Ocular chronic graft-versus-host disease
Conditions
Interventions
Conventional Follow-up Group:The Conventional Follow-up Group (Control Arm) will attend in-person visits at the designated hospital once every month, where physicians who have undergone standardized t
Self-Management Group:The Self-Management Group (Experimental Arm) will perform home-based self-management using the PAOSID device. Participants will capture corneal fluorescein staining (CFS) images
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 18 and 60 years at the time of signing the informed consent form (ICF) (inclusive of 18 and 60), with no restrictions on gender or ethnicity. 2. Patients diagnosed with hematologic diseases by the Department of Hematology and who have undergone allogeneic hematopoietic stem cell transplantation (Allo-HSCT), with stable vital signs. 3. At baseline, both eyes must meet the diagnostic criteria of the National Institutes of Health (NIH) for ocular chronic graft-versus-host disease (oGVHD), fulfilling either criterion A or B: A. Schirmer I test (without anesthesia): mean value of both eyes = 5 mm/5 min; B. Schirmer I test mean value of both eyes between 6–10 mm/5 min and newly developed keratoconjunctivitis sicca confirmed by slit-lamp examination. 4. Patients with moderate-to-severe oGVHD according to the ICCGVHD severity grading scale: Total Score Schirmer I (mm) Corneal Fluorescein Staining (CFS) OSDI Score Conjunctival Hyperemia 0 >15 0 33 / Total Score = Schirmer I test score + corneal fluorescein staining score + OSDI score + conjunctival hyperemia score. Severity classification: Mild-to-moderate: 5–8 points; Severe: 9–11 points. 5. Willing and able to comply with all study visits and follow study instructions as outlined in the protocol. 6.Must be able to use the Portable Automatic Ocular Surface Imaging Device (PAOSID) for image acquisition and operate the mobile application (App) as required.
Exclusion criteria
Exclusion criteria: 1. History of dry eye disease before hematopoietic stem cell transplantation (HSCT). 2. Previous history of acute GVHD. 3. Patients with unstable general status or expected to systematically adjust the drug regimen within 3 months. 4. Current corneal diseases, such as corneal infiltration, corneal perforation, corneal ulcer, keratolysis, infectious keratitis, and pancorneal conjunctivitivization. 5. Current intraocular diseases, such as glaucoma, uveitis, and intraocular infection. 6. Previous eyelid adhesions, corneal plaster, or eyelid fissure sutures. 7. Previous immune-related systemic diseases, such as systemic lupus erythematosus, ankylosing spondylitis, Behçet's syndrome, and Sjogren's syndrome. 8. Current scleral or bandage-type contact lenses. 9. Systemic diseases or uncontrollable diseases other than hematological diseases requiring bone marrow transplantation, affecting the collection of study parameters or patient compliance, such as severe cardiopulmonary disease, uncontrollable hypertension and diabetes. 10. Those who have a history of central nervous system disease or epilepsy, and/or whose mental state cannot cooperate. 11. Pregnant and lactating women, or women of childbearing age, do not use effective contraceptive measures. 12. Anxiety self-rating scale (SAS) for patients with severe anxiety. 13. Patients who are considered unsuitable for the study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| corneal fluorescein stating (NEI criteria);Follow-up mode preference; | — |
Secondary
| Measure | Time frame |
|---|---|
| oGVHD severity grading;Eyelid Margin Score; | — |
Countries
China
Contacts
Public ContactChen Wei
Eye Hospital, Wenzhou Medical University
Outcome results
None listed