Restoration vs. Compensation in Neurovisual Rehabilitation of Visual Field Defects

NCT ID: NCT04043429

Last Updated: 2019-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hemianopia Brain Injuries, Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Vision Restoration Training (VRT)

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Vision Exploration Training (VET)

Intervention Type BEHAVIORAL

Interventions

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Vision Restoration Training (VRT)

Intervention Type BEHAVIORAL

Vision Exploration Training (VET)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Magdeburg

OTHER

Sponsor Role lead

Responsible Party

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Bernhard A. Sabel

Professor, Head of Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Inst. f. Medical Psychology, Univ. of Magdeburg

Magdeburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 24504128 (View on PubMed)

Other Identifiers

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VRT100

Identifier Type: -

Identifier Source: org_study_id

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