The Effect of Bifocals in Children With Down Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-06-30

Brief Summary

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Visual acuity at near improves in children with Down syndrome using bifocals

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Detailed Description

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The accommodation is consistently reduced in 50 to 100% of children with Down syndrome and does not improve with age.

Conditions

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Visual Acuity at Near Accuracy of Accommodation Prevention of Strabismus Task Readiness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single vision glasses

Group Type ACTIVE_COMPARATOR

single vision glasses

Intervention Type DEVICE

single vision glasses

bifocals

bifocal glasses

Group Type EXPERIMENTAL

bifocals

Intervention Type DEVICE

bifocal glasses with an addition of 2.5 Dioptres

Interventions

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bifocals

bifocal glasses with an addition of 2.5 Dioptres

Intervention Type DEVICE

single vision glasses

Intervention Type DEVICE

Other Intervention Names

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bifocal glasses reading glasses

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No