Visual Restoration for Hemianopia
- Conditions
- Stroke Induced Vision LossHemianopiaQuadrantanopia
- Registration Number
- NCT03350919
- Lead Sponsor
- University of Rochester
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint 6 months 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
Name Time Method
Trial Locations
- Locations (3)
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
Bascom Palmer Eye Institute, University of Miami Health Services🇺🇸Miami, Florida, United States