Factors Influencing Corneal Donation in Palliative Care Unit

NCT07868198 | Recruiting

• 1 other identifier: GHDCSS_HLJ_USP_1_2024
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Today, there is a shortage of tissues such as corneas for a variety of reasons. However, it is possible to harvest tissues from people who are usually excluded from donation, particularly cancer diagnosed, by recruiting them into palliative care units. Corneal transplantation is a surgical procedure designed to improve the vision of many persons. A number of diseases now require corneal transplants, such as keratoconus. As with other organs, the shortage of donors remains a major obstacle to the use of this technique, a shortage which became much more acute during the health crisis linked to the pandemic caused by the SARS-CoV-2 virus. In 2022, 10615 participants were waiting for a transplant, but only 46.3% of them received one. Cornea removal differs from the removal of other organs. Firstly, there are fewer contra-indications. It can be performed on persons with chronic conditions that would usually exclude them from receiving other organs, such as cancer. As the cornea is not vascularised, the risk of damage is considered to be zero, except in cases of cancers of cerebral neurological origin or melanoma. Secondly, the donor's remains can be preserved for up to 24 hours after death. This makes it possible to recruit care services that are not usually involved in organ transplants, as these services provide new potential donor recruitment resources. This includes palliative care units. There is currently no French literature on corneal donation specifically in palliative care units. There is a lack of data on the factors that encourage or hinder donation. Based on our experience of corneal donation in our palliative care unit since 2020, the investigators are conducting a clinical study to evaluate the factors that facilitate or impede corneal donation in our hospital palliative care unit.

Conditions

Corneal Transplantation; Corneal Diseases; Corneal Donation

Keywords

Tissue donation; Corneal transplantation; Palliative care unit

Outcome Measures

Primary Outcomes (1)

• Biographical, Care Experience, and Organ donation attitude characteristics as assessed by structured questionnaires.

  Data collected include biographical and social characteristics of the relative, perceived quality of care in the palliative care unit, experience of being approached regarding corneal donation, and attitudes toward organ and tissue donation.

  Enrolment visit and/or month 3

Secondary Outcomes (3)

• Relatives' perceptions of Cornea Donation Requests following death in the Palliative Care Unit assessed by semi-structured interview.

  Enrolment visit and/or month 3

• Perceptions of Corneal donation following death in a Palliative Care Unit assessed by structured questionnaire.

  Enrolment visit and/or month 3

• Questionnaire-Based characteristics of relatives opposed and not opposed to Corneal Donation.

  Month 39

Study Arms (2)

Relatives agree for the corneal donation

Relatives disagree for the corneal donation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The source population concerned by this study corresponds to the relatives of the deceased person who has been treated in the palliative care unit, limited to 3 relatives.

You may qualify if:

• Relative or confidant over 18 years of age.
• Relative or confidant has received written and oral information on the conditions for participation in this study.
• Relative or confidant has signed an informed consent form.

You may not qualify if:

• Confidant person who does not speak or read French.
• Confidant person with a sensory deficit that makes it impossible to carry out an interview.
• Confidant person under protective supervision (guardianship, curatorship, or safeguard of justice.

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Study Sites (1)

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Roger THAY, Doctor

  Groupe Hospitalier Diaconesses Croix Saint-Simon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Djazia BOUZELMAT, Clinical Research Assistant

CONTACT

0144643098; dbouzelmat@hopital-dcss.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: October 9, 2026
• Study Start: February 27, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

FR (1)