Learn more about cataracts and the current FDA approved treatments available. Below you will find the clinical trial(s) Dr. Foster is participating in.
What is this device?
We are excited to be clinical investigators for the IC-8 lens clinical study. The clinical study is designed to evaluate if the IC-8 lens will provide far, intermediate and near vision for patients with cataracts.
The IC-8 lens is a clear monofocal lens with a mini-ring placed in the center. The mini-ring has an opening, or pinhole, designed to increase the range of vision by extending the focus of light rays that enter the eye.
Caution: Investigational Device. Limited by Federal (or United States) law to investigational use.
How many people will receive the device?
There are two ways patients may be able to participate in the clinical study:
- Test Group (IC-8 Lens Group) will have a standard monofocal lens implanted in the first eye. If visual requirements are met after the first lens is implanted, the IC-8 lens will be implanted into the other eye. The IC-8 lens is an investigational device and is being studied to determine if vision at all distances is clearer than with a standard monofocal lens in both eyes.
- Control Group (Monofocal Lens Group) will have a standard monofocal lens implanted in the first eye. If visual requirements are met, a standard monofocal lens will be implanted in the other eye. A standard monofocal lens is designed to provide far vision, but not near or intermediate vision.
The sponsor of this clinical trial plans to enroll 355 patients into the test group and approximately 120 subjects into the control group throughout the United States. Our office plans to enroll approximately 20 subjects in the test group and 7 in the control group.
Comparison of the two groups will help determine the improvement in vision with the IC-8 lens. Patients who participate in either group and comply with study commitments will be compensated.
Will the patient know if they got the device?
Both the doctor and participating patients will know if they receive the investigational lens or the monofocal lens. There will be some technicians that perform tests throughout the study that will not know which lens the patient receives.
Who can participate in this trial?
This is a study for patients that have visually significant cataracts (see worse than 20/40 with glasses) and are ready for cataract surgery.
How long with the trial last?
This clinical study will ask patients to complete 11-12 visits within a specified time frame over the course of 1 year.
For more information on this study please see the resources below: