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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04117386
Enrollment
141
Registered
2019-10-07
Start date
2020-01-01
Completion date
2020-06-15
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papilloma Virus Infection, Pterygium

Keywords

HPV infection, Pterygium, Cytokine, VEGF, auto-inoculation

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

Interventions

DIAGNOSTIC_TESTHPV 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)

DIAGNOSTIC_TESTBio-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

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
HPV prevalence1 hour per participants which is on a day for collecting sample1\. To compare HPV prevalence in subjects with primary pterygium and with recurrent pterygium

Secondary

MeasureTime frameDescription
HPV autoinoculation1 hour per participants which is on a day for collecting sampleTo assess whether HPV autoinoculation is present, we evaluate whether there is an association between HPV ocular infection and genital infection.
cytokine IL-6, IL-18 and VEGF levels1 hour per participants which is on a day for collecting sampleTo 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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026