đź“Š Evidence-Based Reference
methafilcon a soft hydrophilic contact lens for daily wear
Biocompatibles Eyewear
Summary: Methafilcon A is a soft hydrophilic contact lens for daily wear, manufactured by Biocompatibles Eyewear. It is FDA-cleared and primarily used for vision correction. Key evidence includes studies on lens performance and bacterial adhesion.
FDA Clearance Information
Pathway
510K
Number
K980218 ↗
Decision Date
March 23, 1998
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The methafilcon A soft contact lens was cleared by the FDA via the 510(k) pathway on March 23, 1998. It is manufactured by Biocompatibles Eyewear and classified as a Class 2 medical device.
What It Is
Methafilcon A is a soft hydrophilic contact lens designed for daily wear. It functions by providing vision correction through a flexible, water-absorbing material that enhances comfort for the user.
Clinical Applications
Commonly used in scenarios requiring daily vision correction, methafilcon A lenses are suitable for patients seeking comfort and ease of use. They are particularly beneficial for individuals with active lifestyles or those who prefer not to use glasses.
Evidence Summary
The available literature includes three studies, ranging from 2012 to 2019, focusing on clinical performance, bacterial adhesion, and drug diffusion. Study types include RCTs and in vitro analyses.
Reported Outcomes
Published studies report that methafilcon A lenses perform comparably to other large diameter lenses in terms of clinical performance. They also highlight challenges in drug diffusion when bacterial biofilms are present.
Safety Profile
Reported complications include potential bacterial adhesion, as demonstrated in studies involving Staphylococcus aureus and Pseudomonas aeruginosa. No direct adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by a small number of studies and a focus on specific aspects like bacterial adhesion and drug diffusion. Further research is needed to explore long-term safety and efficacy in diverse populations.
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 methafilcon A soft contact lenses?
Methafilcon A lenses are indicated for daily wear to correct refractive errors in patients seeking a comfortable and hydrophilic contact lens option.
What outcomes have been reported in clinical studies?
Studies report comparable performance to other lenses and highlight issues with drug diffusion in the presence of bacterial biofilms.
What complications have been reported?
Safety data indicate potential bacterial adhesion issues, particularly with Staphylococcus aureus and Pseudomonas aeruginosa.
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.