Frequently Asked Questions

A clinical trial is a research investigation in which people volunteer to test new treatments, devices, or interventions to determine their safety and effectiveness in preventing, curing, or treating diseases and medical conditions.

Clinical trials can assess how people respond to a new treatment, how the new treatment compares to existing treatments, and what, if any, side effects might occur.

By participating in a clinical trial with Lions Vision Trials, you can contribute to advancing scientific knowledge in eye health, and in some cases improve your own eye health and that of others with the same condition.

Clinical trials can provide access to new interventions before they become widely available. As an added benefit, studies have shown that those who participate in clinical trials benefit from additional support and attention provided by clinical staff who understand your condition. Clinical trials also improve health care services in general by improving patient care practices.

Lions Vision Trials team members, in collaboration with the Lions Eye Institute’s scientists and clinicians, are at the forefront of eye health research, innovation, and treatment locally, nationally and internationally.

Many of our scientists and clinicians have received Australian and international awards and recognition for the quality of their research and for the practical clinical applications that have been developed as a result of their clinical trials.

Participating in a clinical trial may have benefits to the participant. Clinical trials are an investigation and can also have risks. You can be assured that when you participate in one of our clinical trials, you will have an experienced clinical trial team and world-class medical professionals looking after you.

It is important to realise that all new treatments have already undergone extensive testing for safety before they are permitted to be investigated in patients in a clinical trial.

Benefits of participation might include:

• Receiving a new intervention that is better for your eye condition and has fewer side effects than your current treatment.
• Being offered access to the newest interventions before they are publicly available.
• Playing an active role in your own health care.
• Gaining a greater understanding of your condition.
• Receiving advice, care, and support from trained clinical trials staff and medical professionals who understand your condition.
• Receiving closer monitoring of your condition, care, and treatment as directed by the clinical trials standards.
• Clinical trials may also be valuable for people with rare or difficult-to-treat conditions where there is limited evidence about that condition’s treatment or management.

The risks of a specific clinical trial are described in detail in the Participant Information and Consent Form that will be provided to you prior to your decision to participate. You will also have ample time to discuss the content of the Participant Information and Consent Form with your doctor.

Clinical trials are designed for specific groups of people and have strict inclusion and exclusion criteria for who is eligible to participate. These criteria could include factors such as age, gender, type and stage of your eye condition, previous treatment history, and other medical conditions.

Eligibility is based on requirements that ensure the trial is scientifically sound and produces reliable results. Ultimately, your doctor will determine whether the trial is suitable for you and your medical condition.

For further information related to clinical trials participation, please contact Lions Vision Trials at lionsvisiontrials@lei.org.au or phoning (08) 9381 0777. If you are a patient at the Lions Eye Institute, you can also speak to your doctor to see if there are any trials that would be suitable for you.

If you are considering participating in a clinical trial, the Federal Government provides excellent information on the topic and you can find it at australianclinicaltrials.gov.au/about/what-is-a-clinical-trial.

Before participating in one of our clinical trials, a study doctor and study coordinator will discuss the trial in detail with you and give you a Participant Information and Consent Form. This document details the study’s purpose, duration, required procedures, risks and potential benefits. Any questions you have can be answered at this time.

Every person taking part in a clinical trial must give ‘informed consent’, or have a parent, guardian, or other legally authorised person give consent.

You can take time to discuss your clinical trial participation with your family and/or any of the doctors that may be overseeing your care.

The consent document is not a contract. If you agree to participate in a clinical trial, you can withdraw from the trial at any time.

If you agree to proceed, you will undergo screening tests to determine your eligibility for the clinical trial. The requirements are different for every trial. These may include:

• Measuring what strength glasses give you the best vision (refraction)
• Reading letters on a vision chart (visual acuity assessment)
• Measuring the pressure in your eye (intraocular pressure)
• Photos and scans of your eye (which may include optical coherence tomography (OCT), fluorescein angiography, and other imaging tests)
• Measuring blood pressure, height and weight
• Blood tests and urine tests
• Questions about your general health and medications
• Eye examination.

If there are any changes to the trial you will be kept informed and you may be asked to give your consent again before proceeding with the trial.

Your initial discussions with your study doctor and study coordinator should provide the answers to any questions you may have. However, you should be satisfied that you have been given the answers to some of these questions:

• What is the purpose of the trial?
• Why do researchers think the approach may be effective?
• Who is funding the trial?
• Who has reviewed and approved the trial?
• How are trial results and participant safety being monitored?
• How long will the study last?
• What will my responsibilities be?
• Who will tell me the study’s results and how will I be informed?
• What are the possible short/long-term benefits?
• What are the short/long-term risks and side effects?

Clinical trials at Lions Vision Trials are conducted in accordance with local, national and international guidelines for clinical trials research. They have approval from a National Health and Medical Research Council (NHMRC) certified Human Research Ethics Committee which checks that the research conforms to the requirements of the National Statement on Ethical Conduct in Human Research.

These guidelines, laws, and codes of conduct, in conjunction with the comprehensive informed consent process, aim to protect both trial participants and the integrity of the research.

All clinical trials must follow a carefully controlled protocol, which is a plan that describes what researchers will do in the study and ensures the trial is as safe as possible, that the researchers measure the right things in the right way, and that the results are meaningful.

Participant confidentiality

As a clinical trial progresses, researchers may report the results of the trial at scientific meetings, to medical journals, and to various government agencies. When they do this, the names and personal details of trial participants are kept confidential and not disclosed.

Every clinical trial is led by a principal investigator, usually a Lions Eye Institute ophthalmologist. The principal investigator works with the Lions Vision Trials team members to conduct the trial.

All of our clinical trial participants are seen in the clinic of the Lions Eye Institute in Nedlands. This is situated at the QEII Medical Centre.

If you live regionally in Western Australia, you still may be eligible for participation.

Clinical trials vary in length from months to years. You will be informed at the start of the trial about its anticipated length.

Appointments vary between studies and will depend on what is required at each visit. Most visits take two to three hours, or potentially longer, depending on the trial requirements. You will be informed of the visit schedule and the testing required prior to signing the Participant Information and Consent Form.

Treatments are provided within a clinical trial at no expense to you.

All participants have the right to withdraw from a trial at any point in the study, for any reason. However, the treatment you receive on the trial can’t be continued outside the trial. You should discuss your decision to leave the trial with your doctor as there may be additional follow-up required.

Your withdrawal at any stage won’t result in any penalty or loss of any rights or benefits you’re entitled to.

You can obtain further information about participation in a clinical trial with Lions Vision Trials by emailing lionsvisiontrials@lei.org.au or phoning (08) 9381 0777.

For more general information about clinical trials you may wish to:

• Read the Consumer Guide to Clinical Trials
• See the Australian Clinical Trials website

Read more about eye-related clinical trials.