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Recruiting NCT06830538

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

Observational Cornea Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cornea Transplant. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prospective Observational Spontaneous Study of Anatomical, Functional and QoL Recovery of Patients Undergoing Corneal Transplantation

Overview

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.

Primary outcome measures

  • Anatomical recovery after corneal transplant [Time frame: 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.]
Secondary outcome measures (2)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna

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. PMID 42284092

Identifiers

NCT: NCT06830538 · OFTAFONTANA_OSS_TC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗