Edmonton to Host Clinical Trial for Nova Oculus Medical Device that Could Help Improve Vision for AMD Sufferers
EDMONTON, Alberta, Dec. 14, 2018
EDMONTON, Alberta, Dec. 14, 2018 /PRNewswire-PRWeb/ -- NOVA OCULUS PARTNERS, LLC, and its Canadian partner, the Eye Machine Canada Inc., have been given the green light to immediately begin a clinical patient trial in Edmonton using their pioneering technology for treating Age-Related Macular Degeneration (AMD).
The medical devices bureau of Health Canada has granted what is called an Investigational Testing Authorization for the trial, while approval of the protocol and the study's investigator has been given by the clinical trials committee of the Health Research Ethics Board of Alberta. Recruitment of the trial participants will begin immediately.
The clinical trial will be conducted independently in Edmonton by optometrist Dr. Brent Saik using the company's Nova Oculus II device. Serving as investigator for the trial will be Dr. Michael Fielden, an ophthalmologist with the Calgary Retina Institute. The trial will be double-blind study involving 50 patients. A double-blind study is one in which neither the participants nor those administering the tests know whether the patient is receiving the actual treatment or a placebo. This procedure is utilized to prevent bias in research results.
How long the study will take is unknown. "We will conduct the trial as quickly as possible, but it is a complex trial with a challenging patient population," said Walter O'Rourke, the Fergus, Ontario-based chief operating officer for Nova Oculus. "Our priority is the care of the trial participants and the production of good data."
Results from the trial will play a key role in gaining regulatory approval in Canada for the Nova Oculus II device. It was designed and engineered to use microcurrent electro-therapy technology to treat the dry version of AMD.
AGE-RELATED Macular Degeneration has no cure. It is the No. 1 cause of severe vision loss and legal blindness in adults over 60 in North America. More than 15 million North Americans suffer from this affliction — a figure that is expected to double as baby boomers age.
ABOUT NOVA OCULUS
NOVA OCULUS is the name of the pioneering new medical device engineered and developed to treat the dry form of Age-Related Macular Degeneration—and for the Canadian-American company that created it.
The Nova Oculus II device could revolutionize the treatment protocols for dry AMD and offer hope to millions of North Americans who might otherwise going blind without it. Though dry AMD is an affliction without a cure, the Nova Oculus company's patented microcurrent electro-therapy technology can help mitigate its symptoms.
Nova Oculus Partners boasts a blue-ribbon team of highly experienced engineering professionals leading its efforts to bring Nova Oculus to market. The company has also assembled a medical advisory board that includes some of the leading optometric professionals in the United States who are assisting in developing a plan to earn FDA approval for the Nova Oculus II device and gain its widespread commercialization in the U.S. Efforts toward regulatory approval are also underway in Canada and Mexico.
The Nova Oculus II device has been certified as complying with the quality management standard set by the International Organization of Standardization (ISO) and the electrical safety standard set by the International Electrotechnical Commission (IEC). These global certifications will help pave the way for regulatory approvals for Nova Oculus in Europe and elsewhere.
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SOURCE Nova Oculus