The team here at Conestoga Eye has quite the history with academic and clinical research. Dr. Silbert has published more than 100 articles in his career on topics ranging from surgical techniques to clinical efficiency and new optical screening technology for doctor’s offices. What we like to say, is we are always questioning, always learning, and always looking to improve.
One way we are able to continue our passion for learning is by participating in local, regional, and national research studies, or clinical trials. A research study explores a particular medical strategy, treatment, or device to prove if it is safe and effective for humans. Studies often want to discover if a certain medical approach works best for a specific illness in groups of people.
What kind of studies does Conestoga Eye participate in?
Conestoga Eye takes part in many different kinds of studies. The office participates in studies of refractive, vision screening, and other office technology, pediatric strabismus and amblyopia studies, dry eye studies, studies on ocular allergy, tearing and tear-drain obstruction studies, as well as surgical treatment studies.
How long are the studies?
The length of a study can vary. Some studies look at patient progress over a few weeks, others track progress over years. Generally, studies that last for a period of weeks or months are looking at the effects of a new short-term treatment or investigational product (new medical drug or use for a drug); studies that track patient progress over years are often looking at the long-term success of certain type of treatment or surgery.
Who can participate in research studies?
Any patient who participates in a research study is subject to qualification parameters. Just like when you are doing labs in science class, research studies have to set up standards of sameness and plan for any outside factors that might alter the outcome you are investigating. Because of this, certain criteria must be met by every patient for any study.
This criteria is based on the research question and varies from study to study.
Do you charge my insurance to be in a study?
Charging your insurance, again, depends on the study. In general with studies of new drugs the study visit is not charged to insurance. This means your visits are covered by the study. In most of these studies patients are also compensated for their time.
Other studies, particularly National Institute of Health (NIH) studies sponsored by PEDIG where you must see your doctor anyway as a standard of care, will encourage your doctor to bill your insurance company for regular visits while they will cover any extra visits required.
In both cases, studies will reimburse patients for their participation in the study. The reimbursement amount varies from study to study and takes into account the number of visits needed throughout the study period.
Do I have to pay for anything if I am in a study?
No. If you are screened and/or enrolled for a study there is no cost to you. You do not pay for study product or study treatment.
Is my treatment any different if I am in a study?
Dr. Silbert and his team pride ourselves on our standard of care. When patients agree to participate in a study, it does mean that they may or may not receive different care than traditionally prescribed. This does not mean that the different care is bad or deficient. It is simply a different treatment protocol the study is testing for effectiveness.
What do you mean I may or may not receive different care?
A research study always has at least 2 groups – a control group and a variable group. This is how the study is able to see if the treatment or product they are investigating works. Research patients are randomly assigned to 1 of these groups and tracked for progress. For Dr. Silbert to participate in any study he must have equipoise meaning he is not sure which treatment is best.
For example, if you are part of a dry eye study that is testing a new drop. You may be randomized into the investigational drop group or the placebo group. Patients are not to know which group they are in, and many times, neither is our office.
What do I have to do?
When you are approached to participate in a study you will be asked to review and sign a formal consent for participation. Once you are enrolled in a study, it is vitally important that you complete any study diaries fully and attend your scheduled visits. Study treatment is carefully tracked and nearly all studies require specific checkups and data within a certain amount of time.
Who runs studies?
Studies can be run by various different groups or parties. For example, a specific doctor, large association, or pharmaceutical company can be the lead sponsor of a study.
Will I get to know the outcome of the study?
You will most likely not know the outcome of drug studies sponsored by drug companies.
If the study drug or treatment works, do I get to keep it or continue using it?
For most studies you will not get to continue use of the investigational product or specific type of study treatment. Our office will also not be able to tell you when/if the investigational product ever becomes available on the open market or if it was the same product you tested.
I want to get involved in a study now!
Wonderful! Research studies are part of how the medical field continues to ask questions and advance medicine for the world. A great resource if you would like to participate in a study is https://clinicaltrials.gov . There you can learn more about clinical trials that are currently running both nationally and internationally.
If you are interested in studies with our office, you can contact Heather. She will add you to her study list. Conestoga Eye is currently participating in a national dry eye study and a pediatric amblyopia treatment study.