NCT04043429

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2014

Completed
4.9 years until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

September 18, 2014

Last Update Submit

July 31, 2019

Conditions

HemianopiaBrain Injuries, Traumatic

Outcome Measures

Primary Outcomes (2)

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

    3 months

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

    3 months

Study Arms (2)

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

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

Behavioral: Vision Exploration Training (VET)

Interventions

Vision Restoration Training (VRT)BEHAVIORAL
Vision Restoration Training (VRT)
Vision Exploration Training (VET)BEHAVIORAL
Vision Exploration Training (VET)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inst. f. Medical Psychology, Univ. of Magdeburg

Magdeburg, 39120, Germany

Location

Related Publications (1)

  • 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.

    PMID: 24504128RESULT

MeSH Terms

Conditions

HemianopsiaBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesBlindnessEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain InjuriesBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head of Institute

Study Record Dates

First Submitted

September 18, 2014

First Posted

August 2, 2019

Study Start

January 1, 2003

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

August 2, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After publication
Access Criteria
Contacting the PI

Locations

DE(1)