CUSTOM ICRS PROJECT
CUSTOM-ICRS is an industrial research project focused on developing a new versatile, integral, trustable robust, accurate and fully-monitored manufacturing process based on new cuttingedge production microtechnologies, capable to provide a wider range of customized geometries for ICRS parts, reducing surgery complexity and variability, and offering a better solution to more specific needs of patients. CUSTOM-ICRS is focused on the development of novel manufacturing process of customized intra corneal ring segments based on fully-monitored production micro technologies. Intra corneal ring segments are used in certain ophthalmologic surgical interventions, mainly in keratoconus processes. This disease basically consists on a progressive thinning deformation of the corneal tissue into a cone-shaped profile that entails derivative issues such as diplopia (distortion of vision with multiple images), streaking and sensitive to light. Keratoconus tends to show up in patients below 30 years old, being its appearance ratio between 50 and 200 cases per 100.000 inhabitants, according to recent researches. There are several corrective measures that can be applied in these kinds of diseases. In incipient-case scenario, best solution is based on the use of glasses or specific contact lenses. In cases of severe disease development or intolerance to contact lenses (previously mentioned), most MANUNET TRANSNATIONAL CALL 2014 3 efficient solution involves replacing corneal tissue for a new un-damaged one (corneal transplant), which is known as keratoplasty processes. This provides the best solution but implies going through a fairly traumatic process for the patient, who requires a longer post-surgery recovery time. Due to this fact, it became imperative for ophthalmologists to offer a preventive solution in the middle range, capable of stopping the development of keratocone pathology, avoiding or at least delaying further measures. ICRS appeared as the implantable prosthetic instruments to reach this target, allowing surgeons to place them either individually or in pairs, within the corneal tissue periphery. These parts help modifying corneal topography, so the optical distortions can be corrected. Therefore, there is a clear need the development of flexible and efficient manufacturing processes based on micro-technologies for the high throughput production of biocompatible customized intraocular prosthesis. The combination of micromilling and micro-injection moulding has been identified as promising technologies to face those challenges. However, the current manufacturing processes are still not valid for the direct manufacturing in high volume of customized intraocular prosthesis due to the limitation in manufacturing low cost and rapid molds as well as in the lack of a proper monitorization of the injection process and control of the production atmosphere. The latter is also required to cope with the existing high-res medical regulations. In this line, being able to guarantee the minimization of bacteria transfer both towards the final processed parts, and from the manufacturing tool, is a crucial point in order to establish the basis of a controlled process where final product and working tool are somehow isolated from hostile industrial environment conditions.