIVE COMPARATOR

Cataract surgery with Centurion with Ozil

Device: Cataract surgery with Unity VCS; Device: Cataract surgery with Centurion with Ozil

Interventions

Cataract surgery with Unity VCS DEVICE

Standard cataract surgery

Centurion with Ozil; Unity VCS

Cataract surgery with Centurion with Ozil DEVICE

Standard cataract surgery

Centurion with Ozil; Unity VCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cataracts

You may not qualify if:

• Glaucoma, cornea disease

Sponsors & Collaborators

• Metrolina Eye Associates, PLLC: lead
• Alcon, a Novartis Company: collaborator

Study Sites (1)

Metrolina Eye Associates

Matthews, North Carolina, 28105, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 38076276 BACKGROUND

• 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.

  PMID: 39602355 BACKGROUND

• 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.

  PMID: 38595209 BACKGROUND

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ivan Mac, MD

  Metrolina Eye Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IVAN MAC, MD

CONTACT

7042341930; imac@metrolinaeye.com

Megan Lee

CONTACT

7042341930; mlee@metrolinaeye.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, two-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Unity VCS 4D phaco with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 65mmHg (high IOP) in the other eye usingCenturion Vision System with Ozil.

Study Record Dates

• First Submitted: October 13, 2025
• First Posted: October 29, 2025
• Study Start: October 7, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)