Hemianopia, Quadrantanopia, Stroke Induced Vision Loss
Conditions
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.
Interventions
A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.
DEVICETraining in the intact field
A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.
Sponsors
Envision Solutions, LLC
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint | 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. |
Countries
United States
Participant flow
Pre-assignment details
No subjects were excluded from the study between recruitment and randomization to assigned groups.
Participants by arm
| Arm | Count |
|---|---|
| Training in the Blind Field Training in the blind field using software
Training in the blind field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks. | 25 |
| Training in the Intact Field Training in the intact field using software
Training in the intact field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks. | 23 |
| Total | 48 |
Baseline characteristics
| Characteristic | Training in the Intact Field | Total | Training in the Blind Field |
|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 9.4 | 59.3 years STANDARD_DEVIATION 10.5 | 57.4 years STANDARD_DEVIATION 10.8 |
| Patients with right sided deficits | 10 Participants | 20 Participants | 10 Participants |
| Preliminary deficit size | 755.2 square degrees of visual angle STANDARD_DEVIATION 167.6 | 788.8 square degrees of visual angle STANDARD_DEVIATION 181 | 819.7 square degrees of visual angle STANDARD_DEVIATION 190.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 23 Participants | 48 Participants | 25 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 23 participants | 48 participants | 25 participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Male | 18 Participants | 37 Participants | 19 Participants |
| Time since lesion | 15.5 months | 15.28 months | 15.0 months |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 23 |
| other Total, other adverse events | 0 / 25 | 0 / 23 |
| serious Total, serious adverse events | 0 / 25 | 0 / 23 |
Outcome results
Primary
24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint
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.
Time frame: 6 months
Population: All subjects that completed the assigned training were included in analysis. Each eye was analyzed independently for the primary outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Training in the Blind Field (Left Eye) | 24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint | 0.84 decibels |
| Training in the Intact Field (Left Eye) | 24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint | 0.10 decibels |
| Training in the Blind Field (Right Eye) | 24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint | 0.58 decibels |
| Training in the Intact Field (Right Eye) | 24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint | 0.12 decibels |