The Effect of Bifocals in Children With Down Syndrome

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

Study Overview

• Status: Completed
• Conditions: Visual Acuity at Near; Accuracy of Accommodation; Prevention of Strabismus; Task Readiness
• Intervention / Treatment: Device: single vision glasses; Device: bifocals

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025 AB
      • Isala Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: single vision glasses	Device: single vision glasses; single vision glasses
Experimental: bifocals; bifocal glasses	Device: bifocals; bifocal glasses with an addition of 2.5 Dioptres; Other Names: bifocal glasses; reading glasses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.	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.	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.	baseline to 12 months later
• Change from baseline in accuracy of accommodation response measured in Dioptres.	We will measure the accuracy of accommodation in Dioptres at baseline and after 16 months. We will calculate the difference.	baseline to 12 months later
• Change in percentage of participants with strabismus	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.	baseline to 12 months later
• Change in score of task readiness of the children	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.	baseline to 12 months later

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Possible prognostic determinants at baseline for improvement of visual acuity at near	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	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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: H HL Goossens, PhD, Radboudumc, Dept. Cognitive Neuroscience/126

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 29, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (Estimate): September 16, 2014

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: children; Down syndrome; visual functions; bifocals; visual acuity at near
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Cranial Nerve Diseases; Ocular Motility Disorders; Abnormalities, Multiple; Chromosome Disorders; Strabismus; Down Syndrome; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: R0002308; 2013-23 (Other Identifier: AP HM)