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Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness

NCT07222150 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-10-29

No results posted yet for this study

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

Interventions

DEVICE

Cataract surgery with Unity VCS

Standard cataract surgery

DEVICE

Cataract surgery with Centurion with Ozil

Standard cataract surgery

Sponsors & Collaborators

  • Alcon, a Novartis Company

    collaborator INDUSTRY

  • Metrolina Eye Associates, PLLC

    lead OTHER

Principal Investigators

  • Ivan Mac, MD · Metrolina Eye Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-07
Primary Completion
2026-04-30
Completion
2026-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07222150 on ClinicalTrials.gov