MOUNTAIN VIEW, Calif., June 17 /PRNewswire-FirstCall/ -- 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.
* Vujosevic S, Bottega E, Casciano M, Pilotto E, Convento E, Midena E. Microperimetry and fundus autofluorescence in diabetic macular edema: Subthreshold micropulse diode laser versus modified early treatment diabetic retinopathy study laser photocoagulation. Retina 2010;30(6):908-916.
MicroPulse is a tissue sparing laser delivery modality that works by electronically "chopping" the laser emission into trains of microsecond pulses. This enhances the physician's ability to more precisely control the laser effects on target tissues, offering the potential for ocular treatment options of equal or greater effectiveness, and with less collateral effects than conventional laser treatments.
IRIDEX Corporation was founded in 1989 and is a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems and delivery devices. We provide solutions for multiple specialties, including ophthalmology, dermatology and otolaryngology. We maintain a deep commitment to the success of our customers, with comprehensive technical, clinical, and service support programs. IRIDEX is dedicated to a standard of excellence, offering superior technology for superior results. IRIDEX products are sold in the United States through a direct sales force and internationally through a combination of a direct sales force and a network of approximately 100 independent distributors into 107 countries. For further information, visit the Company's website at http://www.iridex.com.
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, as amended, relating to the Company's clinical results that may be obtained by using the Company's products. These statements are not guarantees of future performance and actual results may differ materially from those described in these forward-looking statements as a result of a number of factors. Please see a detailed description of these and other risks contained in our Annual Report on Form 10-K for the fiscal year ended January 2, 2010 which was filed with the Securities and Exchange Commission and in our Quarterly Report on Form 10-Q for the fiscal quarter ended April 30, 2010. Forward-looking statements contained in this announcement are made as of this date and will not be updated.
SOURCE IRIDEX Corporation