EYE-PCR B.V. is a science and technology based emerging company, applying innovation to improve cataract surgery outcomes.
fixOflex, an artificial capsule reconstructor ring, surgically implanted in the lens capsule after phacoemucification and prior to IOL implantation by using a standard injector. After placement of the fixOflex in the capsule, the IOL is injected, placed, and fixed within the structure. The surgical technique is identical to cataract or clear lens exchange surgery with an additional step of the fixOflex implantation.
The mean overall diameter of fixOflex in its hydrated state is 9.8 mm and in combination with flexible parts on the outer rim adjusts to the size of the human lens capsule. Its raw material is a hydrophilic acrylic, hydrated in pure water, dully tested for biochemical and biological compatibility. EYE-PCR has deployed in-house manufacturing and sterilisation facilities.
fixOflex is reconstructing and holding the human lens capsule open, in a shape similar to its natural form. The ring features an outer rim that’s maintain contact with the inner peripheral surface of the lens capsule thereby providing a circumferential barrier against cell migration and posterior capsule opacification (PCO). Additionally fixOflex has a stable internal rim structure with clips that fix, center and stabilise the optical part of the IOL between the anterior and posterior capsular space. By preserving the anatomical volume pertaining to the crystalline lens fixOflex may prevent forward movement of the vitreous and moreover its internal fixing structures provide a stable environment for possible IOL exchange in the future. fixOflex accepts IOLs within a central opening of 6 mm optic diameter and therefore is compatible with the majority of the commercial IOLs. There is laboratory evidence that fixOflex is blocking the peripheral space between the IOL’s optic and iris while it is also masking the edge of the IOL therefore eliminating both negative and positive dysphotopsias.
The safety and efficacy of fixOflex has been proven in a cohort study with 120 patients with more than 12 months follow up and is currently under clinical evaluation in Egypt, Japan and Greece.
The key outcome goals of fixOflex is to provide an open capsule environment for predictable IOL implantation, stable during primary implantation and after possible IOL exchange while preserving the anatomical space of the crystalline lens and preventing posterior capsule opacification.