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lipiview ocular surface interferometer
Tearscience
Summary: The LipiView Ocular Surface Interferometer, manufactured by TearScience, is a diagnostic device used to measure the lipid layer thickness of the tear film. It is primarily used in the assessment of dry eye disease and meibomian gland dysfunction. Key evidence highlights its efficacy in evaluating tear film changes post-cataract surgery.
FDA Clearance Information
Pathway
510K
Number
K091935 ↗
Decision Date
October 23, 2009
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 October 23, 2009. 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 tool designed to measure the thickness of the lipid layer of the tear film using interferometry. It is intended for use in the evaluation of patients with dry eye disease and meibomian gland dysfunction, providing clinicians with quantitative data on tear film lipid layer thickness.
Clinical Applications
Commonly used in ophthalmology clinics, the LipiView is employed in the assessment of patients with symptoms of dry eye disease, particularly those suspected of having meibomian gland dysfunction. It is also utilized in pre- and post-operative evaluations for cataract surgery to monitor changes in tear film lipid layer thickness.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series, conducted between 2015 and 2022. These studies focus on the device's application in measuring lipid layer thickness and its impact on dry eye management.
Reported Outcomes
Published studies report that the LipiView Ocular Surface Interferometer effectively measures changes in lipid layer thickness in patients with dry eye disease. It has been shown to detect improvements in tear film lipid layer following the use of artificial tears and cyclosporine A. Additionally, it aids in evaluating the impact of topical glaucoma medications on tear film parameters.
Safety Profile
Reported complications include minimal adverse events, primarily related to the non-invasive nature of the device. The studies reviewed did not highlight any significant safety concerns associated with the use of the LipiView Ocular Surface Interferometer.
Evidence Limitations
Current evidence is limited by small sample sizes and the variability in study designs. Further research is needed to establish standardized protocols for the use of the LipiView and to explore its long-term impact on patient outcomes in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for LipiView Ocular Surface Interferometer?
The LipiView is indicated for the assessment of tear film lipid layer thickness in patients with dry eye disease and meibomian gland dysfunction.
What outcomes have been reported in clinical studies?
Studies have reported that the LipiView can effectively measure changes in lipid layer thickness, aiding in the management of dry eye disease and evaluating the effects of treatments like artificial tears and cyclosporine A.
What complications have been reported?
Safety data from the evidence indicates minimal adverse events, with no significant complications reported in the reviewed studies.
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.