The Effect of Bifocals in Children With Down Syndrome

NCT02241356 | Completed DMC

• 2 other identifiers: R00023082013-23
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Down syndrome; visual functions; bifocals; children; visual acuity at near

Outcome Measures

Primary Outcomes (1)

• • Change from baseline in visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.

  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.

  baseline to 12 months later

Secondary Outcomes (5)

• • Visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.

  after 12 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

• • Change from baseline in accuracy of accommodation response measured in Dioptres.

  baseline to 12 months later

• • Change in percentage of participants with strabismus

  baseline to 12 months later

• • Change in score of task readiness of the children

  baseline to 12 months later

Other Outcomes (1)

• • 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

Study Arms (2)

single vision glasses

ACTIVE COMPARATOR

single vision glasses

Device: single vision glasses

bifocals

EXPERIMENTAL

bifocal glasses

Device: bifocals

Interventions

bifocals DEVICE

bifocal glasses with an addition of 2.5 Dioptres

Also known as: bifocal glasses, reading glasses

bifocals

single vision glasses DEVICE

single vision glasses

single vision glasses

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Isala Hospital

Zwolle, Overijssel, 8025 AB, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 20626718 BACKGROUND

• 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.

  PMID: 19470088 BACKGROUND

• 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.

  PMID: 11133848 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• H HL Goossens, PhD

  Radboudumc, Dept. Cognitive Neuroscience/126

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 16, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

NL (1)