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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-07

Study Completion Date

2025-11-07

Brief Summary

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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.

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Detailed Description

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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

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Donor Corneas Preservation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Medical history of a disease that excludes donation;
* serological positivity (HBV, HCV, HIV);

* low endothelial cell density (\<2000 cells/mm2);
* stromal opacities.