Stroke Induced Vision LossNCT03350919
Visual Restoration for Hemianopia
A study testing Training in the blind field and Training in the intact field in people with Stroke Induced Vision Loss and Hemianopia, run by University of Rochester at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Stroke Induced Vision Loss, Hemianopia, Quadrantanopia
- What is being tested?
- Training in the blind field and Training in the intact field
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Mar 2018to 3 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bascom Palmer Eye Institute, University of Miami Health Services
Miami, Florida, 33136
Scheie Eye Institute
Philadelphia, Pennsylvania, 19104
Flaum Eye Institute, University of Rochester Medical Center
Rochester, New York, 14642
About this study
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.
- Conditions
- Stroke Induced Vision Loss, Hemianopia, Quadrantanopia
- Being tested
- Training in the blind field, Training in the intact field
- Medical subject headings
- Hemianopsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in the blind fieldDevice
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.
Training in the intact fieldDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Training in the blind field | Experimental | Training in the blind field using software Receives: Device: Training in the blind field |
| Training in the intact field | Experimental | Training in the intact field using software Receives: Device: Training in the intact field |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start15 Mar 2018
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stroke Induced Vision LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Envision Solutions, LLC
- Responsible party
- Principal investigator, Steven Feldon, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350919
- Sponsor's protocol ID
- 69879
- Status last verified
- Dec 2020
- First submitted
- 18 Nov 2017
- Last updated
- 24 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Restoration for Hemianopia
- ClinicalTrials.gov ID
- NCT03350919
- Acronym / sponsor ID
- 69879
- Conditions
- Stroke Induced Vision Loss, Hemianopia, Quadrantanopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Envision Solutions, LLC
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Posted 24 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training in the blind field | Experimental | Device: Training in the blind fieldTraining in the blind field using software |
| Training in the intact field | Experimental | Device: Training in the intact fieldTraining in the intact field using software |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training in the blind fieldA 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. | Device | Training in the blind field |
| Training in the intact fieldA 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. | Device | Training in the intact field |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in the blind field and Training in the intact field in people with Stroke Induced Vision Loss and Hemianopia, run by University of Rochester at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.