Restoration vs. Compensation in Neurovisual Rehabilitation of Visual Field Defects

July 31, 2019 updated by: Bernhard A. Sabel, University of Magdeburg
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
High Resolution Perimetry - Detectection performance change before vs. after training (%)
Time Frame: 3 months
3 months
Humphrey Field Analyzer (Static Perimetry) - Detectection performance change before vs. after training (%)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Magdeburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

September 18, 2014

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 2, 2019

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VRT100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

After publication

IPD Sharing Access Criteria

Contacting the PI

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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