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Sidebar: VisAbility undergoes phase 3 studies
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Phase 3 safety and efficacy studies are currently being completed for the VisAbility Micro Insert System.
Twelve-month clinical trial data were submitted to the FDA in November 2017 as part of Refocus’ pre-market approval (PMA) application. At the time of publication, the application was currently under FDA review, and the company expects a decision on the future of the technology later this year.
The VisAbility Micro Insert System has evolved over the years to achieve more consistent and reproducible results.
“It has been extremely rewarding to see the advancements in our technology over the past 12 years,” Selene Burke, OD, vice president of clinical affairs for Refocus Group, said. “We have come such a long way and, thanks to the valuable feedback from our physician group, we have greatly improved the usability of our system while improving the overall patient experience.”
Burke’s primary role throughout the clinical trial was to oversee the overall conduct of the study at 13 U.S. study sites. She also led the clinical training efforts, along with her team of clinical site managers who successfully partnered with study teams to recruit 360 surgical subjects in 15 months.
“Optometrists have and will continue to play an integral role in the success of this technology,” she said.
During the clinical trial, optometrists were responsible for preoperative screening, patient selection and postoperative management.
“Because optometrists are normally the first line for patients seeking presbyopic alternatives, they can be a huge referral source for ophthalmologists hoping to offer the VisAbility Micro Insert System as a surgical option,” Burke said.
Disclosure: Burke is employed by Refocus Group.