MicroPulse protocol as effective as ETDRS in treatment of DME: Study

Jun 17 2010

IRIDEX Corporation (Nasdaq: IRIX) announced the recent publication of a clinical study comparing results obtained in the treatment of diabetic macular edema (DME) using an IRIDEX laser and MicroPulse™ treatment protocol to those obtained using the recognized standard of care Early Treatment of Diabetic Retinopathy Study (ETDRS) laser protocol. At one year, the prospective, randomized study demonstrated that a MicroPulse protocol was as effective as the ETDRS protocol in the treatment of DME. Moreover, retinal sensitivity improved in eyes in the MicroPulse treated group and decreased in the ETDRS treated group, with no detectable signs of laser damage to retinal tissues in eyes in the MicroPulse group while all eyes in the ETDRS group developed localized laser scars.

"This is the first laser study to demonstrate a significant improvement in central visual function compared to standard ETDRS laser photocoagulation treatment of DME," stated Mr. Theodore A. Boutacoff, President and CEO. "The study findings are important to IRIDEX because they were achieved using an IRIDEX MicroPulse laser and DME is one of the most frequent retinal laser procedures performed."

"Furthermore, being able to obtain the well known persistent benefits of laser photocoagulation with a tissue sparing approach, that causes no tissue damage even after retreatments, may lead to a reevaluation of patient treatment criteria and ultimately to improved long term visual outcomes in chronic diabetic patients."

The study, performed at the University of Padova in Padua, Italy, prospectively randomized 62 eyes with clinically significant DME. Eyes were treated using either a MicroPulse subthreshold treatment protocol with the IRIDEX OcuLight® SLx laser photocoagulator or the ETDRS photocoagulation protocol with an argon laser photocoagulator. At one year, both groups demonstrated a significantly improved central retinal thickness measurement, and stable visual acuity. There was no significant difference in either of these parameters between groups. There was, however, a significant difference in retinal sensitivity measurements. Retinal sensitivity increased (improved) in the MicroPulse treated group and decreased in the ETDRS treated group. The authors observed that the improvement in retinal sensitivity, an indication of improved central visual function which usually parallels a patient's subjective perception of their general vision quality, encourage the use of subthreshold MicroPulse laser, a less aggressive therapeutic approach, in the treatment of DME.