SafeCross™ – Riboflavin Solution
Riboflavin solution specifically designed for corneal cross-linking in thin corneas, to treat ectatic diseases by means of the CCR+CXL combined technique.
SafeCross™ is the iVis’ CE-marked riboflavin solution, designed for fast penetration and diffusion into the corneal stroma.
SafeCross™, is a scientifically developed yellow sterile, highly purified, non-irritating, transparent, ocular viscoelastic highly concentrated riboflavin solution, with an optimized osmolarity. SafeCross™ is based on a buffered solution of riboflavin (2,5 mg/mL) and hydroxypropyl methyl cellulose (10 mg/mL), producing an amount of superoxide anion higher than 1,50 µmol/ml, when it is irradiated with 5,4 J/cm2 for 30 minutes at a UV-A 365nm power source of 3 mW/cm2.
SafeCross™ maximizes the oxygen availability and optimizes the singlet oxygen activation.
The percentage of riboflavin and of HPMC available in SafeCross™ is specifically designed to maximize oxygen availability and to optimize the singlet oxygen activation. More in detail, an anion superoxide production higher than 1,50 µmol/ml is achieved with an irradiation equal to E = 5,4 J/cm2.
SafeCross™, thanks to its specifically conceived osmolarity, minimizes either the risk of corneal shrinkage and swelling, maximizing the cross-linking bridges activation.
SafeCross™ allows to perform a safe cross-linking on thin corneas, allowing the synthesis of cross-linking bridges among the stromal fibers without damaging the corneal endothelium.
The percentage of riboflavin available in SafeCross™ is specifically conceived to minimize the risk of corneal endothelium damage.
- Riboflavin: 0.25%
- HPMC: 1,00%
- Osmolarity: 260 – 280 mOsm/Kg
- Sterile, Highly purified, Non-irritating, Transparent Ophthalmic solution
SafeCross™ is indicated for the treatment of cross-linking of the corneal collagen to reduce or stop the keratoconus progression, iatrogenic ectasia and marginal pellucid degeneration.
- Combined treatment of transephitelial corneal regularization and crosslinking
- Epithelium-off crosslinking
The corneal structure may be subject to progressive viscous deformations, increasing over time in presence of a permanent stress, such as the intraocular pressure.
A typical case of viscous deformation having a progressive nature is the keratoconus.
The ectatic pathologies show a localized reduction of the elastic module, induced by an intrastromal cross-linking deficiency of the stromal collagen fibers, which initially does not generate a corneal pachymetry thinning.
However, in the subsequent phases, the permanent stress induced by the intraocular pressure causes a progressive slippage of the stromal fibers generating a local reduction of the corneal thickness, consequently inducing an increase of the local stresses and therefore a localized increase of the ectasia and a decrease of the quality of the vision .
The progression of the pathology may be stopped by the increase of the stromal collagen cross-linking induced by a therapeutic treatment through the cross-linking procedure.
SafeCross™, to perform the cross-linking procedure, is dripped onto the cornea and then exposed to ultraviolet light.
The photochemical activation of riboflavin with ultraviolet light induces the chain of chemical events that promotes the formation of bonds between collagen molecules. In a matter of minutes, the collagen cross-linking procedure is complete.
To stop the progressive viscous deformation of the stromal fibers, an artificial aging effect of crosslinking is induced by means of an irradiation of the corneal stroma, soaked with a riboflavin solution, with an UV light focused beam at 365nm.
The crosslinking procedure is nowadays proven to stop the evolution of the corneal ectasia, but does not provide significant improvements in terms of quality of vision for the patient.
For this reason, patients who undergo crosslinking treatments, despite the stopping of the ectasia progression, are generally dissatisfied as per the refractive outcomes.
Performing a customized transepithelial central corneal remodelling (CCR), in the same surgical session, immediately before the cross-linking procedure, grants the following advantages:
- Reduction of HOCMAs’ (High Order Corneal Morphology Aberrations) to relevantly improve the quality of vision;
- Automated epithelium removal to allow the sub-sequent cross-linking procedure and to take care of its own refractive contribute.
The customized CCR (Central Corneal Remodelling) grants a relevant visual improvement and the sub-sequent CXL procedure allows the corneal stabilization over time.
Keratoconus: Patients suffering from keratoconus experience a thinning of the cornea and an increasing of cornea deformation, causing visual impairments that may lead to corneal transplantation with the progression of the pathology. Cross-linking has the ability to stabilize the cornea, repairing its biomechanical structure and halting or slowing the progression of keratoconus in the early phases of the pathology.
Ectasia: Corneal ectasia is a pathology, which may be induced by different causes, for example, it may result as a complication of a LASIK surgery, increasing myopia and irregular astigmatism, with loss of visual acuity. Whether a patient develops ectasia weeks or even years after a LASIK surgery, the cross-linking procedure may stabilize and strengthen the cornea.