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CompletedNCT04117386Updated Jul 14, 2020

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

An observational study in Human Papilloma Virus Infection and Pterygium, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Per ClinicalTrials.gov, last updated 2020-07-14.

Sponsored by Chulalongkorn University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
141
Sex
All
01

Study summary

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

Read the 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
02

Conditions studied

  • Human Papilloma Virus Infection
  • Pterygium

Keywords

  • HPV infection
  • Pterygium
  • Cytokine
  • VEGF
  • auto-inoculation
03

In context

Papillomavirus Infections

576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.

This study's enrollment of 141 is below the median of 490 across 157 observational studies indexed under Papillomavirus Infections.

Browse Papillomavirus Infections studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Population:Patients diagnosed with primary pterygium and recurrent pterygium Target Population: Patients diagnosed with primary pterygium at out-patient clinic, Department of Ophthalmology, King Chulalongkorn Memorial Hospital Control Population: participants without any ocular diseases

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Participants as primary and secondary pterygium group

Inclusion criteria

Inclusion Criteria:

  • Age above 18 years old
  • presence of pterygium invading the cornea

Exclusion criteria

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
141 participants (actual)
Patient registry
No

Groups and cohorts

  • Primary pterygium group

    Participants who was diagnosed with primary pterygium

    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)

  • Secondary pterygium group

    Participants who was diagnosed with secondary pterygium

    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)

  • Healthy participants as control group

    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) · Diagnostic Test: Bio-Plex® 200 system (Bio- Rad, Hercules, CA)

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

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What researchers measure

Primary outcomes

  1. HPV prevalence

    1. To compare HPV prevalence in subjects with primary pterygium and with recurrent pterygium

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

Secondary outcomes

  1. HPV autoinoculation

    To assess whether HPV autoinoculation is present, we evaluate whether there is an association between HPV ocular infection and genital infection.

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

  2. 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

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

07

Study locations

1 site
  • Faculty of medicine, Chulalongkorn university
    Bangkok, 10330, Thailand
08

References and documents

Individual participant data

Plan to share: Yes — If there is anybody contacting our team for data in the purpose of future research, we agree to share our data.

Supporting information: Study protocol, Clinical study report

Time frame: 1 year after published

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2020 to primary completion in Apr 2020, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2019
First posted
Oct 7, 2019
StartActual
Jan 1, 2020
Primary completionActual
Apr 30, 2020
CompletionActual
Jun 15, 2020
Last update
Jul 14, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04117386
Responsible party
Ngamjit Kasetsuwan (Associate professor, Chulalongkorn University) — Principal investigator
First posted
Oct 7, 2019
Start date
Jan 1, 2020
Primary completion
Apr 30, 2020
Completion
Jun 15, 2020
Last update
Jul 14, 2020

Study contacts

Ngamjit Kasetsuwan
principal investigator · Department of Ophthalmology, Chulalongkorn University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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