Visual Perceptual Learning for the Treatment of Visual Field Defect

Not Applicable

Completed

• Conditions: Stroke; Visual Field Defect
• Interventions: Behavioral: Visual perceptual learning

• Registration Number: NCT01959256
• Lead Sponsor: Asan Medical Center

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

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-09
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Learning	Visual perceptual learning	Visual perceptual learning (VPL) group

Primary Outcome Measures

Name	Time	Method
Improvement of visual field scores in visual field defect areas	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 Outcome Measures

Name	Time	Method
Improvement of visual field score in whole visual field area	At 2 months (plus or minus 7days) after baseline evaluation	Improvement of mean deviation scores in whole visual field by Humphrey 750i Field test
Change of subjective visual function	At 2 months (plus or minus 7days) after baseline evaluation	1. Change in Korean version of National Eye institute Visual Functioning Questionnaire-25 (NEI-VFQ-25); 2. Change of subjective visual field area
Performance of visual perceptual learning	At 2 months (plus or minus 7 days) after baseline evaulation	Performance (scores) of visual perceptual learning
Connectivity changes in MRI	Between baseline and 2 months (plus or minus 7 days) after	1. Functional connectivity changes in resting-state functional MRI; 2. Structural connectivity changes in diffusion tensor imaging
Changes of visual evoked potential	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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of