Status:
COMPLETED
Visual Restoration for Hemianopia
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Envision Solutions, LLC
Conditions:
Stroke Induced Vision Loss
Hemianopia
Eligibility:
All Genders
21-75 years
Phase:
NA
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 func...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03350919
Start Date
March 15 2018
End Date
December 3 2019
Last Update
December 24 2020
Active Locations (3)
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1
Bascom Palmer Eye Institute, University of Miami Health Services
Miami, Florida, United States, 33136
2
Flaum Eye Institute, University of Rochester Medical Center
Rochester, New York, United States, 14642
3
Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104