A clinical trial is when a new treatment such as a new medicine, surgery or device, is tested on volunteers to see if it’s effective and, of course, safe.

Up until now, the new treatment may only have been tested in the lab, using animals or computer modelling.

There are many strict rules about clinical trials. An ethics an ethics committee approves the trial to ensure the safety of participants and to protect your wellbeing, rights and dignity.

At Cerulea, all human research is approved by an ethics committee and abides by Australian regulations and governance requirements.

Most of today’s great medical achievements come through clinical trials. This is how we get breakthroughs in our medical knowledge.

Clinical research also improves our health care service here and around the world by improving patient care practices.

We’re continuing to take giant strides in many other therapies to prevent or better manage eye diseases and save or preserve sight. This is thanks to the volunteers who participate in our clinical trials.

A clinical trial can give you access to treatments before they become widely available to the public.

People tell us they also value the care, support and information they get from clinical trial staff who know a lot about the disease or condition.

Sometimes a clinical trial improves the eye health of the person who has participated, but not always.

Many people tell us they want to help the next generation or ‘give back’ to the community.

If a person has an eye condition with a genetic link, they often tell us they are thinking about family members who may inherit these genes.

Although we hope a new intervention will work, the purpose of the trial is to see if it reliably helps many people with the same condition.

Sometimes this doesn’t happen. The new intervention may not be as effective as standard treatments.

If you participate in a clinical trial, we will ask you to come to Cerulea for extra appointments and tests. These may include common procedures such as testing your eyesight, measuring eye pressure, administering eye injections, and taking photographs and scans of your eye.

We might ask you to keep a symptom diary, or take different and more complicated medications, or wear a monitor overnight. In some cases, the trial may involve some discomfort or pain.

Before you join a clinical trial, we explain what’s involved and any risks. Once the trial starts, our team explains each procedure in advance to ensure you understand and are comfortable.

You can talk to your own eye doctor if you’re interested in taking part in a clinical trial, or you can contact Cerulea’s research team directly.

If we are studying your eye condition in a clinical trial, we will invite you in for a screening visit. At this visit, we will run some tests to make sure it is appropriate for you to join the trial. We will also talk with you about your eye condition and overall health, and what appointments are involved.

As you can imagine, clinical trials have strict guidelines about who can take part, so that the results of the trial are useful.

Before starting in the clinical trial, we will discuss the trial with you in detail. Our study doctor and study coordinator will provide detailed information, answer your questions, and ask you to sign a consent form.

Joining a clinical trial is voluntary and entirely up to you.

Once a trial gets going, you will be kept informed of any changes. You may be asked to give your consent again.

At each appointment you will usually be seen by an orthoptist, or eye specialist, before seeing a study doctor.

At the end of the clinical trial, your study doctor will speak to you about your preferences for ongoing care. Depending on your eye condition and personal preferences you may be referred to an optometrist, private ophthalmologist or public hospital or clinic.

As a volunteer in a clinical trial, you can stop at any time. You will be supported in your decision.

It’s important to talk to the Cerulea team to make sure we can discuss any follow-up care.

We will also tell you what will happen to information about you that has been collected for the trial.

There’s lots of helpful information on the Australian Government clinical trials website, and you can read suggested questions to ask here as well as a consumer guide to clinical trials.

You are very welcome to contact us here at Cerulea.

Participation in a clinical trial varies from several months, to years. You will know this before you sign on. If for any reason, it changes (this happens sometimes), we’ll let you know.

This depends on what eye test or procedure is being done. We ask you to allow between two and three hours. Although we might do more tests than a standard clinic appointment, waiting times between tests is usually less.

Once you enrol in a trial, we aim to give you a schedule of visits and tests, so that you can plan for your visit.

Participants in a clinical trial join a treatment group where everyone in that group gets the same medication or intervention. There are usually at least two groups in a trial, with each group receiving a different treatment.

In clinical trials, participants typically don’t know which treatment group they are in. This is called ‘masking’. Depending on the clinical trial, study doctors may also not know which group a participant is in.

Masking reduces the risk of bias. Bias, whether it’s intentional or not, can affect results and make them unreliable.

In some clinical trials, a placebo or sham treatment is used to help researchers find out if a medication is effective.

A placebo treatment looks the same as an active treatment but has no active ingredients. In a ‘sham’ treatment, the doctor will go through the same actions, but no treatment is delivered.

OCT stands for ‘optical coherence tomography’. This test uses near infrared light to measure the thickness of structures of the eye. We use this test to monitor changes in retinal thickness associated with diabetes and macular degeneration.

The OCT test is commonly used, safe and painless, and takes only a few minutes.

Fluorescein angiography is also known as the ‘dye test’. In this test, a small amount of fluorescent dye is injected into a vein in your arm. At the same time, we take a series of photographs of the back of your eye that show the dye reaching the retina and other eye structures. Photographs are taken for five to ten minutes.

Fluorescein angiograms can only be performed once or twice a year.

Injections into the eyeball are common in ophthalmology, as this delivers the medication exactly where it is needed. Most people say eye injections don’t hurt and that they soon get used to them.

A doctor first applies local anaesthetic to the eye to make it numb. The eye and surrounding skin are then carefully cleaned with an antiseptic solution. The eyelid is held open with a special instrument, and the injection given into the jelly-like substance behind the white of the eye. The eye is then rinsed. The whole procedure takes about 10-15 minutes.

Some people describe the injection as feeling like ‘pressure’ on the eye, and others say they can feel a brief pricking sensation. You may experience grittiness in the eye for about 24 hours.

The risk of infection is extremely low. To minimise this risk, we use a dedicated treatment room and follow very strict, sterile procedures.

Sometimes the injection can cause a small blood vessel to bleed in the white of the eye. This can look unpleasant for a few days but it is not dangerous.

Participants do not pay to take part in a clinical trial. All treatments are provided at no cost.

Most participants pay for their own transport costs to and from appointments.

Cerulea is located on Level 7 of the Royal Victorian Eye and Ear Hospital, 32 Gisborne Street, East Melbourne, 3002.

Trial participants can take the Blue Lifts up to the Cerulea’s reception.