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Completed

NCT Number: NCT04117386

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong)

Diagnostic Test

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)

Diagnostic Test

Bioplex was use for measure cytokine IL-6, IL-18 and VEGF from tears collected from Schirmer strip

Primary outcomes

  1. HPV prevalence

    Time frame: 1 hour per participants which is on a day for collecting sample

    • To compare HPV prevalence in subjects with primary pterygium and with recurrent pterygium

Secondary outcomes

  1. HPV autoinoculation

    Time frame: 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.

  2. cytokine IL-6, IL-18 and VEGF levels

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 7, 2019
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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