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The Effect of Bifocals in Children With Down Syndrome

Primary Purpose

Visual Acuity at Near, Accuracy of Accommodation, Prevention of Strabismus

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
bifocals
single vision glasses
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visual Acuity at Near focused on measuring Down syndrome, visual functions, bifocals, children, visual acuity at near

Eligibility Criteria

2 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Isala Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

single vision glasses

bifocals

Arm Description

single vision glasses

bifocal glasses

Outcomes

Primary Outcome Measures

• 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.

Secondary Outcome Measures

• 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.
• 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.
• 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.
• 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.
• 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.

Full Information

First Posted
August 29, 2014
Last Updated
March 12, 2020
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02241356
Brief Title
The Effect of Bifocals in Children With Down Syndrome
Official Title
The Effect of Bifocals in Children With Down Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Acuity at Near, Accuracy of Accommodation, Prevention of Strabismus, Task Readiness
Keywords
Down syndrome, visual functions, bifocals, children, visual acuity at near

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single vision glasses
Arm Type
Active Comparator
Arm Description
single vision glasses
Arm Title
bifocals
Arm Type
Experimental
Arm Description
bifocal glasses
Intervention Type
Device
Intervention Name(s)
bifocals
Other Intervention Name(s)
bifocal glasses, reading glasses
Intervention Description
bifocal glasses with an addition of 2.5 Dioptres
Intervention Type
Device
Intervention Name(s)
single vision glasses
Intervention Description
single vision glasses
Primary Outcome Measure Information:
Title
• Change from baseline in visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.
Description
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.
Time Frame
baseline to 12 months later
Secondary Outcome Measure Information:
Title
• Visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.
Description
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
Title
• Change from baseline in visual acuity at distance measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.
Description
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.
Time Frame
baseline to 12 months later
Title
• Change from baseline in accuracy of accommodation response measured in Dioptres.
Description
We will measure the accuracy of accommodation in Dioptres at baseline and after 16 months. We will calculate the difference.
Time Frame
baseline to 12 months later
Title
• Change in percentage of participants with strabismus
Description
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.
Time Frame
baseline to 12 months later
Title
• Change in score of task readiness of the children
Description
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.
Time Frame
baseline to 12 months later
Other Pre-specified Outcome Measures:
Title
• Possible prognostic determinants at baseline for improvement of visual acuity at near
Description
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H HL Goossens, PhD
Organizational Affiliation
Radboudumc, Dept. Cognitive Neuroscience/126
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isala Hospital
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8025 AB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
20626718
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.
Results Reference
background
PubMed Identifier
19470088
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.
Results Reference
background
PubMed Identifier
11133848
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.
Results Reference
background

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The Effect of Bifocals in Children With Down Syndrome

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