cisis

Focus on quality

The task of securing our standard of quality 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 full potential.

Similarly, CISIS (Corneal Intrastromal Implantation System) requires certain components. CISIS is a premium procedures. The MyoRing has a unique potential of "healing" for 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 possible in each individual case be obtained, including decisions made before and after the surgery takes place. The specialized training of medical practitioners by DIOPTEX (www.dioptex.com), thus, comprises an important part in 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 take full advantage of the high-quality of results the procedures offers.

History:

2003: DIOPTEX GmbH (www.dioptex.com) was founded by Dr. Albert Daxer as a research and development company to improve the treatment possibilities in 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, to perform development and medical device approval in the EU.

2007: Approval as a medical product in the EU.

2008 - 2014: Application and proving of the technology under clinical routine conditions in more than 7000 eyes in more than 20 countries around the world. This evaluation and optimization process was financially supported by the Austrian Research and Science Fund. The result was 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 the optimal mooring dimension for every single case as well as an extremely high degree of effectivity and safety. There is currently no treatment option of keratoconus being as effective as safe as CISIS / MyoRing.

2015: Start of optimized clinical application focused on Europe with the starting point Austria.

2017: First 2 treatment centers in Germany (Munich, Hamburg) which follow the proven treatment guidelines. Already since 2009 a treatment center in Milan and since 2014 a treatment center in Madrid was established.

Quality control:

Quality control

The graph on the right shows the influence of training and methodology on the results of the treatment. Analyses like these allow for pinpointing weaknesses concerning the training offered and to improve it. It shows that using the PocketMaker for preparing the cornea leads to considerably better results (blue line) compared to the application of femtosecond laser (green line). Further, it suggests 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 a rate of fewer annual operation, 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 these results (orange line)

Thus, there is 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:

MyoRing:

Only the MyoRing possesses an entirely regular and closed ring structure. Thus, it not only allows for reshaping the irregular cornea of a keratoconus in favour of obtaining a regular shape in order to enhance the corrected and uncorrected visual acuity, but also, simultaneously, strengthens the cornea mechanically up to a degree which prevents the further development of the disease.

PocketMaker Ultrakeratom:

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 rather 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 are perfect to 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 application of the femtosecond laser. However, the latest improvements in Femtosecond Laser technology will probably also allow performing CISIS / MyoRing treatment assisted by the Femtosecond Laser.

Individual, preoperational calculation of every single cornea:

DIOPTEX does not use nonograms anymore, but a semi-analytical procedure for calculating the optimal dimensions of the MyoRing in each individual case. This procedure could considerably improve the variability of results in addition to the already existing high precision.

Training programme 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. Besides manual skills which are acquired while working with the PocketMaker, general knowledge of treating patients in terms of chirurgical, clinical and biomechanical aspects are conveyed as well. Further, the evaluation of preoperative conditions, as well as postoperative evaluations of the obtained results in case they should require further optimization are considered important. Medical practitioners are supervised in terms of evaluating the obtained results and taking further decisions. In addition, highly-innovative, telemedical tools and processes are used.

 

 

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