NCT02160769

Brief Summary

The investigators study aims to capture the objective effects of pterygium surgery on tear layer lipid thickness and the tear layer. Previous objective studies of the tear film has been limited to corneal staining grading, tear break up time and Schirmer's test which have been shown to poor to moderate repeatability. The effect of pterygiums on tear layer lipid thickness (LLT) has not previously been explored. With the LipiView Ocular Surface Interferometer, the investigators have the ability to assess the optical coherence interference pattern produced by light reflected off the tear film in a safe and non-invasive manner. Software analysis of the image then measures the tear LLT which can be used to objectively quantify the diagnosis of lipid-deficient dry eye.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

6.7 years

First QC Date

June 9, 2014

Last Update Submit

October 20, 2020

Conditions

Dry Eye

Keywords

Tear Lipid ThicknessPterygium surgery

Outcome Measures

Primary Outcomes (1)

  • tear lipid layer thickness

    An increase in tear lipid layer thickness 1 month post pterygium surgery in the operated eye

    1 month

Eligibility Criteria

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

Healthy normal volunteers and Pterygium patients undergoing surgery to remove Pterygium

You may qualify if:

  • Normal controls or patients with pterygium who have consented for pterygium surgery and are willing to participate in this study

You may not qualify if:

  • Active ocular surface conditions such as infections.
  • Any other specified reason as determined by clinical investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Eye Research Institute

Singapore, Singapore., 168751, Singapore

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

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

Study Record Dates

First Submitted

June 9, 2014

First Posted

June 11, 2014

Study Start

November 1, 2013

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations

SG(1)