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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Leon Davies
+44 (0)121 204 4152
l.n.davies@aston.ac.uk


Prof James Wolffsohn
+44 (0)121 204 3900
j.s.w.wolffsohn@aston.ac.uk


Prof Nicola Logan
+44 (0)121 204 3900
n.s.logan@aston.ac.uk


Dr Amy Sheppard
+44 (0)121 204 3900
a.sheppard@aston.ac.uk


Study Location:

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Be Part of Research - Trial Details - The acceptance of spectacle lenses designed to manage short-sightedness in children with unequal spectacle prescriptions
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The acceptance of spectacle lenses designed to manage short-sightedness in children with unequal spectacle prescriptions

Stopped

Open to: All Genders

Age: Child

Birmingham

Medical Conditions

Myopia

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Myopia (also called shortsightedness) is a common refractive eye disorder. The prevalence of myopia is alarmingly high in many Asian countries such as Hong Kong and Singapore where as many as 80% of young adults are myopic. There is a trend of increasing prevalence of myopia and increasing severity of myopia in the last decade. Furthermore, myopic eyes are prone to several ocular diseases, such as retinal degeneration and glaucoma, which can lead to severe visual impairment.
This dispensing study aims to evaluate the clinical acceptance of myopia management spectacle lenses in anisometropic children. (Anisometropia is when there is a difference in refractive power (spectacle prescription) between the 2 eyes.) Anisometropia is commonly found and this study will evaluate whether having a difference in prescription between the two eyes has any significant impact on myopia progression with myopia management spectacle lenses.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

24 Jun 2024 31 Mar 2025

Before the child takes part in the study, the investigators will explain the details of this study. Parents/ guardians will be invited to sign the consent form and the child will need to sign the assent form. Questions about the child’s eye condition and eye history will be asked. Investigators will take some eye and vision measurements to see if the child is eligible to take part. These are called the ‘screening tests’. If the results of the screening tests tell the investigators that the child is eligible for the study, they will be enrolled into the study. The study consists of up to 5 visits over one year. Investigators will provide the child with a new pair of glasses. The child will wear the spectacles full-time for the year. Investigators will take a series of measurements and most of these measurements will use the same instruments that the child is familiar with from regular optometrist examinations.

1st Visit: Screening and baseline measures
At this visit, Investigators will ask the child about their eye health and spectacle wear history. Investigators will measure how well they see letters on a chart (visual acuity) with glasses in place. Investigators will assess the eye coordination (any squint) and the eye health of the child. Investigators will use eye drops to make the child’s pupils larger and to relax the eye’s focusing muscles. These eye drops are used as a standard part of children’s eye examinations. Once these drops are in, Investigators can measure the child’s prescription and the eye length.

2nd Visit: Spectacles collection
The child will attend the clinic to collect the spectacles. Investigators will check the fit and comfort of the new glasses. Investigators will measure visual acuity with high and low-contrast letters with the new spectacles on. No eye drops will be used in this visit. The child is required to wear these glasses as they would normally wear any spectacles. They should wear the spectacles and engage in their usual everyday activities. A diary will be given for recording daily wearing time.

3rd, 4th and 5th Visit: Repeat of baseline measures
At 3, 6 and up to 12 months after wearing the glasses full time, the child will be invited to come to the clinic. Investigators will measure the visual acuity with high and low-contrast letters. Investigators will also measure your child’s prescription and the eye length using the eye drops. In addition, Investigators will give the child a questionnaire to fill in to see how they felt about the glasses. Investigators will also give parents/ guardians a questionnaire to ask about their child’s wearing schedule and comfort.


Children aged between 6 to 12 years old with a spectacle prescription indicating myopia, ranging from ≥-0.50 DS to ≤-2.00 DS mean spherical equivalent (MSE) in one eye and near plano (+0.50 to -0.50 DS) in the contralateral eye, as determined by cycloplegic autorefraction. Additionally, the child should have astigmatism of less than 1.00 DC by cycloplegic autorefraction and a best-corrected level of visual acuity of at least 0.1 logMAR.

You can take part if:



You may not be able to take part if:


1. Aphakic or pseudophakic2. Binocular vision problems (e.g. amblyopia, strabismus, nystagmus etc.)3. Any current or evolving ocular pathology4. Any previous ocular surgery5. Any systemic condition which might have an influence on vision or visual function6. Any medical treatment or medication which might have an influence on vision or visual function7. Is/ has received any myopia management treatment


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Aston University Optometry
    Aston University The Aston Triangle
    Birmingham
    B4 7ET

The child will benefit from gaining more understanding and knowledge of how to manage the progression of myopia. The data obtained will help the investigators to determine how children with different levels of short-sightedness in each eye adapt to the myopia management spectacles lenses. The results will be shared and could be useful to short-sighted children, their parents, optometrists and other eye care professionals.
The side effects of eye drops are the same as those experienced during a routine eye exam. The eye drop is called ‘cyclopentolate’ (1.0%) which is used to dilate pupils and relax the focusing muscles of the eye. The cyclopentolate drops take up to 30 minutes to work. For most people, it takes around 3-4 hours for their focusing ability to return to normal. The pupils may stay dilated for up to 36-48 hours. Sunglasses are advisable on a bright day and care should be taken until the effects of the drops have subsided. However, these eye drops are commonly used in optometric practices for children's eye exams and it is rare for children to have any adverse effects.

Dr Amy Sheppard
+44 (0)121 204 3900
a.sheppard@aston.ac.uk


Prof Nicola Logan
+44 (0)121 204 3900
n.s.logan@aston.ac.uk


Prof Leon Davies
+44 (0)121 204 4152
l.n.davies@aston.ac.uk


Prof James Wolffsohn
+44 (0)121 204 3900
j.s.w.wolffsohn@aston.ac.uk



The study is sponsored by Aston University and funded by SightGlass Vision Inc..



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Read full details for Trial ID: ISRCTN17297434
Last updated 06 March 2025

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