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Prospective cohort study of chronic ocular graft-versus-host disease

Prospective cohort study of chronic ocular graft-versus-host disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070889
Enrollment
Unknown
Registered
2023-04-25
Start date
2023-04-25
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic ocular graft-versus-host disease

Interventions

allo HSCT:None

Sponsors

The Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age range from 6 to 80 years old, regardless of gender; (2) Blood disease patients who require allogeneic hematopoietic stem cell transplantation (allo HSCT); (3) Obtain informed consent from patients and their families, and voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Meeting the diagnostic criteria for dry eyes (refer to the 2020 consensus of Chinese dry eye experts): The patient complained of one of the subjective symptoms such as dry eye sensation, foreign body sensation, burning sensation, fatigue, discomfort, redness of the eye, visual fluctuation, etc., with an ocular surface disease index (OSDI) of >= 13 points, while the patient's FBUT 5 seconds and 5 mm/5 minutes and <= 10mm/5 minutes, the keratoconjunctiva must be examined using fluorescein sodium staining method, and the staining is positive (= 5 points). (2) People with acute eye diseases such as active fungal, bacterial, or viral keratitis or conjunctivitis; (3) Individuals with other chronic eye diseases unrelated to chronic graft versus host disease, such as lacrimal duct disease, uveitis, glaucoma, etc. (4) Wearing contact lenses and unwilling to remove them during the study period; (5) Have undergone eye surgery (including cataract surgery) within the past three months; (6) Unable to cooperate in completing the research as requested by the researcher; (7) Any other situation that the researcher deems unsuitable for inclusion in the study;

Design outcomes

Primary

MeasureTime frame
OSDI;Schirmer?test;FBUT;NIKBUT;Eye surface comprehensive analyzer;In vivo confocal microscopy;Optical coherence tomography angiography;Tear cytokine detection;

Secondary

MeasureTime frame
Best corrected vision;Non contact intraocular pressure;Corneal endothelial cell count;

Countries

China

Contacts

Public ContactRongdi Yuan

The Second Affiliated Hospital of PLA Army Medical University

yuanrongdi@126.com+86 13228687341

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026