IOPtima CO2 Laser-Assisted Sclerectomy Surgery (CLASS)
IOPtima Ltd. has developed the IOPtimate system, a unique, minimally invasive CO2 laser-assisted system for the treatment of Glaucoma.
In utilizing the particular properties of the CO2 laser, CLASS procedure thins the white part of the eye (the sclera wall) by ablating surges at the natural drainage area (the Schlemm’s Canal) without penetrating into the eye. The use of the CO2 laser facilitates adequate, functional percolation of intra-ocular fluid from the eye through the remaining membrane in a simple, highly controlled and specific manner.
As infrared CO2 laser radiation is absorbed and blocked by water and aqueous solutions, it is ineffective in ablating when applied over wet tissues, thus does not allow the procedure to penetrate into the eye like other invasive procedures.
Following the CLASS procedure, the remaining thin scleral layer remains intact, without penetration into the eye, and with no insertion of foreign bodies, which is known to be the source of most ophthalmic surgery complications, adverse events and side effects.
Clinical Evidence and Experience of the CLASS procedure
A multi-center clinical study was performed on 111 patients in 9 global sites (Switzerland, Spain, Italy, Israel, Russia, India and Mexico). Three-year follow up data consistently demonstrate tremendous efficacy in IOP reduction as well as drastic reduction in medication intake. Data also reveals an elevated safety profile by significantly reducing the risk of intra-operative and postoperative complications.
The IOPtimate system utilized for CLASS procedure has received regulatory approvals in Europe (CE Mark), China (CFDA) approval, Israel (AMAR) and Mexico (Cofepris).
CLASS is available in major medical centers across the world and over 700 CLASS procedures have been performed to date.