Can I participate in a clinical study?

Every study we have defines the requirements for participants within that study. Eligibility differs for each study, based on characteristics such as age, medical history, and current medical conditions. If you call our office, we can give a preliminary estimate as to whether you might be a candidate, but the best way to find out is to come in for a free consultation. Then, we will be able to determine whether or not you qualify for a clinical study. What are the financial considerations for clinical studies? Some clinical studies offer reduced pricing when compared to the standard treatment costs. The study sponsor, Sacramento Eye Consultants, and/or the participant may pay for the costs associated with the clinical study. A member of our research will discuss all costs with you before you choose to participate in a clinical study.

Why participate in a clinical study?

Patients generally choose to participate in clinical studies because they are able to benefit from new technologies being studied. Also, patients are able to be a part of the future of refractive surgery. Talk with your physician or come in for a consultation to determine whether you would like to participate in a clinical study at Sacramento Eye Consultants.

How do you protect research participants?

Each study is monitored by an Internal Review Board (IRB), whose responsibility it is to protect the patient’s rights and well­being. The IRB ensures that when someone writes a protocol, it will not minimize risk to patients. They ensure that ethical research is being conducted. The IRB discusses and releases content that informs patients and others about the study protocol, the benefits and risks, and what participants should expect during the study.

As a study participant, what are my rights?

If you decide to participate in a research study, it is important for you to understand what is expected of you and the importance of what you are doing. As you are considering participating in a clinical study, we want you to be assured of the rights that you have as the participant. We will provide more information when you are given the informed consent document for the study.

As a participant of a research study, you have the right to ­be informed of the study information and purpose ­Have the details of the drugs or devices used in the study be explained, have your responsibilities explained to you, have the benefits, as well as the risks, dangers, and discomforts of the study to you, be informed of benefits and drawbacks of alternative drugs or devices that may benefit you, ­be informed of your medical treatment options should you be injured while participating in the study, have the opportunity to ask questions regarding the research study, stop involvement within the research study at any time without affecting your treatment in the future, be given sufficient to decide whether you would like to participate in the study without feeling pressured to participate, and be given a copy of the informed consent form which you have signed and dated.

As a research participant, what do I need to do?

Meeting your healthcare needs is essential to you, the participant. Your wellbeing is your first priority. Other responsibilities include: giving us access to your accurate and complete medical history, listening to and following the instructions and guidance of our research team, communicating with us about any questions or concerns you may have, keeping us informed of any changes in your medical condition, and attending all the follow­up visits required by the study protocol.

What is the difference between preclinical and clinical studies?

Before humans are ever used to determine the safety of a technology, preclinical studies are conducted within a laboratory or animal treatment facility. Once a technology has been determined as promising, then clinical studies are conducted in a very regulated manner and under the supervision of a select group of doctors. Clinical studies help determine the safety and efficacy of the technology, as well as whether the technology is superior to existing technologies. If technology is determined to be safe and effective, then it may receive FDA ­approval, at which point it is available to doctors and patients all across the nation.