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Completed

NCT Number: NCT01959256

Visual Perceptual Learning for the Treatment of Visual Field Defect

This study will test the hypothesis whether visual field defect caused by chronic stroke could be improved by visual perceptual learning. The secondary hypothesis is that improvement of visual field defect would be accompanied by connectivity changes in visual networks. In addition, investigators will evaluate whether improvement of visual field defect could achieve improvement of subjective visual function.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

Study design: A PROBE (Prospective, Randomized, Open-label, Blinded-endpoint) design

Methods:

  • Visual perceptual learning (VPL) group
  • Visual perceptual learning (24 times for 2 months, 3 times per week) in visual field defect areas
  • At baseline and post-VPL evaluations (2 months after): Structural & Functional MRIs, Visual field tests, Visual evoked potential, Visual cognitive tests, Subjective visual function questionnaires
  • Control group
  • At baseline and 2-months later: No VPL, Structural & Functional MRIs, Visual field tests, Visual evoked potential, Visual cognitive tests, Subjective visual function questionnaires
  • Visual perceptual learning after 2-month follow-up evaluation (24 times for 2 months, 3 times per week)

(The patients who were stratified by age (over 65 years old or not) and degree of visual field defect (quadrantanopia or complete hemianopia) will be randomly assigned into the learning and control group.)

  • Investigations
  • Improvement of visual field test scores between VPL group and control group
  • Analysis of brain network changes in MRI data
  • Correlation analysis of improvement of visual field defect and MRI data
  • Correlation analysis of improvement of visual field defect and visual evoked potential (VEP) data
  • Correlation analysis of improvement of visual field defect and neuropsychological data

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient has chronic stroke more than 6 months after onset.
  • The patient has visual field defect (Quadrantanopia or Hemianopia).
  • The patient has corrected eyesight 0.7 or above.

Exclusion criteria

  • The patient has contraindication to MRI scan.
  • The patient has cognitive impairment (Mini-Mental Status Exam score <24).
  • The patient has ophthalmologic diseases (e.g., glaucoma, cataract).

Treatment and study plan

Visual perceptual learning

Behavioral

24 times of training for visual perceptual learning

Primary outcomes

  1. Improvement of visual field scores in visual field defect areas

    Time frame: At 2 months (plus or minus 7 days) after baseline evaluation

    Improvement of mean deviation scores in defected areas by Humphrey 750i Field test

Secondary outcomes

  1. Performance of visual perceptual learning

    Time frame: At 2 months (plus or minus 7 days) after baseline evaulation

    Performance (scores) of visual perceptual learning

  2. Connectivity changes in MRI

    Time frame: Between baseline and 2 months (plus or minus 7 days) after

    • Functional connectivity changes in resting-state functional MRI
    • Structural connectivity changes in diffusion tensor imaging
  3. Improvement of visual field score in whole visual field area

    Time frame: At 2 months (plus or minus 7days) after baseline evaluation

    Improvement of mean deviation scores in whole visual field by Humphrey 750i Field test

  4. Change of subjective visual function

    Time frame: At 2 months (plus or minus 7days) after baseline evaluation

    • Change in Korean version of National Eye institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)
    • Change of subjective visual field area
  5. Changes of visual evoked potential

    Time frame: Between baseline and 2 months (plus or minus 7 days) after

    Changes between baseline and 2 months after in half-field visual evoked potential (VEP) data

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Acronym: VIVID

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2013
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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