Recruiting

Unity VCS & Centurion

Sponsor:

Metrolina Eye Associates, PLLC

Code:

NCT07222150

Conditions

Cataract

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cataract surgery with Unity VCS

Cataract surgery with Centurion with Ozil

Study Details

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

Study ID

NCT07222150

Start date

Oct 7, 2025

Status verified date

Oct, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Cataracts

Exclusion Criteria:

  • Glaucoma, cornea disease

Study Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Unity VCS

Cataract surgery with Unity VCS

active comparator: Centurion with Ozil

Cataract surgery with Centurion with Ozil

Interventions

Cataract surgery with Unity VCS

Standard cataract surgery

Cataract surgery with Centurion with Ozil

Standard cataract surgery

Primary outcome measure

  • Central corneal thickness (CCT) [ Time Frame: Pre-operative, Post-operative day #1, Post-operative day #8 for each arm of the study ]

Central Contacts and Locations

Locations

Metrolina Eye Associates

Recruiting

Matthews, North Carolina, United States, 28105

Contacts

Principal Investigator:

Ivan Mac, MD

More Information

Sponsor

Metrolina Eye Associates, PLLC

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Keywords

  • Cataract Surgery
  • Phacoemulsification

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Metrolina Eye Associates, PLLC on 2025-10-29.