Visual Restoration for Hemianopia

University of Rochester3 sites in 1 country48 target enrollmentMarch 15, 2018

ConditionsStroke Induced Vision Loss Hemianopia Quadrantanopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke Induced Vision Loss
Sponsor: University of Rochester
Enrollment: 48
Locations: 3
Primary Endpoint: 24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 15, 2018

End Date

December 3, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Rochester

Responsible Party

Principal Investigator

Steven Feldon

Professor and Chair of Ophthalmology

University of Rochester

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

Outcomes

Primary Outcomes

24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint

Time Frame: 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.