Over the past several decades, cataract extraction and/or refractive lens exchange (RLE) have been two of the most common surgeries worldwide with significant visual outcomes. Despite the explosion of innovations designed to optimise the visual outcome of the procedure, several postoperative complications may occur related to the fibrotic reaction and collapse of the human lens capsule. In some cases, a tilt can occur while placing the IOL or the IOL may end up in a slightly different depth within the eye than the pre-operative prediction. In other cases, post cataract opacification (PCO) behind the IOL may develop. Both cases lead to deterioration of visual function and may require secondary treatment and/or eventually the use of glasses and/or contact lenses to obtain “glasses free” visual performance.
fixOflex is a novel intraocular ophthalmic implant that was developed to “reconstruct” and hold the human lens capsule similar to its natural form during surgical replacement of the human lens and address post-operative complications. Moreover, it is a placeholder for any IOL and acts as complementary to IOL implantation providing a beneficial optical outcome to the surgery. fixOflex combines low-cost manufacturing, easiness to use, safety and minimal training for surgeons, giving Ophthalmologists’ the opportunity to achieve optimal satisfaction for cataract and RLE patients. The first generation of th edevice was conceived, designed and tested more than 10 years ago. Design and development is advanced, clinical application is ongoing.
Additional technologies may arise as a result of know-how related to intracapsular implants, such as paediatric. The product’s innovation relies on its benefits which are a) circumferential barrier against cell migration and development of PCO, b) consistent “bed” for IOL placement, c) secure IOL replacement at any time, d) partial prevention of forward movement of vitreous, e) universal design, that can be used with most IOLs , and f) preservation of capsular bag form and enclosed volume resembling the normal lens.
This far, the company has managed to achieve completion of a clinical trial towards CE mark application expecting CE marking of the product by mid 2024, expansion of a trial in Japan through the inquiry of a highly respected ophthalmologist from Japan, presentation of clinical results in a number of conferences worldwide with multiple award achievements, final design, optimisation, and manufacturing of additional prototype for paediatric cases, and ISO 13485 certification of the company. Besides presenting on over 300 cases worldwide and a long 3 year follow up on the primary objective of the intracapsular device, a developmental phase on using the device as a scleral fixated artificial capsule and a slow drug release platform will also be presented.