Clinical Trial

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

Study acronym: IRESTORE
Active, Not Recruiting
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Record status
This record was last updated August 21, 2025 (before its estimated November 7, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07134946
Lead Sponsor Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions Donor Corneas Preservation
Enrollment 15 participants
Start Date 2025-03-07
Primary Completion 2025-11-07 (estimated)
Study Completion 2025-11-07 (estimated)
Updated on ClinicalTrials.gov 2025-08-21