Acquired Visual Field DefectsVISIOTRAINNCT01730560
Rehabilitation For Acquired Visual Field Defects: Development Of A Bottom-Up Approach
A study testing Treatment A and Treatment B in people with Acquired Visual Field Defects, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Cortical Visual Field Defects (CFVD) are common after acquired brain injury. They often cause problems with reading and visual exploration which impact on patients' quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acquired Visual Field Defects
- What is being tested?
- Treatment A and Treatment B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2010to 13 Jun 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/Female
- Stroke (ischemia or hemorrhage) documented by CTscan or MRI
- Traumatic brain injury (TBI) documented by CTscan or MRI
- Right or Left hemianopia defined by perimetry
- All subjects must be between the ages of 18-80
- Aetiology of visual field defect : Stroke (ischemia or hemorrhage)
Show all 14Show fewer
- Delay post-stroke : at least 6 months
- Only one lesion on CTscan or MRI (performed in a maximal delay of 6 months)
- Corrected monocular visual acuity > 5/10
- Possible understanding of experimental conditions
- Patient being able to be quiet and sit during at least 2 hours
- Having given written informed consent prior to any procedure related to the study
- Availability for the period of the study
- Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
Who cannot join
- Ophthalmologic criteria : monocular visual acuity < 4/10, strabismus , diplopia , ocular instability , nystagmus, maculopathy , glaucoma , retinopathy , orthoptic rehabilitation
- Neurologic criteria : sever phasic disturbances , neurologic degenerative affection , non controlled seizure , severe handicap non compatible with prolonged sit position or concentration during 30 consecutive minutes
- No command of french language
- Non stabilized medical situation
- Females who are pregnant, nursing, or planning a pregnancy during the study period, or females of childbearing potential, not using a reliable means of contraception.
- Not under any administrative or legal supervision
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Physique et de Réadaptation,Hôpital Henry Gabrielle
Saint-Genis-Laval, 69235
About this study
Cortical Visual Field Defects (CFVD) are common after acquired brain injury. They often cause problems with reading and visual exploration which impact on patients' quality of life. Apart from the substitutive method that uses prisms directly placed on glasses, two main rehabilitative methods have been explored previously: one restorative and one compensatory. The most effective methods seem to be based on compensatory training paradigms that target eye movements. They rely on voluntary mass-practice that induces changes in exploratory saccadic behaviour, particularly into the blind hemifield. Previous studies using this method have shown changes in visual scanning patterns but with only a marginal profit in terms of functional benefit.
In the present study, the investigators developed a new approach to the compensatory visual field training based solely on a bottom-up mechanism. It does not require the patients' ability to voluntarily maintain attention oriented to the affected field, which may be difficult for brain-damaged patients. As previously reported in other pathological contexts (e.g. use of prism adaptation or sensory stimulation in neglect patients), bypassing voluntary and conscious implication of the patient can produce improvements by a more automatic process.
The investigators hypotheses are: 1) that a novel ramp-step search paradigm can be used by hemianopic patients to automatically improve targeted eye movements into their blind visual field; and 2) that this will lead to behavioural improvements on ecologically valid tests of visual search.
- Conditions
- Acquired Visual Field Defects
- Being tested
- Treatment A, Treatment B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment AOther
The computer-based training task consists of a novel ramp-step search paradigm with a stimulus traversing the screen from left to right or right to left. Subjects are asked to pursue the stimulus (ramp phase) and then saccade to find its location when it suddenly jumps (step phase). The stimulus is an open spinning circle. At the end of each movement, the gap can be located at the top or at the bottom, and patients are asked to indicate this location by pushing the response button as quickly as possible.
The starting point will alternate between left and right. The training task includes 3 sessions with 100 movements each. Reaction Times and errors will be monitored online to ensure that the patient performs the task correctly.
Each treatment phase has the same pattern:
- two visits in pre-tests evaluation (V1 and V2),
- one visit to perform treatment (A or B) and to assess immediate and 2h post-effects (V3),
- two visits after treatment (V4 at one week and V5 at one month).
Treatment BOther
Placebo treatment using the same computer-based training task, but including only the ramp phase.
Each treatment phase has the same pattern:
- two visits in pre-tests evaluation (V1 and V2),
- one visit to perform treatment (A or B) and to assess immediate and 2h post-effects (V3),
- two visits after treatment (V4 at one week and V5 at one month).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1:Treatment A | Experimental | Treatment A (active) followed by treatment B (neutral) Receives: Other: Treatment A |
| Arm 2: Treatment B | Experimental | Treatment B (neutral) followed by treatment A (active) Receives: Other: Treatment B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in performance (mean reaction time - RT) of an ecological visual search task between pre-tests and immediate post-test for each patient according to treatment (A or B).
Measured: 1 week
Secondary outcomes (1)
Errors and omissions at each evaluation session for the visual search task
Mean RT difference, errors and omissions at several visual tasks (rapid scanning task, exploratory visual tasks, reading task) at each evaluation session Parameters of visual field perimetry before and after treatment Oculo-motor parameters during the different tasks (i.e. amplitude and latencies for saccades and fixations)
Measured: 1, 2 and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study start29 Nov 2010
- Primary completion13 Jun 2018
- Study completion13 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Visual Field DefectsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Jacquin-Courtois, MD, PhD, Principal investigator, Service de Médecine Physique et de Réadaptation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730560
- Sponsor's protocol ID
- 2010.615
- Other IDs
- 2010-A00702-37
- Acronym
- VISIOTRAIN
- Status last verified
- Sep 2025
- First submitted
- 15 Nov 2012
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Ong YH, Jacquin-Courtois S, Gorgoraptis N, Bays PM, Husain M, Leff AP. Eye-Search: A web-based therapy that improves visual search in hemianopia. Ann Clin Transl Neurol. 2015 Jan;2(1):74-8. doi: 10.1002/acn3.154. Epub 2014 Nov 27.
PubMed 25642437
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation For Acquired Visual Field Defects: Development Of A Bottom-Up Approach
- ClinicalTrials.gov ID
- NCT01730560
- Acronym / sponsor ID
- VISIOTRAIN / 2010.615
- Conditions
- Acquired Visual Field Defects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Nov 2010 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 21 Nov 2012 (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.
Cortical Visual Field Defects (CFVD) are common after acquired brain injury. They often cause problems with reading and visual exploration which impact on patients' quality of life. Apart from the substitutive method that uses prisms directly placed on glasses, two main rehabilitative methods have been explored previously: one restorative and one compensatory. The most effective methods seem to be based on compensatory training paradigms that target eye movements. They rely on voluntary mass-practice that induces changes in exploratory saccadic behaviour, particularly into the blind hemifield. Previous studies using this method have shown changes in visual scanning patterns but with only a marginal profit in terms of functional benefit.
In the present study, the investigators developed a new approach to the compensatory visual field training based solely on a bottom-up mechanism. It does not require the patients' ability to voluntarily maintain attention oriented to the affected field, which may be difficult for brain-damaged patients. As previously reported in other pathological contexts (e.g. use of prism adaptation or sensory stimulation in neglect patients), bypassing voluntary and conscious implication of the patient can produce improvements by a more automatic process.
The investigators hypotheses are: 1) that a novel ramp-step search paradigm can be used by hemianopic patients to automatically improve targeted eye movements into their blind visual field; and 2) that this will lead to behavioural improvements on ecologically valid tests of visual search.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1:Treatment A | Experimental | Other: Treatment ATreatment A (active) followed by treatment B (neutral) |
| Arm 2: Treatment B | Experimental | Other: Treatment BTreatment B (neutral) followed by treatment A (active) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male/Female
- Stroke (ischemia or hemorrhage) documented by CTscan or MRI
- Traumatic brain injury (TBI) documented by CTscan or MRI
- Right or Left hemianopia defined by perimetry
- All subjects must be between the ages of 18-80
Key exclusion criteria (6 listed)
- Ophthalmologic criteria : monocular visual acuity < 4/10, strabismus , diplopia , ocular instability , nystagmus, maculopathy , glaucoma , retinopathy , orthoptic rehabilitation
- Neurologic criteria : sever phasic disturbances , neurologic degenerative affection , non controlled seizure , severe handicap non compatible with prolonged sit position or concentration during 30 consecutive minutes
- No command of french language
- Non stabilized medical situation
- Females who are pregnant, nursing, or planning a pregnancy during the study period, or females of childbearing potential, not using a reliable means of contraception.
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 |
|---|---|---|
| Treatment AThe computer-based training task consists of a novel ramp-step search paradigm with a stimulus traversing the screen from left to right or right to left. Subjects are asked to pursue the stimulus (ramp phase) and then saccade to find its location when it suddenly jumps (step phase). The stimulus is an open spinning circle. At the end of each movement, the gap can be located at the top or at the bottom, and patients are asked to indicate this location by pushing the response button as quickly as possible. The starting point will alternate between left and right. The training task includes 3 sessions with 100 movements each. Reaction Times and errors will be monitored online to ensure that the patient performs the task correctly. Each treatment phase has the same pattern: * two visits in pre-tests evaluation (V1 and V2), * one visit to perform treatment (A or B) and to assess immediate and 2h post-effects (V3), * two visits after treatment (V4 at one week and V5 at one month). | Other | Arm 1:Treatment A |
| Treatment BPlacebo treatment using the same computer-based training task, but including only the ramp phase. Each treatment phase has the same pattern: * two visits in pre-tests evaluation (V1 and V2), * one visit to perform treatment (A or B) and to assess immediate and 2h post-effects (V3), * two visits after treatment (V4 at one week and V5 at one month). | Other | Arm 2: Treatment B |
Primary outcome
Difference in performance (mean reaction time - RT) of an ecological visual search task between pre-tests and immediate post-test for each patient according to treatment (A or B).
Time frame: 1 week
1 secondary outcome
Errors and omissions at each evaluation session for the visual search task
Time frame: 1, 2 and 5 weeks
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 30 Sep 2025.
- Results publication: PubMed 25642437Ong YH, Jacquin-Courtois S, Gorgoraptis N, Bays PM, Husain M, Leff AP. Eye-Search: A web-based therapy that improves visual search in hemianopia. Ann Clin Transl Neurol. 2015 Jan;2(1):74-8. doi: 10.1002/acn3.154. Epub 2014 Nov 27.
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.
Sophie Jacquin-Courtois, MD, PhD principal investigator
Service de Médecine Physique et de Réadaptation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment A and Treatment B in people with Acquired Visual Field Defects, run by Hospices Civils de Lyon at 1 site in France.
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 14 inclusion and 6 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 30 Sep 2025. 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 France. 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?
Difference in performance (mean reaction time - RT) of an ecological visual search task between pre-tests and immediate post-test for each patient according to treatment (A or B). (time frame: 1 week). 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 NCT01730560, which also lists 1 linked publication.
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 30 Sep 2025.