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N/A N=48 Randomized Quadruple-blind Treatment

Visual Restoration for Hemianopia

Stroke Induced Vision Loss · Hemianopia · Quadrantanopia

Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: 24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint — 0.84; 0.10; 0.58; 0.12 decibels

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Training in the blind field (Device); Training in the intact field (Device)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
University of Rochester
Primary completion
Dec 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint
0.84; 0.10; 0.58; 0.12

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03350919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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