Surgical Procedure Efficiency Evaluation stuDy

NCT07228091 | Recruiting

• 1 other identifier: CTV678-H003
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract; Vitreous Hemorrhage; Retinal Detachment; Macular Pucker; Macular Holes

Keywords

anterior segment ophthalmic surgery; posterior segment ophthalmic surgery

Outcome Measures

Primary Outcomes (1)

• Proportion of surgeons replying "efficient" or "very efficient" to the question, "How would you rate overall OR (operating room) efficiency of the console for the combined phaco-vitrectomy surgery (including set-up/tear-down)?

  Responses will be collected on a 5-point scale where 1=Very Inefficient, 2=Inefficient, 3=Neutral, 4=Efficient, and 5=Very Efficient.

  Up to Day 1 post completion of the surgery

Study Arms (2)

UNITY VCS

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

Device: UNITY VCS

CONSTELLATION

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

Device: CONSTELLATION

Interventions

CONSTELLATION 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).

Also known as: CONSTELLATION® Vision System

CONSTELLATION

UNITY VCS 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).

Also known as: UNITY® Vitreoretinal Cataract System (VCS)

UNITY VCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the clinical practice of the participating Investigator.

You may qualify if:

• 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.

You may not qualify if:

• Unplanned/emergency phacovitrectomy.
• Pregnant.
• Past history of phacovitrectomy. cataract, vitrectomy in the planned operative eye.

Sponsors & Collaborators

• Alcon Research: lead
• Manchester Royal Eye Hospital: collaborator

Study Sites (1)

Manchester Royal Eye Hospital

Manchester, M13 9WL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cataract; Vitreous Hemorrhage; Retinal Detachment; Epiretinal Membrane; Retinal Perforations

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Eye Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Diseases

Study Officials

• Manager, Health Economics/Outcomes Research

  Alcon Research, LLC

  STUDY DIRECTOR

Central Study Contacts

Alcon Call Center

CONTACT

1-888-451-3937; alcon.medinfo@alcon.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2025
• First Posted: November 14, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)