Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness

Metrolina Eye Associates, PLLC

Status: Enrolling

Conditions: Cataract

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07222150

IM-25-02 (Other Identifier)

IIT# 98711335

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cataracts

Exclusion criteria

• Glaucoma, cornea disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Unity VCS

Active Comparator group

Description:

Cataract surgery with Unity VCS

Treatment:

Device: Cataract surgery with Centurion with Ozil

Device: Cataract surgery with Unity VCS

Centurion with Ozil

Active Comparator group

Description:

Cataract surgery with Centurion with Ozil

Treatment:

Device: Cataract surgery with Centurion with Ozil

Device: Cataract surgery with Unity VCS