Advanced Laser Vision & Surgical Institute is dedicated to advancing treatment options by participating in Ophthalmology Clinical Trials.
These clinical trials are conducted by Dr. Lipsky and Dr. Stephens in conjunction with Intouch Clinical Research Center which is directed by Teresa Solis, President and CEO.
Clinical trials usually consist of a few office visits over a short period of time. Patients are typically compensated for their time and travel, and they have the benefit of knowing that they are contributing towards a potential new treatment option becoming available in the US.
Why Should I Participate in a Clinical Trial?
Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease.
Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments.
The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.
People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.
Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.
All clinical trials are conducted in phases:
Phase I trials: involve a relatively small group of 20-80 people in order to evaluate safety and identify side effects of a new drug or treatment for the first time.
Phase II trials: involve a bigger group of 100-300 people in order further evaluate a drug’s safety and effectiveness.
Phase III trials: involve even more people, usually between 1,000-3,000, to confirm effectiveness, monitor side effects and compare with typical treatments.
Typically we are involved in Phase III trials at Advanced Laser Vision & Surgical Institute.
Phase IV trials: also referred to as post-market monitoring, occurs after the FDA approves the drug or treatment and the organization monitors its use among the public.
A control group is a group of participants, usually half of all participants, that receives either no treatment or a standard treatment. Researchers compare a control group with a group receiving the experimental treatment in order to determine differences between the two groups.
A placebo is a drug or treatment that is harmless. The placebo is given to the control group in a study without their knowledge. Usually, it is not used if a participant has an illness or condition that would be made worse if he or she went without some kind of treatment.
In order to further reduce bias, researchers conduct blind studies. In single blind studies, patients are not told which treatment they are given. In double-blind studies, neither the research team nor the participants know who is receiving which treatment. Typically, a third party, such as a pharmacist, will know who receives what treatment.
Randomization occurs when different treatments, including placebos, are assigned to participants at random without the knowledge of researchers or participants in order to reduce bias.
Once participants understand the study and understand the lingo used in clinical trials, they should evaluate the benefits and risks of participating.