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lipiview ii ocular surface interferometer
Tearscience
Summary: The LipiView II Ocular Surface Interferometer is a device used to measure tear film lipid layer thickness, primarily for assessing dry eye conditions. Key evidence highlights its repeatability and utility in evaluating tear film changes post-surgery.
FDA Clearance Information
Pathway
510K
Number
K152869 ↗
Decision Date
January 14, 2016
Product Code
HKI
Device Class
Class 2
Evidence
0 studies
The LipiView II Ocular Surface Interferometer was cleared by the FDA via the 510(k) pathway on January 14, 2016. It is manufactured by Tearscience and classified as a Class 2 device under product code HKI.
What It Is
The LipiView II is an ocular surface interferometer designed to measure the thickness of the tear film lipid layer. It is used clinically to assess tear film quality and diagnose conditions like dry eye syndrome.
Clinical Applications
Commonly used in ophthalmology clinics, the device helps in diagnosing and managing dry eye disease by providing quantitative data on tear film lipid layer thickness. It is also used to evaluate the impact of ocular surgeries on tear film parameters.
Evidence Summary
The literature includes 9 studies, comprising randomized controlled trials and retrospective analyses, conducted between 2019 and 2025. These studies explore the device's repeatability, its use in surgical outcomes, and its application in various ocular conditions.
Reported Outcomes
Published studies report that the LipiView II provides reliable measurements of tear film lipid layer thickness. It has been used to assess changes in tear film after surgical interventions and in conditions like nasolacrimal duct obstruction. The device has shown utility in evaluating meibomian gland function in various populations.
Safety Profile
Reported complications include minimal adverse events, primarily related to the non-invasive nature of the device. No significant safety concerns have been highlighted in the available literature.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to explore the device's utility in diverse patient populations and to establish standardized protocols for its use.
Frequently Asked Questions
What are the clinical indications for LipiView II?
The device is indicated for assessing tear film lipid layer thickness, primarily in patients with dry eye syndrome and related conditions.
What outcomes have been reported in clinical studies?
Studies have reported reliable measurements of tear film lipid layer thickness and its changes post-surgery, as well as its utility in evaluating meibomian gland function.
What complications have been reported?
Safety data from evidence indicates minimal adverse events, with no significant complications reported.
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.