Effect of low dose atropine on ocular changes during accommodation in children and young adults with myopia

What is the purpose of this research?

Previous research by our team have found that the eye’s length and optical quality varies in the eyes of children and young adults when they focus at close distances. The purpose of this research is to investigate what effect a very dilute concentration of atropine eye drops (0.025%) (a drug commonly used in the control of short-sightedness in children and adolescents) have on these changes.

This will improve our understanding of the effects of low dose atropine eye drops and how they may slow short-sightedness development in children. The research team believes that this eye drop will be well-tolerated but will alter the changes that occur in the eyes of children and young adults when they focus at close distances.

Are you looking for people like me?

The research team is inviting healthy children (aged 6-16 years) and young adults (17-25 years) who have short-sightedness (myopia) (i.e. requires spectacles or contact lenses to see clearly in the distance) but have otherwise normal vision and eye and general health.

Exclusions to participation include:

• current use of low dose atropine eye drops, OrthoK lenses, bifocal spectacles, or peripheral defocus spectacles or soft contact lenses
• lazy or turned eye(s).

An initial screening assessment will be conducted to assess your child’s eye health and vision using standard clinical eye tests.

What will you ask me to do?

If someone is deemed suitable for the study, their participation will involve a total of two (2) visits to the Contact Lens and Visual Optics Laboratory on the QUT Kelvin Grove campus:

• an initial measurement session (60 minutes duration, which will be conducted immediately following the screening assessment)
• a follow-up session (60 minutes duration), 7 +/- 3 days later.

Following the first visit, the participant will receive low dose atropine (0.025%) eye drops to be used one drop in each eye at night before bed for 7 +/- 3 nights.

During both visits, a series of measurements of the participant’s eye length and focusing ability will be attained using standard, non-invasive, non-contact clinical instruments while the participant views a target within an instrument or an optical system (a series of lenses and mirrors). The amount of focusing effort required for the participant to keep the target clear will be altered during these measurements.

A digital scan of the back of the participant’s eye will also be captured during both visits using another standard, non-invasive, non-contact clinical instrument.

The health of the front of the participant’s eye will also be assessed during each visit with some yellow dye (Fluorescein) and blue light. The study is intended to identify any changes in these measurements after the eye drops have been used for a period of 7 +/- 3 days.

Are there any risks for me in taking part?

The research team believes there is only a low risk of harm involved with participation in this project, and these relate to the inconvenience of time required to participate in the project, and the potential for discomfort associated with the use of the eye drops.

At the baseline visit only, eye drops which cause pupil dilation will be used (1% Tropicamide), and this is typically accompanied by a period of sensitivity to bright light (particularly when outdoors) and of blurred vision (particularly for reading tasks). This side effect may last from 4-8 hours, and during this time participants should wear sunglasses while outdoors during daylight hours if they experience significant light sensitivity.

The potential for more serious side effects associated with pupil dilation will be minimised by screening participants prior to inclusion in the study to exclude those with a high risk of responding adversely. In the very unlikely event that a participant was to react adversely to the dilation procedure, registered, therapeutically-qualified optometrists who are part of the research team will be on hand to provide treatment.

The low dose atropine (0.025%) eye drops that will be used each night for 7 +/- 3 days during this project are a very weak dilution of a commercially available atropine (1%) eye drop which is used for long term pupil dilation and reduced focusing ability. Because it is such a weak dilution (1/40^th the concentration), the normal side effects associated with dilating eye drops (such as sensitivity to bright light and blurred reading vision) will be minimised and are unlikely to affect the participant’s daily activities. The research team would however recommend that all participants use sunglasses while outdoors for the duration of the study if they have significant light sensitivity, and a pair will be provided to the participant if they do not have any. Any temporary changes in pupil size or focusing ability while using the low dose atropine eye drops are completely reversible once usage is stopped, and there have been no serious side effects reported with the use of low dose atropine.

All measurements will be taken using standard clinical techniques used during a normal eye examination, using standard, non-invasive, non-contact, clinical instruments. All members of the research team are trained to correctly perform and interpret the tests used in data collection in this project.

It should be noted that withdrawal from participation in the research project can occur at any time without comment or penalty.

Are there any benefits for me in taking part?

It is expected that this research project will not benefit the participant directly. The outcomes of the research, however, will provide us with a greater understanding of the effects that low dose atropine has on the focusing ability of our eyes, and the way that low dose atropine treatment works to reduce the progression of short-sightedness in children.

Note that the duration of use of low dose atropine in this research project is too brief to have any measurable effect in slowing the progression of, or reducing the degree of myopia, that the participant may have.

Will I be compensated for my time?

There is no payment for participating in this study. Parking permits can be provided for participants at the Contact Lens and Visual Optics Laboratory. To cover the cost of travel to and from visits, the research team can reimburse you up to $30 per visit (in the form of Coles/Myer gift cards).

I am interested - what should I do next?

If you are interested in participating in this study, contact Dr Rohan Hughes, via email rp.hughes@qut.edu.au or phone 3138 5732.

You will be provided with further information to ensure that your decision and consent for your child to participate is fully informed.