Visual Acuity at NearNCT02241356
The Effect of Bifocals in Children With Down Syndrome
A study testing bifocals and single vision glasses in people with Visual Acuity at Near and Accuracy of Accommodation, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Visual acuity at near improves in children with Down syndrome using bifocals Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Visual Acuity at Near, Accuracy of Accommodation, Prevention of Strabismus
- What is being tested?
- bifocals and single vision glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Visual acuity at near improves in children with Down syndrome using bifocals
Read the detailed description
The accommodation is consistently reduced in 50 to 100% of children with Down syndrome and does not improve with age.
- Conditions
- Visual Acuity at Near, Accuracy of Accommodation, Prevention of Strabismus, Task Readiness
- Being tested
- bifocals, single vision glasses
- Keywords
- Down syndrome, visual functions, bifocals, children, visual acuity at near
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bifocalsDevice
Also called bifocal glasses, reading glasses
bifocal glasses with an addition of 2.5 Dioptres
single vision glassesDevice
single vision glasses
| Study group | Role | What they receive |
|---|---|---|
| single vision glasses | Active comparator | single vision glasses Receives: Device: single vision glasses |
| bifocals | Experimental | bifocal glasses Receives: Device: bifocals |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: 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.
visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline to 12 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Visual Acuity at NearStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- H HL Goossens, PhD, Principal investigator, Radboudumc, Dept. Cognitive Neuroscience/126
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241356
- Sponsor's protocol ID
- R0002308
- Other IDs
- 2013-23
- Status last verified
- Mar 2020
- First submitted
- 29 Aug 2014
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 20626718Al-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.
PubMed 19470088Cregg 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.
PubMed 11133848
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bifocals in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT02241356
- Acronym / sponsor ID
- R0002308
- Conditions
- Visual Acuity at Near, Accuracy of Accommodation, Prevention of Strabismus, Task Readiness
- Keywords
- Down syndrome, visual functions, bifocals, children, visual acuity at near
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single vision glasses | Active comparator | Device: single vision glassessingle vision glasses |
| bifocals | Experimental | Device: bifocalsbifocal glasses |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bifocalsAlso: bifocal glasses, reading glassesbifocal glasses with an addition of 2.5 Dioptres | Device | bifocals |
| single vision glassessingle vision glasses | Device | single vision glasses |
Primary outcome
• 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.
5 secondary outcomes
• 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
• 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
• Change from baseline in accuracy of accommodation response measured in Dioptres.
Time frame: baseline to 12 months later
• Change in percentage of participants with strabismus
Time frame: baseline to 12 months later
• Change in score of task readiness of the children
Time frame: baseline to 12 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Background: PubMed 20626718Nandakumar 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.
- Background: PubMed 19470088Al-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.
- Background: PubMed 11133848Cregg 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.
Related trials for Visual Acuity at Near
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H HL Goossens, PhD principal investigator
Radboudumc, Dept. Cognitive Neuroscience/126
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bifocals and single vision glasses in people with Visual Acuity at Near and Accuracy of Accommodation, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: baseline to 12 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02241356, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.