NCT01841580

Brief Summary

Approximately 70 million people world-wide are affected with glaucoma, of whom 6.7 million have bilateral blindness.5 Elevated intro-ocular pressure is the major modifiable risk factor in glaucoma, and reducing intraocular pressure to a consistently low level can delay disease progression and therefore, blindness.6 Topical intraocular pressure -lowering medication remains the first-line treatment for glaucoma, with surgical intervention playing a secondary role in cases suboptimally controlled with medication alone. In this study, we plan to assess the change in tear proteins in trabeculectomy patients before and after operations. It is hoped that this study could help us gain more understanding of the possible mechanism accounting for the development of dry eye disease in glaucoma patients, which could help us develop better screening modalities and therapeutic agents for glaucoma patients at risk to prevent the development of dry eye disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 19, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

4.9 years

First QC Date

April 19, 2013

Last Update Submit

October 29, 2018

Conditions

Glaucoma

Keywords

Tear proteins profilesLongitudinalOcular surface damageTrabeculectomy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the tear protein profiles in trabeculectomy patients at 3 years

    Baseline and 3 years

Secondary Outcomes (4)

  • Symptoms and severity of dry eye disease

    Baseline and 3 years

  • Amount of tears will be measured

    Baseline and 3 years

  • Tear Osmolarity will be measured

    Baseline and 3 years

  • Tear meniscus height will be measured

    Baseline and 3 years

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

120 patients will be recruited for this study

You may qualify if:

  • patients will be recruited from glaucoma clinics in SNEC
  • Patients age ≥ 21 years old
  • Patients who require trabeculectomy operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore National Eye Centre/ Singapore Eye Research Institute

Singapore, 168751, Singapore

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Louis Tong, PhD

    Singapore National Eye Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician-Scientist, Senior Consultant

Study Record Dates

First Submitted

April 19, 2013

First Posted

April 26, 2013

Study Start

November 1, 2013

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 31, 2018

Record last verified: 2018-10

Locations

SG(1)