Tear Cytokine Analysis as a Prediction or Diagnostic Marker in Ocular GvHD

Investigate the profiles of tear cytokines in patients who underwent stem cell transplantation (SCT) and attempted to determine the applicability of tear cytokines in the diagnosis of chronic graft-versus-host disease (GVHD). Evaluate tear cytokines as biomarkers of chronic ocular GVHD severity.

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Key information

Conditions

Chronic Graft-versus-host Disease Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The patients patients aged 20-60 years who visited the clinic 3-12 months after SCT were included in the study.

Exclusion criteria

The patients with histories of ocular surgery; ocular injury; and ocular diseases such as ocular infection, allergy, and autoimmune disease, as well as patients with long-term use of topical ocular medications except artificial tears.

Treatment and study plan

Primary outcomes

tear cytokine

Time frame: 3-12 month after SCT

comparison of tear cytokines (IL-2,4,10,17a, INF-r, TNF-a) concentrations in patients with or without newly diagnosed chronic GVHD after SCT using a multiplex immunobead assay
ocular surface status

Time frame: 3-12 month after SCT
tear film break-up time

Time frame: 3-12 month after SCT
conjunctival injection

Time frame: 3-12 month after SCT
Schirmer's test I

Time frame: 3-12 month after SCT
ocular surface disease index

Time frame: 3-12 month after SCT

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Apr 8, 2015
Registry last updated: Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed