The Effect of Bifocals in Children With Down Syndrome

Not Applicable

Completed

• Conditions: Visual Acuity at Near; Accuracy of Accommodation; Task Readiness; Prevention of Strabismus
• Interventions: Device: single vision glasses; Device: bifocals

• Registration Number: NCT02241356
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-16
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single vision glasses	single vision glasses	single vision glasses
bifocals	bifocals	bifocal glasses

Primary Outcome Measures

Name	Time	Method
• 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

Name	Time	Method
• 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.

Trial Locations

Locations (1)

Isala Hospital; 🇳🇱 Zwolle, Overijssel, Netherlands