Status:
COMPLETED
The Effect of Bifocals in Children With Down Syndrome
Lead Sponsor:
Radboud University Medical Center
Conditions:
Visual Acuity at Near
Accuracy of Accommodation
Eligibility:
All Genders
2-14 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02241356
Start Date
March 1 2014
End Date
June 1 2017
Last Update
March 16 2020
Active Locations (1)
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1
Isala Hospital
Zwolle, Overijssel, Netherlands, 8025 AB