Donor Corneas PreservationIRESTORENCT07134946
In Vitro Study on Donor Corneas Preservation in IRESTORE Storage Medium. A Post Marketing Interventional Study on Device
An observational study of Donor Corneas Preservation, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Donor corneas are harvested and then stored in the Eye Bank to maintain their viability until analysis and subsequent release for transplantation. The storage period of donor corneas is classified in terms of duration and storage temperature: short-intermediate cold (up to two weeks between 2 and 6°C) and long-term… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Donor Corneas Preservation
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 7 Mar 2025to 7 Nov 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: donor corneas
Who may be able to join
- Medical history of a disease that excludes donation;
- serological positivity (HBV, HCV, HIV);
- low endothelial cell density (<2000 cells/mm2);
- stromal opacities.
Who cannot join
- Severe endothelial dystrophy;
- massive endothelial mortality;
- marked stromal opacities.
Trial locations and contacts
1 site in 1 country.
About this study
Donor corneas are harvested and then stored in the Eye Bank to maintain their viability until analysis and subsequent release for transplantation. The storage period of donor corneas is classified in terms of duration and storage temperature: short-intermediate cold (up to two weeks between 2 and 6°C) and long-term warm (up to 4 weeks between 31 and 37°C). Corneal tissues are initially collected and stored cold at 4°C. After evaluation they can be stored in cold storage medium until transplantation or placed in organ culture at 31°C. IRESTORE, a cold storage liquid, has recently become available.
Read the detailed description
The device used in the study is classified as class II A (medium risk) The device iRestore Conservation, sterile liquid for the preservation of corneal grafts in hypothermic conditions up to 14 days. Consists of a 20 ml solution suitable for the temporary preservation of corneal tissues in hypothermia split into a cylindric, optical bottom glass vial, which provides specular microscope examination.
It contains dextran as Osmotic agent; sodium pyruvate, glucose as energy source; salts, aminoacids, vitamins as nutritional sources; gentamycin: 143 µg/mL as preservative system; HEPES, sodium bicarbonate as pH Buffer; Phenol red as pH indicator.
- Conditions
- Donor Corneas Preservation
What is being measured
The primary outcome is the main question the study is designed to answer.
cell density
endothelial cell density at day 7
Measured: 7 days
Secondary outcomes (1)
cell density over time
Change of corneal transparency, endothelial cell density, polymorphism (hexagonality), polymegatism, and pachymetry as a function of storage time of endothelial cells over time.
Measured: days 1, 3, 7, 10, 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start7 Mar 2025
- Primary completion7 Nov 2025 (estimated)
- Study completion7 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Donor Corneas PreservationStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Ceccuzzi, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134946
- Sponsor's protocol ID
- IRESTORE storage medium
- Acronym
- IRESTORE
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Study on Donor Corneas Preservation in IRESTORE Storage Medium. A Post Marketing Interventional Study on Device
- ClinicalTrials.gov ID
- NCT07134946
- Acronym / sponsor ID
- IRESTORE / IRESTORE storage medium
- Conditions
- Donor Corneas Preservation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 7 Nov 2025 (estimated)
- Study completion
- 7 Nov 2025 (estimated)
- First posted
- 21 Aug 2025 (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.
Donor corneas are harvested and then stored in the Eye Bank to maintain their viability until analysis and subsequent release for transplantation. The storage period of donor corneas is classified in terms of duration and storage temperature: short-intermediate cold (up to two weeks between 2 and 6°C) and long-term warm (up to 4 weeks between 31 and 37°C). Corneal tissues are initially collected and stored cold at 4°C. After evaluation they can be stored in cold storage medium until transplantation or placed in organ culture at 31°C. IRESTORE, a cold storage liquid, has recently become available.
Detailed description
The device used in the study is classified as class II A (medium risk) The device iRestore Conservation, sterile liquid for the preservation of corneal grafts in hypothermic conditions up to 14 days. Consists of a 20 ml solution suitable for the temporary preservation of corneal tissues in hypothermia split into a cylindric, optical bottom glass vial, which provides specular microscope examination.
It contains dextran as Osmotic agent; sodium pyruvate, glucose as energy source; salts, aminoacids, vitamins as nutritional sources; gentamycin: 143 µg/mL as preservative system; HEPES, sodium bicarbonate as pH Buffer; Phenol red as pH indicator.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- donor corneas
Key inclusion criteria (4 listed)
- Medical history of a disease that excludes donation;
- serological positivity (HBV, HCV, HIV);
- low endothelial cell density (<2000 cells/mm2);
- stromal opacities.
Key exclusion criteria (3 listed)
- Severe endothelial dystrophy;
- massive endothelial mortality;
- marked stromal opacities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cell density
Time frame: 7 days
endothelial cell density at day 7
1 secondary outcome
cell density over time
Time frame: days 1, 3, 7, 10, 14
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 21 Aug 2025.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Donor Corneas Preservation, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cell density (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2025.