Restoration vs. Compensation in Neurovisual Rehabilitation of Visual Field Defects
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 86
- Locations
- 2
- Primary Endpoint
- Humphrey Field Analyzer (Static Perimetry) - Detectection performance change before vs. after training (%)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
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
Intervention: Vision Restoration Training (VRT) (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
Intervention: Vision Exploration Training (VET) (Behavioral)
Outcomes
Primary Outcomes
Humphrey Field Analyzer (Static Perimetry) - Detectection performance change before vs. after training (%)
Time Frame: 3 months
High Resolution Perimetry - Detectection performance change before vs. after training (%)
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Bernhard A. Sabel
Professor, Head of Institute
University of Magdeburg