NIDEK Gains FDA Approval for Hyperopia and Hyperopic Astigmatism Module on EC-5000 Excimer Laser
August 4th, 2008 by admin
Fremont, California, October 18, 2006
NIDEK, Inc. a global leader in laser and diagnostic instrumentation for the optical and eye care industry, announced today that the U. S. Food & Drug Administration (FDA) has approved its EC-5000 Excimer Laser for the treatment of hyperopia and hyperopic astigmatism for use in LASIK. With this approval, ophthalmic surgeons are able to treat hyperopia and hyperopic astigmatism (+0.50D to +5.00D sphere and up to 2.00D cylinder) in addition to the current approved range for myopia and myopic astigmatism. Hyperopia or farsightedness may be surgically treated by laser vision correction or LASIK. Mr. Motoki Ozawa, Vice President, NIDEK Co., Ltd stated, “This is a historic event for NIDEK and we are especially pleased to have this long-awaited approval. The excellent and outstanding results from 291 eyes demonstrate NIDEK’s commitment to providing an innovative, technologically superior excimer platform for laser vision correction surgery. Furthermore, NIDEK is actively developing its own custom ablation and wavefront technology platform”. “The EC-5000 Excimer Laser System is a perfect pairing to NIDEK’s strong, world-class product portfolio in unsurpassed diagnostic and surgical instrumentation, optical finishing and dispensing products in vision care”, Mr. Ozawa said. The following chart demonstrates six month follow up results of the safety and effectiveness of the EC-5000 Hyperopia clinical results:
Six Month Follow Up Results (291 eyes)
69% within ± 0.5 D
93% within ± 1.0 D
60% 20/20 or better (UCVA)
86% 20/25 or better (UCVA)
99% 20/40 or better (UCVA)
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September 13th, 2011 at 11:15 pm
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