NCT04117386

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

October 3, 2019

Last Update Submit

July 13, 2020

Conditions

Human Papilloma Virus InfectionPterygium

Keywords

HPV infectionPterygiumCytokineVEGFauto-inoculation

Outcome Measures

Primary Outcomes (1)

  • HPV prevalence

    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 Outcomes (2)

  • HPV autoinoculation

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

  • cytokine IL-6, IL-18 and VEGF levels

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

Study Arms (3)

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

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)

Healthy participants as control groupPrimary pterygium groupSecondary pterygium group
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

Healthy participants as control groupPrimary pterygium groupSecondary pterygium group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Chulalongkorn university

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Papillomavirus InfectionsPterygium

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsConjunctival DiseasesEye Diseases

Study Officials

  • Ngamjit Kasetsuwan

    Department of Ophthalmology, Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 7, 2019

Study Start

January 1, 2020

Primary Completion

April 30, 2020

Study Completion

June 15, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
1 year after published

Locations

TH(1)