Surgical Procedure Efficiency Evaluatio… | Clinical Trial

Key information

Conditions

Cataract Epiretinal Membrane Eye Diseases Eye Hemorrhage Hemorrhage Lens Diseases Macular Holes Macular Pucker Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Detachment Retinal Diseases Retinal Perforations Vitreous Hemorrhage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Manchester Royal Eye Hospital

Manchester, M13 9WL, United Kingdom

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: UNITY® Vitreoretinal Cataract System (VCS)

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).

Other names: CONSTELLATION® Vision System

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)?

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alcon Call Center

CONTACT

[email protected]

1-888-451-3937

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Collaborators

Manchester Royal Eye Hospital

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Nov 14, 2025
Registry last updated: Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting