📊 Evidence-Based Reference

Trevues Polymacon Soft Hydrophilic Contact Lenses Tinted Color

Dk Medivision

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Summary: Trevues Polymacon Soft Hydrophilic Contact Lenses are tinted contact lenses designed for vision correction. They are primarily used for daily wear and have been evaluated in various studies for their material properties and potential drug delivery applications.

FDA Clearance Information

Pathway ? 510(k)
Number ? K220045 ↗
Decision Date ? August 5, 2022
Product Code ? LPL
Device Class ? Class 2
Evidence ? 419 studies

The Trevues Polymacon Soft Hydrophilic Contact Lenses were cleared through the FDA 510(k) pathway on August 5, 2022. Manufactured by Dk Medivision, they are classified as Class 2 medical devices.

What It Is

These lenses are soft, hydrophilic contact lenses made from polymacon material, designed for vision correction. They are tinted for aesthetic purposes and are intended for daily wear by individuals requiring vision correction.

FDA-Cleared Indications

  • Correction of refractive errors, including nearsightedness and farsightedness.
  • Daily wear as prescribed by an eye-care professional.

Clinical Applications

  • Vision correction for myopia (nearsightedness).
  • Vision correction for hyperopia (farsightedness).
  • Daily-wear contact lens use under the direction of an eye-care professional.

Reported off-label uses

  • Use as a platform for ocular drug delivery has been studied for soft contact lenses, but this application is not established as an FDA-cleared indication for Trevues lenses.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Evidence Summary

The available literature includes 10 studies, ranging from randomized controlled trials to observational studies, conducted between 2011 and 2021. These studies explore various aspects of contact lens materials, including drug delivery capabilities and material properties.

Reported Outcomes

Published studies report that the lenses maintain good wettability and ionic permeability, with minor effects on physical properties. They have been shown to sustain drug release in experimental settings and exhibit good biocompatibility.

Safety Profile

Reported complications include potential bacterial adhesion, as observed in studies involving pathogens like Staphylococcus aureus and Pseudomonas aeruginosa. However, the lenses are generally considered non-toxic and biocompatible.

Evidence Limitations

The evidence is limited by the small number of studies focusing on clinical outcomes in real-world settings. Further research is needed to explore long-term safety and efficacy, particularly in diverse patient populations.

Practical Considerations

  • The lenses are tinted and made from polymacon, a soft hydrophilic contact-lens material.
  • Available parameters, including base curve, diameter, and optical power, depend on the specific prescription and product configuration.
  • They should be fitted, inserted, removed, cleaned, and replaced according to the manufacturer’s instructions and an eye-care professional’s prescription.
  • Patients with active eye infection, significant ocular inflammation, or conditions that make contact-lens wear unsafe may need to avoid them.
  • Contact lenses are not evaluated for MRI safety in the same way as implanted devices; patients should follow the lens and MRI facility instructions, and lenses are commonly removed before MRI.

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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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 Trevues Polymacon Soft Hydrophilic Contact Lenses?

These lenses are indicated for vision correction in individuals with refractive errors such as myopia or hyperopia.

What outcomes have been reported in clinical studies?

Studies report good material properties, sustained drug release capabilities, and biocompatibility.

What complications have been reported?

Safety data indicate potential bacterial adhesion, but overall, the lenses are considered non-toxic and biocompatible.

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.

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