Back to resultsVisual Restoration for Hemianopia
Primary Purpose
Stroke Induced Vision Loss, Hemianopia, Quadrantanopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training in the blind field
Training in the intact field
Sponsored by
About this trial
This is an interventional treatment trial for Stroke Induced Vision Loss
Eligibility Criteria
Inclusion Criteria:
- Ages 21-75 years old
- Ability and willingness to sign informed consent
- Willingness to participate in both the training and evaluation sessions
- MRI or CT scan demonstrating lesion in the occipital lobe of the brain and/or affecting white matter tracts that provide visual input to the occipital lobe of the brain
- Brain injury due to ischemic or hemorrhagic causes that occurs after age 18 and at least 90 days prior to screening visit
- At least two reliable HVF's demonstrating good fixation and a stable homonymous incomplete (e.g., quadrantanopia or relative defect) or complete hemianopia
- Reliable HVFs with repeat HVFs if randomization takes place more than 4 weeks after screening visit
- A homonymous, contiguous visual deficit measured by the 24-2 HVF to be a minimum of two testing locations high and two testing locations wide, where impaired locations are any that measure a threshold of less than 15 dB.
- Demonstration of good fixation on visual training task - able to fixate the small targets presented as fixation letters reliably for 1000ms with jitter over less than 1 degree of visual angle in any direction away from target edge
Exclusion Criteria:
- Physical, neurological or mental disability that would interfere with study intervention
- Concurrent participation in "vision therapy" other than standard occupational or physical therapy
- Unreliable visual fields on prior testing, indicated by greater than 20% fixation losses, false positives, or false negatives.
- Inability to discontinue medications judged to affect training and/or assessment (e.g., Ritalin, amphetamines, dopamines, or chemotherapeutic agents)
- Physical condition likely to preclude completion of the clinical trial (e.g. end-stage or uncontrolled cancer, uncontrolled epilepsy, or end-stage heart disease)
- Ocular or neurological condition that would interfere with training or assessment (e.g. damage to the optic nerves or lateral geniculate nucleus, any degenerative ocular condition)
- Best corrected vision worse than 20/40
- Impaired foveal Humphrey sensitivity as indicated by the HVF tests.
- Presence of vision loss resulting from ocular disease or disorder
- Presence of bilateral visual acuity loss from any source
- Inability to demonstrate fixation stability on eye movement monitored testing
- Inability to follow training instructions
Sites / Locations
- Bascom Palmer Eye Institute, University of Miami Health Services
- Flaum Eye Institute, University of Rochester Medical Center
- Scheie Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Training in the blind field
Training in the intact field
Arm Description
Training in the blind field using software
Training in the intact field using software
Outcomes
Primary Outcome Measures
24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint
Change in the perimetric mean deviation (PMD) generated by standard Humphrey automated perimetry using a 24-2 testing pattern between baseline and post-training after a 6-month training interval.
Secondary Outcome Measures
Full Information
NCT ID
NCT03350919
First Posted
November 18, 2017
Last Updated
December 23, 2020
Sponsor
University of Rochester
Collaborators
Envision Solutions, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03350919
Brief Title
Visual Restoration for Hemianopia
Official Title
Visual Restoration for Hemianopia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
December 3, 2019 (Actual)
Study Completion Date
December 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Envision Solutions, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. Study Description
Brief Summary
The purpose of this research is to assess the efficacy of a visual training task on reducing the size of a visual field deficit caused by brain damage in adults, and its ability to improve visual functions in this patient population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Induced Vision Loss, Hemianopia, Quadrantanopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training in the blind field
Arm Type
Experimental
Arm Description
Training in the blind field using software
Arm Title
Training in the intact field
Arm Type
Experimental
Arm Description
Training in the intact field using software
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 patient to use at home. They 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 of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.
Intervention Type
Device
Intervention Name(s)
Training in the intact field
Intervention Description
A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They 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 of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.
Primary Outcome Measure Information:
Title
24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint
Description
Change in the perimetric mean deviation (PMD) generated by standard Humphrey automated perimetry using a 24-2 testing pattern between baseline and post-training after a 6-month training interval.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 21-75 years old
Ability and willingness to sign informed consent
Willingness to participate in both the training and evaluation sessions
MRI or CT scan demonstrating lesion in the occipital lobe of the brain and/or affecting white matter tracts that provide visual input to the occipital lobe of the brain
Brain injury due to ischemic or hemorrhagic causes that occurs after age 18 and at least 90 days prior to screening visit
At least two reliable HVF's demonstrating good fixation and a stable homonymous incomplete (e.g., quadrantanopia or relative defect) or complete hemianopia
Reliable HVFs with repeat HVFs if randomization takes place more than 4 weeks after screening visit
A homonymous, contiguous visual deficit measured by the 24-2 HVF to be a minimum of two testing locations high and two testing locations wide, where impaired locations are any that measure a threshold of less than 15 dB.
Demonstration of good fixation on visual training task - able to fixate the small targets presented as fixation letters reliably for 1000ms with jitter over less than 1 degree of visual angle in any direction away from target edge
Exclusion Criteria:
Physical, neurological or mental disability that would interfere with study intervention
Concurrent participation in "vision therapy" other than standard occupational or physical therapy
Unreliable visual fields on prior testing, indicated by greater than 20% fixation losses, false positives, or false negatives.
Inability to discontinue medications judged to affect training and/or assessment (e.g., Ritalin, amphetamines, dopamines, or chemotherapeutic agents)
Physical condition likely to preclude completion of the clinical trial (e.g. end-stage or uncontrolled cancer, uncontrolled epilepsy, or end-stage heart disease)
Ocular or neurological condition that would interfere with training or assessment (e.g. damage to the optic nerves or lateral geniculate nucleus, any degenerative ocular condition)
Best corrected vision worse than 20/40
Impaired foveal Humphrey sensitivity as indicated by the HVF tests.
Presence of vision loss resulting from ocular disease or disorder
Presence of bilateral visual acuity loss from any source
Inability to demonstrate fixation stability on eye movement monitored testing
Inability to follow training instructions
Facility Information:
Facility Name
Bascom Palmer Eye Institute, University of Miami Health Services
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Flaum Eye Institute, University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Scheie Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Visual Restoration for Hemianopia
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