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

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.

Study Overview

• Status: Terminated
• Conditions: Pterygium

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 168751
    • Singapore National Eye Center
  • Singapore, Singapore, 168571
    • Singapore National Eye Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pterygium patients from the investigator's clinic as well as other clinics at the Singapore National Eye Center will be recruited for this study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Singapore National Eye Centre
• Collaborators: Singapore Eye Research Institute
• Investigators: Study Chair: Samanthila Waduthantri, Singapore National Eye Centre; Study Chair: Laurence Lim, MBBS, Singapore National Eye Centre; Study Chair: Federico Luengo Gimeno, Singapore National Eye Centre; Study Chair: Jodhbir Mehta, Singapore National Eye Centre

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 12, 2010
• First Submitted That Met QC Criteria: February 12, 2010
• First Posted (Estimate): February 15, 2010

Study Record Updates

• Last Update Posted (Estimate): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 18, 2015
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Conjunctival Diseases; Recurrence; Pterygium
• Other Study ID Numbers: R707/57/2009