Surgical Procedure Efficiency Evaluation stuDy

NCT07228091 — Recruiting, 180 participants, Alcon Research

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

Registry	NCT07228091
Status	Recruiting
Study type	Observational
Enrollment	180 (Estimated)
Sponsor	Alcon Research (Industry); collaborators: Manchester Royal Eye Hospital
Conditions	Cataract, Vitreous Hemorrhage, Retinal Detachment, Macular Pucker, Macular Holes
Interventions	UNITY VCS, CONSTELLATION (Device)
Dates	start 2026-02-09, primary completion 2027-03-01 (estimated), completion 2027-03-01 (estimated), first posted 2025-11-14, last updated 2026-08-13
Locations	1 site in United Kingdom

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
UNITY VCS		Device: UNITY VCS	Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy)
CONSTELLATION		Device: CONSTELLATION	Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy)

UNITY VCS (Device), also known as UNITY® Vitreoretinal Cataract System (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).
CONSTELLATION (Device), also known as CONSTELLATION® Vision System: 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).

+Outcome measures

Primary outcomes

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)? [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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Manchester Royal Eye Hospital	Manchester	United Kingdom	Recruiting

+Investigators

Manager, Health Economics/Outcomes Research, Study director, Alcon Research, LLC