by Lisa Fulghum, Research Studies Coordinator, Carolina Eye Associates
Clinical research studies find new ways to understand, treat or prevent eye disease and vision loss. These studies in vision research have led to new medicines and surgeries that have saved or improved sight for thousands of people.
What is a clinical trial? Clinical trials are medical research studies in which people, also called human subjects, volunteer to participate. A clinical trial is used to evaluate the safety and effectiveness of an “intervention” to prevent, diagnose or treat an eye disease or disorder. Examples of interventions include:
- biologics (e.g., vaccines, blood, cells)
- procedures (e.g., surgery)
- delivery systems (e.g., telemedicine, face-to-face interviews)
- ways to change health-related behavior (e.g., diet, exercise)
- treatment routines
- prevention strategies
- diagnostic tests
After a treatment shows promise in the laboratory, it is tested in a study to determine if it will be beneficial for patients. The studies are controlled, allowing the researchers to compare the effects of a new treatment with those of another treatment.
Four types, or phases, of clinical trials exist: Phase I clinical trials test a potential new treatment in a small number of volunteers to determine the best dosage and identify potential side effects. Phase II clinical trials test a potential new treatment in a larger number of volunteers to learn how the body responds to the treatment, the optimal dose of the treatment and how the treatment affects a certain eye condition. Phase III and IV clinical trials may include hundreds or thousands of volunteers around the country. These studies compare a new treatment with existing treatments or no treatment to determine if the new treatment works better, the same or not as well. Phase III clinical trials are conducted to get the new treatment approved by regulatory agencies. Phase IV clinical trials are conducted after approval to understand more about the treatment.
The researcher in charge of a clinical trial is called the principal investigator. The person who makes the arrangements for your visits and explains how the study works is the research coordinator. All the doctors involved in the study follow a detailed treatment plan or study protocol. The protocol ensures that all participants are treated in a standard way.
Eyes are one of many body parts that come in pairs. This feature gives researchers additional options when they design the study. If an eye condition affects both of your eyes, one eye might be placed in the treatment group for a study and the other may be in the control group. Generally, the eye that will be treated is randomly assigned.
Clinical trials allow us to translate science into new therapies for our patients. Participation in clinical trials allows participants to play a more active role in their own health care, gain access to new research treatments before they are widely available and help others by contributing to medical research.
Carolina Eye Associates participates in a number of clinical research studies. For more information on the clinical research program, contact Lisa Fulghum, Research Studies Coordinator, at (910) 255-2053.