Your step-by-step guide to participating in an eye trial.
To participate in a clinical trial at the Lions Eye Institute, 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.
If there is a suitable clinical trial available, you will want to know exactly what is involved. Here is a step-by-step guide to what you can expect.
Step 1 - Initial ‘pre-screening’ discussion with the Study Doctor
This initial ‘pre-screening visit’ has several goals. These include:
- Confirming there is a trial available that suits your condition
- Ensuring you’re fully informed about the trial
A study doctor (an ophthalmologist) and a study coordinator will discuss the trial with you in detail and give you written information about it (Patient Information and Consent Form).
- Providing you with an opportunity to ask any questions
At this point, you are encouraged to discuss the study with your family, friends or family doctor.
Step 2 – Screening Visit
The goals of the screening visit are to confirm your consent to proceed with the study and ensure that you are eligible to participate:
- Confirming your consent to proceed
You should ask any questions you have at this visit and feel comfortable that you understand what your involvement entails. If you choose to proceed, both you and the study doctor must sign the Consent Form.
- Ensuring you are eligible to participate in the trial
Once you have signed the Consent Form, you will undergo a number of procedures to ensure the clinical trial is suitable for you and your eye condition. The flow of what you might expect to take place next is below.
Role of the Study Coordinator
A study coordinator will meet with you before you start in a study, and at every study visit.
Study coordinators will let you know what to expect at each of your trial appointments. They will give you their contact details so you can get in touch with them directly at any time during the trial.
Study coordinators will also record your medications and medical history, complete questionnaires with you and may also measure your height, weight, temperature, blood pressure and other vital signs as required by the trial.
The study coordinator will then introduce you to a research orthoptist (an allied health eye care professional) who is trained in performing eye and vision assessments and taking images required for research purposes. Note that the study coordinator may also be a Research Nurse.
Role of the Orthoptist – and some of the tests you may need to undergo
Most trials require a comprehensive vision test. Your orthoptist will measure which lenses give you the best vision (refraction) and you will be asked to read letters on a chart.
We use a variety of machines to take images of your eyes and one of the most common is optical coherence tomography (OCT). An OCT test uses near infra-red light to measure the thickness of a structure of the eye. It can monitor changes in the retina (the layer at the back of your eye) which can be affected by diseases such as macular degeneration. The test is safe and painless and takes only a few minutes.
Orthoptists may also take photographs of the back of the eye using a special camera known as a Fundus camera. If the study requires any other scans or photography this will be discussed with you in detail.
Some scans require your pupils to be dilated with eye drops. Note that it can take 20-30 minutes for your pupils to fully open and your vision will then become blurry. This means you will be sensitive to bright light (so you should bring sunglasses with you for when you leave your appointment) and effects can last a few to several hours, so it may not be safe for you to drive yourself home. Transport costs (such as taxi-fares) are therefore often covered by the trial sponsor.
General Health Check and Laboratory tests
Most studies require a general health check that includes a physical examination performed by a study doctor and possibly blood and urine tests. These will be needed both at the start of the study to ensure you qualify, and throughout it to monitor your overall health and response to the study medications.
We work with on-site and community laboratories to process blood and urine samples. Some samples are also sent to another laboratory to analyse the results centrally for all patients in that study.
A study doctor will examine your eyes, using a special microscope which gives a magnified view of the front and back of your eye. This will usually first require your pupils to be dilated with eye drops so that the doctor can see into your eye. See more information about what pupil dilation involves in the “Eye Scan” section above.
Step 3 – Eligibility Determination
The study doctor will then review all of the screening tests performed on the day and will be able to determine if the trial is suitable for you. In most trials however, the final decision about your eligibility will be determined by an external organisation (such as an imaging reading centre) that reviews the results of your tests.
Clinical trials often have specific criteria and not all patients will be suitable. If this is the case, the doctor will discuss other standard of care options that may be available to you.
If you’re eligible, you’ll be booked for a ‘baseline’ visit where you’ll undergo your first study treatment. Sometimes, this can happen on the same day as your screening visit, but usually it is a few days or more later, whilst we wait for test results to come back.
Step 4 – Treatment
Clinical trials usually compare the current ‘gold standard’ of treatment with a new treatment, or, if there is no currently approved treatment, a new treatment is compared to a placebo (or pretend treatment).
You’ll be assigned to a treatment group at your baseline visit. You, your study doctor and coordinator can’t influence which treatment you receive and might not know which treatment group you’re in. This is called ‘masking’.
There are many forms of treatments that may be offered as part of a clinical trial, but the most common one is an eye injection. Other forms of treatment may involve eye drops, oral medication (tablets), injections into the skin or even an eye operation.
The amount of time you would need to be on the treatment will depend on the specific trial.
Many of our clinical trials involve treatment by an injection into the vitreous (jelly part inside the eye) through the sclera (white part of the eye). This is called an intravitreal injection. This ensures the medication is delivered to where it is needed.
Eye injections are now a routine treatment for many eye diseases including age-related macular degeneration, diabetic macular oedema and retinal vein occlusions. Most studies involve multiple injections over time – how many and how often depends on the study and, in some cases, on how your eye responds.
Regardless of whether the injection is a standard treatment, a new treatment or a placebo, the injection process is the same and is painless.
Step 5: Follow-up & appointment schedule
The Study Coordinator will be able to provide you with an appointment schedule with the approximate dates that you will need to attend the clinic for treatment, and also any follow-up visits that may be required after the treatment has stopped. The Study Coordinator will always confirm the exact dates/times with you as the trial progresses, and what the trial requirements will be at each visit. Trials can last several weeks, months or years.