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FAQs

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Frequently asked questions

What is a clinical trial?

A clinical trial is a study involving human volunteers where two or more treatments or interventions are compared for their safety and effectiveness at preventing or treating disease.

A clinical trial is the best way to establish the safest and most effective way to treat a disease.

Where are CERA clinical trials conducted?

The clinical trials run by the Centre for Eye Research Australia (CERA) are conducted at the Royal Victorian Eye and Ear Hospital in East Melbourne where CERA is based.

What questions should I ask before entering a clinical trial?

You can download a list of questions to ask before entering a clinical trial here:

http://www.australianclinicaltrials.gov.au/_files/files/questions_to_ask_australian_clinical_trials_fs_120815.pdf

What happens during a clinical trial?

Before participating in a clinical trial, a doctor and a coordinator will discuss the trial with you in detail and will also give you a written participant information form.  If you wish to participate in the trial, you will be booked in for a screening visit.  At this visit you will speak to a coordinator and a doctor who will discuss the study and you will be asked to sign a consent form after all of your questions have been answered and you wish to proceed.

Usually the first visit is called a screening visit where you will undergo various tests to determine your suitability. Clinical trials have strict guidelines as to who is suitable to be included on the trial, this is based on the presentation of your condition and any other health problems you may have. You must also be able to attend the required appointments, which may be more frequent or of longer duration than if you weren’t in a clinical trial.

At each appointment you will usually be seen and tested by an orthoptist involved in your trial before seeing one of the doctors . The tests performed will vary, depending on the trial. Sometimes telephone questionnaires may be performed in between your hospital appointments.  You will undergo regular appointments and undergo a series of tests at each visit.

At the conclusion of the trial the investigating doctor will refer you to either a clinic within the Royal Victorian Eye and Ear Hospital or a private ophthalmologist for ongoing management.

What are the benefits of participating in a clinical trial?

Participating in a clinical trial can have both benefits and risks.

The benefits may include:

  • Obtaining access to treatment that is not usually available
  • Frequent monitoring of your condition
  • Helping others by assisting in the development of new treatments

The risks may include:

  • unpleasant or even serious side effects
  • treatment may not be effective for some individuals
  • the study may require receiving extra treatments, or hospital visits

The full risks and benefits will be explained in the participant information form for each study.

What happens if I change my mind about participating?

Participation in a trial is voluntary, and participants are free to leave a trial at any time. However, treatment you receive on the trial may not be continued and you will revert to the routine “standard of care” treatment.  You should discuss this with your doctor as there may be additional follow-up required due to your participation.

How long does participation in a clinical trial last?

Clinical trials vary in length. Participation time may vary from several weeks to years. You will be informed at the start of the anticipated length of the trial.

How long do the appointments take?

This will vary between studies and will depend on what is required at each visit.  Most visits take between 2-3 hours, however you will be informed in more detail about this at the beginning of the study.  There are generally more assessments required for a clinical trial than for a standard clinic appointment, however the waiting time between assessments is usually less.

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.

What is a placebo?

A placebo appears identical to an active treatment, but does not contain any active ingredient.  Placebos are used sometimes in clinical trials to enable researchers to compare treatments and retain masking.

What is masking?

Masking refers to the process in clinical trials where the participant and/or study staff do not know which treatment group participant’s are allocated to.  Masking is common in clinical trials and ensures that results that are obtained during the study are not influenced by any expectations.

What is an OCT?

OCT stands for optical coherence tomography. An OCT test uses near infra-red light to measure the thickness of structures of the eye. It is often used to monitor changes in retinal thickness associated with diabetes and macular degeneration. The test is safe and painless, taking only a few minutes to perform.

What is the procedure for getting an injection into the eye?

Many of our studies involve injections into the eye.  This is a way of ensuring the medication is delivered where it is needed.

Injections into the eye are now a routine procedure used in the treatment of many eye conditions. The treatment is performed by a doctor in a dedicated treatment room.   You will be seated in a reclining chair.  You will receive local anaesthetic in the eye to numb the eye before the injection. The eye and surrounding skin is cleaned thoroughly with an antiseptic solution to kill any germs.  Your eyelids will be held open with a special instrument.  The injection will be placed through the white part of the eye into the jelly like substance inside the eye.  The eye is then rinsed out after the injection has been completed.  The whole procedure takes 10-15 minutes.

Are injections into the eye painful?

Some people describe the injection as feeling like “pressure” on the eye, others are aware of a brief pricking sensation. Most experience grittiness in the eye for about 24 hours following the treatment.

What are the risks of an injection into the eye?

The main risk of an injection in the eye is infection. A sterile procedure is followed to minimise this rare event. Sometimes the injection causes bleeding of a small blood vessel on the white of the eye. Although this may look unpleasant for a few days it is not a dangerous side effect. Other risks are even rarer and your doctor will explain these to you before treatment

Are there any costs associated with being in a clinical trial?

Treatments are provided within a clinical trial at no cost.  Patients are not charged to participate in a trial, however, they may be required to cover the cost of their transport to and from appointments and routine medication costs.

How can I find out more information?

If you are interested in finding out more about clinical trials in general, please visit the Australian Clinical Trials Website: http://australianclinicaltrials.gov.au/consumers

If you are interested in partaking in a trial at CERA you should discuss this with your current health care providers. Unfortunately we are unable to screen everyone who is interested in participating in a trial. Your ophthalmologist (eye doctor) may be able to determine if you would benefit from one of the trials currently running.  A referral is required to participate in a clinical trial.

You can also contact the clinical trials team directly on cera-trials@unimelb.edu.au

If you are currently participating in a clinical trial, you can direct questions to the study coordinator or lead ophthalmologist (principal investigator) at any time.