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The Effect of Bifocals in Children With Down Syndrome

R

Radboud University Medical Center

Status

Completed

Conditions

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

Treatments

Device: bifocals
Device: single vision glasses

Study type

Interventional

Funder types

Other

Identifiers

NCT02241356
R0002308
2013-23 (Other Identifier)

Details and patient eligibility

About

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

Full description

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

Enrollment

120 patients

Sex

All

Ages

2 to 14 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

single vision glasses
Active Comparator group
Description:
single vision glasses
Treatment:
Device: single vision glasses
bifocals
Experimental group
Description:
bifocal glasses
Treatment:
Device: bifocals

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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