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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WITHDRAWN
NA
INTERVENTIONAL
2026-02-28
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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UNITY Vitreoretinal Cataract System (VCS)
Anterior segment ophthalmic surgery in one eye using UNITY Vitreoretinal Cataract System (VCS)
UNITY Vitreoretinal Cataract System
UNITY VCS is a commercially approved surgical system that facilitates the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during eye surgery. It consists of a console, remote control, foot controller, video overlay, and compatible anterior segment devices. In this study, it will be used for the removal of cataracts.
Anterior segment ophthalmic surgery
Cataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification)
CENTURION Vision System with Active Sentry (CAS)
Anterior segment ophthalmic surgery in one eye using CENTURION Vision System with Active Sentry (CAS)
CENTURION Vision System with Active Sentry
CAS is a commercially approved surgical system for use during anterior segment ophthalmic surgery. It consists of a console, foot controller, remote control, video overlay, and compatible anterior segment devices. The Active Sentry handpiece will be used.
Anterior segment ophthalmic surgery
Cataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification)
Interventions
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UNITY Vitreoretinal Cataract System
UNITY VCS is a commercially approved surgical system that facilitates the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during eye surgery. It consists of a console, remote control, foot controller, video overlay, and compatible anterior segment devices. In this study, it will be used for the removal of cataracts.
CENTURION Vision System with Active Sentry
CAS is a commercially approved surgical system for use during anterior segment ophthalmic surgery. It consists of a console, foot controller, remote control, video overlay, and compatible anterior segment devices. The Active Sentry handpiece will be used.
Anterior segment ophthalmic surgery
Cataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Both eyes with similar nuclear sclerotic cataract severity and type (within 1 cataract grade);
* Both eyes able to be implanted with same intraocular lens material;
* Both eyes able to receive the same ophthalmic viscosurgical device (OVD).
Exclusion Criteria
* Laser-assisted cataract surgery in either study eye;
* Any ocular disease and/or condition that, in the investigator's clinical judgement, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Lead, Surgical
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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Wolfe Eye Clinic
West Des Moines, Iowa, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Whitsett Vision Group
Spring, Texas, United States
Berkeley Eye Center
Sugar Land, Texas, United States
The Eye Institute of Utah
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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CTV678-P002
Identifier Type: -
Identifier Source: org_study_id
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