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proclear omafilcon a soft hydrophilic contact lens
Coopervision
Summary: The Proclear Omafilcon A is a soft hydrophilic contact lens manufactured by Coopervision, primarily used for vision correction. Key evidence highlights its role in myopia control with studies showing its impact on eye growth and myopia progression.
FDA Clearance Information
Pathway
510K
Number
K123202 ↗
Decision Date
May 30, 2013
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The Proclear Omafilcon A Soft Hydrophilic Contact Lens was cleared by the FDA via the 510k pathway on May 30, 2013. It is manufactured by Coopervision and classified as a Class 2 medical device.
What It Is
The Proclear Omafilcon A is a soft hydrophilic contact lens designed for vision correction. It is intended for daily wear and is made from omafilcon A material, which provides comfort and moisture retention.
Clinical Applications
This device is commonly used in clinical scenarios for correcting refractive errors such as myopia. It is also utilized in myopia control strategies, particularly in pediatric populations.
Evidence Summary
The available literature includes 9 studies, comprising randomized clinical trials and prospective studies, conducted between 2021 and 2025. These studies focus on the efficacy and safety of the lens in myopia control.
Reported Outcomes
Published studies report that the Proclear Omafilcon A lens is effective in controlling myopia progression and maintaining eye growth at age-normal levels post-treatment. The lens design impacts accommodative microfluctuations and eye movements during reading.
Safety Profile
Reported complications include general ocular health concerns over long-term use, but studies indicate that the lens is safe for daily wear in children over extended periods. No significant adverse events were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the relatively small sample sizes and the short duration of some studies. Further research is needed to explore long-term outcomes and the impact of different lens designs on myopia control.
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 Proclear Omafilcon A Soft Hydrophilic Contact Lens?
The lens is indicated for vision correction in individuals with refractive errors and is used in myopia control strategies.
What outcomes have been reported in clinical studies?
Studies have reported effective myopia control, with reduced progression and maintenance of eye growth at age-normal levels post-treatment.
What complications have been reported?
Reported complications include general ocular health concerns, but no significant adverse events were noted in the studies reviewed.
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.