Press Releases & Archive

PRELIMINARY RESULTS FROM THE ATROPINE IN THE TREATMENT OF MYOPIA (ATOM) STUDY

SERI Research in Myopia
The Singapore Eye Research Institute (SERI) is dedicated to eye research relevant to Asian eye diseases, and Myopia is by far the commonest eye problem in Singapore today. The SERI approach to myopia is multi-faceted. We have studied the prevalence and age of onset of myopia in large population-based projects, and have come up with percentages and figures, which suggest that we have one of the highest rates of myopia in the world. We have evaluated environmental risk factors for the development of myopia in these studies and have identified an association with excessive hours of near work. We have also studied myopia in the laboratory, and made a mouse myopic, so that we can study and better understand how myopia develops in an animal model, in order to develop new treatments to prevent myopia. We are also studying various genes in our population to identify specific genes, if any, which are associated with the development of high myopia in our population.

SERI has been performing randomized clinical trials for the control of myopia progression since 1996, and we have previously investigated the use of contact lenses or multifocal spectacles. Today, we are pleased to announce the results of the first of a series of interventional drug trials conducted in our SERI Myopia Research Clinics. The ATOM Study, otherwise known as "Atropine in the Treatment of Myopia Study" is a 3-year randomized clinical trial to see if the use of atropine eyedrops can retard or prevent myopia progression in children. We are presenting our 2 year results, and at this stage, our study is able to show that atropine is effective in preventing myopia. We believe that this has an important clinical impact, because we now know that we are able to intervene in myopia and retard, or at least delay its progression. Specific details of the trial follow.

ATOM Study
The Atropine in the Treatment of Myopia (ATOM) study is a randomised, double-masked, placebo-controlled clinical trial designed to assess the safety and efficacy of atropine eye drops in controlling the progression of myopia in children.

Four hundred children aged 6-12 years, with myopia of -1 D to -6 D (100 to 600 degrees), were enrolled in this study. Half received atropine eyedrops, once a day, only in one eye, while the other half received non-active placebo eyedrops.

Each subject received treatment for 2 years. After the second year, subjects stopped treatment and were followed-up for another year. At each visit, refraction and measurement of eyeball length were performed.

To date, about 120 children have completed the full 3-year study while the remainder are in their final year of evaluation.

Preliminary 2-Year Results
We have conducted a preliminary analysis of the 2-year data from the study. The results indicate that atropine eye drops are effective in retarding myopia progression. In those eyes of children who were receiving atropine, the average myopia progression over 2 years was only a quarter of a dioptre (25 degrees). In contrast, in those eyes that were not on treatment or were receiving the non-active (placebo) drops, the average myopia progression over 2 years was 1.25 dioptres (125 degrees). This represents a difference in myopia progression of about 1 dioptre (100 degrees) over 2 years.

In addition, we have also looked at the safety aspects of treatment with atropine eye drops. Generally, atropine eye drops are safe and well tolerated. In the 2 years that the children were on treatment, there were NO cases of serious side- effects related to atropine. The most common side-effects were minor side-effects such as allergic reactions that were effectively treated by stopping the use of atropine.

Comments

1.	The ATOM study is the largest randomised controlled trial of its kind to date and the results provide good evidence that childhood myopia progression can be controlled through pharmacological means such as atropine eye drops.
2.	We would like to stress that these are preliminary results. The study is not completed and we have yet to analyse the full 3-year data. We do not know if the effect of atropine on myopia progression will be sustained upon stopping the use of the drug or whether the myopia will continue to progress normally or worse, progress at an accelerated rate to "catch up". Only the third year data can provide the answers. However, our original hypothesis, that atropine eyedrops can reduce myopia progression, has been proven with this study.
3.	Extension of Trial We are planning to continue monitoring all children in the study on a yearly basis, even after the 3rd year, as this will allow us to understand myopia progression, and the long term efficacy of atropine, if any.
4.	New Atropine Programme Even after this trial is completed, we will still not be able to recommend that atropine should be routine treatment for all children with myopia. We plan to conduct further studies on atropine. This will be undertaken by the Singapore National Eye Centre (SNEC) Myopia Clinic Atropine Programme in collaboration with SERI. The Atropine Programme is targeted at children aged between 6-12 years old who have myopia above 200 degrees and who will meet other relevant criteria. We hope to look at different dosages of eye drops to determine what is the best atropine eye drop regimen and duration of treatment etc. For this purpose, a myopia talk cum eye screening will be held on 1 and 8 March 2003 for parents with children who are myopic and interested to come onto the programme. There will also be eye screening for the children to determine their eligibility for the programme. Public can call the Myopia Eye Screening Hotline at Tel: 68777-022 for more details.
5.	Finally, we are also in the midst of concluding clinical trials on another drug, similar to atropine, called Pirenzepine. Pirenzepine belongs to the atropine group of drugs and may have the advantage of having less of the side- effects, such as pupil dilatation, glare, and blurring of near vision. Results of this trial will only be available in mid-2003.

Summary
SERI is dedicated to finding novel and effective treatments for myopia, and the ATOM Study is the first of a series of trials to evaluate the best treatments for myopia progression. ATOM is pivotal, because it has proven that we can prevent or at least retard myopia progression in our children. Further research is ongoing to see exactly how atropine should, or could be used, and which children will best benefit from treatment. We will also see if other newer drugs like pirenzepine, may also be as effective, or better, than atropine.