NCT06830538

Brief Summary

Evaluate the well-being of patients and clinicl outcomes of the cornea after transplantation

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
107mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Nov 2023Feb 2035

Study Start

First participant enrolled

November 11, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2035

Last Updated

February 17, 2025

Status Verified

November 1, 2024

Enrollment Period

11.2 years

First QC Date

January 10, 2025

Last Update Submit

February 14, 2025

Conditions

Cornea Transplant

Outcome Measures

Primary Outcomes (2)

  • Anatomical recovery after corneal transplant

    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

    Visus examination

    postoperatively at 7 days, 30 days, 3 months, and 12 months.

Secondary Outcomes (2)

  • Patients's quality of life

    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

    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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Study Officials

  • Luigi Fontana, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Fontana, MD

CONTACT

+390512142832luigi.fontana6@unibo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2025

First Posted

February 17, 2025

Study Start

November 11, 2023

Primary Completion (Estimated)

February 1, 2035

Study Completion (Estimated)

February 1, 2035

Last Updated

February 17, 2025

Record last verified: 2024-11

Locations

IT(1)