Corneal TransplantationCORPALNCT07868198
Factors Influencing Corneal Donation in Palliative Care Unit
An observational study of Corneal Transplantation and Corneal Diseases, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Transplantation, Corneal Diseases, Corneal Donation
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2025to 31 Mar 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, Paris, 75012
Djazia BOUZELMAT, Clinical Research Assistant, 0144643098, dbouzelmat@hopital-dcss.org
Roger THAY, Doctor
About this study
Official title: Determining the Factors Influencing Corneal Donation in Palliative Care Unit
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.
Read more
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
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Relatives agree for the corneal donation | Not described | |
| Relatives disagree for the corneal donation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Enrolment visit and/or month 3
Perceptions of Corneal donation following death in a Palliative Care Unit assessed by structured questionnaire.
Perceptions and experiences related to corneal donation when death occurs in a palliative care unit, including factors facilitating or hindering consent to donation, assessed through a structured questionnaire administered to relatives of deceased patients.
Measured: Enrolment visit and/or month 3
Questionnaire-Based characteristics of relatives opposed and not opposed to Corneal Donation.
Comparison of demographic characteristics, care experience, and attitudes toward organ and tissue donation between relatives opposed and not opposed to corneal donation, assessed by a structured questionnaire.
Measured: Month 39
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start27 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger THAY, Groupe Hospitalier Diaconesses Croix Saint-Simon
- Investigators
- Roger THAY, Doctor, Principal investigator, Groupe Hospitalier Diaconesses Croix Saint-Simon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868198
- Sponsor's protocol ID
- GHDCSS_HLJ_USP_1_2024
- Acronym
- CORPAL
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided