NIDEK Receives CE Mark Approval for Optical Path Difference Customized Aspheric Treatment (OPDCAT) for NIDEK EC-5000 Excimer Laser System
-June 28, 2005 - Gamagori, JAPAN -
NIDEK Co. Ltd. announced that it has received CE Mark approval for its proprietary Optical Path Difference Customized Aspheric Treatment (OPDCAT) algorithm and software for the NIDEK EC-5000 Excimer Laser System. This regulatory milestone clears the way for NIDEK to market its laser and custom treatment algorithm, known as OPDCAT, throughout the world, especially in Europe and the Middle East for the correction of myopia and myopia with astigmatism with aberrations of the entire optical system.
“This is a major milestone for NIDEK and our refractive surgery business in Asia, Europe, the Middle East and South America. With this approval, NIDEK takes an advanced step forward in providing our customers around the world and their patients with the best possible clinical outcomes in the market today for laser vision correction,” said Hideo Ozawa, President and Founder of NIDEK CO., LTD. “NIDEK can now provide an innovative system designed to improve refractive outcomes for patients and treat aberrations of the entire optical system, with wide ranges of myopia and astigmatism.” Added Mr. Hideo Ozawa.
OPDCAT uses a proprietary and revolutionary ablation algorithm based on topography and wavefront data generated by the NIDEK OPD-Scan. With a combination of slit scan and multi-point ablation, OPDCAT is intended to correct refractive errors as well as optical aberrations of the entire eye. Aberrations based on corneal and entire eye irregularities can result in visual blur and other undesired visual phenomena are reduced with this new ablation algorithm. This results in a shorter visual recovery period and better post-operative visual acuity.
The clinical data submitted to gain CE mark approval showed excellent clinical outcomes with 97 percent of patients having an uncorrected visual acuity of 20/20 or better. In addition, 86 percent of patients gained at least one line of best-corrected visual acuity. 86 percent of patients were within 0.50 diopters of the targeted refractive correction. Average contrast sensitivity was maintained three months post-operatively, indicating the potential of excellent quality of vision after the procedure.
“The use of OPDCAT software algorithm with NIDEK’s excimer laser technology potentially increases the visual acuity and quality of vision while addressing two major issues in refractive surgery: treatment of aberrations of the entire optical system and reducing higher order aberrations that can occur post-ablation. NIDEK’s excimer platform now offers a full suite of treatment algorithms that use wavefront and topography data from the NIDEK OPD-Scan to treat a patient’s refraction needs. We expect an unsurpassed level of patient and physician satisfaction with this improvement in refractive surgery,” noted Mr. Hideo Ozawa
The CE Mark is an indication that a company has met essential health, safety and environmental protection requirements detailed in 22 European Directives covering an array of products including medical devices. The CE Mark allows products to gain access to the EU market, assuring physicians and patients of the safety of the product.
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