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lipiview ocular surface interferometer
Tearscience
Summary: The LipiView Ocular Surface Interferometer is a device used to measure the lipid layer thickness of the tear film. It is primarily used in the assessment of dry eye and meibomian gland dysfunction. Key evidence highlights its utility in evaluating treatment effects on tear film lipid layers.
FDA Clearance Information
Pathway
510K
Number
K122481 ↗
Decision Date
December 31, 2012
Product Code
HKI
Device Class
Class 2
Evidence
0 studies
The LipiView Ocular Surface Interferometer was cleared by the FDA via the 510(k) pathway on December 31, 2012. It is manufactured by TearScience and classified as a Class II device under product code HKI.
What It Is
The LipiView Ocular Surface Interferometer is a diagnostic device that uses interferometry to measure the thickness of the lipid layer in the tear film. It is intended for use in the clinical assessment of patients with dry eye disease and meibomian gland dysfunction.
Clinical Applications
Common clinical scenarios for the LipiView include evaluating patients with symptoms of dry eye, assessing the impact of ocular surgeries on tear film, and monitoring the effectiveness of treatments aimed at improving meibomian gland function.
Evidence Summary
The available literature includes randomized controlled trials, prospective and retrospective studies, and case series, with a total of 10 studies reviewed. The studies range from 2015 to 2022, focusing on the device's efficacy in measuring lipid layer thickness and its role in various ocular conditions.
Reported Outcomes
Published studies report that the LipiView Ocular Surface Interferometer effectively measures lipid layer thickness, providing valuable insights into the tear film's condition. It has been used to assess the impact of treatments such as cyclosporine A and artificial tears on lipid layer thickness. The device has shown repeatability in measurements, making it a reliable tool in clinical settings.
Safety Profile
Reported complications include minimal adverse events, primarily related to the discomfort of the examination process. No significant safety concerns have been identified in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the variability in study designs. Further research is needed to establish standardized protocols and to explore the long-term impact of interventions assessed using the LipiView.
Frequently Asked Questions
What are the clinical indications for LipiView Ocular Surface Interferometer?
The LipiView is indicated for assessing lipid layer thickness in patients with dry eye disease and meibomian gland dysfunction.
What outcomes have been reported in clinical studies?
Studies have reported effective measurement of lipid layer thickness and the device's utility in evaluating treatment effects on the tear film.
What complications have been reported?
Reported complications include minimal discomfort during the examination, with no significant safety concerns noted.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.