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Frequently Asked Questions

Before you decide if the AcuFocus Corneal Inlay clinical research study is right for you, make sure all of your questions are answered.

Below are answers to the most common questions we hear. We encourage you to discuss any additional questions during your office visit with the participating eye surgeon for this research study.

Q: What is an investigational device?
A: An investigational device is one that is used in a clinical research study and is being studied for safety and effectiveness. The device has not been approved for commercial use by the United States Food and Drug Administration (FDA).

Q: Do I have to pay for anything or will my insurance be billed?
A: There is no charge for the procedure or any follow-up visits in the clinical research study. Your insurance will not be billed. The only personal cost to you is your time.

Q: How many times will I have to visit the eye clinic?
A: You will be required to make a number of follow-up visits over a one-year period. During these visits, we will perform a thorough assessment of your eye health.

Q: How long will the appointments last?
A: The research study visits vary in length depending on the type of visit. You can expect your pre-op visit to last between three and four hours. Other visits range from 45-minutes to 2 hours.

Q: Is there a placebo or sham procedure involved in this research study?
A: No. Each participant receives the investigational device.

Q: Does my doctor have to give me permission?
A: It is a good idea to notify your eye doctor about your participation. You may elect to participate without your doctor’s permission.

Q: Will I have to discontinue any of my current medication?
A: Please do not discontinue any of your current medications until you have been instructed to do so by the doctor during an office visit. The Research Study Coordinator can give you more information about your medications.

Q: Are there any side effects, risks, or complications with the procedure or device?
A: The most common side effects are dry eye, glare, and halos. Your Research Study Coordinator or Doctor will discuss these and other potential risks with you during your pre-op visit.

Q: Will I need a stronger AcuFocus Corneal Inlay in the future?
A: No. The corneal inlay does not contain a lens power. It works on the same principle used in camera lenses by increasing your depth of field, which provides a wider range of vision.

Q: What happens if I don’t like the AcuFocus Corneal Inlay?
A: The research doctor can surgically remove the device.

Contact us to learn if you are a potential research subject for this no-cost near vision screening study.

Click here for a complete list of participating eye doctors.

This website contains general information about the AcuFocus Corneal Inlay clinical research study. This information is not intended to provide medical advice. Always consult your doctor for medical advice and treatment.

Caution: Investigational Device. Limited by United States federal law to investigational use.

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