A novel intraocular implant that preserves the 3-D natural form and intracapsular space of the lens’ capsule during replacement of the natural crystalline lens by an intraocular lens!
fixOflex, a definitive solution to complications associated with human lens capsule deformations following cataract and refractive lens exchange treatments.
Designed to mechanically flex the empty capsule with minimal tension and fix the implanted IOL in its place.
How it works
By refilling and maintaining contact with the inner surface of the lens capsule, fixOflex adapts seamlessly to the size of the normal capsule. Its inner rim structures center and stabilize the optical part of the IOL.
Its implantation is similar to an IOL implantation using a standard injector. Following its placement, the surgical technique is identical to cataract or clear lens exchange surgery
A groundbreaking solution that offers a multitude of anticipated revolutionary benefits
Consistent “bed” for IOL placement
Circumferential barrier against cell migration and PCO
Secure IOL replacement at any time
Elimination of some aspects of dysphotopsias
Universal design that can be used with most IOLs
Partial prevention of forward movement of vitreous
Remarkable Design for Unmatched Performance
The initial idea of fixOflex was conceived in 2008 and the first generation was designed, produced, and clinically studied in several patients within the next six years.
The final design of fixOflex™ 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.
Meticulously crafted using CNC machines, the current design has an overall diameter similar to the human lens and is made of hydrophilic acrylic, a time-tested material widely used in IOL manufacturing. The inner opening of the present mode accepts IOLs with 6 mm optic diameter.
Expecting CE Mark by late 2024
Clinical Trials
The initial trial to evaluate the safety and efficacy of fixOflex in 121 patients with a follow up of 12 months launched in December 2019 at the Alexandria University, Egypt and was completed in 2022 (Principal Investigators: Prof. Ahmed Elmassry and Prof. Osama Ibrahim).
Four additional trials worldwide are currently on the way:
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Prof. Oliver Findl - Vienna Institute for Research in Ocular Surgery, Austria.
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Dr. Santaro Noguchi - Asuca Eye Clinic, Japan.
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Dr. Aristidis Athanasiadis - Tzaneio General Hospital of Piraeus, Greece
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Dr. Agathi Kouri - Aglaia Kyriakou, Children’s General Hospital of Athens, Greece
PCO prevention up to, at least, the first year
Refractive stability from week one
* Alexandria Study I, Data on file
Dr. Roberto Zaldivar
Argentina
Part of cataract surgery weakness consists of capsule contraction that modifies the optical quality of the system, which is why I am very Enthusiastic about the fixOflex device to improve performance.
Osamah Al Hasani
Baghdad, Iraq
fixOflex innovative technology with easy loading, implantation, rotation… filling the lens bag as if it is inflated, embracing the IOL easily with good centration inside the lens bag, giving the opportunity to rotate or exchange the IOL at any time with ease.
Dr. Vardhaman Kankaria
India
fixOflex offers many advantages including less or nil incidence of posterior capsular opacification, physiologically maintaining capsule zonular complex and ease of exchange of IOL whenever needed.
Santaro Noguchi
Japan
In my experience with the use of 100 plus fixOflex rings with almost any different type of IOL… I believe strongly that fixOflex is the real tool to maximize our high end IOL performance.
Prof. Ahmed Elmassry
Alexandria, Egypt
After 2 years of follow up of more than 100 eyes this marvelous device prevented the posterior capsular opacification for all cases. It is an outstanding revolutionary reconstructive device that gives the best postoperative refractive outcome and with ease of implantation.
Prof. Burkhard Dick
Germany
fixoflex has way more and better indications and reasons (predictability, potential exchange in pediatric cases, ...) to use it.
