The Effect of Early Glasses on the Development of Amblyopia

NAActive, not recruitingINTERVENTIONAL
Enrollment

601

Participants

Timeline

Start Date

May 10, 2021

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
AmblyopiaRefractive Errors
Interventions
OTHER

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.

OTHER

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.

OTHER

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.

Trial Locations (1)

NL3000CA

Dept. of Ophthalmology Erasmus Medical Center, Rotterdam

Sponsors
All Listed Sponsors
lead

Erasmus Medical Center

OTHER

NCT04740593 - The Effect of Early Glasses on the Development of Amblyopia | Biotech Hunter | Biotech Hunter