Trevues Polymacon Soft Hydrophilic Contact Lenses Tinted Color
Dk Medivision
FDA Clearance Information
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
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
Reported Outcomes
Safety Profile
Evidence Limitations
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)
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →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 →Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →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 →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 →Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →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 →Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →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 →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 →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 →Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →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 →Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →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 →History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →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.