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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
  Purpose

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
Pterygium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium

Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • 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



Biospecimen Retention:   Samples With DNA

Pterygium and conjunctival tissue samples


Enrollment: 1
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068496

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

No publications provided

Responsible Party: Louis Tong, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT01068496     History of Changes
Other Study ID Numbers: R707/57/2009
Study First Received: February 12, 2010
Last Updated: September 1, 2013
Health Authority: Singapore: Health Sciences Authority

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

ClinicalTrials.gov processed this record on November 20, 2014