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Reproducibility of LipiView Ocular Surface Interferometer (LipiView) for Measuring Tear Lipid Layer Thickness

NCT01933165 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-06-10

No results posted yet for this study

Summary

Dry eye clinical research is limited to follow up of disease progression. While a large catalogue of tests, such as corneal staining grading, tear break up time (TBUT) and Schirmer's test, is available, objective assessments demonstrate poor to moderate repeatability. Among these assessments, TBUT has the best repeatability while the Schirmer's test shows good repeatability for more severe forms of the disease.1 As such, currently, most research outcomes are based on subjective patient complaints rather than objective assessment of the condition.

LipiView Ocular Surface Interferometer (LipiView) is a HSA-approved imaging device that has the ability to assess optical interference pattern produced by light reflected off the tear film in a safe and non-invasive manner.2 Software analysis of the image then measures the tear LLT, which is used to objectively quantify the diagnosis of lipid-deficient dry eye.

This current study aims to investigative the inter and intra-examiner reproducibility of measuring tear lipid layer thickness (LLT) with LipiView, which is used in our current clinical setting. LipiView has not been evaluated on its reproducibility of measuring tear lipid layer thickness. The study will also assess for correlation between the magnitude of tear LLT and the inter and intra-examiner reproducibility of LipiView.

Once this method is found to be repeatable, this can be used in future clinical settings and trials as an additional tool to investigate dry eye treatments.

Conditions

  • Dry Eyes

Interventions

DEVICE

LipiView

Sponsors & Collaborators

  • Singapore National Eye Centre

    lead OTHER_GOV

Principal Investigators

  • Louis Tong, PhD · Singapore National Eye Centre

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01933165 on ClinicalTrials.gov