10-Year Study Demonstrates IRIDEX MicroPulseâ„¢ Laser Therapy Safe, Effective for Patients with Diabetic Macular Edema
MOUNTAIN VIEW, Calif., Dec. 12, 2011 /PRNewswire/ -- IRIDEX Corporation (Nasdaq: IRIX) today announced that data from a clinical study(1) compiled over 10 years demonstrates the safety and efficacy of MicroPulse laser therapy for treating diabetic macular edema (DME) without the retina tissue damage associated with conventional laser therapy. According to the United States Centers for Disease Control and Prevention, DME, a swelling of retinal tissue, is the leading cause of new cases of blindness amongst adults aged 20-74 in the US.(2)
The study, which was released via early publication, was led by Jeffrey K. Luttrull, MD, an ophthalmologist and retinal surgeon with the Ventura County Retina Vitreous Medical Group in California. A total of 252 eyes with macular edema (212 eyes due to diabetic retinopathy, 40 eyes due to branch retinal vein occlusion) were followed. Of these, 181 patients met study inclusion criteria, received subvisible MicroPulse laser treatment, and were followed for up to 10 years.
Dr. Luttrull stated, "MicroPulse laser therapy is an ideal first-line treatment for retinal vascular macular edema because of its unique safety profile. Using specific laser parameters discussed in our recent study, MicroPulse laser treatment can be performed which I believe is both absolutely harmless and at least as effective as conventional thermal retinal photocoagulation. Because of its unique ability to produce the desired therapeutic effect without any measurable inflammation or damage to functional retinal tissue, treatment can be initiated earlier, possibly improving long-term outcomes."
Diabetes affects 25.8 million people, or 8.3% of the US population. In 2005-2008, 4.2 million people, or 28.5% of the US population, with diabetes aged 40 years or older had diabetic retinopathy, and of these, 655,000 had advanced diabetic reti