Clinical trial NCT03350919: Visual Restoration for Hemianopia
Official title: Visual Restoration for Hemianopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Induced Vision Loss
Hemianopia
Quadrantanopia
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Envision Solutions, LLC
First posted: 2017-11-22
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute, University of Miami Health Services
state: Florida
city: Rochester
country: United States
facility: Flaum Eye Institute, University of Rochester Medical Center
state: New York
city: Philadelphia
country: United States
facility: Scheie Eye Institute
state: Pennsylvania
Study officials:
References: