Condition category
Eye Diseases
Date applied
09/12/2013
Date assigned
29/01/2014
Last edited
10/11/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The visual field is the portion of the space around a person that can be seen at any one time without moving the eyes. Damage or disease to areas of the brain which process vision can result in a loss of part of the usual field of vision. Recent research has shown that certain rehabilitation approaches can be used to improve the functional vision of adult stroke patients with visual field loss. One particular method has been to use specialised computer software that requires visually scanning the images displayed on a monitor. However, these tools are typically too boring and often unable to engage young people for the long periods required for training to be effective. We are carrying out a feasibility study to pilot a computer game designed to rehabilitate young people with visual field loss. Our goal is to determine whether this training is effective in improving functional vision and to explore the potential of computer games technology to increase engagement with rehabilitation programmes.

Who can participate?
Young people between the ages of 8 and 25 years old can participate if they have a visual field loss due to damage or disease of the visual pathway in the brain. Potential participants must be able to perform a standard automated visual field assessment and have the capability of using a mouse, keyboard or touch screen to play the computer game.

What does the study involve?
All participants will receive the rehabilitation programme. The study involves a 6-week rehabilitation programme where participants are invited to play a computer game at home. Each session takes about half an hour to complete and participants will be asked to complete 30 sessions over the 6-week period (about 5 sessions per week). Participants will be asked to take part in four assessments of their vision one month before the programme, immediately before and after the programme, and one month after the programme.

What are the possible benefits and risks of participating?
Participants may benefit from an improvement in functional vision as part of the rehabilitation programme, and information obtained from this study may benefit future vision rehabilitation programmes by helping us to develop strategies that are more engaging for young people. Repetitive strain injuries have been associated with excessive use of computer games so the rehabilitation programme only allows the player to complete one session per day. Very rarely young people with epilepsy may be photosensitive, which means that flashing lights or certain colour sequences can trigger seizures. To minimise these risks we will be excluding potential participants with photosensitive epilepsy from this study.

Where is the study run from?
The study has been set up by the University of Lincoln and the WESC Foundation in Exeter. Vision assessments will be performed at the WESC Foundation or at Bristol Eye Hospital.

When is the study starting and how long is it expected to run for?
The study is expected to start in April 2014 and is expected to run until November 2014 or until the required number of participants have been recruited and assessed.

Who is funding the study?
The study is being jointly funded by the Technology Strategy Board, Medical Research Council and the WESC Foundation, UK.

Who is the main contact?
Dr Jonathan Waddington
jwaddington@wescfoundation.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jonathan Waddington

ORCID ID

Contact details

WESC Foundation
Topsham Road
Countess Wear
Exeter
EX2 6HA
United Kingdom
jwaddington@wescfoundation.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KTP 008989

Study information

Scientific title

Can a computer game designed to rehabilitate young people with visual field loss improve functional vision? A case series intervention and feasibility study

Acronym

Study hypothesis

Visual field loss is a visual impairment caused by damage to the visual pathway or areas of the brain that process vision, which results in missing areas of vision. This study will assess whether a computer game that has been designed to rehabilitate young people with visual field loss can improve their functional vision.

Hypothesis 1: We anticipate that rehabilitation using the computer game will lead to improvements in the speed and efficiency of day-to-day activities that require visual search, and improvements in patient-reported outcome measures of functional vision and quality of life.

Hypothesis 2: We do not anticipate a significant improvement in the border of the visual field.

Ethics approval

NRES Committee North East – Newcastle & North Tyneside 1, 30/05/2014, REC ref: 14/NE/0097

Study design

Case series intervention and feasibility study (interrupted time series design)

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Visual field loss

Intervention

All participants will receive training that will consist of playing the computer game for approximately 20-30 minutes to complete one session, and completing five sessions per week for 6 weeks (30 training sessions in total).

We will make four assessments of functional vision: one month before the rehabilitation programme begins, immediately before and immediately after the rehabilitation, and one month after the rehabilitation ends.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The speed at which participants perform 'activities of daily living' (ADLs). Measured one month before the rehabilitation programme begins, immediately before and immediately after the rehabilitation, and one month after the rehabilitation ends.

Secondary outcome measures

1. Perimeter and size of the visual field border
2. Scores on two patient-reported outcome questionnaires:
2.1. The Impact of Vision Impairment for Children (IVI_C) and
2.2. The Cardiff Visual Ability Questionnaire for Children (CVAQC)
3. Speed at which participants perform a mobility course and the percentage of brightly coloured cards found that are placed along the route.

Outcome measures one month before the rehabilitation programme begins, immediately before and immediately after the rehabilitation, and one month after the rehabilitation ends.

Overall trial start date

01/04/2014

Overall trial end date

01/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Young people (8-25 years old, male and female) with bilateral visual field loss caused by a lesion of the post-geniculate optic pathway or visual cortex.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Cognitive or physical impairments which cause a formal assessment of the visual field (standard automated perimetry) to be impractical.
2. The inability to use either a mouse, keyboard or touch screen to access the game.

Recruitment start date

01/04/2014

Recruitment end date

01/11/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

WESC Foundation
Exeter
EX2 6HA
United Kingdom

Sponsor information

Organisation

University of Lincoln (UK)

Sponsor details

c/o Professor Sara Owen
Brayford Pool
Lincoln
LN6 7TS
United Kingdom

Sponsor type

University/education

Website

http://www.lincoln.ac.uk

Funders

Funder type

Research council

Funder name

Part-funded by a grant from the Technology Strategy Board and Medical Research Council as part of a Knowledge Transfer Partnership.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Part-funded by contributions to the Knowledge Transfer Partnership by the WESC Foundation (UK)

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