ATS22 (Amblyopia in Children) - Clinical Trial

What is the Purpose of this Study?

If your child joins this study, they will:

- Be randomly assigned (like a coin flip) to 1 of 2 groups

-- One group will receive glasses and patching at the same time

-- The other group will receive glasses first and then receive patching only if necessary

Your child will visit our clinic 9 times over the course of 1 year. We will occasionally ask you to complete quality of life questionnaires related to your child's eyes and vision during the study.

What is the Condition Being Studied?

Amblyopia

Who Can Participate in the Study?

Children ages 3-12 who:

- Are diagnosed with amblyopia

- Have normal vision in their good eye

- Do not wear glasses or contacts

- Are not currently being treated for amblyopia

For more information about who can join this study, please contact the study team at DEC-RA@duke.edu.

Age Group
Children

What is Involved?

We are doing this study to find out if treating amblyopia with glasses and patching at the same time improves vision as well as treating amblyopia first with glasses and then with patching, if needed.

Study Details

Full Title
A Randomized Trial to Evaluate Sequential vs Simultaneous Spectacles plus Patching for Amblyopia in Children 3 to <13 Years Old
Principal Investigator
Pediatric Optometrist
Protocol Number
IRB: PRO00106669
NCT: NCT04378790
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment