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

Completed

• Conditions: Pterygium; Human Papilloma Virus Infection

• Registration Number: NCT04117386
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-07
• Study Start: 2020-01-01
• Primary Completion: 2020-04-30
• Study Completion: 2020-06-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HPV prevalence	1 hour per participants which is on a day for collecting sample	1. To compare HPV prevalence in subjects with primary pterygium and with recurrent pterygium

Secondary Outcome Measures

Name	Time	Method
cytokine IL-6, IL-18 and VEGF levels	1 hour per participants which is on a day for collecting sample	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
HPV autoinoculation	1 hour per participants which is on a day for collecting sample	To assess whether HPV autoinoculation is present, we evaluate whether there is an association between HPV ocular infection and genital infection.

Trial Locations

Locations (1)

Faculty of medicine, Chulalongkorn university; 🇹🇭 Bangkok, Thailand