- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07752563
Pilot RCT of Computer-based Eye Movement Training (CRYSTAL)
August 3, 2026 updated by: Glasgow Caledonian University
Computer-based Eye Movement Training for Stroke-related Visual Field Loss: a Pilot Randomised Controlled Trial
The goal of this study is to learn whether NeuroEyeCoach, a computer-based eye movement training programme, can help stroke survivors with visual field loss. The study will also assess whether a larger clinical trial is feasible. The main questions it aims to answer are:
- Can stroke survivors be successfully recruited, randomised and followed up in a larger trial?
- Is NeuroEyeCoach acceptable and practical to use?
- Is there early evidence that NeuroEyeCoach improves vision-related functioning and wellbeing? Researchers will compare NeuroEyeCoach plus usual care with usual care alone.
Participants will:
- Be randomly assigned to receive NeuroEyeCoach plus usual care or usual care alone
- Complete six weeks of training if allocated to NeuroEyeCoach
- Complete questionnaires and tests of vision, daily activities, quality of life, confidence and wellbeing
- Take part in follow-up assessments over six months This pilot trial will include 60 stroke survivors living with visual field loss after stroke. Findings will be used to inform the design of a larger study.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christine Hazelton, PhD
- Phone Number: 0141 331 8181
- Email: christine.hazelton@gcu.ac.uk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- adult (>18 years)
- stroke survivor
- stroke-related homonymous VFL (minimum quadrantanopia)
- sufficient language, cognitive, and upper limb ability to participate in trial activities.
Exclusion Criteria:
- pre-existing (ie pre-stroke) registration as sight impaired (partially sighted) or severely sight impaired (blind)
- • history of seizure disorders, especially those of a photosensitive nature
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Eye movement training + usual care
Usual post-stroke care, plus eye movement training (VISIOcoach)
|
computer based eye movement training for visual field loss in stroke
Usual post-stroke care
|
|
Other: usual care
Usual post-stroke care
|
Usual post-stroke care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment rate
Time Frame: through study completion, estimated at 15 months
|
Rate of recruitment to the trial
|
through study completion, estimated at 15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention Rate
Time Frame: through study completion, estimated at 15 months
|
Rate of retention of participants in the study
|
through study completion, estimated at 15 months
|
|
Screening and eligibility rate
Time Frame: Active screening period
|
Screening and eligibility rate
|
Active screening period
|
|
Outcome measure completion rate
Time Frame: over data collection period
|
through study completion, estimated at 15 months
|
over data collection period
|
|
intervention adherence
Time Frame: 6 weeks
|
adherence to recommended training regime (duration)
|
6 weeks
|
|
Adverse events
Time Frame: up to 6 weeks
|
any adverse eventa experienced
|
up to 6 weeks
|
|
Support and computer provision needs
Time Frame: up to 6 weeks
|
To what extent must technical equipment or assistance be given
|
up to 6 weeks
|
|
NEI VFQ 25 (National Eye Institute Visual Function Questionnaire-25)
Time Frame: baseline, 6 weeks post randomisation, 6 months post randomisation
|
Patient-reported measure of vision-related functioning.
Minimum value is 0, and maximum value is 100; higher scores mean a better outcome
|
baseline, 6 weeks post randomisation, 6 months post randomisation
|
|
EQ-5D 5L
Time Frame: baseline, 6 weeks post randomisation, 6 months post randomisation
|
Generic health related quality of life Maximum value 1.0; better scores mean a better outcome
|
baseline, 6 weeks post randomisation, 6 months post randomisation
|
|
IReST (International Reading Speed Test)
Time Frame: baseline, 6 weeks post randomisation, 6 months post randomisation
|
Reading test (words per minute)
|
baseline, 6 weeks post randomisation, 6 months post randomisation
|
|
Melbourne Rapid Fields
Time Frame: baseline, 6 weeks post randomisation, 6 months post randomisation
|
visual field test
|
baseline, 6 weeks post randomisation, 6 months post randomisation
|
|
Confidence after Stroke Measure
Time Frame: baseline, 6 weeks post randomisation, 6 months post randomisation
|
Validated questionnaire that explores self-confidence, positive attitude and social confidence Minimum score is 0 and the maximum score is 81; a higher score indicates better outcome Ref: Horne JC, Lincoln NB, Logan PA.
Measurement of confidence: the development and psychometric evaluation of a stroke-specific, measure of confidence.
Clin Rehabil.
2017 Nov;31(11):1529-1537. doi: 10.1177/0269215517705424.
Epub 2017 May 3. PMID: 28466669; PMCID: PMC5652651.
|
baseline, 6 weeks post randomisation, 6 months post randomisation
|
|
Warwick-Edinburgh Mental Wellbeing Scale
Time Frame: baseline, 6 weeks post randomisation, 6 months post randomisation
|
Mental wellbeing questionnaire Minimum raw score is 7 and the maximum raw score is 35; higher score means a better outcome
|
baseline, 6 weeks post randomisation, 6 months post randomisation
|
|
health care resource use
Time Frame: baseline, 6 weeks post randomisation, 6 months post randomisation
|
health care resource use, covering general, stroke specific, and vision specific resources
|
baseline, 6 weeks post randomisation, 6 months post randomisation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Study Registration Dates
First Submitted
December 3, 2025
First Submitted That Met QC Criteria
August 3, 2026
First Posted (Actual)
August 7, 2026
Study Record Updates
Last Update Posted (Actual)
August 7, 2026
Last Update Submitted That Met QC Criteria
August 3, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HLS/LS/25/032
- TCS/24/40 (Other Grant/Funding Number: Chief Scientist Office Scotland)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
We have not yet discussed and decided our IPD sharing position
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.