ClinicalTrials.gg
RecruitingNCT07228091Updated Oct 28, 2026

Surgical Procedure Efficiency Evaluation stuDy

An observational study in Cataract, Vitreous Hemorrhage and Retinal Detachment, sponsored by Alcon Research. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Alcon Research (part of Alcon) · Observational

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Updated Oct 28, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

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

Keywords

  • anterior segment ophthalmic surgery
  • posterior segment ophthalmic surgery
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 180 is above the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

Key Inclusion Criteria:

  • Able to understand and sign an 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceUNITY 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).

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

  • DeviceCONSTELLATION

    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

06

What researchers measure

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.

    Time frame: Up to Day 1 post completion of the surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Mar 2027→Jun 2027
Oct 28, 2026
Study completion
Mar 2027→Jun 2027
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    Primary completion Mar 2027→Jun 2027
    Study completion Mar 2027→Jun 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07228091
Lead sponsor
Alcon Research
Collaborators
Manchester Royal Eye Hospital
Responsible party
Sponsor
First posted
Nov 14, 2025
Start date
Feb 9, 2026
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Oct 28, 2026

Study contacts

Alcon Call Center
Contact
alcon.medinfo@alcon.com
1-888-451-3937
Manager, Health Economics/Outcomes Research
study director · Alcon Research, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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