Observational Cohort Study on Ocular Chronic Graft-Versus-Host Disease

A Multicenter, Prospective, Non-Interventional Observational Cohort Study on Ocular Chronic Graft-Versus-Host Disease After Hematopoietic Stem Cell Transplantation - The Bright Study

This study is a multicenter, prospective, observational cohort study designed to enroll a total of 340 patients undergoing allogeneic hematopoietic stem cell transplantation. Through comprehensive evaluations by hematology departments, ophthalmology departments, and patient-reported outcomes, the study aims to assess patient-reported outcomes, overall incidence, risk factors, and other clinical outcomes in patients with chronic ocular graft-versus-host disease following allogeneic hematopoietic stem cell transplantation.

Inclusion Criteria:

• Age ≥14 years, both genders eligible;

• First allogeneic hematopoietic stem cell transplantation;

  • 100 days post-transplantation, with donor hematopoietic stem cell engraftment confirmed;

• The subject or their legally authorized representative has provided full informed consent, signed the informed consent form, and is willing to complete subsequent follow-up visits

Exclusion Criteria:

• Preexisting moderate-to-severe ocular surface disease prior to transplantation;
• Active ocular infection;
• Presence of other ocular conditions that, in the opinion of the ophthalmologist, may significantly affect the diagnosis of chronic ocular graft-versus-host disease, the evaluation of ocular surface parameters, or the completion of long-term follow-up;
• Patients with active hematologic malignancies.