Optimizing Operational Parameters for Diagnostic Vitrectomy

NCT07408466 | Not Yet Recruiting

• 1 other identifier: CELLVIT
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

No Disease or Condition is Being Studied

Outcome Measures

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.

  Same-day assessment, immediately after processing

Secondary Outcomes (2)

• Δ values for the listed CBC parameters

  Same-day assessment, immediately after processing

• Semiquantitative cytology integrity score (smear evaluation)

  Same-day assessment, immediately after processing

Study Arms (4)

HV/HC

High vacuum (650 mmHg) / High cut rate (10,000 cpm)

Other: Simulated vitrectomy

HV/LC

High vacuum (650 mmHg) / Low cut rate (800 cpm)

Other: Simulated vitrectomy

LV/HC

Low vacuum (300 mmHg) / High cut rate (10,000 cpm)

Other: Simulated vitrectomy

LV/LC

Low vacuum (300 mmHg) / Low cut rate (800 cpm)

Other: Simulated vitrectomy

Interventions

Simulated vitrectomy OTHER

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).

HV/HC; HV/LC; LV/HC; LV/LC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Related Publications (5)

• Menean M, Cicinelli MV, Rivolta MC, Marchese A, Modorati G, Bandello F, Miserocchi E. The Silent Masquerade: Clinical and Imaging Features of Asymptomatic Vitreoretinal Lymphoma. Am J Ophthalmol. 2024 Nov;267:153-159. doi: 10.1016/j.ajo.2024.07.004. Epub 2024 Jul 6.

  PMID: 38977150 BACKGROUND

• Iuliano L, Marchese A, Miserocchi E, Corbelli E, Bongiovanni L, Ponzoni M, Bandello F, Codenotti M. Subretinal lavage during diagnostic vitrectomy: an adjunctive technique for cell sampling in suspected vitreoretinal lymphoma. Retin Cases Brief Rep. 2025 Apr 23. doi: 10.1097/ICB.0000000000001766. Online ahead of print.

  PMID: 40279539 BACKGROUND

• Quintyn JC, Olle P, Courtade-Saidi M, Laurent C, Oberic L, Quintyn-Ranty ML. Cytological diagnosis of vitreoretinal lymphomas: A case series. Cytopathology. 2019 Jul;30(4):385-392. doi: 10.1111/cyt.12711. Epub 2019 May 23.

  PMID: 31033057 BACKGROUND

• Iuliano L, Kacerik M, Corbelli E, Miserocchi E, Modorati G, Bandello F, Codenotti M. Panuveitis of undetermined origin after diagnostic pars plana vitrectomy: clinical characterization and long-term outcome from a tertiary referral center. Int Ophthalmol. 2023 Aug;43(8):2841-2849. doi: 10.1007/s10792-023-02683-5. Epub 2023 Mar 13.

  PMID: 36913167 BACKGROUND

• Hwang CS, Yeh S, Bergstrom CS. Diagnostic vitrectomy for primary intraocular lymphoma: when, why, how? Int Ophthalmol Clin. 2014 Spring;54(2):155-71. doi: 10.1097/IIO.0000000000000022.

  PMID: 24613891 BACKGROUND

Central Study Contacts

Adelaide Pina

CONTACT

+39 02 2643 3598; oculistica@hsr.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share