Can early glasses prevent the development of amblyopia in children with high refractive errors at age one?

Can early glasses prevent the development of amblyopia in children with high refractive errors at age one? - The Early Glasses Study (EGS)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51136

Enrollment

2000

Registered

2021-04-30

Start date

2021-05-11

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

amblyopia lazy eye

Interventions

Children assigned to the intervention group will be examined by the study orthoptist one to three times yearly until final examination, and will be fitted with glasses, based on accurate determinati

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The occurrence of amblyopia at the final examination, stratified according to visual acuity of the amblyopic eye in the intervention group and in the control group. The final examination will take place at the age of 4, unless children have been referred to an orthoptist and/or ophthalmologist before, for example when amblyopia or strabismus are suspected before the age of 4.	—

Secondary

Measure	Time frame
Secondary outcome measures are: - Prevalence of amblyopia at age 1; - Type and severity of refractive error at age 1; - Occurrence of amblyopia at the final examination, stratified according to visual acuity of the amblyopic eye in the children without high refractive error at age 1; - Pre-literacy skills in the intervention and control group at age 4; - Occurrence of strabismus, determined at the final examination in all groups. Other outcome measures: - Electronically measured compliance with spectacles wearing; - The evolution of refractive error between age 1 and 4; - Gender; - Family history for ocular disease; - Ethnicity; - Parental level of education, social economic status and language skill.	—

Measure

Time frame

Secondary outcome measures are: - Prevalence of amblyopia at age 1; - Type and severity of refractive error at age 1; - Occurrence of amblyopia at the final examination, stratified according to visual acuity of the amblyopic eye in the children without high refractive error at age 1; - Pre-literacy skills in the intervention and control group at age 4; - Occurrence of strabismus, determined at the final examination in all groups. Other outcome measures: - Electronically measured compliance with spectacles wearing; - The evolution of refractive error between age 1 and 4; - Gender; - Family history for ocular disease; - Ethnicity; - Parental level of education, social economic status and language skill.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)