Comparative Assessment of Lipid Layer Thickness Measurements

Comparative Assessment of Lipid Layer Thickness Measurements Across Three Devices and Their Correlation With Clinical Indicators in Dry Eye Disease

This study compares ocular lipid layer thickness (LLT) measurements obtained from three commonly used clinical diagnostic devices to evaluate their agreement and consistency. It further examines which device's LLT measurements show the strongest correlation with established clinical indicators of dry eye disease severity.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye
• Intervention / Treatment: Device: LipiView; Device: Omnicad; Device: Bruder Ocular Surface Analyzer

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Anna Tichenor; Phone Number: 8128550520; Email: annatich@iu.edu

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Recruiting
      • Atwater Eye Care Center
      • Contact: Anna Tichenor; Phone Number: 812-855-0520; Email: annatich@iu.edu
      • Principal Investigator: Anna Tichenor, OD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the clinic with dry eye disease symptoms will be included in the study.

Description

Inclusion Criteria:

• Dry eye disease

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dry Eye; Patients with dry eye disease will undergo measurement of lipid layer thickness on all 3 devices in random order.	Device: LipiView; Subjects will undergo lipid layer thickness measurement; Device: Omnicad; Subjects will undergo lipid layer thickness measurement; Device: Bruder Ocular Surface Analyzer; Subjects will undergo lipid layer thickness measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid Layer Thickness	Average and minimum lipid layer thickness measurements will be compared across devices	measurements taken at single visit, baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation with dry eye clinical measurements	Correlations will be compared and analyzed with clinical dry eye measuremetns	measurements taken at single visit, baseline

Collaborators and Investigators

• Sponsor: Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): December 20, 2028
• Study Completion (Estimated): December 20, 2028

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 29789

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No