Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium

Pterygium Clinical Trial

Official title:

Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01068496
• Other study ID #: R707/57/2009
• Status: Terminated
• Phase: N/A
• First received: February 12, 2010
• Last updated: May 18, 2015
• Start date: March 2010
• Est. completion date: December 2014

Study information

• Verified date: January 2013
• Source: Singapore National Eye Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Observational

Clinical Trial Summary

This study looks at global gene expression in pterygium and found the derangement of matrix genes in particular to be a feature of pterygium. In the investigators opinion, it would be more beneficial to elicit changes in gene expression before the recurrence of pterygium and by developing a panel of biomarkers that are associated with pterygium recurrence; one would be able to predict the post surgical prognosis of patients after resection.Biomarker levels will be compared to discover a biomarker panel for prediction of recurrence.

Description:

A comprehensive questionnaire will be used to evaluate the environmental, biological, physical and behavioral risk factors of associated with the recurrence after pterygium excision.

Slit lamp digital color photographs will be taken on primary and recurrent pterygium and pterygium will be graded in three levels of severity, based on relative transparency of pterygium tissue; grade 1 (transparent), grade 2 (intermediate), and grade 3 (opaque) to see whether the risk factors correlate to the morphology of the pterygium.

Tear samples will be collected before surgery using schirmers strip.Proteins in tear samples will be analyzed using the iTRAQ method.

The transcriptional differences in pterygium and conjunctival tissue samples will be analyzed using western blot, qPCR and immunohistochemistry assays.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of primary and recurrence pterygium

• Must agree to participate in this study

• Must sign informed consent form

Exclusion Criteria:

• Hepatitis

• HIV/AIDS

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pterygium

Locations

Country	Name	City	State
Singapore	Singapore National Eye Center	Singapore
Singapore	Singapore National Eye Centre	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore National Eye Centre	Singapore Eye Research Institute

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biomarkers	Elevation of biomarkers in pterygium tissue and tears (transcripts, proteins, or tear proteins) at the time of initial presentation of primary pterygium may predict the post-surgical recurrence within one year.; visits: 2 further visits at 6 months and 12 months after surgery	12 months	No