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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03576300
Collaborator
(none)
120
Enrollment
1
Location
5.9
Actual Duration (Months)
20.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Comparison of Ocular Surface Features in Patients With Diabetes and Dry Eye Syndrome
    Actual Study Start Date :
    Feb 1, 2018
    Actual Primary Completion Date :
    Jul 1, 2018
    Actual Study Completion Date :
    Aug 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 74 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Third Hospital Beijing Beijing China 100191

    Sponsors and Collaborators

    • Peking University Third Hospital

    Investigators

    • Study Director: Hong Qi, MD, Peking University Third Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hong Qi, MD.PHD., Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT03576300
    Other Study ID Numbers:
    • IRB00006761-M2017354
    First Posted:
    Jul 3, 2018
    Last Update Posted:
    May 3, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Keywords provided by Hong Qi, MD.PHD., Peking University Third Hospital
    ocular surface
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Syndrome

    Study Results

    No Results Posted as of May 3, 2022