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CompletedNCT04043429Updated Aug 2, 2019

Restoration vs. Compensation in Neurovisual Rehabilitation of Visual Field Defects

A Phase 2 interventional study of Vision Restoration Training (VRT) and Vision Exploration Training (VET) in Hemianopia and Brain Injuries, Traumatic, sponsored by University of Magdeburg. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-02.

Sponsored by University of Magdeburg · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hemianopia
  • Brain Injuries, Traumatic
03

In context

Hemianopsia

63 studies on the registry are indexed under Hemianopsia; 24 are open to participants now.

This study's enrollment of 86 is above the median of 32 across 53 interventional studies indexed under Hemianopsia.

Browse Hemianopsia studies →

Lead sponsor

University of Magdeburg is the lead sponsor of 35 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • hemispatial neglect
  • complete blindness
  • severe psychotic diseases
  • serious drug abuse
  • chronic degenerative diseases (dementia, multiple sclerosis)
  • severe motor impairments
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    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

    Behavioral: Vision Restoration Training (VRT)

  • Active comparator
    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

    Behavioral: Vision Exploration Training (VET)

Interventions

  • BehavioralVision Restoration Training (VRT)
  • BehavioralVision Exploration Training (VET)
06

What researchers measure

Primary outcomes

  1. High Resolution Perimetry - Detectection performance change before vs. after training (%)

    Time frame: 3 months

  2. Humphrey Field Analyzer (Static Perimetry) - Detectection performance change before vs. after training (%)

    Time frame: 3 months

07

Study locations

1 site
  • Inst. f. Medical Psychology, Univ. of Magdeburg
    Magdeburg, 39120, Germany
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: After publication

Access criteria: Contacting the PI

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2003, a primary completion of Jan 2005 and a completion of Jan 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2014
First posted
Aug 2, 2019
Start
Jan 2003
Primary completionActual
Jan 2005
CompletionActual
Jan 2005
Last update
Aug 2, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04043429
Lead sponsor
University of Magdeburg
Responsible party
Bernhard A. Sabel (Professor, Head of Institute, University of Magdeburg) — Principal investigator
First posted
Aug 2, 2019
Start date
Jan 2003
Primary completion
Jan 2005
Completion
Jan 2005
Last update
Aug 2, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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