Surgical Procedure Efficiency Evaluation stuDy

August 12, 2026 updated by: Alcon Research

Surgical Procedure Efficiency Evaluation stuDy (SPEED): Combination Phaco-Vitrectomy Surgeries With UNITY VCS vs. Constellation in a Real-World Operating Room Setting

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Manchester Royal Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Key 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.

Key Exclusion Criteria:

  • Unplanned/emergency phacovitrectomy.
  • Pregnant.
  • Past history of phacovitrectomy. cataract, vitrectomy in the planned operative eye.
  • Other protocol-defined exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
UNITY VCS
Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy)
Device: 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).
Other Names:
  • UNITY® Vitreoretinal Cataract System (VCS)
CONSTELLATION
Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy)
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).
Other Names:
  • CONSTELLATION® Vision System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)?
Time Frame: Up to Day 1 post completion of the surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Collaborators

Manchester Royal Eye Hospital

Investigators

  • Study Director: Manager, Health Economics/Outcomes Research, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

November 12, 2025

First Submitted That Met QC Criteria

November 12, 2025

First Posted (Actual)

November 14, 2025

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 12, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTV678-H003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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