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RecruitingNCT06830538Updated Feb 17, 2025

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

An observational study in Cornea Transplant, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-17.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cornea Transplant
03

In context

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • be eighteen years old
  • diagnosis of corneal disease with prescription of surgical treatment of corneal transplantation
  • sign the informed consent

Exclusion criteria

Exclusion Criteria:

  • no exclusion criteria
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Anatomical recovery after corneal transplant

    Anatomical recovery will be assessed by the regularity of the cornea.

    Time frame: postoperatively at 7 days, 30 days, 3 months, and 12 months.

  2. Visual-functional recovery after corneal transplant

    Visus examination

    Time frame: postoperatively at 7 days, 30 days, 3 months, and 12 months.

Secondary outcomes

  1. Patients's quality of life

    Administration to patients of Health-related SF12 questionnaire

    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.

  2. Patients's quality of life

    Administration to patients of Schedule for the Evaluation of Individual Quality of Life (SEI-QoL) questionnaire

    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.

07

Study locations

1 of 1 sites recruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Bologna, 40138, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06830538
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Responsible party
Sponsor
First posted
Feb 17, 2025
Start date
Nov 11, 2023
Primary completion
Feb 1, 2035 (estimated)
Completion
Feb 1, 2035 (estimated)
Last update
Feb 17, 2025

Study contacts

Luigi Fontana, MD
Contact
luigi.fontana6@unibo.it
+390512142832
Luigi Fontana, MD
principal investigator · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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