I Know Why Refractive Surgeons Wear Glasses
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EyeKnowWhy - VISX Disclaimer Text Updated: 3/10/98 Bugs?
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The VISX Excimer Laser System is approved for photorefractive keratectomy (PRK) for the reduction or elimination of nearsightedness (0 to -12.0 D) with up to -4.0 D of astigmatism. Alternatives to PRK include eyeglasses, contact lenses or radial keratotomy. The following are the results of the clinical studies in patients who are mildly nearsighted (MN), mildly nearsighted with astigmatism (MNA), and highly nearsighted with or without astigmatism (HN) at approximately 1 year after surgery: eyes could see 20/40 or better without the help of glasses (MN=94%; MNA=91%; HN=90%), eyes could see 20/20 or better with glasses before surgery and could see 20/40 or better after surgery with the help of glasses (MN=99%; MNA=98%; HN=99%). The following is a list of adverse events and complications that occurred in patients at approximately 1 year after treatment: overcorrection by more than 1 diopter (MN=1.2%, MNA=1.2%; HN=5.1%), overcorrection by more than 2 diopters (MN=0.3%; MNA=1.2%; HN=1.9%), worsening of best spectacle corrected vision with a loss of more than 2 lines of vision (MN=0.4%; MNA=3.5%; HN=2.5%), double vision (MN=1.5%; MNA=5.4%; HN - not available), sensitivity to bright lights (MN=4.8%; MNA=13.0%; HN - not available), increase in astigmatism (MN=3.1%; MNA and HN - not available), difficulty with night vision (MN=5.2%; MNA=18.5%; HN - not available), increase in intraocular pressure (MN=1.8%, MNA=2.2%; HN=0.7%), corneal haze (MN=0.6%; MNA=4.3%; HN=1.3%). The long term risks of PRK have not been studied. This laser is not indicated to correct farsightedness. It is not to be used in procedures other than PRK as described in the approved Operator's Manual.


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