RELATED PRODUCTS
Keratome System MK-2000	Pachymeter UP-1000	Non-Contact Tonometers	NAVEX Quest NIDEK Advanced Vision Excimer Laser System	ConfoScan4

Risks and Benefits

The EC-5000 CXIII Excimer Laser System 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; for the correction of hyperopia ranging from +0.5D to +5.0D sphere and up to 2.0D cylinder; 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.

In PRK of moderate myopia with astigmatism, due to cylinder coupling effects on sphere, the lower range of the intended use must be restricted in a step-wise fashion, with a nomogram lookup table provided for specific treatment combinations.

In PRK studies of 587 eyes (consistent cohort) after final treatment with refractive data at 6 months, 91.3% were corrected to 20/40 or better and 60.6% were corrected at 20/20 or better without spectacles or contact lenses.
Approval of the PRK for moderate myopia with astigmatism application was based on clinical trials with 749 eyes treated, of which 635 of 748 eligible eyes were followed for 6 months together with supplemental safety and effectiveness information from the 9 through 24 months examination intervals. This clinical investigation extended for 24 months. In PRK for moderate myopia with astigmatism studies of 635 eyes with refractive data at 6 months of follow-up, 93.5% were corrected to 20/40 or better and 64.3% were corrected to 20/20 or better without spectacles or contact lenses. Long term risks of PRK for moderate myopia with astigmatism beyond this time interval have not been studied.

Approval of the LASIK application is based on a clinical trial of 1126 eyes (622 primary and 504 secondary) of which 722 eyes were treated for astigmatic myopia and 404 for spherical myopia. Of all eyes treated, 966 eyes were available for analysis at 3 months, and 758 eyes were followed for 6 months or more. Accountability was 88.3% at 3 months and 82.5% at 6 months. The data analysis was based on the refractive data at the 6 month follow-up examination for 758 total eyes. This analysis showed that 640/758 (84.4%) eyes were corrected to 20/40 or better and 359/758 (47.4%) were corrected to 20/20 or better visual acuity without spectacles or contact lenses. Long term risks of LASIK for myopia or myopic astigmatism have not been determined.

Approval of the LASIK for the correction of hyperopia and hyperopic astigmatism is based on a clinical trial of 291eyes. Six months follow-up results showed the predictability 69% within +/- 0.5D and 93% within +/- 1.0D; the efficacy 60% were corrected to 20/20 or better, 86% were corrected to 20/25 or better, and 99% were corrected to 20/40 or better without spectacles and contact lenses.


Adverse Events and Complications Reported:
In PRK clinical trials the percentage of individuals with 20/20 or better pre-op had best corrected spectacle visual acuity worse than 20/25 in the following proportions; 4.0% (-6.00 to -9.00 D) and 4.8% (>-10.00 D). Complications reported by subjects: An increase in fluctuation of vision (34.1% pre-op vs. 48.1% post-op); glare (26.9% pre-op vs. 34.4% post-op); and difficulty in night driving (23.5% pre-op vs. 48% post-op.)

In PRK for moderate myopia with astigmatism adverse events were reported by at least 1% of subjects at 6 months post final treatment; increased glare (3.7%); increase in fluctuation of vision (5.2%); and an increased difficulty in night driving (19.6%).

Alternatives to PRK for myopia and to PRK for moderate myopia with astigmatism: PRK and PRK for moderate myopia with astigmatism are elective procedures with the alternatives including but not limited to eyeglasses, contact lenses, LASIK, radial keratotomy or automated lamellar keratoplasty.

Contraindications, Warnings & Cautions:
PRK and LASIK are contraindicated in patients with autoimmune, immunodeficiency, or collagen vascular disease, signs of keratoconus, susceptibility to excessive keloid formation, or who are pregnant or nursing, or on certain ocular or systemic steriod regimens. Laser surgery is NOT recommended for patients with a history of ocular Herpes simplex or ocular Herpes zoster. Caution should be exercised when considering performing laser eye surgery on patients with unstable refraction, systemic disease likely to adversely affect wound healing, active ocular disease, glaucoma/ocular hypertension, insulin-dependent diabetes or clinically significant atopic disease, corneal epithelial, stromal, or endothelial dystrophy, previous corneal scarring, previous penetrating ocular or corneal surgery, or in patients currently taking medications which may adversely affect corneal wound healing. The safety and effectiveness of performing laser eye surgery on these patients has not been determined.

Adverse Events for LASIK
The LASIK study showed that most adverse events occurred in trace amounts (<1%). Those that were greater than 1% included 13 eyes (1.2%) that required surgical fixation of a loose flap; and foreign bodies or apparent infection were observed in 20 eyes (1.8%). In addition, at 6 months post final treatment, ghost/double images occurred at 1.3%.

LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), radial keratotomy, astigmatic keratotomy or automated lamellar keratectomy.

In the United States, this device is not to be used in procedures other than those described in the approved U.S. version Operator's Manual.