Clinical trial NCT02241356: The Effect of Bifocals in Children With Down Syndrome
Official title: The Effect of Bifocals in Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity at Near
Accuracy of Accommodation
Prevention of Strabismus
Task Readiness
Keywords: Down syndrome
visual functions
bifocals
children
visual acuity at near
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: • Change from baseline in visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.
timeFrame: baseline to 12 months later
Secondary outcomes:
measure: • Visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.
timeFrame: after 12 months
measure: • Change from baseline in visual acuity at distance measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.
timeFrame: baseline to 12 months later
measure: • Change from baseline in accuracy of accommodation response measured in Dioptres.
timeFrame: baseline to 12 months later
measure: • Change in percentage of participants with strabismus
timeFrame: baseline to 12 months later
measure: • Change in score of task readiness of the children
timeFrame: baseline to 12 months later
Other outcomes:
measure: • Possible prognostic determinants at baseline for improvement of visual acuity at near
timeFrame: 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
Locations:
city: Zwolle
country: Netherlands
facility: Isala Hospital
state: Overijssel
Study officials:
affiliation: Radboudumc, Dept. Cognitive Neuroscience/126
name: H HL Goossens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nandakumar K, Leat SJ. Bifocals in children with Down syndrome (BiDS) - visual acuity, accommodation and early literacy skills. Acta Ophthalmol. 2010 Sep;88(6):e196-204. doi: 10.1111/j.1755-3768.2010.01944.x.
citation: Al-Bagdady M, Stewart RE, Watts P, Murphy PJ, Woodhouse JM. Bifocals and Down's syndrome: correction or treatment? Ophthalmic Physiol Opt. 2009 Jul;29(4):416-21. doi: 10.1111/j.1475-1313.2009.00646.x. Epub 2009 May 11.
citation: Cregg M, Woodhouse JM, Pakeman VH, Saunders KJ, Gunter HL, Parker M, Fraser WI, Sastry P. Accommodation and refractive error in children with Down syndrome: cross-sectional and longitudinal studies. Invest Ophthalmol Vis Sci. 2001 Jan;42(1):55-63.