Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness
NCT ID: NCT07222150
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
105 participants
INTERVENTIONAL
2025-10-07
2026-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Unity VCS
Cataract surgery with Unity VCS
Cataract surgery with Unity VCS
Standard cataract surgery
Cataract surgery with Centurion with Ozil
Standard cataract surgery
Centurion with Ozil
Cataract surgery with Centurion with Ozil
Cataract surgery with Unity VCS
Standard cataract surgery
Cataract surgery with Centurion with Ozil
Standard cataract surgery
Interventions
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Cataract surgery with Unity VCS
Standard cataract surgery
Cataract surgery with Centurion with Ozil
Standard cataract surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Alcon, a Novartis Company
INDUSTRY
Metrolina Eye Associates, PLLC
OTHER
Responsible Party
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Principal Investigators
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Ivan Mac, MD
Role: PRINCIPAL_INVESTIGATOR
Metrolina Eye Associates
Locations
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Metrolina Eye Associates
Matthews, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IM-25-02
Identifier Type: OTHER
Identifier Source: secondary_id
IIT# 98711335
Identifier Type: -
Identifier Source: org_study_id
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