Surgical Procedure Efficiency Evaluation stuDy

NCT ID: NCT07228091

Last Updated: 2026-01-14

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-06-30

Brief Summary

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The purpose of this real-world evidence study is to compare surgical procedure times for UNITY® VCS and CONSTELLATION® Vision System.

Detailed Description

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Eligible subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy). This single visit, time-and-motion study will be conducted in the United Kingdom. This study will be conducted by Alcon Vision LLC.

Conditions

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Cataract Vitreous Hemorrhage Retinal Detachment Macular Pucker Macular Holes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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UNITY VCS

Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy)

UNITY VCS

Intervention Type DEVICE

UNITY® VCS is a CE-marked, FDA-approved ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The focus of this study will be on combined anterior-posterior segments surgery (phacovitrectomy).

CONSTELLATION

Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy)

CONSTELLATION

Intervention Type DEVICE

CONSTELLATION is a CE-marked, FDA-approved ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The focus of this study will be on combined anterior-posterior segments surgery (phacovitrectomy).

Interventions

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UNITY VCS

UNITY® VCS is a CE-marked, FDA-approved ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The focus of this study will be on combined anterior-posterior segments surgery (phacovitrectomy).

Intervention Type DEVICE

CONSTELLATION

CONSTELLATION is a CE-marked, FDA-approved ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The focus of this study will be on combined anterior-posterior segments surgery (phacovitrectomy).

Intervention Type DEVICE

Other Intervention Names

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UNITY® Vitreoretinal Cataract System (VCS) CONSTELLATION® Vision System

Eligibility Criteria

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Inclusion Criteria

* Able to understand and sign an informed consent form (ICF) that has been approved by an ethics committee.
* Planned combined phacovitrectomy procedure at one of the selected surgical sites.
* Planned combined phacovitrectomy procedure with 25-gauge (G) vitrectomy tools.

Exclusion Criteria

* Unplanned/emergency phacovitrectomy.
* Pregnant.
* Past history of phacovitrectomy. cataract, vitrectomy in the planned operative eye.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Manchester Royal Eye Hospital

OTHER

Sponsor Role collaborator

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manager, Health Economics/Outcomes Research

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Manchester Royal Eye Hospital

Manchester, , United Kingdom

Site Status

Countries

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United States United Kingdom

Central Contacts

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Alcon Call Center

Role: CONTACT

1-888-451-3937

Other Identifiers

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CTV678-H003

Identifier Type: -

Identifier Source: org_study_id

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