Diabetic Retinopathy Clinical Trial
Official title:
Assessment the Sensitivity of Traditional Chinese Medical Diagnostic Tools for Diabetic retinopathy-a Pilot Study
Diabetic retinopathy (DR) is the leading cause of impaired visual function and blindness in
adults. The fundus photographs were examined to detect DR. The DR severity was graded
non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR)
according to the International Clinical Diabetic Retinopathy and Diabetic Macular Edema
Disease Severity Scales. The pathogenesis of DR is complex and not fully understood, and
platelet aggregation, microvascular damage, microvascular enlargement, leakage, hemorrhage,
or obstruction, resulting in retinal hypoxia and retinal neovascularization. Traditional
Chinese medicine (TCM) diagnostic tools are non-invasive and convenient. This study apply TCM
diagnostic tools for clinical diseases, providing objective diagnostic data for evaluation to
assess the association of blood stasis and DR. Furtherly we would evaluate the sensitivity
and specificity of TCM diagnostic tools.
This study is a prospective cross-sectional study. We enroll participants form the department
of Chinese medicine, China Medical University Hospital. In total, 100 participants , composed
of 50 of type 2 diabetes and 50 of diabetic retinopathy, whom previously had a retinal
examination. We apply tongue diagnosis system, pulse wave analysis, body constitution
questionnaires, and nailfold capillaroscopy to assess the differences of TCM diagnosis in DR.
This study aims to identify the clinical symptoms of DR with TCM diagnostic tools and
investigate the pattern difference and treatment for DR. Furtherly, we could design a
clinical trial with improving blood circulation to treat or prevent DR, and improve the
health status and quality of life in patients with type 2 diabetes.
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