Staar Surgical has announced that patient enrollment for the primary study analysis cohort of 300 subjects has been achieved in its FDA clinical trial, “A Multicenter Clinical Evaluation of the EVO/EVO+ Visian Implantable Collamer Lens.” Primary study analysis will be conducted when 300 primary eyes complete 6 months of follow-up, which is anticipated early in the second quarter of 2021 with submission of the study results to the FDA shortly thereafter.
“Completion of patient enrollment in the clinical trial is a critical step towards the future availability of our proprietary EVO Visian ICL family of products in the U.S. We are very grateful to our clinical trial sites and study investigators for their dedicated work and commitment to successfully achieving the trial’s enrollment milestone in the midst of a challenging COVID-19 operating environment,” Caren Mason, President and CEO of STAAR Surgical, said in a company news release.
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.1 Staar’s EVO lenses are designed with a central hole, which restores more natural aqueous flow and eliminates the need for preoperative peripheral iridotomies. The objective of the U.S. pivotal study is to evaluate the safety, and to collect supportive data on effectiveness, of the EVO Visian ICLs in study participants who have a diagnosis of myopia or myopia with astigmatism. The study includes the following EVO lenses:
- EVO Visian ICL for Myopia
- EVO Visian Toric ICL for Myopia with Astigmatism
- EVO+ Visian ICL for Myopia
- EVO+ Visian Toric ICL for Myopia with Astigmatism
By eliminating the need for preoperative peripheral iridotomies Staar’s EVO Visian ICL provides a simpler, less time-consuming procedure for patients seeking visual freedom. Eliminating the need for preoperative peripheral iridotomies also increases surgeon efficiency and reduces the number of procedures thereby reducing the overall cost and complexity while improving the patient experience and potential positive outcomes.
More than 750,000 EVO Visian ICLs have been implanted in patients outside the U.S. Additional details on the U.S. clinical trial are available on ClinicalTrials.gov here.
1 Neesurg Mehta, MD and Angie Wen, MD, “Myopia: A Global Epidemic, An Overview of the Problem and Efforts to Address It”, Eye, Nov/Dec 2019.