~ENROLLMENT CURRENTLY CLOSED~
Presbyopia Correction Clinical Research Trial
Dr. Ralph Chu at Chu Vision Institute in coordination with Refocus Group (www.refocus-group.com) is currently conducting clinical studies to determine if the VisAbility™ Implant System (VIS) Procedure and the VisAbility™ Implant will eliminate or reduce the need for corrective eyewear arising from presbyopia. This system is investigational and has not been approved by the FDA.
What is Presbyopia?
Presbyopia (which literally means "aging eye") is an age-related eye condition that makes it more difficult to see up close, such as when you are reading. Like gray hair and wrinkles, presbyopia is a symptom caused by the natural course of aging, not a disease.
The first signs of presbyopia are usually noticed between the ages of 40 and 50, and can include:
• difficulty focusing on fine print and/or small objects (particularly in low light);
• the need to hold reading materials further away in order to focus;
• eyestrain when reading for long periods; and/or,
• momentary blurred vision when transitioning between viewing distances.
Presbyopia differs from myopia (nearsightedness), hyperopia (farsightedness) and astigmatism, which are related to the shape of the eyeball and are caused by genetic and environmental factors. Unlike these commonly known eye disorders, presbyopia is simply a symptom of aging and eventually affects every individual.
Dr. Ralph Chu at Chu Vision Institute can diagnose presbyopia as part of a comprehensive eye examination. In addition to checking for other eye problems, he will determine your degree of presbyopia by using a standard vision test, and discuss treatment options.
About the VisAbility™ Implant System (VIS) Procedure
The VIS Procedure is a minimally invasive outpatient procedure which typically takes 15 to 20 minutes per eye. Prior to surgery, you will be given numbing and anti-anxiety medication. These medications will keep you comfortable and relaxed during the procedure. After the procedure, you can expect your eye to be somewhat red and slightly irritated. Although the irritation and inflammation usually go away in a few days, complete healing typically takes three to four weeks.
About the VisAbility™ Implant
VisAbility™ implants are precision molded from an ophthalmic PMMA polymer, a material which has been safely implanted in human eyes for various surgical procedures for over 50 years. Its small size and transparency allow it to be cosmetically and physically unobtrusive for the patient.
Actual VisAbility™ Implant on a Penny:
Am I Candidate?
You may be a candidate for the VIS procedure clinical trials for presbyopia if you meet the following criteria:
• You are between the ages of 45 and 60 years old
• You have difficulty focusing on close objects
• You do not need glasses or contacts to see objects that are far away
• You have not had prior eye surgery
• You have not been diagnosed with any major medical conditions
• You live within one hour of Dr. Ralph Chu at Chu Vision Institute
Note: VIS studies are only available to patients who meet the selected criteria.
How Do I Join the Study?
If you think you may be a candidate and are interested in being considered for inclusion in the study, please contact Nic Jacobs at Chu Vision Institute.
Nic Jacobs, VP Clinical Research and Regulatory
Local | 952.835.1235
Toll-free | 866.400.EYES
For more information, please visit Refocus Group's website at www.refocus-group.com.