Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness

Part of paid clinical trials in Matthews, North Carolina.

Sponsor
Metrolina Eye Associates, PLLC
Study ID
NCT07222150
Status
Recruiting
Apply to this trial

Conditions

  • Cataract

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cataract surgery with Unity VCS — DEVICE
    Standard cataract surgery
  • Cataract surgery with Centurion with Ozil — DEVICE
    Standard cataract surgery

Study Details

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.

Key Dates

Start date
Oct 7, 2025
Status verified
Oct 2025
Primary completion
Apr 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Unity VCS
    Cataract surgery with Unity VCS
  • Active Comparator: Centurion with Ozil
    Cataract surgery with Centurion with Ozil

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

Locations (1)

FacilityCityStateZIPSite coordinators
Metrolina Eye AssociatesMatthewsNorth Carolina28105
Megan Lee
[email protected]
7042341930
Elisabeth Torres
[email protected]
704234
Ivan Mac, MD (PRINCIPAL_INVESTIGATOR)
Charles A Blotnick, MD (SUB_INVESTIGATOR)

Find similar trials in Matthews, NC

By research site
Metrolina Eye Associates· Matthews, NC

Related Studies