Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2018-03-15
2019-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Training in the blind field
Training in the blind field using software
Training in the blind field
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.
Training in the intact field
Training in the intact field using software
Training in the intact field
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.
Interventions
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Training in the blind field
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.
Training in the intact field
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
75 Years
ALL
No
Sponsors
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Envision Solutions, LLC
OTHER_GOV
University of Rochester
OTHER
Responsible Party
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Steven Feldon
Professor and Chair of Ophthalmology
Locations
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Bascom Palmer Eye Institute, University of Miami Health Services
Miami, Florida, United States
Flaum Eye Institute, University of Rochester Medical Center
Rochester, New York, United States
Scheie Eye Institute
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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69879
Identifier Type: -
Identifier Source: org_study_id