All studies
Active not recruitingNAINTERVENTIONAL

Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness

This research is investigating a new type of spectacle lens, called Diffusion Optics Technology (DOT) lenses, in children aged 8 to 14. We're trying to understand if these lenses can impact the choroid, a layer of tissue at the back of the eye. The choroid's thickness is believed to play a role in how children's eyesight develops, especially in conditions like myopia (short-sightedness) and its progression. By comparing DOT lenses to standard lenses, the study aims to see if they can help manage myopia in young people. This study is important because finding effective ways to slow down the worsening of myopia in children could have long-term benefits for their eye health.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
SightGlass Vision, Inc.
Enrolment target
30
Start
18 Jan 2023
Estimated completion
31 Dec 2026

What is this study about?

This study is all about understanding how a special type of glasses lens, called Diffusion Optics Technology (DOT) lenses, might affect the eyes of children aged 8 to 14. Doctors and scientists are looking into problems like myopia, which is also known as short-sightedness. This is when faraway objects look blurry. With children, sometimes their short-sightedness can get worse over time, which is called myopia progression.

At the back of the eye, there's a layer called the choroid. Scientists believe the thickness of this choroid might be connected to how myopia develops and progresses in children. This study will compare how the DOT lenses affect the choroid's thickness and blood flow compared to regular glasses lenses. We want to see if these new lenses could be a helpful way to manage short-sightedness in young people.

Understanding if these special lenses can help prevent short-sightedness from getting worse is really important. If we can find ways to manage myopia in children, it could significantly improve their eye health and vision for years to come. This research helps us learn more about the eye and potential new treatments.

Key takeaways

  • This study is testing special glasses lenses (DOT lenses) for children.
  • It aims to see if these lenses affect a part of the eye called the choroid, which is linked to short-sightedness.
  • Short-sightedness (myopia) getting worse in children is a key focus.
  • Children aged 8-14 who meet specific eye health criteria can be considered.
  • Participation involves wearing specific glasses and attending eye check-ups.
  • The goal is to find new ways to manage childhood short-sightedness.

Who may be eligible?

To join this study, children need to be between 8 and 14 years old. They should be able to read and understand information about the study, or have it read to them, and agree to take part. A parent or guardian must also be able to understand the study details and give their permission for the child to participate.

Their eyesight, checked with a special machine without eye drops, should be within a certain range (+1.00D and -1.00D). This means they shouldn't be too short-sighted or too long-sighted to start with. They also need to be willing and able to follow instructions from the study team.

However, some things would mean a child can't take part. These include if they are already in another study, have had treatment for myopia in the last year, or have certain eye conditions like amblyopia (lazy eye), an eye infection, or other eye health problems. Children with certain overall health conditions (like diabetes) or who are taking medications that might affect the study results (like Atropine eye drops) would also not be able to join. If a child has had eye surgery or is related to a member of the study team, they also can't take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Is your child aged between 8 and 14 years old?
  2. Can your child read and understand information (or have it read to them) and agree to participate?
  3. Are you, as a parent/guardian, able to understand and give permission?
  4. Has your child NOT had any myopia treatment in the last year?
  5. Does your child NOT have a 'lazy eye' or any other active eye disease?
  6. Is your child generally healthy and not on medication that might affect their eyes?
Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will either wear the new Diffusion Optics Technology (DOT) lenses or standard lenses. The study will involve several visits to the clinic where their eyes will be checked. These checks might include measuring the thickness of the choroid (a layer at the back of the eye) using special imaging equipment. The exact number of visits, tests, and the total length of time your child would be in the study will be fully explained to you by the study team. You won't be given any new medication to take, and no surgery is involved. The main part of taking part is wearing the assigned glasses and attending follow-up appointments.

Potential risks and benefits

There is a possibility that wearing the special DOT lenses might help to slow down the progression of short-sightedness or positively affect the health of the back of the eye. However, we cannot guarantee any benefits, as this is a research study. Potential risks are generally low, as this involves wearing spectacle lenses. There might be minor discomforts associated with eye examinations, similar to a routine eye check-up. Participants can withdraw from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

  • Centre for Ocular Research and Education
    Verified postcode
    Waterloo, Canada

Common questions

What is 'myopia'?

Myopia is a common eye condition where faraway objects look blurry, also known as short-sightedness.

What is the choroid?

The choroid is a layer of blood vessels and tissue at the back of your eye that provides nutrients to the retina, which is important for vision.

Will my child get to keep the special glasses?

The study will provide all necessary lenses for the duration of the study. Details about keeping them afterwards will be explained by the study team.

Does my child's current prescription matter?

Yes, for this study, children need to have a specific range of eyesight (not too short-sighted or long-sighted) at the very start to be included.

Can my child leave the study at any time?

Yes, your child can stop participating in the study at any point, and it will not affect their regular medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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