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Clinical Trials/NCT01959256
NCT01959256
Completed
Not Applicable

Visual Perceptual Learning for the Treatment of Visual Field Defect

Asan Medical Center1 site in 1 country36 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Asan Medical Center
Enrollment
36
Locations
1
Primary Endpoint
Improvement of visual field scores in visual field defect areas
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

Study design: A PROBE (Prospective, Randomized, Open-label, Blinded-endpoint) design Methods: 1. Visual perceptual learning (VPL) group 1. Visual perceptual learning (24 times for 2 months, 3 times per week) in visual field defect areas 2. 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 2. Control group 1. At baseline and 2-months later: No VPL, Structural \& Functional MRIs, Visual field tests, Visual evoked potential, Visual cognitive tests, Subjective visual function questionnaires 2. 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.) 3. Investigations 1. Improvement of visual field test scores between VPL group and control group 2. Analysis of brain network changes in MRI data 3. Correlation analysis of improvement of visual field defect and MRI data 4. Correlation analysis of improvement of visual field defect and visual evoked potential (VEP) data 5. Correlation analysis of improvement of visual field defect and neuropsychological data

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
January 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dong-Wha Kang

MD, PhD

Asan Medical Center

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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

  • Improvement of visual field score in whole visual field area(At 2 months (plus or minus 7days) after baseline evaluation)
  • Change of subjective visual function(At 2 months (plus or minus 7days) after baseline evaluation)
  • Performance of visual perceptual learning(At 2 months (plus or minus 7 days) after baseline evaulation)
  • Connectivity changes in MRI(Between baseline and 2 months (plus or minus 7 days) after)
  • Changes of visual evoked potential(Between baseline and 2 months (plus or minus 7 days) after)

Study Sites (1)

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