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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

Conditions: Donor Corneas Preservation

Study type: Observational

Funder types: Other

Identifiers

NCT07134946

IRESTORE storage medium

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.