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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03576300
• Other study ID #: IRB00006761-M2017354
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: May 2022
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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): ?OSDI=13,?positive 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.

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear cytokines levels	Comparision the tear cytokines (EGF, IL-17A, IL-1ß, IL-8 and TNF-a)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	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