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

NCT01933165 | Completed

• 2 other identifiers: R1028/43/20132013/327/A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dry Eyes; LipiView; Lipid thickness

Outcome Measures

Primary Outcomes (1)

• The repeatability of objective tear lipid layer thickness measurements of LipiView from the same examiner.

  1 day

Study Arms (1)

LipiView

OTHER

Device: LipiView

Interventions

LipiView DEVICE

LipiView

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers that are medically fit and willing to participate in this study.

You may not qualify if:

• No eye surgery done within the previous 3 months
• Active ocular surface conditions such as infection or pterygium that may affect tear film stability.
• Any other specified reason as determined by clinical investigator.

Sponsors & Collaborators

• Singapore National Eye Centre: lead

Study Sites (1)

Singapore Eye Research Institute

Singapore, Singapore, 168751, Singapore

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Louis Tong, PhD

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Scientist, Senior Consultant

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 2, 2013
• Study Start: September 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 10, 2014

Record last verified: 2014-06

Locations

SG (1)