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

• Sponsor: Chulalongkorn University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04117386
• Collaborator: (none)
• Enrollment: 141
• Location: 1
• Actual Duration (Months): 5.5
• Patients Per Site Per Month: 25.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Human Papilloma Virus Infection; 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)

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 Design

• Study Type: Observational
• Actual Enrollment: 141 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Prevalence of HPV-associated Eye Infection and Cytokine Levels in Tears From Patients Diagnosed With Pterygium
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Apr 30, 2020
• Actual Study Completion Date: Jun 15, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. HPV prevalence [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

Secondary Outcome Measures

1. HPV autoinoculation [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine, Chulalongkorn university	Bangkok		Thailand	10330

Sponsors and Collaborators

• Chulalongkorn University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ngamjit Kasetsuwan, Associate professor, Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT04117386
• Other Study ID Numbers: IRB NO. 405/62
• First Posted: Oct 7, 2019
• Last Update Posted: Jul 14, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ngamjit Kasetsuwan, Associate professor, Chulalongkorn University: HPV infection; Pterygium; Cytokine; VEGF; auto-inoculation
• Additional relevant MeSH terms: Infections; Communicable Diseases; Papillomavirus Infections; Eye Infections; Papilloma; Pterygium

Study Results

No Results Posted as of Jul 14, 2020