Visual Restoration for Hemianopia

Completed · Not applicable

Conditions studied: Stroke Induced Vision Loss, Hemianopia, Quadrantanopia

In brief

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.

Key facts

Study ID

NCT03350919

Run by

University of Rochester

People needed

48

Starts

2018-03-15

Expected to finish

2019-12-03

Last updated by the study team

2020-12-24

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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