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

This study has been terminated.
(Other and future studies on lipiview in pterygium will cover this current trial sufficiently.)
Sponsor:
Collaborator:
Singapore Eye Research Institute
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT01068496
First received: February 12, 2010
Last updated: September 1, 2013
Last verified: January 2013

February 12, 2010
September 1, 2013
March 2010
September 2013   (final data collection date for primary outcome measure)
biomarkers [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

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. [ Time Frame: 2 futher visits at 6 months and 12 months after surgery ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01068496 on ClinicalTrials.gov Archive Site
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Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Pterygium and conjunctival tissue samples

Non-Probability Sample

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

Pterygium
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
December 2014
September 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01068496
R707/57/2009
No
Louis Tong, Singapore National Eye Centre
Singapore National Eye Centre
Singapore Eye Research Institute
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
Singapore National Eye Centre
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP