Purpose of this Study
This study is being done to find out if atropine eyedrops (0.05% atropine, 99.95% inactive solution) and/or special eyeglass lenses are an effective strategy to slow down the progression of myopia for young children with nearsightedness.
Who Can Participate?
Eligibility
Children ages 5-11 who:
- Have myopia
- Need to wear eye glasses regularly
- Do not have an allergy to atropine
Age Range
5-11
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to have your child join this study, they will participate for about two and a half years. You and your child will come in for a study visit every three months. Half of the visits will be eye exams. The other half will be eyedrop pickup visits where your child won't see the eye doctor.
Your child will also have five visits to get fitted with new study glasses. The study will involve testing how well children can see, how well their eyes focus, and how nearsighted their eyes are. We will also ask your child to answer questions about how well they can see in their everyday activities.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Randomized Placebo-controlled Trial of Spectacles with Highly Aspherical Lenslets or 0.05% Atropine to Slow Progression of Myopia in Children - MTS2
Principal Investigator
Nathan
Cheung
Protocol Number
PRO00118558
Phase
III
Enrollment Status
Pending Open to Enrollment