Cornea TransplantNCT06830538
Study of the Anatomical and Functional Recovery and Quality of Life of Patients Undergoing Corneal Transplantation
An observational study of Cornea Transplant, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Evaluate the well-being of patients and clinicl outcomes of the cornea after transplantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cornea Transplant
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 11 Nov 2023to 1 Feb 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients with corneal disease who will undergo corneal transplantation.
Who may be able to join
- be eighteen years old
- diagnosis of corneal disease with prescription of surgical treatment of corneal transplantation
- sign the informed consent
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Luigi Fontana, MD, +390512142832, luigi.fontana6@unibo.it
About this study
Official title: Prospective Observational Spontaneous Study of Anatomical, Functional and QoL Recovery of Patients Undergoing Corneal Transplantation
Evaluate the well-being of patients and clinicl outcomes of the cornea after transplantation
Read the detailed description
The study aims to evaluate patients affected by corneal diseases who will undergo corneal transplantation.
The evaluation will be carried out pre and post transplantation to evaluate the clinical outcome of the patients and the quality of life and functional anatomical recovery.
- Conditions
- Cornea Transplant
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical recovery after corneal transplant
Anatomical recovery will be assessed by the regularity of the cornea.
Measured: postoperatively at 7 days, 30 days, 3 months, and 12 months.
Visual-functional recovery after corneal transplant
Visus examination
Measured: postoperatively at 7 days, 30 days, 3 months, and 12 months.
Secondary outcomes (2)
Patients's quality of life
Administration to patients of Health-related SF12 questionnaire
Measured: One week before surgery and at seven days, thirty days, three months, six months, one year, two years, three years, and four years after surgery.
Patients's quality of life
Administration to patients of Schedule for the Evaluation of Individual Quality of Life (SEI-QoL) questionnaire
Measured: One week before surgery and at seven days, thirty days, three months, six months, one year, two years, three years, and four years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start11 Nov 2023
- Primary completion1 Feb 2035 (estimated)
- Study completion1 Feb 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cornea TransplantStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Fontana, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830538
- Sponsor's protocol ID
- OFTAFONTANA_OSS_TC
- Status last verified
- Nov 2024
- First submitted
- 10 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Astolfi A, Potenza M, Ciavarella C, Moramarco A, Bonci P, Zaghi A, Foschi C, D'Eliseo LA, D'Eliseo D, Lazzarotto T, Fontana L, Versura P. Distinct Ocular Surface Microbial Profiles in Corneal Transplant Candidates. Cornea. 2026 Jun 12. doi: 10.1097/ICO.0000000000004088. Online ahead of print.
PubMed 42284092
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Spontaneous Study of Anatomical, Functional and QoL Recovery of Patients Undergoing Corneal Transplantation
- ClinicalTrials.gov ID
- NCT06830538
- Acronym / sponsor ID
- OFTAFONTANA_OSS_TC
- Conditions
- Cornea Transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 1 Feb 2035 (estimated)
- Study completion
- 1 Feb 2035 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the well-being of patients and clinicl outcomes of the cornea after transplantation
Detailed description
The study aims to evaluate patients affected by corneal diseases who will undergo corneal transplantation.
The evaluation will be carried out pre and post transplantation to evaluate the clinical outcome of the patients and the quality of life and functional anatomical recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with corneal disease who will undergo corneal transplantation.
Key inclusion criteria (3 listed)
- be eighteen years old
- diagnosis of corneal disease with prescription of surgical treatment of corneal transplantation
- sign the informed consent
Key exclusion criteria (1 listed)
- no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anatomical recovery after corneal transplant
Time frame: postoperatively at 7 days, 30 days, 3 months, and 12 months.
Anatomical recovery will be assessed by the regularity of the cornea.
Visual-functional recovery after corneal transplant
Time frame: postoperatively at 7 days, 30 days, 3 months, and 12 months.
Visus examination
2 secondary outcomes
Patients's quality of life
Time frame: One week before surgery and at seven days, thirty days, three months, six months, one year, two years, three years, and four years after surgery.
Patients's quality of life
Time frame: One week before surgery and at seven days, thirty days, three months, six months, one year, two years, three years, and four years after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 42284092Astolfi A, Potenza M, Ciavarella C, Moramarco A, Bonci P, Zaghi A, Foschi C, D'Eliseo LA, D'Eliseo D, Lazzarotto T, Fontana L, Versura P. Distinct Ocular Surface Microbial Profiles in Corneal Transplant Candidates. Cornea. 2026 Jun 12. doi: 10.1097/ICO.0000000000004088. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luigi Fontana, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cornea Transplant, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luigi Fontana, MD (+390512142832, luigi.fontana6@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical recovery after corneal transplant (time frame: postoperatively at 7 days, 30 days, 3 months, and 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06830538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.