Frequently asked questions about eye studies include:
- What is involved in clinical trials for eye conditions?
- What eye conditions are currently being studied in clinical trials?
- How long will participation in an eye clinical trial last?
- How long will the appointments take?
- What is a placebo/sham treatment?
- What is masking?
- What is an OCT?
- What is a fluorescein angiogram?
- What is the procedure for getting an injection into the eye?
- Are injections into the eye painful?
- What are the risks of an injection into the eye?
- Are there any costs associated with being in a clinical trial?
What is involved in clinical trials for eye conditions?
Prior to your first clinical trial appointment, you must discuss the trial with a study doctor and study coordinator and will receive written information about the trial (Participant Information and Consent Form).Your first appointment will be a screening visit where the study team will discuss the study with you in detail and answer any questions. You will be asked to sign the Consent Form if you agree to proceed further.
You will undergo tests to determine your eligibility for the clinical trial. These tests will vary for different trials but may include:
- Measuring what strength glasses give you the best vision (refraction)
- Reading letters down 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)
- Measuring blood pressure, height and weight
- Blood tests and urine tests
- Questions about your general health and medications
- Eye examination
If these tests demonstrate you qualify for the trial, a second appointment will be arranged for you to begin the trial medication. The procedures above may be repeated. In many clinical trials, you will be assigned to one of two or more groups that will determine which treatment you 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 drops, or oral medication.
What eye conditions are currently being studying in clinical trials?
We are currently recruiting for clinical trials investigating age-related macular degeneration (both neovascular ‘wet’ and geographic atrophy ‘dry, late stage’), diabetic macular oedema, uveitis and retinal vein occlusions.
How long will participation in an eye clinical trial last?
Clinical trials vary in length from several months to years. You will be informed at the start of the trial about its anticipated length.
How long will the appointments take?
Appointments vary between studies and will depend on what is required at each visit. Most visits take 2-3 hours. 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/sham treatment?
A placebo or sham treatment appears identical to an active treatment, but does not contain any active ingredient. Placebos and sham treatments 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 participants 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 means 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. This is a commonly used procedure which is safe and painless, taking only a few minutes to perform.
What is a fluorescein angiogram?
Fluorescein angiography is often referred to as the ‘dye test’ and is used to better assess the blood vessels in the retina of the back of the eye. A small fluorescent dye is injected into vein in your arm, while a photographer takes photographs of the back of your eye with a special light. It takes only seconds for the dye to reach your eye and the photograph session lasts five to ten minutes.
What is the procedure for getting an injection into the eye?
Many studies involve injections into the eye. This ensures the medication is delivered where it is needed.
Injections into the eye are a routine procedure for the treatment of many eye conditions. The treatment is performed by a doctor in a dedicated treatment room. You are seated in a reclining chair. You receive local anaesthetic in the eye to numb the eye before the injection. The eye and surrounding skin are cleaned thoroughly with an antiseptic solution to kill any germs. Your eyelids are held open with a special instrument and the injection is 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?
A local anaesthetic is used to numb the eye prior to the eye injection. Some people describe the injection as feeling like “pressure” on the eye, others are aware of a brief pricking sensation. You may 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.