By Christopher J. Rapuano, MD
This part underwent significant revision for the 2008-2009 edition.Reviews the underlying thoughts in refractive surgical procedure, together with its clinical foundation, the position of the FDA, and sufferer assessment. particular strategies are mentioned intimately, and using refractive surgical procedure to regard presbyopia is tested. a brand new bankruptcy discusses overseas views.
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Additional resources for 2008-2009 Basic and Clinical Science Course: Section 13: Refractive Surgery
00 mm Treatment of certain patients with symptomatic decentered ablations from previous laser surgery In addition, devices are classified into I of 3 regulatory control groups (I, II, III). This classification of medical devices identifies any regulatory control specific to the class that is necessary to ensure the safety and effectiveness of a device. Class I devices (eg, refractometers, perimeters, sunglasses, visual acuity charts) are usually considered minimal-risk devices. Although these devices are subject to general 36 .
Consequently, the device is not approved in this subset of patients, and the labeling will indicate that dry eyes are an exclusion criteria. This does not mean that the device is contraindicated in dry-eye patients but that the safety and effectiveness of the device cannot be evaluated in this population because there are no data. Some exclusion criteria may be contraindications to treatment. For example, keratoconus could be an exclusion criterion as well as a contraindication to laser in situ keratomileusis (LASIK).
CHAPTER 1: The Science of Refractive Surgery. 15 Retinal pointsource Reflected wavefront t Lenslet array Laser Figure '-6 Schematic of a Hartmann-Shack wavefront sensor. Wavefront aberrations can be represented in different ways. One approach is to represent the wavefront aberrations as 3-dimensional shapes. This is currently the approach most commonly adopted for refractive surgery. Two-dimensional contour plots may become more popular in the future. In both systems, optical aberrations can be resolved into a variety of basic shapes, the combination of which represents the total aberration of the system, just as conventional refractive error is a combination of sphere and cylinder.
2008-2009 Basic and Clinical Science Course: Section 13: Refractive Surgery by Christopher J. Rapuano, MD