No Disease or Condition is Being StudiedCELLVITNCT07408466
Optimizing Operational Parameters for Diagnostic Vitrectomy
An observational study of No Disease or Condition is Being Studied, run by IRCCS San Raffaele.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- No Disease or Condition is Being Studied
- What is being tested?
- Simulated vitrectomy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- No additional exclusion criteria are defined beyond standard blood donation regulations. Exclusion from the study will therefore coincide with ineligibility for blood donation according to institutional protocols (e.g., due to infection, hematologic disease, recent surgery, or medication use that affects blood composition).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimizing Operational Parameters to Preserve Cellular Integrity During Diagnostic Vitrectomy: An Ex-Vivo Pilot Study With Blinded Outcome Assessment
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.
Read the detailed description
Primary vitreoretinal lymphoma (VRL) is a rare but aggressive intraocular malignancy, typically classified as a subtype of primary central nervous system lymphoma. It predominantly involves the retina and vitreous and is frequently associated with central nervous system disease. Clinical presentation often mimics chronic uveitis, leading to diagnostic delays and suboptimal management.
Definitive diagnosis of VRL requires cytopathologic confirmation through diagnostic vitrectomy, which provides vitreous samples for cytology, immunohistochemistry, flow cytometry, and molecular analyses (e.g., MYD88 mutation testing, IL-10/IL-6 ratio). However, despite the central role of vitreous biopsy, its diagnostic sensitivity remains limited to approximately 70% (Iuliano L et al. Int Ophthalmol 43, 2841-2849 (2023)), primarily due to the mechanical fragility and scarcity of malignant lymphoid cells.
During vitrectomy, the vitreous is fragmented and aspirated through a high-speed cutting probe (vitrector), which applies both mechanical cutting and vacuum forces. These operational parameters, while optimized for surgical efficiency and visualization, may inadvertently damage cells by rupturing membranes or disrupting nuclei, thereby reducing the yield and integrity of cellular material available for analysis.
Given the critical importance of maximizing diagnostic sensitivity in a disease with high morbidity and mortality, refining vitrectomy parameters to minimize cellular damage could represent a major advancement in the diagnostic workflow of VRL.
The present study aims to systematically evaluate the effect of different combinations of vacuum pressure and cut rate on cellular recovery and morphological preservation in a controlled ex-vivo vitreous model. Approximately 100 healthy donors will be enrolled and stratified into four experimental groups, each undergoing simulated diagnostic vitrectomy procedures under distinct parameter settings:
- Group A: Low vacuum / Low cut rate
- Group B: Low vacuum / High cut rate
- Group C: High vacuum / Low cut rate
- Group D: High vacuum / High cut rate This design enables direct comparison of operational conditions to identify settings that optimize cell preservation and recovery. The ultimate goal is to inform best-practice recommendations for diagnostic vitrectomy in suspected VRL, potentially improving cytologic yield and overall diagnostic accuracy.
- Conditions
- No Disease or Condition is Being Studied
- Being tested
- Simulated vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated vitrectomyOther
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).
| Study group | Role | What they receive |
|---|---|---|
| HV/HC | High vacuum (650 mmHg) / High cut rate (10,000 cpm) Receives: Other: Simulated vitrectomy | |
| HV/LC | High vacuum (650 mmHg) / Low cut rate (800 cpm) Receives: Other: Simulated vitrectomy | |
| LV/HC | Low vacuum (300 mmHg) / High cut rate (10,000 cpm) Receives: Other: Simulated vitrectomy | |
| LV/LC | Low vacuum (300 mmHg) / Low cut rate (800 cpm) Receives: Other: Simulated vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Same-day assessment, immediately after processing
Secondary outcomes (2)
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.
Measured: Same-day assessment, immediately after processing
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.
Measured: Same-day assessment, immediately after processing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for No Disease or Condition is Being StudiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Iuliano, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408466
- Sponsor's protocol ID
- CELLVIT
- Acronym
- CELLVIT
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38977150Iuliano 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.
PubMed 40279539Quintyn 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.
PubMed 31033057Iuliano 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.
PubMed 36913167Hwang 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.
PubMed 24613891
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Operational Parameters to Preserve Cellular Integrity During Diagnostic Vitrectomy: An Ex-Vivo Pilot Study With Blinded Outcome Assessment
- ClinicalTrials.gov ID
- NCT07408466
- Acronym / sponsor ID
- CELLVIT / CELLVIT
- Conditions
- No Disease or Condition is Being Studied
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary vitreoretinal lymphoma (VRL) is a rare but aggressive intraocular malignancy, typically classified as a subtype of primary central nervous system lymphoma. It predominantly involves the retina and vitreous and is frequently associated with central nervous system disease. Clinical presentation often mimics chronic uveitis, leading to diagnostic delays and suboptimal management.
Definitive diagnosis of VRL requires cytopathologic confirmation through diagnostic vitrectomy, which provides vitreous samples for cytology, immunohistochemistry, flow cytometry, and molecular analyses (e.g., MYD88 mutation testing, IL-10/IL-6 ratio). However, despite the central role of vitreous biopsy, its diagnostic sensitivity remains limited to approximately 70% (Iuliano L et al. Int Ophthalmol 43, 2841-2849 (2023)), primarily due to the mechanical fragility and scarcity of malignant lymphoid cells.
During vitrectomy, the vitreous is fragmented and aspirated through a high-speed cutting probe (vitrector), which applies both mechanical cutting and vacuum forces. These operational parameters, while optimized for surgical efficiency and visualization, may inadvertently damage cells by rupturing membranes or disrupting nuclei, thereby reducing the yield and integrity of cellular material available for analysis.
Given the critical importance of maximizing diagnostic sensitivity in a disease with high morbidity and mortality, refining vitrectomy parameters to minimize cellular damage could represent a major advancement in the diagnostic workflow of VRL.
The present study aims to systematically evaluate the effect of different combinations of vacuum pressure and cut rate on cellular recovery and morphological preservation in a controlled ex-vivo vitreous model. Approximately 100 healthy donors will be enrolled and stratified into four experimental groups, each undergoing simulated diagnostic vitrectomy procedures under distinct parameter settings:
- Group A: Low vacuum / Low cut rate
- Group B: Low vacuum / High cut rate
- Group C: High vacuum / Low cut rate
- Group D: High vacuum / High cut rate This design enables direct comparison of operational conditions to identify settings that optimize cell preservation and recovery. The ultimate goal is to inform best-practice recommendations for diagnostic vitrectomy in suspected VRL, potentially improving cytologic yield and overall diagnostic accuracy.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HV/HC | – | Other: Simulated vitrectomyHigh vacuum (650 mmHg) / High cut rate (10,000 cpm) |
| HV/LC | – | Other: Simulated vitrectomyHigh vacuum (650 mmHg) / Low cut rate (800 cpm) |
| LV/HC | – | Other: Simulated vitrectomyLow vacuum (300 mmHg) / High cut rate (10,000 cpm) |
| LV/LC | – | Other: Simulated vitrectomyLow vacuum (300 mmHg) / Low cut rate (800 cpm) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- No additional exclusion criteria are defined beyond standard blood donation regulations. Exclusion from the study will therefore coincide with ineligibility for blood donation according to institutional protocols (e.g., due to infection, hematologic disease, recent surgery, or medication use that affects blood composition).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulated vitrectomyThe 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). | Other | HV/HC, HV/LC, LV/HC, LV/LC |
Primary outcome
Difference in absolute lymphocyte count between post-processing and baseline measurements (Δ lymphocyte count).
Time frame: Same-day assessment, immediately after processing
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.
2 secondary outcomes
Δ values for the listed CBC parameters
Time frame: Same-day assessment, immediately after processing
Semiquantitative cytology integrity score (smear evaluation)
Time frame: Same-day assessment, immediately after processing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 38977150Menean 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.
- Background: PubMed 40279539Iuliano 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.
- Background: PubMed 31033057Quintyn 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.
- Background: PubMed 36913167Iuliano 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.
- Background: PubMed 24613891Hwang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of No Disease or Condition is Being Studied, run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adelaide Pina (+39 02 2643 3598, oculistica@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in absolute lymphocyte count between post-processing and baseline measurements (Δ lymphocyte count). (time frame: Same-day assessment, immediately after processing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07408466, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.