OptiMedica laser systems in major clinical trial

OptiMedica, Sunnyvale, CA, USA, has been awarded a tender for five Catalys Precision Laser Systems for use in a French multi-center randomized clinical study sponsored by University Hospital of Bordeaux, France.

Financed by the French Ministry of Health, the project will compare the efficacy and cost-effectiveness of laser cataract surgery versus manual cataract surgery in 2,000 eyes at five leading academic centers.

Mark Forchette, CEO at OptiMedica, commented, "We thank the French research coordinators for choosing Catalys for this important study.

"We are confident that patients and surgeons will benefit from the performance that Catalys has been shown to deliver, and we look forward to working closely with each center."

Study coordinator Cedric Schweitzer, MD, University Hospital of Bordeaux, said, "Cataract surgery is one of the most widely performed procedures in the world, and it is only expected to rise as our patient population continues to age.

"This research study is an important initiative that will allow us to investigate the best way to deliver the procedure for the benefit of the patient, surgeon and healthcare system in the future."

Catalys is a precision laser cataract surgery platform that delivers gentle, highly customized procedures with best-in-class accuracy and performance. OptiMedica says Catalys is the only laser platform designed specifically for laser cataract surgery, and it offers several benefits for surgeons and patients.

These include: precise capsulotomies (to within within 30μm), lens fragmentation that segments and softens the cataract, enabling near elimination of ultrasound energy in a number of cataract grades, and custom corneal incision architecture based on anatomical landmarks.

Key proprietary features of the system include a Liquid Optics Interface that ensures gentle docking with minimal intraocular pressure rise and clear optics for unsurpassed imaging and laser delivery; and Integral Guidance, 3D Full Volume Optical Coherence Tomography (OCT) and automated surface mapping algorithms that guide laser delivery.

Background to Catalys

At the end of 2011, optics.org reported on OptiMedica's receiving 510(k) market clearance from the US Food and Drug Administration (FDA) enabling its Catalys laser system to be used for cataract surgery.