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NCT Number: NCT03576300

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

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

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Key information

Conditions

Dry Eye Syndrome Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Dry Eye Syndromes Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Lacrimal Apparatus Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Tear cytokines levels

    Time frame: 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 outcomes

  1. Clinical correlations of the tear cytokines

    Time frame: through study completion,an average of two weeks

    Analysis of tear cytokines and clinical correlations by Spearman correlation coefficient

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 3, 2018
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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