An observational study in Diabetic Retinopathy, sponsored by China Medical University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by China Medical University Hospital · Observational
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.
791 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.
This study's planned enrollment of 100 is below the median of 150 across 268 observational studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →China Medical University Hospital is the lead sponsor of 479 studies on the registry; 115 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The participants in this prospective cross-sectional study were recruited from the outpatient clinic of endocrinology in China Medical University Hospital, Taichung, Taiwan.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in the type 2 DM group were diagnosed with DM based on criteria recommended by the American Diabetes Association and required to have a fasting plasma glucose of ≥7mmol/L or an HbA1c of ≥6.5%, as measured on 2 separate occasions.
Diagnostic Test: tongue diagnosis system
Participants in th ediabetic retinopahty group group were diagnosed according to the International Clinical Diabetic Retinopathy and Diabetic Macular Edema Disease Severity Scales.
Diagnostic Test: tongue diagnosis system
This study apply TCM diagnostic tools for clinical diseases, providing objective diagnostic data for evaluation to assess the association of blood stasis and DR.
Also known as: pulse wave analysis, body constitution questionnaires, nailfold capillaroscopy
Automatic tongue diagnosis
We observe the tongue features of blood stasis, such as bluish tongue, petechiae, and engorged sublingual vessels, and compare the relationship between diabetic retinopathy and blood stasis.
Time frame: 12 months
body constitution questionnaire
We observe the body constitution questionnaires, such as yi deficiency, yang deficiency and phlegm-stasis, and compare the relationship between diabetic retinopathy and blood stasis.
Time frame: 12 months
Nailfold videocapillaroscopy (NVC)
We evaluate the capillary density, length, morphology, distribution, presence of enlarged loops or hemorrhages, and blood flow. NVC score was used to quantitate the aforementioned characteristics.
Time frame: 12 months
pulse examinatin
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
China Medical University Hospital →