Surgical Procedure Efficiency Evaluation stuDy

Sponsor
Alcon Research
Study ID
NCT07228091
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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).
  • 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).

Study Details

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

Key Dates

First listed
Nov 14, 2025
Start date
Feb 9, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
180 participants (estimated)

Arms

  • Arm: UNITY VCS
    Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy)
  • Arm: CONSTELLATION
    Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy)

Primary Outcome Measure

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 ]

Central Contacts

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