Prevalence of HPV-associated Eye Infection and Cytokine Levels in Tears From Patients Diagnosed With Pterygium

Pterygium Clinical Trial

Official title:

Prevalence of HPV-associated Eye Infection and Cytokine Levels in Tears From Patients Diagnosed With Pterygium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117386
• Other study ID #: IRB NO. 405/62
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: June 15, 2020

Study information

• Verified date: July 2020
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prevalence of HPV-associated eye infection and cytokine levels in tears from patients diagnosed with pterygium

Description:

The main purpose of this study is to evaluate the prevalence of HPV infection in primary and recurrent pterygium and the association of HPV types collecting from conjunctiva swab and urine. The second purpose is to compare a quantity of cytokines including IL-6, IL-18 and growth factor including VEGF found in tears of patients with primary and recurrent pterygium to participants with free of ocular disease Primary hypothesis

• The prevalence of HPV infection in primary pterygium is difference with prevalence in recurrent pterygium patients.

Secondary hypothesis

• Ocular HPV infection has association with HPV genitalia infection.

• Tears cytokine and growth factor level (IL-6, IL-18 and VEGF) are higher in pterygium HPV infection than non-HPV infection and also more than normal population

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: June 15, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Participants as primary and secondary pterygium group

Inclusion Criteria:

• Age above 18 years old

• presence of pterygium invading the cornea

Exclusion Criteria:

• Other ocular inflammation that could affect the results of the study (such as conjunctivitis, keratitis, conjunctival tumor, etc) or would preclude the enrollment for safety reasons

Participant without ocular disease Inclusion criteria

• Age above 18 years old Exclusion criteria

• Presence of any ocular inflammation diseases

Related Conditions & MeSH terms

• Communicable Diseases
• Eye Infections
• Human Papilloma Virus Infection
• Infection
• Papilloma
• Papillomavirus Infections
• Pterygium

Intervention

Diagnostic Test:
• HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong)
HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong) for swab sample collected from pterygium and normal conjunctiva and also for urine collected in Colli-PeeTM device (Novosanis, Belgium)
• Bio-Plex® 200 system (Bio- Rad, Hercules, CA)
Bioplex was use for measure cytokine IL-6, IL-18 and VEGF from tears collected from Schirmer strip

Locations

Country	Name	City	State
Thailand	Faculty of medicine, Chulalongkorn university	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV prevalence	1. To compare HPV prevalence in subjects with primary pterygium and with recurrent pterygium	1 hour per participants which is on a day for collecting sample
Secondary	HPV autoinoculation	To assess whether HPV autoinoculation is present, we evaluate whether there is an association between HPV ocular infection and genital infection.	1 hour per participants which is on a day for collecting sample
Secondary	cytokine IL-6, IL-18 and VEGF levels	To compare cytokine IL-6, IL-18 and VEGF levels among various subgroups, including recurrent pterygium subjects with HPV positive and HPV negative status, primary pterygium subjects with HPV positive and HPV negative, and subjects without ocular diseases	1 hour per participants which is on a day for collecting sample