Saturday, December 3, 2022

Evolution Optiks Limited Completes Enrollment of U.S. FDA Clinical Study of LFR-260 Phoropter

Evolution Optiks Limited, a global leader in light field technology applications, announced today the completion of enrollment of the pivotal U.S. Food and Drug Administration (FDA) clinical study to evaluate the safety and efficacy of its subjective light field LFR-260 tele-phoropter (investigational device). Results from the study will be used in the submission to the FDA to support clearance that the company currently anticipates to receive in the middle of 2023.

This study was a multi-center, open-label 2×2 cross-over designed to investigate the effectiveness of the LFR-260 phoropter device compared to traditional phoropters. With the study concluded, we look forward to the final analysis and the subsequent opportunity to present the clinical and patient experience to the ophthalmic community,” says Dr. Anne Reuter, principal investigator of the study.

The LFR-260, a world-first subjective phoropter (investigational device) designed with a proprietary light field engine as its core, tele-operability, and unique capabilities such as QuadView™, is Evolution Optiks’ key product, within the newly launched Optokare division, focusing on eye care medical devices. It is intended to replace the memory-based, back-and-forth guessing that patients experience when obtaining their prescription, by providing up to four views at the same time, each with a slightly different prescription. In addition, its tele-operability is purposed to allow eye care practitioners to access patients in remote areas.

“We are delighted with how the study was conducted and would like to thank the patients, investigators and research teams who are participating in the LFR-260 study. Their hard work and dedication have resulted in a timely enrollment amid challenging circumstances presented by the COVID-19 pandemic. This speaks volumes about the interest to investigate the potential clinical benefits of our device,” comments Raul Mihali, President and Chief Executive Officer of Evolution Optiks.

Andreas Kusay, Chairman of Evolution Optiks, adds: “The regulatory clearance of the LFR-260 to be used as a tele-operable phoropter would add a very attractive solution to a rather stagnant market and unlock a significant addressable market expansion opportunity. With the completion of the enrollment phase, we look forward to shifting to the analysis phase of the study in anticipation of submitting the clinical data to the FDA.”

Medical Device News Magazine
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that 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 purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.
Subscribe to Medical Device News Magazine

Bone Health Technologies announces positive Topline Results from Groundbreaking Pivotal Trial of Non-pharmacological Treatment for Osteopenia

The trial by Bone Health Technologies was conducted in partnership with Laura Bilek, Ph.D., the Associate Dean for Research in the College of Allied Health Professions at the University of Nebraska Medical Center (UNMC) and expert in clinical research for the treatment of low bone mass.

Covalon’s SurgiClear Dressing Plays an Important Part in Preventing Surgical Wound Infections at Top Children’s Hospital

Jeremy Harman, PA-C, an author of the study, commented, "The trifecta of breathable barrier protection, antimicrobials, and the ability to monitor the site is what makes this a great dressing. It's easier for us to assess the wound and is more comfortable for patients."

Verve Medical Announces Results of Feasibility Trial for Transurethral Renal Pelvic Denervation for Uncontrolled Hypertension

The results of the Verve study were published last week in the American Heart Association’s (“AHA”) Hypertension journal. Hypertension is the leading risk factor for preventable deaths worldwide. See link to AHA publication below: (

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