PEDIG ATS22 - Amblyopia Treatment Study 22
Clinical trial to evaluate sequential versus simultaneous spectacles plus patching for Amblyopia in children 3 to less than 13 years old.
Summary of Study
Amblyopia is the most common cause of monocular visual impairment in children. The choice of a sequential approach versus a simultaneous approach to “optical treatment (glasses) plus patching treatment” remains unresolved, with some existing data supporting one approach and some data supporting the other. There is a reasonable rationale for either approach. This unresolved controversy results in a dichotomy of current clinical practice, with some care providers favoring one approach and others favoring the opposite approach. In addition, the influence of adherence to patching on treatment response is not well understood.
The Pediatric Eye Disease Investigator Group (PEDIG) is conducting a clinical trial to evaluate 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. This study will also use occlusion dose monitors (ODMs) to record adherence with prescribed patching treatment, to study dose-response. The study is supported through funding from the National Eye Institute of the U.S. National Institutes of Health and is being coordinated by the Jaeb Center for Health Research in Tampa, Florida.
Study specifics
- 544 children are expected to be enrolled
- Children must be between 3 to less than 13 years old
- Visual acuity in the amblyopic eye must be between 20/40 and 20/200
- Random assignment to either:
- Sequential treatment: full-time glasses first, with subsequent patching for 2 hours per day/7 days per week if there is no further improvement in amblyopic eye visual acuity with glasses alone and there is residual
amblyopia, or - Simultaneous treatment: full-time glasses and part-time patching for 2 hours per day/7 days per week
- Sequential treatment: full-time glasses first, with subsequent patching for 2 hours per day/7 days per week if there is no further improvement in amblyopic eye visual acuity with glasses alone and there is residual
- Occlusion dose monitors (ODMs) will be used to record actual patch wear time during prescribed patching
- Follow-up visits every 8 weeks for 56 weeks
- No previous treatment for amblyopia is allowed, including glasses or contact lenses.
How can you help?
- Your assistance is needed in referring children who may qualify.
- Referrals can be sent to the investigator listed below, or for more information, visit the PEDIG website or call the PEDIG Coordinating Center toll free at 1-888-797-3344.
Contact Information
For more information please contact:
Sherri Olsen
Clinical Research Coordinator
solsen@midwestern.edu