Study of the Anatomical and Functional Recovery and Quality of Life of Patients Undergoing Corneal Transplantation

February 14, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

Study Overview

Status

Recruiting

Conditions

Cornea Transplant

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Luigi Fontana, MD
Phone Number: +390512142832
Email: luigi.fontana6@unibo.it

Study Locations

Italy
- - Bologna, Italy, 40138
    - Recruiting
    - IRCCS Azienda Ospedaliero-Universitaria di Bologna
    - Contact:
      
      Luigi Fontana, MD
      
      Phone Number: +390512142832
      
      Email: luigi.fontana6@unibo.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients with corneal disease who will undergo corneal transplantation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	postoperatively at 7 days, 30 days, 3 months, and 12 months.
Visual-functional recovery after corneal transplant Time Frame: postoperatively at 7 days, 30 days, 3 months, and 12 months.	Visus examination	postoperatively at 7 days, 30 days, 3 months, and 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Administration to patients of Schedule for the Evaluation of Individual Quality of Life (SEI-QoL) questionnaire	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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Principal Investigator: Luigi Fontana, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2023

Primary Completion (Estimated)

February 1, 2035

Study Completion (Estimated)