Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04740593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-07
First Post:
2021-01-14
Brief Title:
The Effect of Early Glasses on the Development of Amblyopia
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
The Early Glasses Study Can Early Glasses Prevent the Development of Amblyopia in Children With High Refractive Errors at Age One
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EGS
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 early literacy will be compared in groups with and without glasses
Detailed Description:
Background of the study
Amblyopia prevalence approx 34 develops in early childhood when the childs eyes have severe refractive error when they squint or both It can effectively be treated with glasses and patching the better eye but treatment should start before age 6 to be effective Therefore visual acuity should be measured in all children aged 4-5 to detect amblyopia early enough In an effort to prevent the development of amblyopia all together in some countries devices are being used to measure refractive error in toddlers and when refractive error is severe fit them glasses before amblyopia develops In Flanders the measurement of refractive error in 1- and 25-year-olds began in 2012 in addition to regular vision screening with measurement of the visual acuity at the age of 3 4 and 5 Between 2012 and 2017 the percentage of 4-year-old glasses wearing children had risen from 47 to 64 but it was unknown how many cases of amblyopia had been prevented from developing A prospective comparison seems warranted between this new method and the current national vision screening program in the Netherlands
Objective of the study
To investigate whether treating children with high refractive errors at age one with glasses prevents the development of amblyopia
Study design
We will perform an interventional prevention study comparing the effect of prescribing glasses to children with high refractive error at age 1 intervention versus no prescription of glasses control on the prevalence of amblyopia at age 4 12-18-months-old children will be recruited by the study physician after visiting the childrens healthcare centers CHCs at 11 or 14 months Refractive error will be determined by retinoscopy in cycloplegia in all children Children with refractive error exceeding the AAPOS 2003 criteria Donahue et al 2003 are considered to have high refractive error in this study We anticipate that 8 of all children will have high refractive error according to these criteria These children will be randomized to the intervention group or the control group and will be followed up until final examination at age 4 with visual acuity serving as primary outcome In case amblyopia or strabismus develops during the course of the study children will be referred for immediate treatment and visual acuity at the moment of referral will be used as primary outcome In all children in the intervention group compliance with wearing spectacles will be measured electronically At age 4 pre-literacy skills will be measured in the intervention group and the control group
The majority of children approximately 92 will have mild or no refractive error at age one After the first examination these children will continue regular vision screening at the CHCs They will have their visual acuity measured at the age of 4 as part of standard vision screening in the Netherlands at the CHCs which will serve as secondary outcome If there is uncertainty about the visual outcome at the CHC the child will receive a supplementary examination Children with amblyopia or strabismus at the age of one will be excluded from this study and referred for immediate treatment Due to ethical considerations children with severe refractive error at the age of one ie exceeding the AAPOS 2003 criteria twofold will also be excluded from this study and referred for immediate treatment with glasses Due the nature and design of the study blinding of the researchers on site and of participants will not be possible
Study population
For this study we will recruit an estimated 2000-4000 healthy children aged 12-18 months after visiting one of the participating CHCs located in different regions of the Netherlands Utrecht HarderwijkErmeloPutten TielGeldermalsenCulemborgRoermondVenlo and Eindhoven It is estimated that approximately 8 of all included children will have high refractive error
Intervention if applicable
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 determinations of refractive error by retinoscopy in cycloplegia Children with high refractive error assigned to the control group will be examined by the study orthoptist one to three times yearly until final examination but will not be fitted with glasses
Primary study parametersoutcome of the study
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 andor ophthalmologist before for example when amblyopia or strabismus are suspected before the age of 4
Secondary study parametersoutcome of the study
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
Nature and extent of the burden and risks associated with participation benefit and group relatedness
The expected burden and risks associated with participation can be considered minimal In order to measure refractive error accurately retinoscopy will be done by study orthoptists after the instillation of cycloplegic eye drops as happens daily in clinical practice of orthoptists and pediatric ophthalmologists We will install 1 eyedrop of cyclopentolate 1 in each eye which we will repeat after 10 minutes Cyclopentolate can cause sleepiness in rare cases children are difficult to awaken for several minutes but can be awoken thereafter which is without sequelae without exception
Amblyopia prevalence approx 34 develops in early childhood when the childs eyes have severe refractive error when they squint or both It can effectively be treated with glasses and patching the better eye but treatment should start before age 6 to be effective Therefore visual acuity should be measured in all children aged 4-5 to detect amblyopia early enough In an effort to prevent the development of amblyopia all together in some countries devices are being used to measure refractive error in toddlers and when refractive error is severe fit them glasses before amblyopia develops In Flanders the measurement of refractive error in 1- and 25-year-olds began in 2012 in addition to regular vision screening with measurement of the visual acuity at the age of 3 4 and 5 Between 2012 and 2017 the percentage of 4-year-old glasses wearing children had risen from 47 to 64 but it was unknown how many cases of amblyopia had been prevented from developing A prospective comparison seems warranted between this new method and the current national vision screening program in the Netherlands
Objective of the study
To investigate whether treating children with high refractive errors at age one with glasses prevents the development of amblyopia
Study design
We will perform an interventional prevention study comparing the effect of prescribing glasses to children with high refractive error at age 1 intervention versus no prescription of glasses control on the prevalence of amblyopia at age 4 12-18-months-old children will be recruited by the study physician after visiting the childrens healthcare centers CHCs at 11 or 14 months Refractive error will be determined by retinoscopy in cycloplegia in all children Children with refractive error exceeding the AAPOS 2003 criteria Donahue et al 2003 are considered to have high refractive error in this study We anticipate that 8 of all children will have high refractive error according to these criteria These children will be randomized to the intervention group or the control group and will be followed up until final examination at age 4 with visual acuity serving as primary outcome In case amblyopia or strabismus develops during the course of the study children will be referred for immediate treatment and visual acuity at the moment of referral will be used as primary outcome In all children in the intervention group compliance with wearing spectacles will be measured electronically At age 4 pre-literacy skills will be measured in the intervention group and the control group
The majority of children approximately 92 will have mild or no refractive error at age one After the first examination these children will continue regular vision screening at the CHCs They will have their visual acuity measured at the age of 4 as part of standard vision screening in the Netherlands at the CHCs which will serve as secondary outcome If there is uncertainty about the visual outcome at the CHC the child will receive a supplementary examination Children with amblyopia or strabismus at the age of one will be excluded from this study and referred for immediate treatment Due to ethical considerations children with severe refractive error at the age of one ie exceeding the AAPOS 2003 criteria twofold will also be excluded from this study and referred for immediate treatment with glasses Due the nature and design of the study blinding of the researchers on site and of participants will not be possible
Study population
For this study we will recruit an estimated 2000-4000 healthy children aged 12-18 months after visiting one of the participating CHCs located in different regions of the Netherlands Utrecht HarderwijkErmeloPutten TielGeldermalsenCulemborgRoermondVenlo and Eindhoven It is estimated that approximately 8 of all included children will have high refractive error
Intervention if applicable
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 determinations of refractive error by retinoscopy in cycloplegia Children with high refractive error assigned to the control group will be examined by the study orthoptist one to three times yearly until final examination but will not be fitted with glasses
Primary study parametersoutcome of the study
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 andor ophthalmologist before for example when amblyopia or strabismus are suspected before the age of 4
Secondary study parametersoutcome of the study
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
Nature and extent of the burden and risks associated with participation benefit and group relatedness
The expected burden and risks associated with participation can be considered minimal In order to measure refractive error accurately retinoscopy will be done by study orthoptists after the instillation of cycloplegic eye drops as happens daily in clinical practice of orthoptists and pediatric ophthalmologists We will install 1 eyedrop of cyclopentolate 1 in each eye which we will repeat after 10 minutes Cyclopentolate can cause sleepiness in rare cases children are difficult to awaken for several minutes but can be awoken thereafter which is without sequelae without exception
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None