Status:
ACTIVE_NOT_RECRUITING
The Effect of Early Glasses on the Development of Amblyopia
Lead Sponsor:
Erasmus Medical Center
Conditions:
Amblyopia
Refractive Errors
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief 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 earl...
Detailed Description
Background of the study: Amblyopia (prevalence approx. 3.4%) develops in early childhood when the child's eyes have severe refractive error, when they squint, or both. It can effectively be treated w...
Eligibility Criteria
Inclusion
- Registered at one of the participating CHCs;
- 12-18 months of age;
- Voluntary approval for participation by the parents or legal representative/guardian with provided written informed consent;
- Willingness of the parents/guardian(s) to comply with the study procedures
Exclusion
- Congenital syndromes;
- Psychomotor retardation;
- Known hereditary defects;
- Known cardiac disease;
- Severe comorbidity;
- Children's whose parents do not agree to cyclopegia with the use of cyclopentolate 1% eye drops for orthoptic examination (retinacopy) by the study orthoptist;
- Refractive error higher than the AAPOS criteria twofold (i.e. hyperopia \>7 dioptres, anisometropia \>3 dioptres and astigmatism of \>3 dioptres at 90º or 180º and \>2 dioptres in oblique axis (\>10º eccentric to 90º or 180º);
- Strabismus;
- Amblyopia;
- Ptosis;
- Cataract or other media opacity;
- Other ophthalmic disease requiring immediate referral;
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
601 Patients enrolled
Trial Details
Trial ID
NCT04740593
Start Date
May 10 2021
End Date
March 31 2026
Last Update
August 11 2025
Active Locations (1)
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1
Dept. of Ophthalmology Erasmus Medical Center
Rotterdam, Netherlands, NL3000CA