2008-2009 Basic and Clinical Science Course: Section 13: by Christopher J. Rapuano, MD

By Christopher J. Rapuano, MD

This part underwent significant revision for the 2008-2009 edition.Reviews the underlying innovations in refractive surgical procedure, together with its clinical foundation, the position of the FDA, and sufferer assessment. particular systems are mentioned intimately, and using refractive surgical procedure to regard presbyopia is tested. a brand new bankruptcy discusses overseas views.

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Refractive Surgery Because contact lens wear can change the shape of the cornea (corneal warpage), discontinuing contact lens wear is recommended prior to the refractive surgery evaluation and also prior to the surgery. The exact amount of time the patient should be out of contact lenses has not been established. Current clinical practice typically involves discontinuing soft contact lenses for at least 3 days to 2 weeks and rigid contact lenses for at least 2-3 weeks. Some surgeons keep patients out of rigid contact lenses for 1 month for every decade of contact lens wear.

These devices must be used in a facility with an institutional review board (IRB). The FDA has 75 days to review and make a decision on an HDE application. Premarket Approval The PMA process is the primary pathway to market for class III devices. Clinical data from the IDE study, along with manufacturing information, preclinical bench testing, animal data (if needed), and labeling, are submitted to the FDA as a PMA application. The FDA must decide within \80 days whether the information submitted in the application demonstrates the safety and effectiveness of the device in question.

Types of Photoablating Lasers Photoablating lasers can be divided into broad-beam lasers, scanning-slit lasers, and flying-spot lasers. Broad-beam lasers have larger-diameter beams and slower repetition rates and rely on optics or mirrors to create a smooth and homogeneous multi mode laser beam of up to approximately 7 mm in diameter. These lasers have very high energy per pulse and require a small number of pulses to ablate the cornea. Scanning-slit lasers use excimer technology to generate a narrower slit beam that is scanned over the surface of the tissue to alter the photoablation profile, improving the smoothness of the ablated cornea and allowing for larger-diameter ablation zones.

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