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

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

Detailed Description
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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

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

Conditions
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Human Papilloma Virus Infection, Pterygium

Intervention / Treatment
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* Diagnostic Test: HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong)
* Diagnostic Test: Bio-Plex® 200 system (Bio- Rad, Hercules, CA)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary pterygium group<br>Participants who was diagnosed with primary pterygium | Diagnostic Test: HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong)<br>* 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)<br>Diagnostic Test: Bio-Plex® 200 system (Bio- Rad, Hercules, CA)<br>* Bioplex was use for measure cytokine IL-6, IL-18 and VEGF from tears collected from Schirmer strip<br>|
| Secondary pterygium group<br>Participants who was diagnosed with secondary pterygium | Diagnostic Test: HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong)<br>* 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)<br>Diagnostic Test: Bio-Plex® 200 system (Bio- Rad, Hercules, CA)<br>* Bioplex was use for measure cytokine IL-6, IL-18 and VEGF from tears collected from Schirmer strip<br>|
| Healthy participants as control group<br>Participants who have no pterygium and other inflammation disease in eyes | Diagnostic Test: HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong)<br>* 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)<br>Diagnostic Test: Bio-Plex® 200 system (Bio- Rad, Hercules, CA)<br>* Bioplex was use for measure cytokine IL-6, IL-18 and VEGF from tears collected from Schirmer strip<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV infection, Pterygium, Cytokine, VEGF, auto-inoculation