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Completed

NCT Number: NCT02241356

The Effect of Bifocals in Children With Down Syndrome

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

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Key information

Conditions

Visual Acuity at Near Abnormalities, Multiple Accuracy of Accommodation Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Prevention of Strabismus Task Readiness

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isala Hospital

Zwolle, Overijssel, 8025 AB, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bifocals

Device

bifocal glasses with an addition of 2.5 Dioptres

Other names: bifocal glasses, reading glasses

single vision glasses

Device

single vision glasses

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.

    Time frame: 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 outcomes

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

    Time frame: after 12 months

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

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

    Time frame: 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.

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

    Time frame: 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.

  4. • Change in percentage of participants with strabismus

    Time frame: 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.

  5. • Change in score of task readiness of the children

    Time frame: 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.

Other outcomes

  1. • Possible prognostic determinants at baseline for improvement of visual acuity at near

    Time frame: 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

    Applying a multivariate logistic regression model using a backward variable elimination procedure (selection criterion P < 0.05, removal criterion P < 0.10) to test a key set of independent prognostic variables (measured at baseline) for better visual acuity at near after 12 months

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 16, 2014
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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