Professor Augusto Azuara-Blanco speaks to OT about a randomised trial evaluating the effectiveness and safety of 0.01% atropine eye drops for children with myopia funded by the National Institute for Health Research.
The research team incorporates several academic optometrists, including Dr Nicola Logan, who is the co-chief investigator. Professor Azuara-Blanco explains why the research is being conducted and its significance for optometrists.
Why are you conducting this study?
There is already quite good evidence that atropine works to reduce or stop myopia progression in children. The vast majority of studies on atropine have been done in Asia. Perhaps the UK population may respond differently to atropine – we don’t know. That was one important reason: whether the evidence that is available from studies in Singapore, Hong Kong and China is directly applicable to a UK population?
The other reason is that the evidence for the very low dose of atropine is not very strong at the moment. There are several trials with 1% atropine, 0.5%, 0.2% atropine and 0.1% atropine but 0.01% only has one trial that was comparing different concentrations without a control group and treating only 75 children.
How is the trial being conducted?
We are recruiting 289 participants between the ages of six and 12 across five UK sites; Belfast, Glasgow Caledonian University, Aston University, Anglia Ruskin University and Moorfields Eye Hospital. We will have roughly 60 participants at each site. The range of myopia in the children who are recruited will vary from half a dioptre to 10 dioptres. They cannot have any other systemic health problems or ocular problems such as existing amblyopia or astigmatism of more than two dioptres.
This is a placebo-controlled trial. We are asking participants to use one drop every day for two years. The drops may either be 0.01% atropine or a placebo that has the same pH, the same preservatives and the same vehicle as the low dose atropine. They have to attend research visits at baseline and then every six months. Twice as many children will have atropine compared with placebo.
We are also monitoring the compliance using an electronic monitoring system where the bottle of eye drops is within a larger plastic bottle that has a microchip in the cap. We will know exactly when the parents open the bottle. That will be used to monitor compliance and also mean that we can potentially support those who are having problems.
Other trials using low dose atropine are also happening in Dublin and Western Australia at the same time. At the end of our trial, we are going to merge the data because we have shared protocols. It is a joint effort in a way.
What outcomes will be measured?
Our primary outcome is degrees of severity of myopia measured under cyclopegia with an autorefractometer. Another very important outcome is the axial length, which is an important secondary outcome. We are also evaluating safety and tolerability and other secondary outcomes.
What relevance does this research have for optometrists?
Optometrists may be interested in this research because atropine eye drops are something that they may potentially prescribe in the future. I think optometrists are in the best position to handle myopia interventions. I don’t think this needs to be managed by ophthalmologists if low dose atropine works well and is safe, as we expect. I think it should be offered in the community.
What are the chances that atropine will be made available after the trial?
The National Institute for Health Research funds trials that are important for the health of the population. It doesn’t necessarily follow that the results of the study will always be implemented from a policy perspective. However, the chances are, yes, if something is effective and cost effective (atropine is a relatively cheap drug) that it will be made available to the public. That is a decision that will need to be made by policymakers after the trial.
Practitioners interested in finding out more about the low dose atropine trial can email Professor Azuara-Blanco.