The Effect of Bifocals in Children With Down Syndrome

N/ACompletedNCT02241356

Radboud University Medical Center120 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

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

Interventions

bifocalsDEVICE

bifocal glasses with an addition of 2.5 Dioptres

single vision glassesDEVICE

single vision glasses

Eligibility

Sex: ALLMin age: 2 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Locations (1)

Isala Hospital

Zwolle, Overijssel, Netherlands

Outcomes

Primary Outcomes

• Change from baseline in visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.

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.

Time frame: baseline to 12 months later

Secondary Outcomes

• Visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.

visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.

Time frame: after 12 months

• Change from baseline in visual acuity at distance measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.

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.

Time frame: baseline to 12 months later

• Change from baseline in accuracy of accommodation response measured in Dioptres.

We will measure the accuracy of accommodation in Dioptres at baseline and after 16 months. We will calculate the difference.

Time frame: baseline to 12 months later

• Change in percentage of participants with strabismus

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.

Time frame: baseline to 12 months later

• Change in score of task readiness of the children

Data from ClinicalTrials.gov

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