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Effect of Visual Retraining on Visual Loss Following Visual Cortical Damage

Primary Purpose

Vision Loss Partial, Hemianopia, Hemianopia Homonymous

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training in the Blind Field
Training in the Sighted Field
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vision Loss Partial

Eligibility Criteria

17 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Cortically Blind Subject Inclusion Criteria:

  • Subjects between the ages of 17 and 75, who have sustained damage to primary visual cortex at age 17 or later, and are rendered blind over a portion of their visual field.
  • Subjects must have some intact visual cortical areas (other than primary visual cortex) in the damaged brain hemisphere. This assessment will be made from MRI or CT scans of the subject's head, which will be obtained via standard release from their neurologist.
  • Subjects who demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field.
  • Subjects who are competent and responsible, as determined by the Principal Investigator.
  • Subjects who will receive retinal electrophysiology (mfERG) testing must have a report from their ophthalmologist stating that they are able to receive dilating drops

Cortically Blind Subject Exclusion Criteria:

  • Subjects who do not possess damage of primary visual cortex or its immediate afferents
  • Subjects who are suffering from an active disease process involving their nervous system.
  • Subjects who are unable to fixate visual targets precisely with their eyes
  • Subjects who have unreliable vision fields from prior testing indicated by greater than 20% fixation losses, false positives or false negatives
  • Best corrected visual acuity worse than 20/40 in either eye
  • Impaired foveal sensitivity as indicated by visual field tests
  • Presence of vision loss from ocular disease or disorder
  • Presence of bilateral visual acuity loss from any source
  • Subjects who are suffering from one-sided attentional neglect
  • Subjects who have impaired auditory thresholds that would influence test results and training efficacy (all our testing and training involves sound as a cue for trial/stimulus onset or as feedback)
  • Persons who lack the competence or are otherwise unable to perform the visual training exercises as directed.

Control Subject Inclusion Criteria:

  • Subjects must be between the ages of 17 and 75 years of age
  • Subjects must report no history of neurological disorder.
  • Subjects who are competent and responsible, as determined by the Principal Investigator.

Control Subject Exclusion criteria:

  • Subjects who possess damage to the visual system
  • Subjects who are suffering from an active disease process involving their nervous system.
  • Subjects who are unable to fixate visual targets precisely with their eyes
  • Best corrected visual acuity worse than 20/40 in either eye
  • Presence of vision loss from ocular disease or disorder
  • Presence of bilateral visual acuity loss from any source
  • Subjects who are suffering from one-sided attentional neglect
  • Subjects who have impaired auditory thresholds that would influence test results and training efficacy (all our testing and training involves sound as a cue for trial/stimulus onset or as feedback)
  • Persons who lack the competence or are otherwise unable to perform the visual testing/training exercises as directed.

Sites / Locations

  • Flaum Eye Institute, University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cortically Blind Subjects

Control

Arm Description

Outcomes

Primary Outcome Measures

Direction Discrimination Threshold
For each subject, the investigators will measure the change in ability to detect differences in the motion direction of visual stimuli relative to horizontal, measured in degrees of visual angle. These assessments will be based on what can be reliably detected at a 72-75% correct level of performance. These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Direction Integration Threshold
This will measure the change in ability of subjects to integrate across a range of motion directions measured in degrees of visual angle. These assessments will be based on what range of motion directions can be reliably integrated at a 72-75% correct level of performance. These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Contrast Sensitivity for Direction
Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for direction discrimination. This is a change metric as transfer must be compared from pre- to post- each course of training. For each subject, the investigators will measure the ability to correctly detect the motion direction of visual stimuli that are also varying in contrast against a grey background. We will measure the luminance contrast that can be reliably detected at a 72-75% correct level of performance. These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Contrast Sensitivity for Static Orientation
Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for static orientation discrimination. This is a change metric as transfer must be compared from pre- to post- each course of training. For each subject, the investigators will measure the ability to correctly detect the orientation of non-moving visual stimuli that vary in contrast against a grey background. We will measure the luminance that can be reliably detected at a 72-75% correct level of performance. These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.

Secondary Outcome Measures

Humphrey 10-2 and 24-2 perimetry
The investigators will measure the change in visual sensitivity (measured in decibels) at all locations tested by the system. These measures will be evaluated at baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Goldmann perimetry
The investigators will measure the change in area of vision (degrees squared) as encompassed by each isopter, measured by one of 3 different light stimuli. The 3 isopters which will be compared are: I2e 1asb, 0.25 mm^2 I4e 10asb, 0.25 mm^2 V4e 1000asb, 64 mm^2 These measures will be evaluated at baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
MAIA Visual Field Perimetry
The investigators will measure the change in visual sensitivity (measured in decibels) at all locations tested by the system. These measures will be evaluated at baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.

Full Information

First Posted
October 13, 2021
Last Updated
August 16, 2023
Sponsor
University of Rochester
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT05098236
Brief Title
Effect of Visual Retraining on Visual Loss Following Visual Cortical Damage
Official Title
Effect of Visual Retraining on Visual Loss Following Visual Cortical Damage
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 26, 2003 (Actual)
Primary Completion Date
October 15, 2031 (Anticipated)
Study Completion Date
October 15, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This project is intended to collect data using standard clinical tests and psychophysics to quantify the effect of visual cortical damage on the structure of the residual visual system, visual perception, spatial awareness, and brain function. The investigators will also assess the effect of intensive visual retraining on the residual visual system, processing of visual information and the use of such information in real-world situations following damage. This research is intended to improve our understanding of the consequences of permanent visual system damage in humans, of methods that can be used to reverse visual loss, and of brain mechanisms by which visual recovery is achieved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vision Loss Partial, Hemianopia, Hemianopia Homonymous, Quadrantanopia, Stroke, Ischemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cortically Blind Subjects
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Training in the Blind Field
Intervention Description
A computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. Subjects will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion, the presence of motion, or the orientation of a visual stimulus (either a small cloud of dots or bars) located at a predetermined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least 3 and up to 12 months at a time.
Intervention Type
Device
Intervention Name(s)
Training in the Sighted Field
Intervention Description
This training will take place in lab at the University of Rochester Medical Center. Subject will perform one daily training session, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion, the presence of motion, or the orientation of a visual stimulus (either a small cloud of dots or bars) located at a predetermined location in the visual field. The computer program will automatically create a record of patient performance during each training session. Subjects will train daily (about 30-40 minutes total), 5 to 7 days per week for at 7 - 14 days.
Primary Outcome Measure Information:
Title
Direction Discrimination Threshold
Description
For each subject, the investigators will measure the change in ability to detect differences in the motion direction of visual stimuli relative to horizontal, measured in degrees of visual angle. These assessments will be based on what can be reliably detected at a 72-75% correct level of performance. These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Time Frame
Baseline, 4-months, 12-months
Title
Direction Integration Threshold
Description
This will measure the change in ability of subjects to integrate across a range of motion directions measured in degrees of visual angle. These assessments will be based on what range of motion directions can be reliably integrated at a 72-75% correct level of performance. These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Time Frame
Baseline to 4-months, 12-months
Title
Contrast Sensitivity for Direction
Description
Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for direction discrimination. This is a change metric as transfer must be compared from pre- to post- each course of training. For each subject, the investigators will measure the ability to correctly detect the motion direction of visual stimuli that are also varying in contrast against a grey background. We will measure the luminance contrast that can be reliably detected at a 72-75% correct level of performance. These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Time Frame
Baseline, 4-months, 12-months
Title
Contrast Sensitivity for Static Orientation
Description
Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for static orientation discrimination. This is a change metric as transfer must be compared from pre- to post- each course of training. For each subject, the investigators will measure the ability to correctly detect the orientation of non-moving visual stimuli that vary in contrast against a grey background. We will measure the luminance that can be reliably detected at a 72-75% correct level of performance. These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Time Frame
Baseline, 4-months, 12-months
Secondary Outcome Measure Information:
Title
Humphrey 10-2 and 24-2 perimetry
Description
The investigators will measure the change in visual sensitivity (measured in decibels) at all locations tested by the system. These measures will be evaluated at baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Time Frame
Baseline, 4-months, 12-months
Title
Goldmann perimetry
Description
The investigators will measure the change in area of vision (degrees squared) as encompassed by each isopter, measured by one of 3 different light stimuli. The 3 isopters which will be compared are: I2e 1asb, 0.25 mm^2 I4e 10asb, 0.25 mm^2 V4e 1000asb, 64 mm^2 These measures will be evaluated at baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Time Frame
Baseline, 4-months, 12-months
Title
MAIA Visual Field Perimetry
Description
The investigators will measure the change in visual sensitivity (measured in decibels) at all locations tested by the system. These measures will be evaluated at baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Time Frame
Baseline, 4-months, 12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Cortically Blind Subject Inclusion Criteria: Subjects between the ages of 17 and 75, who have sustained damage to primary visual cortex at age 17 or later, and are rendered blind over a portion of their visual field. Subjects must have some intact visual cortical areas (other than primary visual cortex) in the damaged brain hemisphere. This assessment will be made from MRI or CT scans of the subject's head, which will be obtained via standard release from their neurologist. Subjects who demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field. Subjects who are competent and responsible, as determined by the Principal Investigator. Subjects who will receive retinal electrophysiology (mfERG) testing must have a report from their ophthalmologist stating that they are able to receive dilating drops Cortically Blind Subject Exclusion Criteria: Subjects who do not possess damage of primary visual cortex or its immediate afferents Subjects who are suffering from an active disease process involving their nervous system. Subjects who are unable to fixate visual targets precisely with their eyes Subjects who have unreliable vision fields from prior testing indicated by greater than 20% fixation losses, false positives or false negatives Best corrected visual acuity worse than 20/40 in either eye Impaired foveal sensitivity as indicated by visual field tests Presence of vision loss from ocular disease or disorder Presence of bilateral visual acuity loss from any source Subjects who are suffering from one-sided attentional neglect Subjects who have impaired auditory thresholds that would influence test results and training efficacy (all our testing and training involves sound as a cue for trial/stimulus onset or as feedback) Persons who lack the competence or are otherwise unable to perform the visual training exercises as directed. Control Subject Inclusion Criteria: Subjects must be between the ages of 17 and 75 years of age Subjects must report no history of neurological disorder. Subjects who are competent and responsible, as determined by the Principal Investigator. Control Subject Exclusion criteria: Subjects who possess damage to the visual system Subjects who are suffering from an active disease process involving their nervous system. Subjects who are unable to fixate visual targets precisely with their eyes Best corrected visual acuity worse than 20/40 in either eye Presence of vision loss from ocular disease or disorder Presence of bilateral visual acuity loss from any source Subjects who are suffering from one-sided attentional neglect Subjects who have impaired auditory thresholds that would influence test results and training efficacy (all our testing and training involves sound as a cue for trial/stimulus onset or as feedback) Persons who lack the competence or are otherwise unable to perform the visual testing/training exercises as directed.
Facility Information:
Facility Name
Flaum Eye Institute, University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Visual Retraining on Visual Loss Following Visual Cortical Damage

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