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

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ClinicalTrials.gov Identifier: NCT01068496
Recruitment Status : Terminated (Other and future studies on lipiview in pterygium will cover this current trial sufficiently.)
First Posted : February 15, 2010
Last Update Posted : May 20, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
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 Design

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium
Study Start Date : March 2010
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. biomarkers [ Time Frame: 12 months ]

    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



Biospecimen Retention:   Samples With DNA
Pterygium and conjunctival tissue samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01068496


Locations
Singapore
Singapore National Eye Centre
Singapore, Singapore, 168571
Singapore National Eye Center
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
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
More Information

Responsible Party: Louis Tong, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT01068496     History of Changes
Other Study ID Numbers: R707/57/2009
First Posted: February 15, 2010    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: January 2013

Additional relevant MeSH terms:
Recurrence
Pterygium
Disease Attributes
Pathologic Processes
Conjunctival Diseases
Eye Diseases