Staar Surgical announced the first patient was implanted in the company’s US 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.
“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,” Caren Mason, President & CEO of Staar Surgical, said in a company news release. “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 investigators 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 6 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.