Can early glasses prevent the development of amblyopia in children with high refractive errors at age one?
Recruiting
- Conditions
- amblyopialazy eye10047518
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2000
Inclusion Criteria
All children of 12-18 months old, born after uneventful pregnancy (>36 weeks),
registered at one of the participating children*s healthcare centers (CHCs) and
with informed consent by the parents/guardians
Exclusion Criteria
Prematurity and perinatal birth damage; 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, Refractive error higher than the AAPOS 2003
criteria twofold, Strabismus; Amblyopia; Ptosis; Cataract or other media
opacity; Other ophthalmic disease requiring immediate referral.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The occurrence of amblyopia at the final examination, stratified according to<br /><br>visual acuity of the amblyopic eye in the intervention group and in the control<br /><br>group. The final examination will take place at the age of 4, unless children<br /><br>have been referred to an orthoptist and/or ophthalmologist before, for example<br /><br>when amblyopia or strabismus are suspected before the age of 4.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are:<br /><br>- Prevalence of amblyopia at age 1;<br /><br>- Type and severity of refractive error at age 1;<br /><br>- Occurrence of amblyopia at the final examination, stratified according to<br /><br>visual acuity of the amblyopic eye in the children without high refractive<br /><br>error at age 1;<br /><br>- Pre-literacy skills in the intervention and control group at age 4;<br /><br>- Occurrence of strabismus, determined at the final examination in all groups.<br /><br><br /><br>Other outcome measures:<br /><br>- Electronically measured compliance with spectacles wearing;<br /><br>- The evolution of refractive error between age 1 and 4;<br /><br>- Gender;<br /><br>- Family history for ocular disease;<br /><br>- Ethnicity;<br /><br>- Parental level of education, social economic status and language skill.</p><br>