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

Completed

• Conditions: Dry Eye Syndrome; Diabetes Mellitus Type 2

• Registration Number: NCT03576300
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-21
• Primary Completion: 2018-07-01
• Study First Posted: 2018-07-03
• Study Completion: 2018-08-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-01
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. 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)
2. type 2 diabetes diagnosis according to American Diabetes Association：Standards of Medical Care in Diabetes -2017(ADA, American Diabetes Association)
3. Willing to sign the consent form.

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Exclusion Criteria

1. Having known Eye infection, allergy, malformation, abnormal eye movement
2. Exclusion of eye injury, any kind of eye surgery
3. Exclusion of other disease may cause neuropathy or influence tear producing
4. Using systematic or local antibiotics that may influence tear producing

Elimianation Criteria

1. poor compliance
2. voluntary withdrawal
3. any other kind of situation that researchers consider not suitable for further study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tear cytokines levels	through study completion,an average of two weeks	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).

Secondary Outcome Measures

Name	Time	Method
Clinical correlations of the tear cytokines	through study completion,an average of two weeks	Analysis of tear cytokines and clinical correlations by Spearman correlation coefficient

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China