Comparison of Ocular Surface Features in Patients With Diabetes and Dry Eye Syndrome

Study Overview
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Brief Summary
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The study aims to compare the differences of ocular surface features in controls and patients with diabetes and dry eye syndrome, to thoroughly evaluate the ocular surface health of diabetics, and to find out the relationship between dry eye syndrome and diabetes

Detailed Description
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In this study, we perform a completely comparison of ocular surface characteristic including the Ocular Surface Disease Index (OSDI) questionnaire,tearfilm break up time(BUT),corneal fluorescein scores(CFS),Shirmer test,corneal sensitivity)among diabetic patients with DE, diabetic patients without DE, non-diabetic patients with DE and normal subjects and analysis of EGF, IL-17A, IL-1β, IL-8 and TNF-α in tears and their clinical correlations are also performed to investigate potential biomarkers for diagnosis of diabetic with DE.

Official Title
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Comparison of Ocular Surface Features in Patients With Diabetes and Dry Eye Syndrome

Conditions
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Dry Eye Syndrome, Diabetes Mellitus Type 2

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: dry eye diagnosis according to Expert's Consensus About Clinical Diagnosis and Treatment（Corneal Disease Group of Ophthalmological Society, Chinese Medical Association）: ①OSDI≥13，②positive dry eye soigns(ST≤10mm/5min；BUT≤10s；CFS>0) type 2 diabetes diagnosis according to American Diabetes Association：Standards of Medical Care in Diabetes -2017(ADA, American Diabetes Association) Willing to sign the consent form. Exclusion Criteria: Having known Eye infection, allergy, malformation, abnormal eye movement Exclusion of eye injury, any kind of eye surgery Exclusion of other disease may cause neuropathy or influence tear producing Using systematic or local antibiotics that may influence tear producing Elimianation Criteria poor compliance voluntary withdrawal any other kind of situation that researchers consider not suitable for further study.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control<br>subjects without dry eye and diabetes | |
| patients with diabetes and dry eye<br>diabetic patients with dry eye | |
| diabetics without dry eye syndrome<br>diabetic patients without dry eye | |
| dry eye syndrome patients without diabetes<br>non-diabetic patients with dry eye | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear cytokines levels | Comparision the tear cytokines （EGF, IL-17A, IL-1β, IL-8 and TNF-α）levels in different groups using using a Milliplex Map Kit (Human Th17 Magnetic Bead Panel, Millipore, Billerica, MA). | through study completion,an average of two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical correlations of the tear cytokines | Analysis of tear cytokines and clinical correlations by Spearman correlation coefficient | through study completion,an average of two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ocular surface