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


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


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


Study Location:

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Be Part of Research - Trial Details - Vision in children with spectacle lenses designed to manage short-sightedness
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Vision in children with spectacle lenses designed to manage short-sightedness

Not Recruiting

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 short-sightedness, is a common refractive eye disorder. Later in life it can lead to eye diseases. Currently, there are spectacle lenses available to correct and manage myopia and its progression. In this study we are going to evaluate the speed of adaptation with myopia management spectacle lenses in children.

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:

05 Dec 2023 31 Oct 2024

Before child participants take part in the study, the investigators will explain the details of this study to the parents/ guardians and the child. Parents/ guardians will be invited to sign the consent form and the child participant will be asked to sign the assent form. Investigators will ask questions about the child’s eye condition and eye history, and 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. The study consists of 5 visits to the Aston University Optometry Clinic in the Vision Sciences Building. The child will be provided with three new pairs of glasses, wearing each of them full-time for one week (7 days). Most measurements taken during the study are the same as those used by optometrists to conduct site tests.

1st Visit: Screening (approximately 90 mins)
At this visit the child will be asked 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 eyedrops are used as a standard part of children’s eye examinations. Once these drops are administered, the investigators will measure the child’s prescription.

2nd Visit: Baseline measures and spectacles collection (approximately 60 mins)
The child will be given your a pair of glasses to wear for 30 mins. The investigators will measure the thickness of the child’s retina (a structure that is at the back of the eye) and the eye length using non-invasive devices. Visual acuity will also be measured. No eyedrops will be used in this visit. After the measurements have been taken, the child will be given a pair of glasses to take home. Before they leave, the investigators will measure the visual acuity with these glasses whilst the child looks through both the lens centre and periphery under normal room light conditions and in dim light. The child is then required to wear these glasses as they would normally wear any spectacles for a period of 1 week.

3rd Visit: Repeat of baseline measures and second spectacle lens collection (approximately 60 mins)
After wearing the glasses full time for one week, the child will be invited to come to return to the clinic. The investigators will repeat the measurement for visual acuity, eye length and thickness of the retina. In addition, the investigators will give the child a short questionnaires to fill in to see how they felt about the glasses. The child will then be given a second new pair of glasses to take away and wear for a period of 1 week.

4th Visit: Repeat of baseline measures and third spectacle lens collection (approximately 60 mins)
Same as the 3rd visit, but the child will be given another new pair of glasses to take away and wear for a period of 1 week.

5th Visit: Repeat of baseline measures (approximately 60 mins)
Same as the 3rd and 4th visit, but the child will exit the study once all measures are taken.


Myopic (short-sighted) children aged 6-12 years old with good vision and healthy eyes.

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
    The Aston Triangle
    Birmingham
    B4 7ET

Benefits- The parent/ guardian and child will gain more understanding and knowledge of how to manage the progression of myopia. The data obtained will help the investigators determine how children with short-sightedness adapt to myopia management spectacles lenses. The results will be shared and could be useful to short-sighted children, their parents/ guardians, optometrists and other eye care professionals. Risks- The risks associated with all procedures and devices in this study are extremely low. The side effects of eye drops that are used in this study are the same as those children experiences 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. So, the child’s eye will be more sensitive to light and their vision will be slightly blurred. 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 child eye exams and it is rare for children to have any adverse effects. The myopia management spectacles lenses used in this study are the same as those of commercially available spectacles lenses. The child may observe blurriness in the periphery of their vision. They may feel tired and may experience slight disorientation. The child may also experience increased glare (discomfort to vision) or halos (bright circles around lights) with bright lights. However, most of these symptoms would be temporary and breaks will be given whenever required.

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


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


Prof Nicola Logan
+44 (0)121 204 3900
n.s.logan@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: ISRCTN20591209
Last updated 21 November 2024

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