Frequently Asked Questions

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

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.

Most modern medical interventions are a direct result of clinical trials research.

By participating in a Lions Eye Institute clinical trial, 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, and you could benefit from additional support and attention provided by clinical staff who understand your condition.

Clinical research also improves health care services in general by improving patient care practices.

Lions Eye Institute scientists and clinicians are at the forefront of eye health research, innovation and treatment locally, nationally and internationally. Many 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 can have both benefits and risks.

Lions Eye Institute researchers do everything in their power to eliminate risk, and you can be assured that when you participate in one of our clinical trials, you will have the best clinical and medical professionals looking after you.

It is important to realise, too, that most new treatments have already undergone extensive testing before they are permitted to be tested in clinical trials.

Benefits 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 staff who understand your condition.
• Receiving closer monitoring of your condition, care and treatment.
• 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.

Some possible risks might include:

• The new intervention in the clinical trial may not work for you.
• The new intervention may not be as effective as established interventions or standard care.
• There may be unpleasant, serious or even life-threatening side-effects associated with the new intervention.
• There may be a need for additional treatment, tests, hospital visits or complicated medication requirements arising out of your participation in the trial. For example, you might need to keep a symptom and/or medication diary, complete health-related questionnaires, have blood/urine tests or perform extra eye/vision tests.
• Depending on the type and phase of the trial, there can be unanticipated risks due to limited use or testing of the intervention in humans.
• Some clinical trials may require a major commitment and some tests may involve some discomfort.

The risks of a specific trial are described in detail in the participant information and consent form that will be provided to you prior to your decision to participate.

Our clinical trials are designed for specific groups of people and have strict Inclusion and Exclusion Criteria on 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.

Participants in our trials can also include people who don’t have any eye conditions. In these trials, healthy participants receive the same test, procedure or drug as the patient group. Our researchers can then compare the effects of the new test between the two groups.

The goal of these inclusion and exclusion criteria is to ensure the trial will produce useful and reliable results.

The first step in considering clinical trial participation is to learn more about clinical trials in general. The federal government provides excellent information on the topic and you can find it at www.australianclinicaltrials.gov.au/what-clinical-trial

To participate in a Lions Eye Institute clinical trial, you will need a referral to see one of our ophthalmologists, who will identify whether there is a trial that may be suitable for you.

You can also obtain further information by emailing our Clinical Trials team at clinicalresearch@staging.lei.org.au or phoning them on 08 9381 0750.

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 or your medical doctor. If you decide to proceed, you can sign the consent document, which means you are agreeing to take part in the trial and understand what is involved.

The consent document is not a contract. You can’t be entered into a trial if you don’t want to be and 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. 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.

At each appointment, you will usually be seen and tested by an orthoptist involved in your trial before seeing one of the study doctors. The tests performed will vary, depending on the trial.

In many clinical trials, you will be assigned to one of two or more groups that will determine which treatment you will receive. You may not be aware of which treatment group you are in. This is called ‘masking’.

Treatments may be injections into the eye, eye implants, eye drops, subcutaneous injections or oral medication.

When the trial finishes, the study doctor will refer you to one of the Lions Eye Institute’s ophthalmologists for ongoing management.

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?

Lions Eye Institute clinical trials are conducted in accordance with the local, national and international guidelines for clinical trials research and 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 must be kept confidential and not disclosed.

Every clinical trial or study is led by a principal investigator, usually a Lions Eye Institute ophthalmologist. The principal investigator works with a research team that can include doctors, nurses, social workers and other health care professionals.

Our research team can also include optometrists, orthoptists and clinical trial coordinators.

All of our clinical trial participants are seen in the clinical areas of our Nedlands centre situated at the QEII health campus.

This means you would need to be in Perth for both the pre-trial screening tests and for the trial period itself. Because of this, it is not possible for participants who are based overseas or interstate to participate unless they are in Perth for an extended period of time.

If you live regionally in Western Australia and are confident you can commit to the requirements of the trial, you can be considered for participation.

LEI also offers ophthalmic assessments for other clinical trial centres which don’t have access to our specialist on-site equipment, so you may be referred to LEI as a clinical trial participant of another health care service or hospital.

In those settings, you may be on a trial where the experimental treatment could have an impact on your eye health.

Clinical trials vary in length from several weeks, or 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 2-3 hours. Generally, you are provided with a schedule of visits and the testing required once you enrol in a trial. This allows you to plan for your visit.

Treatments are provided within a clinical trial at no cost. Patients are not charged to participate in a trial, however in some cases, you may be required to cover your transport costs to and from appointments and for routine medication costs.

All participants have the right to withdraw from a trial at any point in the study, for any reason. However, 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 LEI clinical trials by emailing our Clinical Trials team on: clinicalresearch@staging.lei.org.au or phoning them on 08 9381 0750.

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

• Read the Consumer Guide to Clinical Trials
• See The Australian Clinical Trials Website

For specific information about eye-related clinical trials click here.