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Recruiting NCT07228091

Surgical Procedure Efficiency Evaluation stuDy

— Observational Cataract Vitreous Hemorrhage Retinal Detachment Macular Pucker

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UNITY VCS, CONSTELLATION.
Who it may be relevant to
Registry conditions: Cataract, Vitreous Hemorrhage, Retinal Detachment, Macular Pucker. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • 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).
  • 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).

Primary outcome measures

  • 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]

Eligibility criteria

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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Manchester Royal Eye Hospital — Manchester

Identifiers

NCT: NCT07228091 · CTV678-H003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗