ClarVista Medical is a clinical-stage ophthalmic company that is introducing the HARMONI Modular IOL system to help surgeons navigate “the increasingly demanding environment of cataract surgery,” CEO Paul McLean said. Intraocular lens (IOL) design has not undergone a fundamental change in decades, but that’s about to change, he promised.
“Until we can solve the dilemma of predictable lens position, refractive outcomes after surgery will always be somewhat unpredictable,” he said. The HARMONI system comprises a base component and an optic component that work together “in elegant simplicity” based upon a stable foundation in the capsular bag. Both components are made of the same material delivered through a clear corneal incision. An advantage of the system is that surgeons can replace the optic component at any time “for a new standard of optimized outcomes,” McLean said. Optic components include monofocal, multifocal, toric, and extended depth of focus to customize vision to patients’ needs.
The system received the CE mark in 2015, and is undergoing three new studies. These studies now have hundreds of patients enrolled that will comprise the foundation for the FDA submission. Full results of these studies are expected in fourth-quarter 2016[correct?], “but what we’re seeing is consistent with earlier studies,” McLean stated.
The system remains stable in the eye, unlike traditional IOLs, which showed greater fluctuation in anterior chamber depth. Posterior capsular opacity (PCO) rates are about 0.5% (compared with the Alcon SA60 lens, with a 3.0% PCO rate).
Paul McLean is President and CEO of ClarVista Medical. ClarVista Medical is clinical stage, ophthalmic device Start-up Company focused on the development of the HARMONI modular intra-ocular lens system to optimize vision in the setting of cataract surgery.