The task of securing our quality standards at CISIS can be illustrated best by comparing it to Formula 1:
At Formula 1, you need excellent cars as well as a driver who can take full advantage of the car’s potential.
Similarly, CISIS (Corneal IntraStromal Implantation System) requires certain components. CISIS is a premium procedure. The MyoRing has a unique potential of "healing" keratoconus. Medical practitioners who wish to apply it have to undergo extensive training in order to take full advantage of the potential the procedure offers. Practitioners have to possess a profound knowledge of keratoconus itself and they have to be experienced in the field of corneal surgery. Further, they have to thoroughly understand the clinical, biochemical and pathological interplay of the procedure. Only if all of these circumstances apply can the best result be obtained in each case. This includes the decision-making process before and after the surgery takes place. The specialized training of medical practitioners by DIOPTEX (www.dioptex.com), thus, represents an important part of the successful treatment of keratoconus.
CISIS/MyoRing was developed by DIOPTEX and Dr. Daxer for treating keratoconus and specific forms of nearsightedness. DIOPEX has developed high-quality training for medical practitioners, which allows them to achieve the exceptional results that can be accomplished with the procedure.
2003: DIOPTEX GmbH (www.dioptex.com) is founded by Dr. Albert Daxer as a research and development company to improve the treatment possibilities for keratoconus and complicated myopia.
2005: Financial support from AWS (Austria Wirtschaft Service), the support bank of the Republic of Austria for new and innovative technologies, for the development and approval as a medical device in the EU.
2007: Approval as a medical device in the EU.
2008 - 2014: Application and approval of the technology under clinical routine conditions in more than 7,000 eyes and more than 20 countries around the world. This evaluation and optimization process receives financial support from the Austrian Research and Science Fund. The result is an optimized and clinically and technically mature technology, an optimal treatment scheme, a perfect plan for the training of ophthalmologists, a mathematical process to calculate the ideal MyoRing dimension for every single case as well as an extremely high degree of effectiveness and safety. There is currently no treatment option for keratoconus which is as safe and effective as CISIS/MyoRing.
2015: Start of optimized clinical application focused on Europe, with the starting point in Austria.
2017: First two treatment centers in Germany (Munich, Hamburg) which follow the proven treatment guidelines. In 2009, a treatment center had already been established in Milan and another center in Madrid followed in 2014.
The graph on the right shows the influence of training and methodology on the results of the treatment. An analysis like this allows for pinpointing weaknesses concerning the offered training and ways to improve it. It shows that a well-trained practitioner needs at least 45 annual operations in order to utilize the full treatment potential of the method. In case of fewer annual operations, not the method itself is subjected to evaluation, but the ability of the corresponding practitioner. Practitioners who lack the specific training offered by DIOPTEX hardly ever obtain superior results (orange line).
Thus, there is a plethora of factors which influence whether or not the full potential of healing a keratoconus can be reached by practitioners for the benefit of the patient.
The most important factors are:
Only the MyoRing possesses an entirely regular and closed ring structure. Thus, it not only allows for reshaping the irregular cornea of a keratoconic eye in favour of obtaining a regular shape in order to enhance the corrected and uncorrected visual acuity, but simultaneously strengthens the cornea mechanically up to a degree which prevents a progression of the disease.
Only the PocketMaker provides the gentle and precise preparation of the tissue which is necessary for obtaining excellent results. Via the introduction of the MyoRing into a lamellar gap at a depth of the cornea of 300 micro metres, it is possible to reshape the cornea into a regular form in a biomechanical manner. Ideally, the frontal corneal lamella has to be able to slide against the rear lamella along the lamellar gap in order to reach a new equilibrium. However, the stronger the frictional and the sliding resistance, the less optimal the reshaped form. For this reason, the femtosecond laser leads to considerably worse results than results obtained in CISIS centres which are obliged to use the PocketMaker. As opposed to the ultra-thin, highly precise and with lamellar micro-vibration equipped diamond of the PocketMaker Ultrakeratom, the femtosecond laser does not lead to a perfect cut. Rather, the shots fired by the femtosecond laser lead to explosions within the tissue, which it “rips open” along the treated section. This fairly rough procedure of preparation by the femtosecond laser increases the possibility of interphase reaction of the tissue, as well as frictional and sliding resistance along proximal areas against an adjustment of optimal balance. Contrary, the proximal area between the frontal and the rear corneal lamella created by using the PocketMaker Ultrakeratom is perfect to such an extent that even bio microscopes (slit lamp) cannot recognize it. Thus, the results obtained by the PocketMaker are considerably better than results obtained by the femtosecond laser. However, the latest improvements in femtosecond laser technology will probably also allow performing CISIS/MyoRing treatment with the femtosecond laser.
Individual preoperational calculation of every single cornea:
DIOPTEX does not use nomograms anymore, but a semi-analytical procedure for calculating the optimal dimensions of the MyoRing in each individual case. This procedure considerably improved the variability of results in addition to the already existing high precision.
Training program for medical practitioners:
The thorough training of medical practitioners, who have previously been trained as cornea specialists and are, thus, highly qualified, takes place over the course of one year. Aside from manual skills, which are acquired while working with the PocketMaker, general knowledge of treating patients in terms of surgical, clinical and biomechanical aspects are conveyed. Further, the evaluation of preoperative conditions, as well as postoperative evaluations of the obtained results (in case they require further optimization) are considered as important. Medical practitioners are supervised in terms of evaluating the obtained results and making further decisions. In addition, highly-innovative telemedical tools and processes are used.