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

NCT ID: NCT04117386

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

141 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-06-15

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

Conditions

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Human Papilloma Virus Infection Pterygium

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Primary pterygium group

Participants who was diagnosed with primary pterygium

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

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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)

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

* Presence of any ocular inflammation diseases
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Ngamjit Kasetsuwan

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ngamjit Kasetsuwan

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Chulalongkorn University

Locations

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Faculty of medicine, Chulalongkorn university

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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IRB NO. 405/62

Identifier Type: -

Identifier Source: org_study_id

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