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Clinical Trials in Italy / NCT07134946
Active, not recruiting Observational

In Vitro Study on Donor Corneas Preservation in IRESTORE Storage Medium. A Post Marketing Interventional Study on Device

NCT07134946 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-03-07
Last updated
2025-08-21

Condition(s) studied

Donor Corneas Preservation

Study 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 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion criteria (donor): * Medical history of a disease that excludes donation; * serological positivity (HBV, HCV, HIV); Inclusion criteria (cornea): * low endothelial cell density (\<2000 cells/mm2); * stromal opacities. Exclusion criteria (cornea): * Severe endothelial dystrophy; * massive endothelial mortality; * marked stromal opacities.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Policlinico San Matteo Pavia Italy

More Fondazione IRCCS Policlinico San Matteo di Pavia trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07134946 on ClinicalTrials.gov ↗ ← All trials in Italy