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The Role of Cytokines and Mast Cell in the Pathogenesis of SLK, Conjunctivochalasis, and Dry Eye

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02160327
Collaborator
(none)
105
Enrollment
1
Location
45
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The specific aims of the the investigators studies are as follows:

  • To collect the tear samples from patients with different ocular surface disorders, including SLK, conjunctivochalasis, and keratoconjunctivitis sicca (KCS).

  • To evaluate the differential expression of tear cytokines and pH values between different ocular surface disorders.

  • To collect the surgical conjunctival specimens from the patients with SLK and conjunctivochalasis.

  • To evaluate the factors inducing mast cell migration and how mast cell is activated in SLK via surgical specimens and cultivated fibroblast.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    1. Detection of various tear cytokine levels in patients with superior limbic keratoconjunctivitis, conjunctivochalasis, and keratoconjunctivitis sicca
    • Basal tear samples will be collected atraumatically from the inferolateral tear meniscus by using glass capillary tubes. Care is taken to avoid touching the corneal and conjunctival surface. Approximately 30 μl of tear samples is obtained, and then the samples are centrifuged for 10 minutes at 1500 rpm (225g). Tear sample are placed in microtubes (Eppendorf) and stored at -70°C. IL-1β, IL-17, TNF-α, and IFN-γ levels will be measured by enzyme-linked immunosorbent assay kits.
    1. Immunohistochemistry stain method for conjunctival specimens - The conjunctiva will be collected from SLK and conjunctivochalasis patients who received superior and inferior bulbar conjunctival resection as needed. The redundant conjunctiva noted after peritomy during cataract or retinal surgery will be excised to serve as a normal control. The conjunctival specimens of all the SLK, conjunctivochalasis, and control groups are sent to the pathology department for routine paraffin embedding and hematoxylin and eosin staining. The surgical specimens are placed into 4% paraformaldehyde at 4 C for one to two days and then stored in 1% sodium phosphate buffer at 4 C. They then are embedded in paraffin. To enhance tissue adhesion, 5-micrometer thick sections are mounted on glass slides pre- treated with Vectabond (Vector Laboratories, Burlingame, California, USA). The paraffin sections are deparaffinized, rehydrated and washed with phosphate-buffered saline (PBS; pH 7.4). Antigen retrieval is performed by immerse the sections in 0.1% trypsin in water bath for 15 mins. The endogenous peroxidase activity is quenched by placing the slides in 3% hydrogen peroxide. The slides are then blocked with serum followed by incubation with primary antibodies. Primary antibodies (TSL and SCF) are incubated overnight at 4°C. Thereafter, incubation with biotin conjugated secondary antibody is performed at room temperature for 60 min. Further, incubation with avidin-biotin horseradish peroxidase complex is then performed at room temperature as well for 30 min using Vectastain elite® ABC kit (Vector labs, CA USA). The location where the enzyme is bound will be visualized by the addition of the substrate 3,3'-diaminobenzidine (DAKO, CA, USA), a chromogen which produces a brown insoluble precipitate. The sections are then counterstained with haematoxylin, which is followed by dehydration and mounting with Vecta Mount Mounting medium was used to evaluate the slides.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    105 participants
    Time Perspective:
    Prospective
    Official Title:
    The Role of Cytokines and Mast Cell in the Pathogenesis of Ocular Surface Inflammation Diseases Including Superior Limbic Keratoconjunctivitis, Conjunctivochalasis, and Dry Eye
    Study Start Date :
    Mar 1, 2014
    Anticipated Primary Completion Date :
    Dec 1, 2017
    Anticipated Study Completion Date :
    Dec 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Tear cytokines change measured by ELISA [Tear will be collected before treatment, one month and six months follow-up visits]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    • Part I. Tear sample

    Inclusion criteria:

    1. age 20-85 years old

    2. diagnosed as a patients of superior limbic keratoconjunctivitis (SLK) or conjunctivochalasis or keratoconjunctivitis sicca (KCS)

    Exclusion criteria:

    1. pregnancy

    2. any ocular surgery within 3 months

    • Part II. Surgical conjunctiva specimen
    Inclusion criteria:

    1. age 20-85 years old

    2. disease group: SLK or conjunctivochalasis patients refractory to medical treatment and receiving conjunctival resection surgery

    3. control group: patients receiving retinal or cataract surgery with redundant conjunctiva after peritomy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Zhongzheng Dist Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Fung-Rong Hu, MD, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT02160327
    Other Study ID Numbers:
    • 201312127RINB
    First Posted:
    Jun 10, 2014
    Last Update Posted:
    Jun 24, 2014
    Last Verified:
    Jun 1, 2014
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Keratoconjunctivitis

    Study Results

    No Results Posted as of Jun 24, 2014