Hemianopsia, HomonymousFOMNCT00731796
Testing of a Functional Outcome Measure for Those With Visual Field Defects
An observational study of Hemianopsia, Homonymous, run by NovaVision, Inc. at 3 sites in United States.
Trial summary
This study is designed in two Phases. In phase 1, the Functional Outcome Measure will be tested to determine its validity and reliability in three populations, subjects that have not had a stroke and have no visual field defect, subjects that have had a stroke but do not have a visual field defect, and lastly subjects… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemianopsia, Homonymous
- What is being tested?
- Functional Outcome Measure
- Type of treatment
- Medical device
- How many people
- 190 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2007to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal participants who have not suffered a stroke and do not have a visual field deficit. Individuals who have suffered a stroke and do not have a visual field deficit. Individuals who have suffered a stroke and do have a visual field deficit.
Who may be able to join
- Stroke victim
- Read / Speak English (required to respond to the questionaire)
- Ability to provide consent
- Homonymous visual field defect evident on a suprathreshold visual field test (High Resolution Perimetry)
- 18 years fo age and older
Who cannot join
- Contraindication to visual stimulation: history of photogenic seizures
- Inability to complete Vision Restoration Therapy
- Significant cognitive impairment
- Complete blindness or the inability to focus on a fixation point
- Severe physical or behavioral limitations
- Aphasia
- Onset of Visual field defect less than 3 months prior to enrollment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University School of Medicine Atlanta VA Medical Center Research
Atlanta, Georgia, 30332
NovaVision, Inc.
Boca Raton, Florida, 33431
University of Miami Bascom Palmer
Miami, Florida, 33136
About this study
This study is designed in two Phases. In phase 1, the Functional Outcome Measure will be tested to determine its validity and reliability in three populations, subjects that have not had a stroke and have no visual field defect, subjects that have had a stroke but do not have a visual field defect, and lastly subjects that have had a stroke and have a visual field defect. The second phase will employ an amended version of the functional outcome measure to be administered to two groups of subjects. The first group of subjects will be those subjects diagnosed with a visual field defect from retrochiasmatic insults and they will perform vision restoration therapy. The second group with a similar diagnosis to the first but who do not undergo vision restoration therapy.
Read the detailed description
The study will be conducted over 18 months and will be conducted in two phases:
Phase 1 In the first phase, we will determine the validity and reliability of Functional Outcome Measure by applying the Functional Outcome Measure to 20 subjects with homonymous visual field defects (VFD) due to a stoke, 20 stroke cases without visual field defects and 20 normal individuals. They will be asked to perform the Functional Outcome Measure a second time within the following 1-2 weeks in order to evaluate test-retest reliability. The expectation is that those without VFD (stroke and normal individuals) will have good or excellent results on the Functional Outcome Measure, while those with VFD will have abnormal results, thus reflecting the ability of this instrument to record the impairment present in those with VFD. In addition, it is anticipated that the results will be similar after retesting, ensuring test-retest reliability. An interim analysis will determine if the instrument is valid and if all its components correlate with the magnitude of visual field loss (as measured by High Resolution perimetry). Once the validation of the instrument has been accomplished, the functional outcome measure will be amended as suggested by this analysis to include only the items that correlate well with VFD.
The functional outcome measure will be administered either at the NovaVision, Inc. office (normal individuals) or in cooperating medical centers (stroke patients with or without visual field defect).
Phase 2 In the second phase, the amended version of the Functional Outcome Instrument will be administered to individuals with VFD. Two groups will be studied: 100 cases which will perform Vision Restoration Therapy (VRT), and 50 controls that will not. The latter group will include the 20 patients with VFD studied in Phase 1. Both groups will undergo visual field testing with high resolution perimetry, and will complete the Functional Outcome Measure on 4 occasions: twice within a 2 week interval at baseline, once after three months, and once after 6-7 months, with one of the groups having completed therapy during this time.
Visual field testing (high resolution perimetry) will be administered at cooperating medical centers. While patients undergoing VRT will perform the functional outcome measure once at the center and once on their VRT device at home, controls will perform their functional outcome measure at the medical center only, as they don't have access to a VRT device at home.
- Conditions
- Hemianopsia, Homonymous
- Being tested
- Functional Outcome Measure
- Keywords
- Stroke, Retrochiasmatic, Vision, VFD
- Medical subject headings
- Hemianopsia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Outcome MeasureDevice
Functional Outcome Measure is a computerized test performed by the subject. The subject sits at a computer and answers questions about their visual deficit and its impact. The patient then performs a Vision Preference Scale test intended to rate the overall quality of life. A reading test is performed that measures reading speed, accuracy, and comprehension. Finally a Visuospatial Attention test is given to measure object localization, object recognition,and motion recognition.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Stroke victims with a visual field deficit that undergo vision restoration therapy Receives: Device: Functional Outcome Measure | |
| 2 | Stroke victims with a visual field deficit who do not undergo any rehabilitation intervention Receives: Device: Functional Outcome Measure | |
| 3 | Stroke victims that do not have a visual field deficit Receives: Device: Functional Outcome Measure | |
| 4 | Normal individuals who have not had a stroke and do not have a visual field deficit Receives: Device: Functional Outcome Measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the ability of a Functional Outcome Measure to distinguish visual impairment in those with retrochiasmatic insults and visual field defects compared to those without visual field defects
Measured: 18 Months
Secondary outcomes (2)
Identify the correlation between the degree of functional impairment and the amount of visual field loss
Measured: 18 months
Determine the ability of a Functional Outcome Measure to detect change after a rehabilitation intervention
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemianopsia, HomonymousStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovaVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sigrid Kenkel, Principal investigator, NovaVision, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731796
- Sponsor's protocol ID
- NUSRPFOM01
- Acronym
- FOM
- Status last verified
- Mar 2011
- First submitted
- 7 Aug 2008
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of a Functional Outcome Measure for Those With Visual Field Defects
- ClinicalTrials.gov ID
- NCT00731796
- Acronym / sponsor ID
- FOM / NUSRPFOM01
- Conditions
- Hemianopsia, Homonymous
- Keywords
- Stroke, Retrochiasmatic, Vision, VFD
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Lack of funding
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- NovaVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed in two Phases. In phase 1, the Functional Outcome Measure will be tested to determine its validity and reliability in three populations, subjects that have not had a stroke and have no visual field defect, subjects that have had a stroke but do not have a visual field defect, and lastly subjects that have had a stroke and have a visual field defect. The second phase will employ an amended version of the functional outcome measure to be administered to two groups of subjects. The first group of subjects will be those subjects diagnosed with a visual field defect from retrochiasmatic insults and they will perform vision restoration therapy. The second group with a similar diagnosis to the first but who do not undergo vision restoration therapy.
Detailed description
The study will be conducted over 18 months and will be conducted in two phases:
Phase 1 In the first phase, we will determine the validity and reliability of Functional Outcome Measure by applying the Functional Outcome Measure to 20 subjects with homonymous visual field defects (VFD) due to a stoke, 20 stroke cases without visual field defects and 20 normal individuals. They will be asked to perform the Functional Outcome Measure a second time within the following 1-2 weeks in order to evaluate test-retest reliability. The expectation is that those without VFD (stroke and normal individuals) will have good or excellent results on the Functional Outcome Measure, while those with VFD will have abnormal results, thus reflecting the ability of this instrument to record the impairment present in those with VFD. In addition, it is anticipated that the results will be similar after retesting, ensuring test-retest reliability. An interim analysis will determine if the instrument is valid and if all its components correlate with the magnitude of visual field loss (as measured by High Resolution perimetry). Once the validation of the instrument has been accomplished, the functional outcome measure will be amended as suggested by this analysis to include only the items that correlate well with VFD.
The functional outcome measure will be administered either at the NovaVision, Inc. office (normal individuals) or in cooperating medical centers (stroke patients with or without visual field defect).
Phase 2 In the second phase, the amended version of the Functional Outcome Instrument will be administered to individuals with VFD. Two groups will be studied: 100 cases which will perform Vision Restoration Therapy (VRT), and 50 controls that will not. The latter group will include the 20 patients with VFD studied in Phase 1. Both groups will undergo visual field testing with high resolution perimetry, and will complete the Functional Outcome Measure on 4 occasions: twice within a 2 week interval at baseline, once after three months, and once after 6-7 months, with one of the groups having completed therapy during this time.
Visual field testing (high resolution perimetry) will be administered at cooperating medical centers. While patients undergoing VRT will perform the functional outcome measure once at the center and once on their VRT device at home, controls will perform their functional outcome measure at the medical center only, as they don't have access to a VRT device at home.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Functional Outcome MeasureStroke victims with a visual field deficit that undergo vision restoration therapy |
| 2 | – | Device: Functional Outcome MeasureStroke victims with a visual field deficit who do not undergo any rehabilitation intervention |
| 3 | – | Device: Functional Outcome MeasureStroke victims that do not have a visual field deficit |
| 4 | – | Device: Functional Outcome MeasureNormal individuals who have not had a stroke and do not have a visual field deficit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal participants who have not suffered a stroke and do not have a visual field deficit. Individuals who have suffered a stroke and do not have a visual field deficit. Individuals who have suffered a stroke and do have a visual field deficit.
Key inclusion criteria (5 listed)
- Stroke victim
- Read / Speak English (required to respond to the questionaire)
- Ability to provide consent
- Homonymous visual field defect evident on a suprathreshold visual field test (High Resolution Perimetry)
- 18 years fo age and older
Key exclusion criteria (7 listed)
- Contraindication to visual stimulation: history of photogenic seizures
- Inability to complete Vision Restoration Therapy
- Significant cognitive impairment
- Complete blindness or the inability to focus on a fixation point
- Severe physical or behavioral limitations
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 |
|---|---|---|
| Functional Outcome MeasureFunctional Outcome Measure is a computerized test performed by the subject. The subject sits at a computer and answers questions about their visual deficit and its impact. The patient then performs a Vision Preference Scale test intended to rate the overall quality of life. A reading test is performed that measures reading speed, accuracy, and comprehension. Finally a Visuospatial Attention test is given to measure object localization, object recognition,and motion recognition. | Device | 1, 2, 3, 4 |
Primary outcome
Determine the ability of a Functional Outcome Measure to distinguish visual impairment in those with retrochiasmatic insults and visual field defects compared to those without visual field defects
Time frame: 18 Months
2 secondary outcomes
Identify the correlation between the degree of functional impairment and the amount of visual field loss
Time frame: 18 months
Determine the ability of a Functional Outcome Measure to detect change after a rehabilitation intervention
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
- NovaVision Corporate Web SiteLink provided by the sponsor.
- Emory University School of MedicineLink provided by the sponsor.
- University of Miami Bascom Palmer Eye InstituteLink provided by the sponsor.
Related trials for Hemianopsia, Homonymous
Not yet recruiting
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Active, not recruiting
Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
Not yet recruitingObservational study
Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
Homonymous Hemianopia, Stroke
Not yet recruiting
Effects of Optokinetic Stimulation Without a Reading Task in Patients With Hemianopic Alexia
Hemianopia Homonymous, Stroke
Recruiting
Home-based Vision Rehabilitation Guided by Brain Imaging
Visual Field Defect, Stroke
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.
Sigrid Kenkel principal investigator
NovaVision, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemianopsia, Homonymous, run by NovaVision, Inc. 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 5 inclusion and 7 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: paused, as of the sponsor's last update on 8 Mar 2011. 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?
Results are not available in the source record.
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?
Determine the ability of a Functional Outcome Measure to distinguish visual impairment in those with retrochiasmatic insults and visual field defects compared to those without visual field defects (time frame: 18 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 8 Mar 2011.