Surgical Procedure Efficiency Evaluation stuDy

ConditionsCataract Vitreous Hemorrhage Retinal Detachment Macular Pucker Macular Holes

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAlcon Research

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Unplanned/emergency phacovitrectomy.

Pregnant.

Past history of phacovitrectomy. cataract, vitrectomy in the planned operative eye.

Other protocol-defined exclusion criteria may apply.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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).

Treatment groups

180 Participants

are divided into 2 treatment groups

Group A: UNITY VCS1 intervention

Group B: CONSTELLATION1 intervention

Trial outcomes

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)?

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alcon Research

Lead sponsor

Manchester Royal Eye Hospital

Collaborator

Source ClinicalTrials.gov

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