Clinical Trial: Comparing the Quality of Topical Autologous Serum in Different Etiologies of Dry Eye Syndrome

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Comparing the Quality of Topical Autologous Serum in Different Etiologies of Dry Eye Syndrome

Brief Summary: Human autologous serum is commonly used in the treatment of dry eye disease. However, different patients may have different effect with autologous serum treatment. We would like to find if different autologous serum had different component of cytokines in different etiologies of dry eye.

Detailed Summary:

Dry eye is an important issue in the filed of ophthalmology and has great influence on the quality of life in many patients. Traditional treatment was mainly focused on artificial tear supplement. Inflammatory factors are identified in the recent days and are thought to play an important role in the etiology of dry eye. Anti-inflammatory agent like topical immunosuppressant has become another choice in the treatment of dry eye.

Conventional artificial tear has similar biochemical features and osmolarity with natural tear but lacks the anti-inflammatory cytokines. Therefore, autologous serum has been applied as a substitute of natural tear because it has more anti-inflammatory cytokines. Clinical trials have shown that autologous serum drops improve ocular irritation symptoms, and conjunctival and corneal dye staining in dry eye.

However, in the manufacture of autologous serum, it is hard to standardize every step and control quality. What's more, the patient may have different etiology of dry eye, including primary Sjogren's syndrome, secondary Sjogren's syndrome, other autoimmune disease, or ocular graft versus host disease. The etiology of dry eye may have different response to autologous serum. However, we don't know if the autologous serum from different patients' have different components and the different components of cytokines may have different treatment efficacy. This is what we want to know in this study.

Since human autologous serum is needed for cytokine analysis, we proposed this project to collect human serum from volunteers。


Sponsor: National Taiwan University Hospital

Current Primary Outcome:

  • Epidermal growth factor concentration in human autologous serum from different etiologies of dry eye [ Time Frame: 1 year ]

    We would measure Epidermal growth factor concentration (ng/ml) by ELISA according to the manufactures instruction.

    We plan to collect 40 patients from different groups.

  • Transforming growth factor beta (ng/ml) concentration in human autologous serum from different etiologies of dry eye [ Time Frame: 1 year ]

    We would measure Transforming growth factor beta (ng/ml) by ELISA according to the manufactures instruction.

    We plan to collect 40 patients from different groups.

  • Fibronectin (ug/ml) concentration in human autologous serum from different etiologies of dry eye [ Time Frame: 1 year ]

    We would measureFibronectin (ug/ml) concentration by ELISA according to the manufactures instruction.

    We plan to collect 40 patients from different groups.

  • Hyaluronic acid (ug/ml) concentration in human autologous serum from different etiologies of dry eye [ Time Frame: 1 year ]

    We would measure Hyaluronic acid (ug/ml) concentration by ELISA according to the manufactures instruction.

    We plan to collect 40 patients from different group

    Original Primary Outcome: Cytokine component in human autologous serum from different etiologies of dry eye [ Time Frame: 1 year ]

    We would measure different pro-inflammatory and anti-inflammatory cytokines in the autologous serum in different etiologies of dry eye. Including:

    1. Epidermal growth factor concentration (ng/ml)
    2. Transforming growth factor beta (ng/ml)
    3. Fibronectin (ug/ml)
    4. Hyaluronic acid (ug/ml)

    These cytokines were measured by ELISA according to the manufactures instruction.

    We plan to collect 40 patients from different groups.



    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: National Taiwan University Hospital

    Dates:
    Date Received: January 10, 2016
    Date Started: January 2016
    Date Completion: January 2017
    Last Updated: December 6, 2016
    Last Verified: December 2016