IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Location status: Recruiting
Recruiting
NCT Number: NCT06830538
Study of the Anatomical and Functional Recovery and Quality of Life of Patients Undergoing Corneal Transplantation
Evaluate the well-being of patients and clinicl outcomes of the cornea after transplantation
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- be eighteen years old
- diagnosis of corneal disease with prescription of surgical treatment of corneal transplantation
- sign the informed consent
Exclusion criteria
- no exclusion criteria
Treatment and study plan
Primary outcomes
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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.
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Visual-functional recovery after corneal transplant
Time frame: postoperatively at 7 days, 30 days, 3 months, and 12 months.
Visus examination
Secondary outcomes
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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.
Administration to patients of Health-related SF12 questionnaire
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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.
Administration to patients of Schedule for the Evaluation of Individual Quality of Life (SEI-QoL) questionnaire
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Registry information
Official study title
Prospective Observational Spontaneous Study of Anatomical, Functional and QoL Recovery of Patients Undergoing Corneal Transplantation
Important dates
- Study start
- 2023
- Primary completion
- 2035
- Study completion
- 2035
- First posted
- Feb 17, 2025
- Registry last updated
- Feb 17, 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.