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New Treatment to Restore Near Vision Approved

FDA OKs NearVision CK for Presbyopia
By Jennifer Warner
WebMD Health News

March 23, 2004 -- The FDA has approved a new treatment that may make it easier for millions of baby boomers to read this article.

 

Yesterday, the agency approved the NearVision CK procedure for the treatment of presbyopia. The minimally invasive treatment uses radio waves to reshape the cornea and bring vision back into focus for aging eyes.

 

It's the first FDA-approved technology for the condition that affects most people by age 40 and everyone by age 51. Researchers estimate that 90 million baby boomers either have presbyopia or will develop it in the next 10 years.

 

The condition causes near vision to fade as the eye's lens gradually hardens with age and makes it difficult to read things up close. Sufferers typically hold things at arm's length to help focus items properly. Many people with presbyopia must use reading or magnifying glasses to perform simple tasks like reading a menu or newspaper.

New Treatment for Presbyopia

The NearVision CK procedure is performed using a probe thinner than a human hair that releases radiofrequency energy into the eye. The radio waves shrink areas of tissue to increase the curvature of the cornea and restore near vision.

 

The procedure requires use of an eye-drop anesthesia and can be performed in a few minutes in a doctor's office. It's typically performed in only one eye to improve near vision without compromising distance vision.

 

The FDA based its approval on clinical trials that showed NearVision CK significantly improved patients' near vision. Twelve months after the procedure, 98% of patients could see magazine- and newspaper-size print in the treated eye, and 87% could see 20/20 in the distance and also read phonebook-size print.

 

The procedure was previously approved in 2002 for age-related farsightedness (hyperopia).

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