Active not recruitingNAINTERVENTIONAL

Control of Myopia Using Novel Spectacle Lens Designs

This study is exploring a new kind of glasses lens designed to help control short-sightedness in children. Short-sightedness, also known as myopia, means distant objects look blurry. Children aged between 6 and 10 who are already short-sighted are invited to take part. The study will last for three years and aims to find out if these new special lenses can safely and effectively slow down the progression of short-sightedness. Half the children will wear the new lenses, and the other half will wear standard lenses. Neither the children nor the researchers will know who is wearing which lens, to ensure fair results. This is an important study that could help many children with their eyesight.

At a glance

Status

Active not recruiting

Phase

Sponsor

SightGlass Vision, Inc.

Enrolment target

266

Start

16 Jul 2018

Estimated completion

31 Dec 2026

Juvenile Myopia

What is this study about?

This research study is looking into a new type of glasses lens that might help slow down how quickly short-sightedness (also called myopia) gets worse in children. Short-sightedness is a common eye condition where distant objects appear blurry, and it often starts in childhood and can get gradually worse over time.

The study wants to find out if wearing these new innovative lenses can safely and effectively reduce how much a child's short-sightedness changes over three years. Some children in the study will get the new lenses, while others will get regular glasses lenses. Neither the children nor the people carrying out the study will know who has which type of lens until the study is over. This is done to make sure the results are as accurate and unbiased as possible.

This kind of research is really important because if short-sightedness can be slowed down, it could mean children's eyesight might not get as bad, or they might not need stronger glasses as often. It could also help reduce the risk of other eye problems that can sometimes be linked to very severe short-sightedness later in life. We want to improve the eye health of children in the long term.

Key takeaways

This study evaluates new glasses lenses to slow down short-sightedness in children.
It involves children aged 6-10 with existing short-sightedness.
The study lasts for three years, with regular eye check-ups.
Neither participants nor researchers will know who receives the new or standard lenses.
Participants must wear the study glasses daily and not use contact lenses.
The aim is to find a safe and effective way to manage childhood short-sightedness.

Who may be eligible?

To join this study, children need to be between 6 and 10 years old. They must already be short-sighted, with their current glasses prescription falling within a specific range.

Critically, they should not have previously used contact lenses or tried other special treatments designed to control short-sightedness. Children who have worn bifocal glasses or progressive lenses are also not able to take part. Their short-sightedness in one eye shouldn't be much different from the other eye, and they shouldn't have a very high degree of astigmatism (another common sight problem where the eye isn't perfectly round).

Finally, children joining the study must be able and willing to wear their assigned glasses for the full three years of the study and should not wear contact lenses during this time.

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.

Is your child between 6 and 10 years old?
Does your child currently wear glasses for short-sightedness?
Has your child never worn contact lenses before?
Has your child never used special lenses (like bifocals) or other treatments for short-sightedness?
Is your child willing to wear the study glasses for three years?
Is your child happy not to wear contact lenses during the study?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will be given a special type of glasses lens to wear for three years. They will need to attend regular appointments at the study clinic throughout this time, where eye tests will be carried out to monitor their vision and how their short-sightedness is progressing. These appointments will involve standard eye check-ups, and the study team will be there to support you and your child. It's important that your child wears the study glasses daily and doesn't use contact lenses during the three-year study period. The exact number and frequency of visits will be explained in full detail by the study team.

Potential risks and benefits

Taking part in this study could potentially slow down how much your child's short-sightedness progresses. However, there's no guarantee that the new lenses will work for every child, and some children might find their short-sightedness continues to get worse. At this stage, the main risk is that the new lenses might not be more effective than standard lenses, meaning your child continues to need prescription changes as normal. As with any study, you and your child are free to withdraw at any time without giving a reason, and this will not affect their future medical care.

Locations (14)

Golden Optometric Group
Verified postcode
Whittier, United States
Sabal Eye Care
Verified postcode
Longwood, United States
Visual Performance Center
Verified postcode
Pensacola, United States
Kannarr Eye Care
Verified postcode
Pittsburg, United States
Eye Associates of Northeast Louisiana (DBA Haik Humble Eye Center) Research Dept
Verified postcode
West Monroe, United States
Advanced Eyecare, PC
Verified postcode
Raytown, United States
SUNY School of Optometry
Verified postcode
New York, United States
Sacco Eye Group
Verified postcode
Vestal, United States
Dept of Clinical Research, South Shore Eye Care, LLP
Verified postcode
Wantagh, United States
Dunes Eye Consultants
Verified postcode
Dakota Dunes, United States
Total Eye Care
Verified postcode
Memphis, United States
University of Houston College of Optometry
Verified postcode
Houston, United States

Common questions

What is 'short-sightedness'?

Short-sightedness, also called myopia, is when distant objects look blurry, but close-up objects are clear. It's a common eye condition, often starting in childhood.

What happens if my child is in the study?

Your child will receive special glasses lenses and attend regular eye check-ups over three years to see how their vision is changing. They will wear their assigned glasses daily.

Will we know if my child gets the new or regular lenses?

Neither you, your child, nor the study team will know if your child has the new lenses or standard lenses until the study is finished. This helps make the study results fair.

How long will the study last?

The study will last for three years, during which your child will wear the study glasses and have regular eye examinations.

Can my child wear contact lenses during the study?

No, children taking part in this study cannot wear contact lenses; they must rely solely on the study glasses for their vision correction.