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

NCT02774707 | Unknown

• 1 other identifier: 201511091RINB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndrome

Keywords

Dry eye

Outcome Measures

Primary Outcomes (4)

• Epidermal growth factor concentration in human autologous serum from different etiologies of dry eye

  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.

  1 year

• Transforming growth factor beta (ng/ml) concentration in human autologous serum from different etiologies of dry eye

  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.

  1 year

• Fibronectin (ug/ml) concentration in human autologous serum from different etiologies of dry eye

  We would measureFibronectin (ug/ml) concentration by ELISA according to the manufactures instruction. We plan to collect 40 patients from different groups.

  1 year

• Hyaluronic acid (ug/ml) concentration in human autologous serum from different etiologies of dry eye

  We would measure Hyaluronic acid (ug/ml) concentration by ELISA according to the manufactures instruction. We plan to collect 40 patients from different groups.

  1 year

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Patients who need autologous human serum as treatment of dry eye disease 2. Healthy volunteers

You may qualify if:

• Healthy volunteer control without ophthalmic history
• Patients with Primary Sjogren's syndrome: according to the classification of American European Consensus Group of rheumatologist and Ophthalmologists,
• Patient with Secondary Sjogren's syndrome: Sjogren's syndrome associated with systemic lupus erythematosus, systemic sclerosis (scleroderma), rheumatoid arthritis, mixed connective tissue disease, inflammatory muscle disease, autoimmune liver disease, and autoimmune thyroid disease
• Ocular graft versus host disease
• Volunteers with dry eye symptoms but not diagnosed with primary Sjogren's syndrome, secondary Sjogren's syndrome and ocular graft versus host disease

You may not qualify if:

• Patients who decline to receive the venipuncture for blood sampling.
• Patients younger than 20 years old or older than 80 years old.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Wei-Li Chen

  ational Taiwan University Hospital, Ophthalmology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2016
• First Posted: May 17, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

TW (1)