Accuracy of Accommodation, Prevention of Strabismus, Task Readiness, Visual Acuity at Near
Conditions
Keywords
Down syndrome, visual functions, bifocals, children, visual acuity at near
Brief summary
Visual acuity at near improves in children with Down syndrome using bifocals
Detailed description
The accommodation is consistently reduced in 50 to 100% of children with Down syndrome and does not improve with age.
Interventions
DEVICEbifocals
bifocal glasses with an addition of 2.5 Dioptres
DEVICEsingle vision glasses
single vision glasses
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Down syndrome (DS) * Accommodation lag \>0.5 Dioptres for children with DS \<12 years and \>0.75 Dioptres for children older than age 12 or Visual acuity at near is worse than at distance and \>0.1 * Age range 2-14 years * Speaks Dutch as the first language * Must be verbal or able to understand instructions * Must be able to perform a task sitting on a chair and working at a table
Exclusion criteria
* Visual acuity at near \< 0.1 * Not able to do vision tests at age over 5 * Has worn bifocals already * Other significant eye diseases, such as keratoconus, cataract or high myopia (\>S-6.00). * Diagnoses of any neurological, sensory or behavioural disorders such as autism, microcephaly or significant hearing loss. * Prematurity, born premature after a pregnancy term less than 36 weeks * Born after severe perinatal problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • Change from baseline in visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months. | baseline to 12 months later | visual acuity is measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at baseline and at the end of the study 16 months later. We will calculate the difference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • Change from baseline in accuracy of accommodation response measured in Dioptres. | baseline to 12 months later | We will measure the accuracy of accommodation in Dioptres at baseline and after 16 months. We will calculate the difference. |
| • Visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months. | after 12 months | visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months. |
| • Change in percentage of participants with strabismus | baseline to 12 months later | We will calculate the percentage of participants with strabismus at baseline and at the end of the study, 16 months later. Then we can calculate the difference in percentage of participants with strabismus. |
| • Change in score of task readiness of the children | baseline to 12 months later | We will measure task readiness in scores of attention, reaction time, inhibition and working memory at baseline and at the end of the study 16 months later. Then we calculate the difference in this score. |
| • Change from baseline in visual acuity at distance measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months. | baseline to 12 months later | Visual acuity at distance is measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at baseline and at the end of the study 16 months later. We will calculate the difference. |
Other
| Measure | Time frame | Description |
|---|---|---|
| • Possible prognostic determinants at baseline for improvement of visual acuity at near | participants will be followed for the duration of 12 months, after the last included participant has been followed up for 18 months we will do this analysis | Applying a multivariate logistic regression model using a backward variable elimination procedure (selection criterion P \< 0.05, removal criterion P \< 0.10) to test a key set of independent prognostic variables (measured at baseline) for better visual acuity at near after 12 months |
Countries
Netherlands
Outcome results
None listed