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Active, Not Recruiting

NCT Number: NCT07134946

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Donor Corneas Preservation

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. cell density

    Time frame: 7 days

    endothelial cell density at day 7

Secondary outcomes

  1. cell density over time

    Time frame: days 1, 3, 7, 10, 14

    Change of corneal transparency, endothelial cell density, polymorphism (hexagonality), polymegatism, and pachymetry as a function of storage time of endothelial cells over time.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Acronym: IRESTORE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.