Condition category
Eye Diseases
Date applied
04/04/2006
Date assigned
04/04/2006
Last edited
19/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ralf Cox

ORCID ID

Contact details

Bartiméus
P.O. Box 1003
Zeist
3700 BA
Netherlands
r.cox@bartimeus.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

When young visual impaired children can participate in a training (game) in which a magnifier is used, they learn to handle the magnifier (fine motor skills), they learn to observe small symbols (visual behaviour) and they become interested in the world of small things and know how to visualize these things.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Visual impairment

Intervention

The experimental group trains with a magnifier. The control group trains without a magnifier.
The training (game) is the intervention. It is given twice a week (20 minutes) for 6 weeks.

The material consists of eight different patterns, each with four pathways made out of small symbols (LH), somewhat like 'ant trails'. The pathways either go horizontal, vertical or round, and they can cross each other. By following the paths with the magnifier, movements are induced in all directions. The goal of the task is to find the symbol at the end of the pathway corresponding to the symbol at the start. The size of the symbols is adjusted to each individual child's visual acuity.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Can the training teach children to handle a magnifier?
2. Can we find a difference in performance after the training (in motor skills, symbol discrimination, visual behaviour)?

Preliminary analysis (updated 15/11/2006):
Preliminary analysis revealed that the 12-session training had a positive influence on children’s performance on the task. The number of correctly found end-points, attained by adequately following the corresponding path, increased for both training groups. There was however a difference in the amount of increase between the two groups.

On average, the group that has trained without the magnifier performed twice as good. That is, in the post-test they found twice as much correct end-point figures as compared to the pre-test. In the group that has trained with the magnifier, this number was four times as high. Now we are studying the rich data we collected to uncover the relevant variables that determine children’s progression and the differences between the groups. In addition we are looking for a possible transfer of this progression to other domains of their development (e.g., fine-motor skills).

Secondary outcome measures

1. How do young visual-impaired children work with a visual aid?
2. Can they perform the complex task of training and magnifier, and do they have a dominant hand and dominant eye?

Overall trial start date

01/02/2006

Overall trial end date

01/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children, aged 2.5 to 6 years old, with visual impairment: visual acuity 0.3 or less. All children have normal development
2. Children included will have an ophthalmologic examination, an examination of their gross and fine motor skills, and an examination of their overall level of development

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

47

Participant exclusion criteria

1. Developmental delay
2. Impairment of motor skills
3. Prematurity

Recruitment start date

01/02/2006

Recruitment end date

01/09/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Bartiméus
Zeist
3700 BA
Netherlands

Sponsor information

Organisation

Bartiméus (The Netherlands)

Sponsor details

P.O. Box 1003
Zeist
3700 BA
Netherlands

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw), Stichting Oogfonds Nederland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes