A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

EVO Implantable Lens US Clinical Trial is Underway: Announces STAAR Surgical

1st Patient Implanted at Price Vision Group in Indianapolis on January 30th

STAAR Surgical Company today announced the first patient was implanted in the Company’s U.S. human clinical study for its EVO ICL family of lenses. The investigational study, “A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens,” will be conducted at more than a dozen ophthalmology clinics across the United States.

EVO Visian ICLs are intended to treat a wide range of refractive error, including myopia (nearsightedness) which is the need for distance vision correction. Myopia is the most common ocular disorder worldwide and its incidence is increasing rapidly. An estimated 1.9 billion people globally have myopia and this number is projected to rise by 52% by the year 2050.1

STARR Surgical President & CEO Caren Mason notes: “Enrolling and implanting patients in the U.S. trial of our EVO family of implantable Collamer lenses is the next step in opening the U.S. market, the second-largest market in the world for refractive vision correction, to our latest generation of lenses.”

She added, “Surgeons outside the U.S. have implanted in excess of 750,000 of our EVO lenses in patients as the need for distance vision correction grows. We look forward to the U.S. study of our EVO lenses generating additional safety data on our implantable Collamer lenses.”

Ophthalmology clinics participating in the study include locations in the following metropolitan areas: Indianapolis, Chicago, Dallas, Washington D.C., Philadelphia, St. Louis, San Antonio, Kansas City, Cleveland, Honolulu, Omaha, Fargo and Salt Lake City.

The first patient in the U.S. clinical study of EVO implantable lenses was enrolled at Price Vision Group in Indianapolis. Francis W. Price, Jr. MD, study investigator and founder of Price Vision Group and the Cornea Research Foundation of America, stated, “My team and I very much enjoy investigating new and next-generation approaches that may help patients. I am honored to be the first member of the principal investigator’s group to enroll and implant a patient with the EVO ICL in the United States. This latest version of the Visian ICL, the EVO lens, has a central port that eliminates the need for a peripheral iridotomy (a hole in the iris or colored part of the eye) prior to implanting the lens. Slightly smaller in size to a contact lens, these remarkable ICL lenses are designed to provide vision correction and intended to remain in place as long as the patient is satisfied with his or her vision. The lenses are made of a very thin, soft, flexible and highly-biocompatible Collamer material and are removable if the patient is not happy, or develops a cataract as part of the normal aging process. Price Vision Group already has extensive experience working with the earlier versions of the Visian ICL that have been approved in the U.S. since 2005. Our practice has routinely sought out opportunities to evaluate the most promising vision correction treatments on the horizon, and we look forward to our continued participation in this current study of the EVO lenses.”

A list of participating clinics across the U.S. and additional details on the clinical trial protocol, which has a primary endpoint at six months follow-up, will be posted on ClinicalTrials.gov under “A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens” in late February.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The Evolut ™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
The study was an analysis of AstraZeneca’s Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF). The patient data from the trial was processed with Brainomix’s e-Lung tool. The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
“Since the algorithm for matching patients with donors is changing across for all organs, this was a prime time to better understand whether transplant team decisions to accept a donated organ varied by patient race and gender,” she said. “We wanted to understand how the process of receiving a transplant after listing varied by race and gender, and the combination of the two, so that steps can be taken to make that process more equitable," said Khadijah Breathett, MD.
The Mount Sinai study found that primary care physicians’ approach reflects a dearth of evidence-based guidance for lung cancer screening shared decision-making in patients with complex comorbidities
This is the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

By using this website you agree to accept Medical Device News Magazine Privacy Policy