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Company Milestones
2006
This year, the number of NearVision
SM
CK
®
treatments is expected to increase 50 percent over 2005 to 150,000 procedures.
Phase Three of the Post-LASIK clinical trial studying the safety and efficacy of NearVision CK to improve near vision in patients with a history of LASIK (laser-assisted in-situ keratomileusis) surgery is expected to be completed by 2007.
2005
December 31, 2005: More than 100,000 treatments were performed in 2005, reflecting an over 30 percent increase in the number of procedures performed in 2004.
More than 800 physicians nationwide are certified to perform the NearVision CK treatment.
October 4, 2005: The US Food and Drug Administration (FDA) grants Refractec final approval to study the safety and effectiveness of the modified
LightTouch
surgical technique and the associated nomogram for improvement of near vision in hyperopic and emmetropic presbyopes.
February 18, 2005: The FDA grants Refractec final approval for a phase-three clinical trial to study CK’s ability to improve near vision in patients who previously had LASIK (laser-assisted
in-situ
keratomileusis) surgery.
2004
December 31, 2004: More than 75,000 CK treatments have been performed since 2002 when the FDA first granted approval (47,828 cases in 2004 alone, reflects a 50% increase in procedure volume over 2003 due to boomers’ demand for CK’s presbyopia solution).
October 25, 2004: NearVision CK becomes the nation’s leading non-laser refractive procedure according to research firm Market Scope. The 2004 Annual Survey of Refractive Surgeons found that the non-laser refractive procedure market as a whole grew 54.7% over 2003, fueled in part by the expanded indication for CK.
March 22, 2004: The US FDA approves NearVision CK for the millions of baby boomers with presbyopia; making it the first and only FDA-approved vision technology for the nation’s most-prevalent eye condition.
February 9, 2004: NearVision CK receives unanimous recommendation from FDA ophthalmic devices panel, which recommends approval. Unprecedented decision considering CK is the first treatment for presbyopia ever presented to the FDA for approval consideration.
2003
December 31, 2003: Some 22,491 CK treatments are performed nationwide by more than 350 physicians. CK also closes out the year by capturing 14 percent of the US refractive market in CK's approved range, according to Market Scope and Refractec’s sales data.
August 25, 2003: Refractec files with the FDA for pre-market approval using CK for the treatment of presbyopia.
2002
December 31, 2002: Refractec completes enrollment of presbyopia clinical trial with 150 patients / 188 eyes treated.
From May 2002 to December 31, 2002, more than 5,500 CK treatments are performed.
April 16 2002: FDA approves CK for the treatment of farsightedness (hyperopia) in people over age 40.
2001
May 2001: First eyes treated in FDA-approved clinical trial of CK for presbyopia, making it the first treatment to be studied for patients who struggle with reading glasses after age 40.
2000
April 2000: Breakthrough CK procedure reviewed at American Society of Cataract and Refractive Surgeons (ASCRS) Meeting in Boston. World-renowned ophthalmologists Dr. Marguerite McDonald and Dr. Jonathan Davidorf release initial results from FDA clinical trials for hyperopia (farsightedness), as well as the first comparison study of CK to LASIK.
1999
November 1999: Refractec begins international clinical trial to study the effectiveness of CK for hyperopia and presbyopia.
February 1999: Dr. Edward Manche of Stanford University treats the first patients with CK technology. Refractec gains FDA approval to begin clinical trial for hyperopia.
1993
Refractec founded, specializing in innovative ophthalmic refractive surgery technologies.
ViewPoint
®
CK System developed, applying the first use of radiofrequency energy for shrinking corneal tissue to create refractive change.
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