The Effect of Bifocals in Children With Down Syndrome

Sponsor

Radboud University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02241356

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity at Near Accuracy of Accommodation Prevention of Strabismus Task Readiness	Device: bifocals Device: single vision glasses	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect of Bifocals in Children With Down Syndrome

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: single vision glasses single vision glasses	Device: single vision glasses single vision glasses
Experimental: bifocals bifocal glasses	Device: bifocals bifocal glasses with an addition of 2.5 Dioptres Other Names: bifocal glasses reading glasses

Arm

Intervention/Treatment

Active Comparator: single vision glasses

single vision glasses

Device: single vision glasses

single vision glasses

Experimental: bifocals

bifocal glasses

Device: bifocals

bifocal glasses with an addition of 2.5 Dioptres

Other Names:

bifocal glasses

reading glasses

Outcome Measures

Primary Outcome Measures

• 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 Outcome Measures

• 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 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.
• 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.
• 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.

Other Outcome Measures

• 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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