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

NCT03576300 | Completed

• 1 other identifier: IRB00006761-M2017354
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye Syndrome; Diabetes Mellitus Type 2

Keywords

ocular surface

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical correlations of the tear cytokines

  through study completion,an average of two weeks

Study Arms (4)

control

subjects without dry eye and diabetes

patients with diabetes and dry eye

diabetic patients with dry eye

diabetics without dry eye syndrome

diabetic patients without dry eye

dry eye syndrome patients without diabetes

non-diabetic patients with dry eye

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Asian

You may qualify if:

• 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.

You may not qualify if:

• Having known Eye infection, allergy, malformation, abnormal eye movement
• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

tears from the subjects

MeSH Terms

Conditions

Dry Eye Syndromes; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hong Qi, MD

  Peking University Third Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.PHD.

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 3, 2018
• Study Start: February 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: May 3, 2022

Record last verified: 2022-05

Locations

CN (1)