---
title: The Effect of Bifocals in Children With Down Syndrome
nct_id: NCT02241356
overall_status: COMPLETED
phase: NA
sponsor: Radboud University Medical Center
study_type: INTERVENTIONAL
primary_condition: Visual Acuity at Near
countries: Netherlands
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02241356.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02241356"
ct_last_update_post_date: 2020-03-16
last_seen_at: "2026-05-12T06:22:59.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Effect of Bifocals in Children With Down Syndrome

**NCT ID:** [NCT02241356](https://clinicaltrials.gov/study/NCT02241356)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** Radboud University Medical Center
- **Conditions:** Visual Acuity at Near, Accuracy of Accommodation, Prevention of Strabismus, Task Readiness
- **Start Date:** 2014-03
- **Completion Date:** 2017-06
- **CT.gov Last Update:** 2020-03-16

## 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.

## Eligibility

- **Minimum age:** 2 Years
- **Maximum age:** 14 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **single vision glasses** (ACTIVE_COMPARATOR) — single vision glasses
- **bifocals** (EXPERIMENTAL) — bifocal glasses

## Interventions

- **bifocals** (DEVICE) — bifocal glasses with an addition of 2.5 Dioptres
- **single vision glasses** (DEVICE) — single vision glasses

## Primary Outcomes

- **• 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

- **• 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)_

## Locations (1)

- Isala Hospital, Zwolle, Overijssel, Netherlands

## Recent Field Changes (last 30 days)

- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.isala hospital|zwolle|overijssel|netherlands` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02241356.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02241356*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*