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What are clinical trials and why are they so important?
Clinical trials provide crucial information about the safety, effectiveness, and proper use of new drugs, diagnostic tests, and treatments in people. They are a critical piece of the development of new treatments and medicines. Clinical trials in vision research have led to many new medicines and treatments that have saved or improved sight for thousands of people.
Why should I participate?
You can really make a difference by participating in a clinical study. Improved treatments and new medicines cannot become a reality without going through the process of testing in people. Every clinical study we participate in focuses on a specific eye problem. Each one contributes valuable knowledge toward improving vision. You can be assured a clinical study happens when there is strong evidence that what is being studied is as good as, or better than current treatments. Every participant in ophthalmic clinical studies is vital to finding better ways to save or improve sight, and treat eye diseases and disorders.
Can anyone join a clinical trial?
Anyone can volunteer for a clinical trial, but not everyone will be accepted. All clinical studies have guidelines for determining who can participate. Some studies require people with healthy eyesight, while others require people with a specific visual diagnosis, eye disease or disorder. Before joining a clinical study, your physician will evaluate whether you meet the guidelines and criteria for that particular study. The guidelines and criteria are used to identify appropriate participants, keep them safe, and ensure the study is scientifically designed.
Where are clinical trials held?
Cincinnati Eye Institute conducts clinical studies primarily at the Blue Ash location (1945 CEI Drive, Cincinnati, OH) and at the Edgewood location (580 South Loop Rd., Suite 200, Edgewood, KY). We do selectively involve our other Cincinnati Eye Institute locations and the CVP ambulatory surgery centers.
What happens during a clinical trial?
Participants in a clinical studies will have frequent contact with our research team. Each study has a person in charge, one of our ophthalmologists, who is called a principal investigator. They are in charge of all aspects of the study at our offices. One of your main contacts will be our clinical research coordinator. They can explain all about the study and handle any arrangements for you. In most studies, you will likely have to have eye exams and other tests. You may have to come back for follow-up examinations.
What should I know before I join a clinical trial?
You should know as much as possible about the research study. The informed consent will explain the details of the study. It is important for you to feel comfortable asking questions to our research team about anything you do not understand or anything you would like more information about.
What about participant safety?
There are several safeguards in place that protect study participants. The protection of your safety is essential to us, and it will always be our priority. If we ever believe your safety could be jeopardized,we may ask you to leave the study. You will also be protected by the Institutional Review Board (IRB). Before agreeing to participate, we will review with you the Informed Consent form. This is specifically written for this study and approved by the IRB. It details the nature of the study, any investigational medicine, and any risks involved. We want to make sure you understand it completely before we ask you to sign it. The IRB will be involved and monitoring the study throughout. It is also the IRB’s objective to make sure no undue risk is involved.
What happens when a clinical trial is over?
We will partner with the sponsor to carefully look at all the data collected during the study. This will help us decide about further testing and potential next steps. If the results are particularly important, they can be published in journals and begin the process of FDA approval as a standard approved practice. You can be assured that your personal information and privacy will remain secure.
