Clinical Research Directory
Browse clinical research sites, groups, and studies.
The Effect of Early Glasses on the Development of Amblyopia
Sponsor: Erasmus Medical Center
Summary
In a randomized controlled trial, we will establish whether early glasses for high refractive error at age one reduce the development of amblyopia between age one and four. As a secondary outcome early literacy will be compared in groups with and without glasses.
Official title: The Early Glasses Study: Can Early Glasses Prevent the Development of Amblyopia in Children With High Refractive Errors at Age One
Key Details
Gender
All
Age Range
12 Months - 18 Months
Study Type
INTERVENTIONAL
Enrollment
601
Start Date
2021-05-10
Completion Date
2026-03-31
Last Updated
2025-08-11
Healthy Volunteers
Yes
Conditions
Interventions
Orthoptic care with the prescription of glasses from age 12-18 months onwards
Children assigned to the intervention group (group 1) will receive orthoptic care, including exams 1-3 (depending on the refractive error) times a year, and glasses, based on accurate determinations of refractive error by retinoscopy in cycloplegia by the study orthoptists at age 12-18 months. The spectacles for the children in this study will be provided by the study via their optician without costs.
Orthoptic care without the prescription of glasses from age 12-18 months onwards
Children with high refractive error in the control group (group 2) will also receive orthoptic care, including exams 1-3 (depending on the refractive error) times a year, but they will not receive glasses.
First measurement only
Children who have no or mild refractive error (group 3), the majority of all children, will be examined by the study orthoptists only once at the age of 12-18 months, after which youth health care (YHC) physicians and nurses will continue standard vision screening at CHCs, as part of screening for general health disorders and vaccinations. Visual acuity is measured routinely at 42-48 months as part of standard vision screening.
Locations (1)
Dept. of Ophthalmology Erasmus Medical Center
Rotterdam, Netherlands