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Sioux Valley Physician Participates in FDA Clinical Trial

The U.S. Food and Drug Administration has approved a U.S. Clinical Trial to test the effectiveness of the AcuFocus ACI 7000 Inlay.

The U.S. Food and Drug Administration has approved a U.S. Clinical Trial to test the effectiveness of the AcuFocus ACI 7000 Inlay. The inlay is inteded to improve new vision in patients with presbyopia ("aging eyes") for reading without glasses. Qualified participants will receive this investigational procedure at no charge.

Some of the first procedures in the United States will be performed at Sioux Valley Clinic-Vance Thompson Vision. The inlay is placed in the eye’s outer layer (cornea). There, it sits securely without the use of sutures. Vance Thompson, MD, will perform the procedures. He is one of the few surgeons in the United States that will be leading the U.S. Clinical Trials, having recently devoted extensive study to current corneal inlay clinical trials around the world, including Istanbul, Turkey and Mexico City.

“We’ve seen excellent results overseas, and are excited to make the clinical trials available to people here in the U.S.,” said Dr. Thompson, who’s performed more than 32,000 laser and surgical vision correction procedures. “This procedure is very different than anything we’ve done with vision correction procedures before.”

“We are very pleased to have Dr. Thompson and his research team involved in the leadership of this clinical trial,” said AcuFocus president, Ed Peterson. “They have established a great reputation for running very efficient studies while following FDA protocol to the letter. Also, the people of Sioux Falls are always very good about completing the follow up visits and other requirements of participants.”

Who can benefit?
Anyone who has trouble reading or the need for reading glasses.

What’s involved?
Implanting the inlay is a simple surgical procedure that takes less than 15 minutes. After the procedure, participants will be required to return for scheduled follow-up examinations. Return visits will occur nine times over a two-year period and participants will receive the procedure and all examinations at no charge.

What is presbyopia?
The Greek word for “aging eye,” presbyopia is the most prevalent eye condition in America, affecting most people after the age of 40 and everyone by age 51. Presbyopia causes near vision to fade with age, making it difficult to see things up-close. An estimated 90 million baby-boomers either have presbyopia or will develop the condition within the next 10 years. These people struggle to read or do hobby work, and must rely on magnifying reading glasses for even the most mundane of daily tasks, like checking their watch.

How Can I Learn More?

Anyone interested in participating in the clinical trial in the Sioux Falls area should contact Vance Thompson Vision at (605) 328 3937, or register for the next Free Reading Glasses Seminar.