fixOflexTM for optimizing
Over the past several decades, through improved diagnostic and therapeutic options, cataract extraction and clear lens exchange have been two of the most common surgeries worldwide with significant visual outcomes.
Despite the explosion of innovations designed to improve the quality of vision, several postoperative complications may occur related to the fibrotic reaction and collapse of the lens capsule, that may be the cause of posterior capsule opacification (PCO) and dislocation of the intraocular lens (IOL).
Moving forward, fixOflexTM is a novel intraocular ophthalmic implant that was developed to “reconstruct” and hold the human lens capsule similar to its natural form to address the above-mentioned complications.
fixOflexTM aims to more personalized care, tailored specifically to every single patient’s needs, giving Ophthalmologists’ the prospect for improvement to achieve optimal satisfaction.
fixOflexTM, circumferential barrier against cell migration and posterior capsule opacification (PCO).
The structures of fixOflexTM’s outer rim maintain contact with the inner peripheral surface of the lens capsule thereby providing a barrier against cell migration
fixOflexTM, consistent “bed” for IOL placement
fixOflexTM contains stable internal rim structures that fix, centre and stabilise the optical part of the IOL between the anterior and posterior capsular fixed space.
fixOflexTM, secure IOL replacement at any time
By preserving the capsular bag form and enclosed volume, the internal fixed structures of fixOflexTM provide a stable environment for any future IOL replacements.
fixOflexTM, partial prevention of forward movement of vitreous
fixOflexTM partially refills the normal lens volume within the capsular bag and may prevent forward movement of the vitreous.
fixOflexTM, universal design, that can be used with most IOLs
fixOflexTM accepts IOLs with a central opening of 6 mm optic diameter permitting the placement of the majority of the commercial IOLs.
fixOflexTM, preservation of capsular bag form and enclosed volume resembling the normal lens
fixOflexTM’s dimensions and flexibility partially resemble the normal lens and, as a result, it preserves the capsular bag’s form and enclosed volume.
The design of fixOflexΤΜ has the shape of a torus like structure that includes both stable and flexible parts
The mean overall diameter of fixOflexTM 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.
The inner opening of the present mode accepts IOLs with 6 mm optic diameter permitting the fitting of the majority of the commercial IOLs. The inner rim includes additional structures to secure the optics in place. The raw material used for the production is a hydrophilic acrylic, hydrated in pure water, a material proven for decades in IOL manufacturing. Each item is precision cut using CNC machines and delivered sterile and hydrated in glass vials.
The manufacturing and sterilization processes adhere to high quality standards pertaining to the manufacturing of IOLs and other intraocular implants.
How it works
fixOflexTM was designed to fix the implanted IOL in its place and flex the empty capsule of the human crystalline lens. This is accomplished by refilling and maintaining contact with the inner peripheral surface of the lens capsule to reconstruct its shape similar to the normal dimensions of the human lens.
The internal rim structures fix, center and stabilize the optical part of the IOL between the anterior and posterior capsular fixed space. The proprietary flexible structures on the outer rim change their exact angulation in order to stretch the lens capsule with minimal tension and adjust fixOflexTM to the bag. In addition, they adhere to Wieger’s ligament area to prevent PCO. Overall, the structure partially refills the capsular bag, thus preventing forward movement of the capsule and vitreous.
Surgically, fixOflexTM is implanted in the lens capsule prior to IOL implantation by using a standard injector, similar to an IOL implantation. After placement of the fixOflexTM 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 fixOflexTM implantation.
The initial idea of fixOflexTM was conceived in 2008 and the first generation was designed, produced, and clinically studied in several patients within the next six years.
This initial design had an external diameter of 10.5 mm, a cross sectional diameter of 1.2 mm, an opening of 2 mm, and was made of medical grade silicone elastomer featuring an internal groove to accommodate different IOL haptics. A lid adjacent to the groove and implanted anteriorly facilitated the insertion of the IOL haptics in the groove.
The final design of the fixOflexTM was completed towards the end of 2018, with significant modifications and improvements, based on a thorough simulation analysis of its biomechanical properties in relation to the human capsular bag.
Furthermore, the design was amended with an additional size in early 2020 to account for the variability on human crystalline lens and capsule size. “Completion of the final design, preliminary in-vitro testing for IOL fitting in the product prototype, and literature review have warranted the initiation of clinical trials in December 2019.
Upon completion of the clinical trials during the second quarter of 2021, the plan is to obtain CE mark certification by mid-2022.
Currently, two sites are running clinical trials to evaluate the safety and efficacy of fixOflexTM.
The initial trial launched in December 2019 at the Alexandria University, Egypt (Principal Investigators: Prof. Ahmed Elmassry and Prof. Osama Ibrahim) with the objective to perform the fixOflexTM implantation and 12-month follow up in 120 patients.
An additional trial is planned to be launched mid-2020 at the University Hospital of Heraklion, Crete, Greece (Principal Investigator: Prof. Efstathios Detorakis) with the intention being to elaborate more on the clinical findings in a small number of patients.
The Medical School of Crete
The University Hospital of Heraklion
Application (early 2020) and patent pending approval in Europe, Canada, China, Brazil, and Japan