NCT01068496

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2010

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 20, 2015

Status Verified

January 1, 2013

Enrollment Period

4.8 years

First QC Date

February 12, 2010

Last Update Submit

May 18, 2015

Conditions

Pterygium

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Clinical diagnosis of primary and recurrence pterygium
  • Must agree to participate in this study
  • Must sign informed consent form

You may not qualify if:

  • Hepatitis
  • HIV/AIDS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Singapore National Eye Centre

Singapore, Singapore, 168571, Singapore

Location

Singapore National Eye Center

Singapore, 168751, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pterygium and conjunctival tissue samples

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Study Officials

  • 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 CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Singapore National Eye Centre

Study Record Dates

First Submitted

February 12, 2010

First Posted

February 15, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 20, 2015

Record last verified: 2013-01

Locations

SG(2)