N/A
N=48
Visual Restoration for Hemianopia
Stroke Induced Vision Loss · Hemianopia · Quadrantanopia
Bottom Line
View on ClinicalTrials.gov: NCT03350919 ↗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
| Outcome | Result | p-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
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.