Refractive Errors Clinical Trial
— EGSOfficial title:
The Early Glasses Study: Can Early Glasses Prevent the Development of Amblyopia in Children With High Refractive Errors at Age One
Verified date | September 2023 |
Source | Erasmus Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 4000 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Months to 18 Months |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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; |
Country | Name | City | State |
---|---|---|---|
Netherlands | Dept. of Ophthalmology Erasmus Medical Center | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center |
Netherlands,
Donahue SP, Arnold RW, Ruben JB; AAPOS Vision Screening Committee. Preschool vision screening: what should we be detecting and how should we report it? Uniform guidelines for reporting results of preschool vision screening studies. J AAPOS. 2003 Oct;7(5):314-6. doi: 10.1016/s1091-8531(03)00182-4. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Electronically measured compliance with spectacles wearing | During home visits an Occlusion Dose Monitor (ODM) will be fixed firmly to the spectacles next to the temple by imbedding the ODM in an occlusion eye patch for one week. After one week it will be removed during a subsequent home visit and the recording will be downloaded. | Yet to be defined, probably time = 12-24 months | |
Other | The evolution of hyperopia, anisometropia and astigmatism, all three based on the means of these three types of discrete variables, measured repeatedly between age 1 and 4 by retinoscopy in cycloplegia in all children with high refractive error at age 1. | It involves three longitudinal outcome measures, based on the repeated measurement of the three types of refractive errors that are of interest for this study from age 1 to 4 (each potentially stratified for severity of refractive error at age 1). A Mixed Model linear regression model will be use to correct for inner participant data clustering. | First to final examination, time = 0 to 30-36 months | |
Other | Family history for ocular disease | Anamnesis | First examination, time = 0 | |
Other | Ethnicity | Anamnesis | First examination, time = 0 | |
Other | Parental level of education, social economic status and language skill | Anamnesis | First examination, time = 0 | |
Other | Gender | Anamnesis | First examination, time = 0 | |
Primary | The occurrence of amblyopia at the final examination, stratified according to visual acuity of the amblyopic eye in the intervention group (group 1) and in the control group (group 2) | The prevalence of amblyopia at age 4 stratified according to visual acuity of the amblyopic eye in the intervention group (group 1) and the control group (group 2) at the final examination. When a child is diagnosed with amblyopia during the course of the study, the child's visual acuity at the moment of referral will be used as primary outcome, after correcting for age. | Final examination, time = 30-36 months | |
Secondary | Prevalence of amblyopia at age 1 | Defined/noted by study orthoptist | First examination, time = 0 | |
Secondary | Type and magnitude of refractive error at age 1 | Measured by retinoscopy in cyloplegia | First examination, time = 0 | |
Secondary | Occurrence of amblyopia at age 4 stratified according to visual acuity of the amblyopic eye at the final examination in the children without refractive error at age 1 (group 2 and 3). | Defined/noted by study orthoptist | Final examination, time = 30-36 months | |
Secondary | Pre-literacy skills in the intervention and control group at age 4 | Measured with the Test of Preschool Early Literacy (TOPEL) | Final examination, time = 30-36 months | |
Secondary | In all groups, occurrence of strabismus at the final examination | Defined/noted by study orthoptist | Final examination, time = 30-36 months |
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