Optimizing Operational Parameters for Diagnostic Vitrectomy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provision of written informed consent authorizing the anonymized research use of residual blood samples.
Age 18-65 years at the time of donation.
Eligibility for routine whole blood donation, according to the institutional and national standards of the Blood Transfusion Center.
Good general health, as per standard donor screening procedures.
Disqualifiers
None
Trial population
Approximately 100 healthy adult volunteers meeting standard blood donation eligibility criteria at the Blood Transfusion Center of IRCCS Ospedale San Raffaele will be included. Only residual anonymized blood samples obtained from routine donor activity will be used for this study. No additional collection, manipulation, or intervention will be performed on donors for research purposes. Given that the objective of the study is to assess the variation (Δ) in cellular composition before and after ex-vivo processing, rather than the absolute baseline characteristics of individual samples, no disease-specific inclusion or exclusion criteria are required beyond those routinely applied for standard blood donation eligibility.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Simulated vitrectomy
Other interventionThe 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).
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: HV/HC1 intervention
Group B: HV/LC1 intervention
Group C: LV/HC1 intervention
Group D: LV/LC1 intervention
Trial outcomes
Primary outcomes
1
Difference in absolute lymphocyte count between post-processing and baseline measurements (Δ lymphocyte count).
To quantify the impact of different vitrectomy parameter combinations (vacuum pressure and cut rate) on lymphocyte recovery after ex-vivo processing of whole blood using a vitreous trap model.
Time frame
Same-day assessment, immediately after processingSecondary outcomes
1
Δ values for the listed CBC parameters
To quantify the pre/post variation (Δ) in complete blood count (CBC) parameters - including WBC, RBC, PLT, HGB, HCT, MCV, MCH, MCHC, NEUT, MONO, EO, and BASO. To compare outcomes across the four parameter combinations in order to identify the settings that best preserve cellular integrity and recovery.
Time frame
Same-day assessment, immediately after processing2
Semiquantitative cytology integrity score (smear evaluation)
To assess differences in cytological integrity on optical smears across the four parameter combinations in order to identify the settings that best preserve cellular integrity and recovery.
Time frame
Same-day assessment, immediately after processingLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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