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Optimizing Operational Parameters for Diagnostic Vitrectomy
Sponsor: IRCCS San Raffaele
Summary
Single-center ex-vivo study using blood samples from healthy donors processed through a 25-gauge vitrectomy system. The study compares four combinations of operational parameters (vacuum pressure and cut rate) to evaluate their impact on cellular recovery and morphological preservation. Pre- and post-procedure complete blood counts and cytology smears will be analyzed to identify the settings that minimize cell loss and mechanical damage, with the ultimate goal of optimizing diagnostic yield in vitreoretinal lymphoma (VRL) vitrectomy.
Official title: Optimizing Operational Parameters to Preserve Cellular Integrity During Diagnostic Vitrectomy: An Ex-Vivo Pilot Study With Blinded Outcome Assessment
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2026-04
Completion Date
2026-12
Last Updated
2026-02-17
Healthy Volunteers
Yes
Conditions
Interventions
Simulated vitrectomy
The simulated vitrectomy is performed using the cutter handpiece, a microcannulated probe that combines a pneumatic cutting mechanism and a controlled aspiration system. The probe is directly inserted into the collection tube (ex-vivo model), allowing mechanical fragmentation and aspiration of donor suspended cells under the selected physical parameters (vacuum and cut rate, according to protocol).