HemianopiaPhase 2NCT04043429
Restoration vs. Compensation in Neurovisual Rehabilitation of Visual Field Defects
A Phase 2 study testing Vision Restoration Training (VRT) and Vision Exploration Training (VET) in people with Hemianopia and Brain Injuries, Traumatic, run by University of Magdeburg at 1 site in Germany.
Trial summary
Visual field defects (VFD) are a frequent effect of cerebral lesions especially after posterior cerebral artery stroke. The present study was conducted to compare effects of vision restoration training (VRT) and compensation training (Visual Exploration Training, VET) on visual field performance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemianopia, Brain Injuries, Traumatic
- What is being tested?
- Vision Restoration Training (VRT) and Vision Exploration Training (VET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2003to Jan 2005
- Phase
- Phase 2
- 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
- Visual field defects after brain damage
- lesion age above 6 months
- documented brain lesions due to ischemic stroke, hemorrhage or tumor demonstrated by computer tomography or by magnet resonance imaging
Who cannot join
- hemispatial neglect
- complete blindness
- severe psychotic diseases
- serious drug abuse
- chronic degenerative diseases (dementia, multiple sclerosis)
- severe motor impairments
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- noticeable low intelligence influencing proper comprehension of diagnostic and training instructions
- considerable impaired vision (visual acuity below 0.1 generated by amblyopia, opacity of cornea or lens, maculopathy and other retinal diseases where vision impairment is expected in the next month (e.g. subretinal neovascularisation, retinitis pigmentosa, diabetic retinopathy)
- inability to fixate due to central scotoma, pathological nystagmus or other forms of fixation disabilities
Trial locations and contacts
1 site in 1 country.
Germany1 site
Inst. f. Medical Psychology, Univ. of Magdeburg
Magdeburg, 39120
About this study
Visual field defects (VFD) are a frequent effect of cerebral lesions especially after posterior cerebral artery stroke. The present study was conducted to compare effects of vision restoration training (VRT) and compensation training (Visual Exploration Training, VET) on visual field performance.
- Conditions
- Hemianopia, Brain Injuries, Traumatic
- Being tested
- Vision Restoration Training (VRT), Vision Exploration Training (VET)
- Medical subject headings
- Hemianopsia, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vision Restoration Training (VRT)Behavioural
Vision Exploration Training (VET)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Vision Restoration Training (VRT) | Experimental | home-based rehabilitation program which applies intense light stimulation via a PC-monitor to areas of residual vision with a duration of 1 hour daily/six days a week, subjects are asked to respond via button press upon appearance of light stimuli without eye movements Receives: Behavioral: Vision Restoration Training (VRT) |
| Vision Exploration Training (VET) | Active comparator | home-based rehabilitation program to train eye movements upon visual stimuli presented via a PC-monitor with a duration of 1 hour daily/six days a week, subjects are asked to shift their gaze towards targets and respond via button press upon detection of targets Receives: Behavioral: Vision Exploration Training (VET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Resolution Perimetry - Detectection performance change before vs. after training (%)
Measured: 3 months
Humphrey Field Analyzer (Static Perimetry) - Detectection performance change before vs. after training (%)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study startJan 2003
- Primary completionJan 2005
- Study completionJan 2005
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 HemianopiaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernhard A. Sabel, University of Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043429
- Sponsor's protocol ID
- VRT100
- Status last verified
- Jul 2019
- First submitted
- 18 Sep 2014
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Sabel BA, Gudlin J. Vision restoration training for glaucoma: a randomized clinical trial. JAMA Ophthalmol. 2014 Apr 1;132(4):381-9. doi: 10.1001/jamaophthalmol.2013.7963.
PubMed 24504128
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration vs. Compensation in Neurovisual Rehabilitation of Visual Field Defects
- ClinicalTrials.gov ID
- NCT04043429
- Acronym / sponsor ID
- VRT100
- Conditions
- Hemianopia, Brain Injuries, Traumatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 2 Aug 2019 (actual)
- 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.
Visual field defects (VFD) are a frequent effect of cerebral lesions especially after posterior cerebral artery stroke. The present study was conducted to compare effects of vision restoration training (VRT) and compensation training (Visual Exploration Training, VET) on visual field performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vision Restoration Training (VRT) | Experimental | Behavioral: Vision Restoration Training (VRT)home-based rehabilitation program which applies intense light stimulation via a PC-monitor to areas of residual vision with a duration of 1 hour daily/six days a week, subjects are asked to respond via button press upon appearance of light stimuli without eye movements |
| Vision Exploration Training (VET) | Active comparator | Behavioral: Vision Exploration Training (VET)home-based rehabilitation program to train eye movements upon visual stimuli presented via a PC-monitor with a duration of 1 hour daily/six days a week, subjects are asked to shift their gaze towards targets and respond via button press upon detection of targets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Visual field defects after brain damage
- lesion age above 6 months
- documented brain lesions due to ischemic stroke, hemorrhage or tumor demonstrated by computer tomography or by magnet resonance imaging
Key exclusion criteria (9 listed)
- hemispatial neglect
- complete blindness
- severe psychotic diseases
- serious drug abuse
- chronic degenerative diseases (dementia, multiple sclerosis)
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 |
|---|---|---|
| Vision Restoration Training (VRT) | Behavioural | Vision Restoration Training (VRT) |
| Vision Exploration Training (VET) | Behavioural | Vision Exploration Training (VET) |
Primary outcome
High Resolution Perimetry - Detectection performance change before vs. after training (%)
Time frame: 3 months
Humphrey Field Analyzer (Static Perimetry) - Detectection performance change before vs. after training (%)
Time frame: 3 months
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 2 Aug 2019.
- Results publication: PubMed 24504128Sabel BA, Gudlin J. Vision restoration training for glaucoma: a randomized clinical trial. JAMA Ophthalmol. 2014 Apr 1;132(4):381-9. doi: 10.1001/jamaophthalmol.2013.7963.
- Individual participant dataSharing planned: Yes
Related trials for Hemianopia
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
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Multisensory Rehabilitation of Vision Loss After Cortical Damage
Cortical Blindness
Recruiting
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Active, not recruiting
Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
Not yet recruitingObservational study
Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
Homonymous Hemianopia, Stroke
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vision Restoration Training (VRT) and Vision Exploration Training (VET) in people with Hemianopia and Brain Injuries, Traumatic, run by University of Magdeburg at 1 site in Germany.
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 3 inclusion and 9 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 2 Aug 2019. 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 Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
High Resolution Perimetry - Detectection performance change before vs. after training (%) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT04043429, 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 2 Aug 2019.