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

July 13, 2020 updated by: Ngamjit Kasetsuwan, Chulalongkorn University
Prevalence of HPV-associated eye infection and cytokine levels in tears from patients diagnosed with pterygium

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

141

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Faculty of Medicine, Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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 test: Bio-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
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)
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 test: Bio-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
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)
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 test: Bio-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV prevalence
Time Frame: 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
1 hour per participants which is on a day for collecting sample

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour per participants which is on a day for collecting sample
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
1 hour per participants which is on a day for collecting sample

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Ngamjit Kasetsuwan, Department of Ophthalmology, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

June 15, 2020

Study Registration Dates

First Submitted

October 3, 2019

First Submitted That Met QC Criteria

October 3, 2019

First Posted (Actual)

October 7, 2019

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB NO. 405/62

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

IPD Sharing Time Frame

1 year after published

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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