đź“Š Evidence-Based Reference
savie-aqua 55uv methafilcon a tinnted blue soft hydrophilic contact lens
St. Shine Optical
Summary: The savie-aqua 55uv methafilcon a is a tinted blue soft hydrophilic contact lens primarily used for vision correction. Key evidence highlights its impact on ocular surface health and drug delivery capabilities.
FDA Clearance Information
Pathway
510K
Number
K121201 ↗
Decision Date
October 26, 2012
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The savie-aqua 55uv methafilcon a was cleared by the FDA through the 510(k) pathway on October 26, 2012. It is manufactured by St. Shine Optical and classified as a Class 2 medical device.
What It Is
The savie-aqua 55uv methafilcon a is a soft hydrophilic contact lens designed for vision correction. It features a tinted blue color for ease of handling and is made from methafilcon A material.
Clinical Applications
This device is commonly used in scenarios requiring vision correction, such as myopia or hyperopia. It is also explored for its potential in delivering medications directly to the eye.
Evidence Summary
The literature includes 10 studies ranging from 2015 to 2023, encompassing randomized controlled trials and other study designs. These studies explore various aspects of contact lens use, including ocular health and drug delivery.
Reported Outcomes
Published studies report that the savie-aqua 55uv methafilcon a contact lens can affect ocular surface health, potentially leading to contact lens-induced dry eye. It has also been shown to facilitate sustained drug delivery in experimental settings.
Safety Profile
Reported complications include changes in ocular surface parameters such as central corneal thickness and tear osmolarity. Some studies noted the potential for biofilm formation, which could inhibit drug diffusion.
Evidence Limitations
The evidence is limited by the small sample sizes and the use of non-human primate models in some studies. Further research is needed to confirm findings in human populations and to explore long-term safety and efficacy.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for savie-aqua 55uv methafilcon a?
The device is indicated for vision correction in conditions such as myopia and hyperopia.
What outcomes have been reported in clinical studies?
Studies have reported effects on ocular surface health and the potential for sustained drug delivery.
What complications have been reported?
Safety data indicate potential changes in ocular surface parameters and biofilm formation affecting drug diffusion.
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.