Status:
ACTIVE_NOT_RECRUITING
In Vitro Study on Donor Corneas Preservation in IRESTORE Storage Medium. A Post Marketing Interventional Study on Device
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Donor Corneas Preservation
Eligibility:
All Genders
Brief 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 ...
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. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 7 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 7 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07134946
Start Date
March 7 2025
End Date
November 7 2025
Last Update
August 21 2025
Active Locations (1)
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1
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100