Ischemic StrokeNOR-OCCIPNCT02307981
Norwegian Occipital Ischemic Stroke Study
An observational study of Ischemic Stroke and Visual Field Defect, run by Haukeland University Hospital at 2 sites in Norway.
Trial summary
Patients who suffer an ischemic stroke in the occipital lobe often experience Visual Field defects. Visual Field defects are negatively correlated to falling, institutionalisation, rehabilitation outcome and quality of life. Patients are often not properly examined and seldom receive rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Visual Field Defect
- What is being tested?
- Training with vision teacher (visual rehabilitation)
- How many people
- 75 participants
- Where
- 2 sitesNorway
- Study dates
- Aug 2013to Jun 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Hospital based
Who may be able to join
- Written consent obtained,
- age >18,
- acute occipital infarction on brain imaging and ability to cooperate for examination with autoperimetry
Who cannot join
- Pathological processes that severely affect eyesight.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Stavanger University Hospital
Stavanger, Rogaland
St. Olav University Hospital
Trondheim
About this study
Official title: Management and Outcome of Visual Field Defects in Occipital Infarction (NOR-OCCIP)- A Multi-center Prospective Study
Patients who suffer an ischemic stroke in the occipital lobe often experience Visual Field defects. Visual Field defects are negatively correlated to falling, institutionalisation, rehabilitation outcome and quality of life. Patients are often not properly examined and seldom receive rehabilitation. NOR-OCCIP aims to evaluate the Natural history of Visual Field defects after occipital infarction and to determine whether rehabilitation is effective.
Read the detailed description
BACKGROUND: Visual Field defects after cerebral infarction is an increasingly acknowledged problem, which has consequences for patient outcome. The aim of the Norwegian Occipital Ischemic Stroke Study (NOR-OCCIP) is to: 1.) Improve clinical diagnostics and management of visual field defects in occipital stroke. 2.) Identify and estimate the need for visual rehabilitation among patients with VFD by studying the natural course and the rate of spontaneous recovery. 3.) Study the effect of visual rehabilitation both on visual function as well as on quality of life. METHODS: Patients with acute ischemic occipital stroke on MRI are recruited from Bergen, Stavanger and Trondheim. Patients are included for a period of 1.5 years, starting August 15th 2013. Patients are eligible for inclusion if >18 years, written consent is obtained and the patient is able to co-operate to examination with autoperimetry. Within one week patients are examined by ophthalmologist after a standardized protocol including autoperimetry. During week four patients are examined by vision teacher after a standardized protocol and a structured interview on vision specific function and quality of life (VFQ-25) is conducted by a study nurse via telephone. If visual rehabilitation is provided by the municipality in which the patient lives, the patient will be referred to such. Eye examination including autoperimetry, vision teacher assessment and VFQ-25 is repeated after 6 months. All patients will be registered in the national stroke registry, and the following variables will be analysed: Demographic variables, lifestyle factors, clinical status at admission (scores on NIHSS), clinical status at discharge and 3 months post-stroke (scores on modified Rankin Scale). So far 62 patients have been included. Limited research exists on visual impairment after cerebral infarction. It is important to establish the natural course of visual impairment after ischemic stroke, and to evaluate the effect of visual rehabilitation.
- Conditions
- Ischemic Stroke, Visual Field Defect
- Being tested
- Training with vision teacher (visual rehabilitation)
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with vision teacher (visual rehabilitation)Other
Individually adapted training With vision teacher
| Study group | Role | What they receive |
|---|---|---|
| Visual field defect with vision teacher | Patients With occipital ischemic stroke and Visual Field defect that live in a geographical region where training With vision teacher is an available service (vision Teachers are a Limited Resource in Norway) Receives: Other: Training with vision teacher (visual rehabilitation) | |
| Visual field defect without vision teacher | Patients With occipital ischemic stroke and a Visual Field defect, who live in a geographical area where training With vision teacher is not an available service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Field defect
Change in Visual Field defect as measured by autoperimetry
Measured: 6 months
Secondary outcomes (3)
Change in Visual function
Change in Visual function as measured by standardized mapping by vision teacher according to pre-specified protocol
Measured: 6 months
Quality of life and self reported Visual function
Vision specific QoL and function as measured by VFQ-25
Measured: 6 months
NIHSS
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startAug 2013
- Primary completionSep 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Stavanger HF, St. Olavs Hospital, Statped Vest, Stavanger Municipality
- Responsible party
- Principal investigator, Kristin Modalsli Sand, Haukeland University Hospital
- Investigators
- Kristin Modalsli Sand, MD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307981
- Sponsor's protocol ID
- 2012/2307
- Acronym
- NOR-OCCIP
- Status last verified
- Aug 2015
- First submitted
- 28 Nov 2014
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management and Outcome of Visual Field Defects in Occipital Infarction (NOR-OCCIP)- A Multi-center Prospective Study
- ClinicalTrials.gov ID
- NCT02307981
- Acronym / sponsor ID
- NOR-OCCIP / 2012/2307
- Conditions
- Ischemic Stroke, Visual Field Defect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helse Stavanger HF, St. Olavs Hospital, Statped Vest, Stavanger Municipality
- Study start
- Aug 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 4 Dec 2014 (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.
Patients who suffer an ischemic stroke in the occipital lobe often experience Visual Field defects. Visual Field defects are negatively correlated to falling, institutionalisation, rehabilitation outcome and quality of life. Patients are often not properly examined and seldom receive rehabilitation. NOR-OCCIP aims to evaluate the Natural history of Visual Field defects after occipital infarction and to determine whether rehabilitation is effective.
Detailed description
BACKGROUND: Visual Field defects after cerebral infarction is an increasingly acknowledged problem, which has consequences for patient outcome. The aim of the Norwegian Occipital Ischemic Stroke Study (NOR-OCCIP) is to: 1.) Improve clinical diagnostics and management of visual field defects in occipital stroke. 2.) Identify and estimate the need for visual rehabilitation among patients with VFD by studying the natural course and the rate of spontaneous recovery. 3.) Study the effect of visual rehabilitation both on visual function as well as on quality of life. METHODS: Patients with acute ischemic occipital stroke on MRI are recruited from Bergen, Stavanger and Trondheim. Patients are included for a period of 1.5 years, starting August 15th 2013. Patients are eligible for inclusion if >18 years, written consent is obtained and the patient is able to co-operate to examination with autoperimetry. Within one week patients are examined by ophthalmologist after a standardized protocol including autoperimetry. During week four patients are examined by vision teacher after a standardized protocol and a structured interview on vision specific function and quality of life (VFQ-25) is conducted by a study nurse via telephone. If visual rehabilitation is provided by the municipality in which the patient lives, the patient will be referred to such. Eye examination including autoperimetry, vision teacher assessment and VFQ-25 is repeated after 6 months. All patients will be registered in the national stroke registry, and the following variables will be analysed: Demographic variables, lifestyle factors, clinical status at admission (scores on NIHSS), clinical status at discharge and 3 months post-stroke (scores on modified Rankin Scale). So far 62 patients have been included. Limited research exists on visual impairment after cerebral infarction. It is important to establish the natural course of visual impairment after ischemic stroke, and to evaluate the effect of visual rehabilitation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual field defect with vision teacher | – | Other: Training with vision teacher (visual rehabilitation)Patients With occipital ischemic stroke and Visual Field defect that live in a geographical region where training With vision teacher is an available service (vision Teachers are a Limited Resource in Norway) |
| Visual field defect without vision teacher | – | –Patients With occipital ischemic stroke and a Visual Field defect, who live in a geographical area where training With vision teacher is not an available service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital based
Key inclusion criteria (3 listed)
- Written consent obtained,
- age >18,
- acute occipital infarction on brain imaging and ability to cooperate for examination with autoperimetry
Key exclusion criteria (1 listed)
- Pathological processes that severely affect eyesight.
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 with vision teacher (visual rehabilitation)Individually adapted training With vision teacher | Other | Visual field defect with vision teacher |
Primary outcome
Visual Field defect
Time frame: 6 months
Change in Visual Field defect as measured by autoperimetry
3 secondary outcomes
Change in Visual function
Time frame: 6 months
Quality of life and self reported Visual function
Time frame: 6 months
NIHSS
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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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.
Kristin Modalsli Sand, MD principal investigator
Haukeland University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Visual Field Defect, run by Haukeland University Hospital at 2 sites in Norway.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Visual Field defect (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 19 Aug 2015.