Health TrialsbyHealthPanel

Comparison of Two Phacoemulsification Systems in Cataract Surgery (UNITY VCS vs. Centurion)

ConditionCataract Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Sveti Duh

About this trial

This prospective, randomized, contralateral (crossover) study compares the ultrasound efficiency and early postoperative outcomes (Day 1 and Day 7) of two phacoemulsification platforms - the UNITY® VCS system with 4D Phaco and the Centurion® Vision System with ACTIVE SENTRY® Handpiece - used in the two eyes of the same patient undergoing cataract surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients scheduled for uncomplicated phacoemulsification with comparable cataract density between eyes (within one LOCS III grade)

Disqualifiers

Prior corneal or intraocular surgery

Significant corneal pathology

Significant asymmetry between eyes in: cataract density, astigmatism, or axial length

Trial design

Design model

Crossover

Treatments tested in this trial

  • UNITY VCS SYSTEM ®

    Device

    4D PHACO PROBE

  • CENTURION VISION SYSTEM ®

    Device

    ACTIVE SENTRY PROBE

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: UNITY VCS SYSTEM ®Active comparator 1 intervention
Group B: CENTURION VISION SYSTEM ®Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ultrasound efficiency evaluated through Cumulative Dissipated Energy (CDE) required to remove the cataract

Time frame
Intraoperative

Secondary outcomes

1

Ultrasound efficiency evaluated through Ultrasound (U/S) Total Time

Time frame
Intraoperative
2

Ultrasound efficiency evaluated through Total Aspiration Time

Time frame
Intraoperative
3

Ultrasound efficiency evaluated through Estimated Fluid Aspirated

Time frame
Intraoperative
4

Ultrasound efficiency evaluated through Total Case Time

Time frame
Intraoperative

Other outcomes

1

Ultrasound efficiency evaluated through number of Actuations (iS vs ASM)

Time frame
Intraoperative

Sponsors and contacts

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

University Hospital Sveti Duh

Lead sponsor

Source ClinicalTrials.gov
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