Clinical trials are research studies that test treatments in development. They are conducted to evaluate the safety and effectiveness of medications, procedures and diagnostic methods. Studies are approved by an institutional review board to ensure the science is sound and patients are protected.
While it is a great act of generosity, volunteering to participate in a clinical trial is a serious decision which should be made with a complete understanding of the commitment involved. Although there is no guarantee you will benefit directly from the research, it’s important to understand that you are contributing to the knowledge base which is likely to help many people collectively over the long term. Discuss the clinical trial with your physician, other health care providers who are involved in your care and your family during the decision-making process. It is important that you ask any questions you might have before you make your decision.
Establishing your eligibility for a vision research study may require the diagnosis of an eye condition. Generally, subjects are screened with a medical history, physical examination, sometimes with a blood test and a comprehensive eye exam including reading a vision chart, measurement of the eye pressure and dilation to evaluate the lens, vitreous and retina. Additional screening may involve questionnaires, lab tests and non-invasive imaging.
Generally, if you participate in a clinical trial, you can receive at least some of the testing procedures for free, including the new medications/surgical procedures being evaluated. You might either receive the treatment under investigation or the standard of care for your condition. The duration of the trial and frequency of visits is variable depending on the trial and knowing this is important before you commit to participating.
Participants of clinical trials are integral to the development of treatments along with the manufacturing companies, physicians and study staff so it is important that you make this decision carefully. It is best to ask your physician or clinic staff if there are any clinical trials you would be eligible for.
Examples of Questions to Ask
Take time to carefully consider the criteria and the commitment. Here are the questions you should have answers for.
- What is the trial’s purpose and who is the sponsor?
- What are the participation criteria?
- Who has reviewed and approved this study?
- Has the treatment been used in other trials?
- What is the investigational treatment being compared to?
- How often is the treatment given?
- How often will you have to come to the doctor’s office?
- How long is the trial?
- What are the potential benefits, short and long term?
- What are the possible risks and side effects, including irreversible vision loss?
- Will you incur any costs and/or will your health insurance be billed for any study procedures?
- Will there by any stipend and/or coverage of transportation costs?
Eligible participants must sign an Informed Consent which describes the purpose of the trial, criteria for eligibility, the treatment, potential risks and benefits, the patients’ rights and responsibilities.