Four-dimensional ultrasound versus torsional ultrasound phacoemulsification in cataracta nigra: a single-nucleus ex vivo bench pilot.
Rosa Giglio, Daniele Tognetto
https://pubmed.ncbi.nlm.nih.gov/42079756/Actively Recruiting
Led by University Hospital Sveti Duh · Updated on 2026-08-10
30
Participants Needed
1
Research Sites
1 weeks
Total Duration
Researchers are comparing the efficiency and early recovery outcomes between two phacoemulsification systems used in cataract surgery. This study focuses on adult patients undergoing uncomplicated cataract surgery in both eyes, evaluating the performance of the UNITY VCS system with 4D Phaco and the Centurion Vision System with ACTIVE SENTRY Handpiece. The goal is to assess ultrasound efficiency and postoperative recovery within the first week after surgery. Participants will have one eye randomly assigned to be treated with the UNITY VCS system and the other eye with the Centurion Vision System. The surgeries will be performed by the same surgeon using the same low intraocular pressure fluidics settings, with the second eye surgery scheduled two weeks after the first. The study measures ultrasound efficiency through several machine-recorded parameters during surgery. During the study, participants will be monitored for ultrasound efficiency indicators such as cumulative dissipated energy, ultrasound time, aspiration time, fluid aspirated, and total case time. Postoperative assessments include measurements of best-corrected visual acuity and central corneal thickness on Days 1 and 7 after surgery. The studys total participation period spans from the first surgery through the postoperative evaluations in the week following the second surgery.
CONDITIONS
Comparison of Two Phacoemulsification Systems in Cataract Surgery (UNITY VCS vs. Centurion)
P
Prof. Biljana Kuzmanović Elabjer, M.D., Ph.D.
I
Iva Ćubela, M.D.
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University Hospital Sveti Duh
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks between surgeries
Participants undergo cataract surgery in one eye using the UNITY VCS system and the other eye using the Centurion Vision System, performed by the same surgeon with the same settings. The second eye surgery occurs two weeks after the first.
2 surgery visits
Duration - 7 days after each surgery
Participants have postoperative evaluations including best-corrected visual acuity and central corneal thickness measurements on Days 1 and 7 after each surgery.
2 visits per eye (Day 1 and Day 7)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Rosa Giglio, Daniele Tognetto
https://pubmed.ncbi.nlm.nih.gov/42079756/Rosa Braga-Mele, Satish Yalamanchili, Sarah Makari...
https://pubmed.ncbi.nlm.nih.gov/41739972/University Hospital Sveti Duh
Lead Sponsor