Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium
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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 |
- 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
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
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 |
Pterygium patients from the investigator's clinic as well as other clinics at the Singapore National Eye Center will be recruited for this study.
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| Contact: Louis Tong, PhD | 98186221 | louistong@hotmail.com |
| Singapore | |
| Singapore National Eye Center | Recruiting |
| Singapore, Singapore, 168751 | |
| Principal Investigator: Louis Tong, FRCS, MD | |
| Singapore National Eye Centre | Recruiting |
| Singapore, Singapore, 168571 | |
| 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: | January 30, 2013 |
| Health Authority: | Singapore: Health Sciences Authority |
Additional relevant MeSH terms:
|
Pterygium Recurrence Conjunctival Diseases |
Eye Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013