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FDA panel to consider study guidelines for clear lens exchange

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Guidelines for clinical studies of clear lens exchange will be the focus of a meeting of a government advisory panel in Washington next month. The Ophthalmic Devices Panel, an advisory body to the Food and Drug Administration, will discuss “general issues surrounding the use of intraocular lenses for correction of presbyopia after clear lens extraction,” according to information posted on the FDA’s Web site. The procedure is commonly referred to as clear lens exchange (CLE) or PRELEX, for presbyopic lens exchange.

The group will address clinical study design elements, including the risk:benefit ratio for patients with various refractive errors, study sample size, the need for control groups, inclusion and exclusion criteria and the incidence of retinal detachment and other complications.

For more about the PRELEX procedure, click here.