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Information about LASIK and Custom LASIK Procedures
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Nidek Seeks Hyperopia Approval from FDA
NIDEK Hyperopia Clinical Study Update & Future FDA Studies
-Fremont, CA USA, May 4th, 2004-
NIDEK, Inc. announced today that it has completed and submitted 3-month clinical data for its new hyperopia study to the FDA. This marks an important milestone in the study process, as additional treatment eyes will be initiated in the study protocol effective immediately. NIDEK also received approval from the FDA to expand the clinical study to 300 eyes under the current treatment protocol. The expansion will include 150 eyes each for spherical hyperopia and hyperopic astigmatism. NIDEK has worked closely with the FDA on the design, initiation and evaluation of the clinical study.
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Study of Indication and use of Nidek in treating myopia and astigmatism
The NIDEK EC-5000 Excimer Laser System (including EC-5000CX/CXII) has been approved for use in the United States to perform photorefractive keratectomy (PRK) for the reduction or elimination of myopia in the low, moderate or high ranges (-0.75 to -13.00 D), spherical equivalent at the spectacle plane, uncomplicated by refractive astigmatism (i.e. equal or less than 0.75 D in any meridian), and of moderate myopia with astigmatism from -1.00 to -8.00 D spherical equivalent with astigmatism from -0.50 to -4.00 D absolute cylinder by manifest refraction in subjects who are 21 years or older, and to perform laser in-situ keratomileusis (LASIK) for the correction of myopia ranging from -1.00 D to -14.00 D MRSE with or without less than or equal to -4.00 D astigmatism; in patients who are over 21 years of age; and in patients with documentation of stable manifest refraction as defined in the indications statement over the past year.
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How To Read Your Prescription
About Your Prescription (Rx)
Your prescription provides us with your doctor's recommendation for clear and comfortable vision. Please take a brief moment now to review your information with our 3 samples shown here. They represent 3 different ways of writing the same prescription:
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All About NearVision CK®
NearVision CK® (Conductive Keratoplasty) is a non-laser procedure developed specifically for baby boomers who have had clear vision all their life, but now struggle to see life's details with reading glasses.
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New 10-Year Study Says LASIK Surgery Boosts Vision Long Term
Study Shows Vision Correction From LASIK or PRK Lasts 10 Years After Surgery
By Kathleen Doheny
WebMD Medical News
http://www.webmd.com/content/article/129/117490?src=RSS_PUBLIC
Nov. 13, 2006 -- If you're considering laser surgery to correct your nearsightedness, you can rest assured that the results will last long term.
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Dr. Farzad Yaghouti of Global Laser Vision San Diego wins "Best Lasik Surgeon 2006"
SAN DIEGO, Nov. 8 2006 -- Dr. Farzad Yaghouti of Global Laser Vision San Diego wins the 2006 San Diego CityBEAT Readers' Choice Award as the "Best Lasik Surgeon 2006".
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Overview of NearVisionSM CK® Fact, Stats &Trivia
One of the Safest and the First FDA Approved Technology for Presbyopic Patients
The ViewPoint® CK System, used to perform the NearVision CK treatment, is the first FDA-approved refractive technology for improving the loss of near vision that accompanies presbyopia.
The NearVision CK treatment has one of the highest safety profiles in the refractive market thanks to the use of radio waves, instead of a laser or scalpel, that gently change the shape of the cornea to improve vision.
In addition to its approved indications for hyperopia (farsightedness) and presbyopia (aging eyes), the FDA recently granted approval for a phase-three clinical trial to study CK?s ability to improve near vision in patients who previously had LASIK surgery.
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NearVisionSM CK® (Conductive Keratoplasty®) Scientific Concept
NearVision CK is the first vision treatment specifically for baby boomers who want freedom from their reading glasses. CK is performed using the ViewPoint® CK System; the first FDA-approved technology for improving near vision in presbyopic patients. Nearly 90 million baby boomers have or will soon develop presbyopia, the most common eye condition in America.
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NearVision SM CK® (Queratoplastia Conductiva®)
Cómo se practica la NearVision CK?
La NearVision CK usa ondas de radio, en lugar de un láser o un bisturí, para remodelar la córnea y así volver a enfocar la visión de cerca. NearVision CK se practica usando una pequeña sonda, más fina que un cabello humano, que emite ondas de radio. La sonda se aplica siguiendo un patrón circular en la parte exterior de la córnea para contraer áreas diminutas de colágeno. Este patrón de contracción circular crea una banda de constricción (como al apretar un cinturón), aumentando de este modo la curvatura global de la córnea. El procedimiento, que dura menos de tres minutos, se practica en una consulta usando sólo anestesia tópica (gotas).
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NearVisionSM CK® Hoja informativa
La primera y única tecnología aprobada por la FDA para pacientes presbiopes
El Sistema ViewPoint? CK, que se usa para practicar NearVision CK, es la primera unica tecnología refractiva aprobada por la FDA para mejorar la pérdida de la visión cercana que acompaña a la presbiopía. LASIK no está aprobada para ello; ni tampoco lo están los IOLs (lentes intraoculares).
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Improvement of NearVision after Lasik:Early Results from the Multicenter Clinical Trial
INTRODUCTION
Many myopes who had LASIK in earlier years to improve their distance vision are dismayed by the loss of near vision after the onset of presbyopia. However, many of these patients would not welcome areturn to spectacles or contact lenses.
Surgical options to correct their near vision loss would include hyperopic LASIK, a procedure that has requires a large flap and has the risks of flap complications and epithelial ingrowth. Also, dry eye post-LASIK is not infrequent and is especially undesirable in older patients who have decreased tear production.
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Queratoplastia Conductiva® (CK®) Hoja informativa
NearVision CK es el único procedimiento que corrige la visión indicado específicamente para personas mayores de 40 años (?baby boomers?) que desean liberarse de sus espejuelos de leer. NearVision CK SÓLO puede realizarse usando el Sistema ViewPoint? CK: que es la ÚNICA tecnología aprobada por la FDA para mejorar la visión cercana en los pacientes presbiopes. Casi 90 millones de ?baby boomers? ya experimentan o contraerán en corto plazo presbiopía, la condición ocular más común en los Estados Unidos.
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CK Helps Near Vision in Presbyopic, Post-surgical Eyes
Conductive keratoplasty (CK) (NearVision, Refractec Inc.) improves near vision in presbyopic eyes and in presbyopic eyes that had undergone an excimer laser procedure. Two experts in the technique discuss how the procedure has been incorporated into their practices. ?CK is a non-ablative, collagen-shrinking procedure that changes the corneal curvature. It is the first corneal-based procedure approved by the FDA specifically to improve near vision in patients with presbyopia,? Stephen E. Pascucci,MD, said.He noted that use of CK after an excimer laser procedure is an off-label application. ?Patients who have undergone LASIK, PRK, or LASEK may be dissatisfied with their near vision after the onset of presbyopia.
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Anatomy & Function Of The Eye
Eye Function
The eye works much like a camera. Like the eye, a camera produces images by focusing light to create a visual impression on film. In vision, light enters the eye through the cornea, which with the lens focuses the image onto the retina where it is then transferred to the brain via the optic nerve. The eye?s ability to focus on objects up-close is accomplished by tensing or relaxing the muscles of the lens in the eye. However, with age, the eye loses its ability to focus, making near vision ? the ability to see things up-close ? difficult without the aid of reading glasses.
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About the Actual NearVision CK® Surgical Procedure
Before the CK® Procedure
First, if you have an interest in CK®, you will need to have an examination before treatment to determine if your eye is healthy and suitable for CK®. This exam will include a complete medical and eye history, and a complete evaluation of both eyes. In addition, this examination will involve mapping your cornea with a computer to determine if it is smooth and properly shaped.
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