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Restoration vs. Compensation in Neurovisual Rehabilitation of Visual Field Defects

Primary Purpose

Hemianopia, Brain Injuries, Traumatic

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Vision Restoration Training (VRT)

Vision Exploration Training (VET)

About this trial

This is an interventional treatment trial for Hemianopia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Inst. f. Medical Psychology, Univ. of Magdeburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vision Restoration Training (VRT)

Vision Exploration Training (VET)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04043429

First Posted

September 18, 2014

Last Updated

July 31, 2019

Sponsor

University of Magdeburg

1. Study Identification

Unique Protocol Identification Number

NCT04043429

Brief Title

Restoration vs. Compensation in Neurovisual Rehabilitation of Visual Field Defects

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

January 2005 (Actual)

Study Completion Date

January 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Magdeburg

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemianopia, Brain Injuries, Traumatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vision Restoration Training (VRT)

Arm Type

Experimental

Arm Description

Arm Title

Vision Exploration Training (VET)

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Vision Restoration Training (VRT)

Intervention Type

Behavioral

Intervention Name(s)

Vision Exploration Training (VET)

Primary Outcome Measure Information:

Title

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

Time Frame

3 months

Title

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Inst. f. Medical Psychology, Univ. of Magdeburg

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

After publication

IPD Sharing Access Criteria

Contacting the PI

Citations:

PubMed Identifier

24504128

Citation

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.

Results Reference

result

Learn more about this trial

Restoration vs. Compensation in Neurovisual Rehabilitation of Visual Field Defects

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